Sample records for diagnostics laboratory cmdl
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Novelli, P. C.; Masarie, K. A.
1994-01-01
Individual site files provide CO mixing ratios in parts per billion (ppb) (ppb = parts in 109 by mole fraction) based on measurements from the NOAA/CMDL Cooperative Air Sampling Network beginning 1988. Data are provided through June 1993 for stations at which the first sample was collected before July 1991. All samples were analyzed for CO at the NOAA/CMDL laboratory in Boulder by gas chromatography with mercuric oxide reduction detection, and all measurements are referenced to the CMDL CO scale (Novelli et al., 1991, Novelli et al., 1994).
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NASA Technical Reports Server (NTRS)
Novelli, P. C.; Collins, J. E., Jr.; Myers, R. C.; Sachse, G. W.; Scheel, H. E.
1994-01-01
The carbon monoxide (CO) reference scale created by the National Oceanic and Atmospheric Administration/Climate Monitoring and Diagnostics Laboratory (NOAA/CMDL) is used to quantify measurements of CO in the atmosphere, calibrate standards of other laboratories and to otherwise provide reference gases to the community measuring atmospheric CO. This reference scale was created based upon a set of primary standards prepared by gravimetric methods at CMDL and has been propagated to a set of working standards. In this paper we compare CO mixing ratios assigned to the working standards by three approaches: (1) calibration against the original gravimetric standards, (2) calibration using only working standards as the reference gas, and (3) calibration against three new gravimetric standards prepared to CMDL. The agreement between these values was typically better than 1%. The calibration histories of CMDL working standards are reviewed with respect to expected rates of CO change in the atmosphere. Using a Monte Carlo approach to simulate the effect of drifting standards on calculated mixing ratios, we conclude that the error solely associated with the maintenance of standards will limit the ability to detect small CO changes in the atmosphere. We also report results of intercalibration experiments conducted between CMDL and the Diode Laser Sensor Group (DACOM) at the NASA Langley Research Center (Hampton, Virginia), and CMDL and the Fraunhofer-Institut (Garmisch-Partenkirchen, Germany). Each laboratory calibrated several working standards for CO using their reference gases, and these results were compared to calibrations conducted by CMDL. The intercomparison of eight standards (CO concentrations between approximately 100 and approximately 165 ppb) by CMDL and NASA agreed to better than +/- 2%. The calibration of six standards (CO concentrations between approximately 50 and approximately 210 ppb) by CMDL and the Fraunhofer-Institut agreed to within +/- 2% for four standards, and to within +/- 5% for all six standards.
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Conway, Thomas [NOAA Climate Monitoring and Diagnostics Laboratory, Boulder, CO (USA); Tans, Pieter [NOAA Climate Monitoring and Diagnostics Laboratory, Boulder, CO (USA)
2009-01-01
The National Oceanic and Atmospheric Administration's Climate Monitoring and Diagnostics Laboratory (NOAA/CMDL) has measured CO2 in air samples collected weekly at a global network of sites since the late 1960s. Atmospheric CO2 mixing ratios reported in these files were measured by a nondispersive infrared absorption technique in air samples collected in glass flasks. All CMDL flask samples are measured relative to standards traceable to the World Meteorological Organization (WMO) CO2 mole fraction scale. These measurements constitute the most geographically extensive, carefully calibrated, internally consistent atmospheric CO2 data set available and are essential for studies aimed at better understanding the global carbon cycle budget.
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Dlugokencky, E. J. [National Oceanic and Atmospheric Administration, Boulder, Colorado (USA); Lang, P. M. [National Oceanic and Atmospheric Administration, Boulder, Colorado (USA); Masarie, K. A. [National Oceanic and Atmospheric Administration, Boulder, Colorado (USA); Steele, L. P. [Commonwealth Scientific and Industrial Research Organisation, Aspendale, Victoria, Australia
1994-01-01
This data base presents atmospheric methane (CH4) mixing ratios from flask air samples collected over the period 1983-1993 by the National Oceanic and Atmospheric Administration, Climate Monitoring and Diagnostics Laboratory's (NOAA/CMDL's) global cooperative air sampling network. Air samples were collected approximately once per week at 44 fixed sites (37 of which were still active at the end of 1993). Samples were also collected at 5 degree latitude intervals along shipboard cruise tracks in the Pacific Ocean between North America and New Zealand (or Australia) and at 3 degree latitude intervals along cruise tracks in the South China Sea between Singapore and Hong Kong. The shipboard measurements were made approximately every 3 weeks per latitude zone by each of two ships in the Pacific Ocean and approximately once every week per latitude zone in the South China Sea. All samples were analyzed for CH4 at the NOAA/CMDL laboratory in Boulder, Colorado, by gas chromatography with flame ionization detection, and each aliquot was referenced to the NOAA/CMDL methane standard scale. In addition to providing the complete set of atmospheric CH4 measurements from flask air samples collected at the NOAA/CMDL network sites, this data base also includes files which list monthly mean mixing ratios derived from the individual flask air measurements. These monthly summary data are available for 35 of the fixed sites and 21 of the shipboard sampling sites.
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NASA Astrophysics Data System (ADS)
Hurst, D. F.; Elkins, J. W.; Montzka, S. A.; Butler, J. H.; Dutton, G. S.; Hall, B. D.; Mondeel, D. J.; Moore, F. L.; Nance, J. D.; Romashkin, P. A.; Thompson, T. M.
2005-12-01
Back in 1978, NOAA/CMDL initiated the weekly filling of flasks at CMDL observatories in Alaska, Hawaii, American Samoa, and Antarctica for analyses of CFC-11, CFC-12 and N2O in the home laboratory. A decade later, each observatory was outfitted with an automated gas chromatograph to make routine, in situ measurements of these three source gases plus methyl chloroform and carbon tetrachloride. Both measurement programs are ongoing, having expanded over the years to include methyl halides and substitutes for regulated halocarbons, to presently account for 95% of the total burden of long-lived Cl and Br believed to enter the stratosphere. These long-term monitoring data have been assimilated into temporal records of the global tropospheric burdens of ozone-depleting chlorine and bromine which are critical input to models that predict future trends in stratospheric ozone. Other information pivotal to ozone projections, such as the atmospheric lifetimes of source gases, stratospheric entry values for total chlorine and total bromine, and identification of the stratospheric sink regions for long-lived source gases, has been gained from in situ measurements by NOAA/CMDL instruments aboard NASA high-altitude aircraft (ER-2 and WB-57) and balloons since 1991. Though CMDL's routine monitoring activities provide important historical records of halogenated source gases in the atmosphere, significant inaccuracies in ozone projections may propagate from the uncertain estimates of impending emissions of ozone-depleting gases. Scenarios of future halocarbon emissions require substantial assumptions about past and pending compliance with the Montreal Protocol, and the sizes and release rates of existing global reservoirs (banks) of halocarbons. Recent work by CMDL has focused on quantifying halocarbon bank emission rates in Russia, the USA, and Canada through geographically extensive measurements aboard trains and low-altitude aircraft. The USA and Canada results indicate that globally significant emissions continued to emanate from these two countries in 2003, more than 7 years after the Montreal Protocol-mandated production phase-out. Large-scale, measurement-based emission estimates such as these provide important checks of our understanding of contemporary halocarbon emissions and will undoubtedly help to improve the accuracy of projected future halocarbon abundances and ozone recovery rates.
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NASA Astrophysics Data System (ADS)
Moore, F.; Dutton, G.; Elkins, J.; Hall, B.; Hurst, D.; Nance, D.; Ray, E.; Romashkin, P.; Thompson, T.; Volk, C. M.
2005-12-01
Accurate models of atmospheric transport are crucial to our current understanding of ozone production/loss and its coupling with climate change. Over the last ``20 years'', improvements in the ability to predict ``The Antarctic Ozone Hole and Polar Ozone Loss'' have tracked improvements in transport models. Data taken from the NOAA/CMDL airborne in-situ GC's (ACATS, LACE, PANTHER, and UCATS) have and will continue to play key roles in quantifying many aspects of stratospheric transport. Our data have been used in many of the model assessments to date. We will display an overview of the transport issues studied over the years using our data. They include descent with mixing within and into the polar vortex, entrainment of mid-latitude air across the vortex edge, upwelling and entrainment in the tropical pipe, isentropic transport across the tropopause into the lowermost stratosphere, mean ages of air parcels in the stratosphere, and stratospheric path distributions. ACATS - Airborne Chromatograph for Atmospheric Trace Species LACE - Lightweight Airborne Chromatograph Experiment PANTHER - PAN and Other Trace Hydrohalocarbons ExpeRiment UCATS - Unmanned aerial systems Chromatograph for Atmospheric Trace Species
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NASA Technical Reports Server (NTRS)
Courchaine, Brian; Venable, Jessica C.
1995-01-01
Methane is an important trace gas because it is a greenhouse gas that affects the oxidative capacity of the atmosphere. It is produced from biological and anthropogenic sources, and is increasing globally at a rate of approximately 0.6% per year [Climate Change 1992, IPCC]. By using National Oceanic and Atmospheric Administration/Climate Monitoring and Diagnostics Laboratory (NOAA/CMDL) ground station data, a global climatology of methane values was produced. Unfortunately, because the NOAA/CMDL ground stations are so sparse, the global climatology is low resolution. In order to compensate for this low resolution data, it was compared to in-situ flight data obtained from the NASA Global Tropospheric Experiment (GTE). The smoothed ground station data correlated well with the flight data. Thus, for the first time it is shown that the smoothing process used to make global contours of methane using the ground stations is a plausible way to approximate global atmospheric concentrations of the gas. These verified climatologies can be used for testing large-scale models of chemical production, destruction, and transport. This project develops the groundwork for further research in building global climatologies from sparse ground station data and studying the transport and distribution of trace gases.
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NASA Technical Reports Server (NTRS)
Thompson, Anne M.; Witte, Jacquelyn C.; Oltmans, Samuel J.; Schmidlin, Francis J.
2003-01-01
A lack of sounding data has limited the accuracy of ozone satellite retrievals in the tropics and our understanding of chemical-dynamical interactions in a region strongly influenced by natural variability and anthropogenic activity. In 1998, NASA s Goddard Space Flight Center, NOAA's Climate Monitoring and Diagnostics Laboratory (CMDL) and a team of international sponsors established the SHADOZ (Southern Hemisphere ADditional OZonesondes) project to address the gap in tropical ozone soundings. SHADOZ augments launches at selected sites and provides a public archive of ozonesonde and radiosonde data from twelve tropical and subtropical stations at http://croc.gsfc.nasa.gov/shadoz. Instrumentation, data and a summary of the first scientific findings from SHADOZ are presented.
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NASA Technical Reports Server (NTRS)
Hogan, Kathleen B.; Harriss, Robert C.
1994-01-01
The carefully measured decrease in the growth rate of atmospheric methane (CH4) in 1992 reported by Dlugokencky et al. (1994) is an impressive accomplishment, and testimony for the importance of maintaining high-quality, long-term monitoring of atmospheric composition. The changing growth rate of atmospheric CH4 has important implications for assessing and understanding the potential magnitude and rates of a future greenhouse gas-induced climate change. Furthermore, the CH4 data from the current Climate Monitoring and Diagnostics Laboratory (CMDL) globally-distributed network of cooperative air sampling sites are clearly the best record of global CH4 trends and distribution currently available. However, we argue briefly here that the speculation by Dlugokencky et al. (1994) on possible mechanisms for the decreased growth rate in 1992 is only one scenario of many that could possibly fit with the constraints imposed by the reported data. Our comments are to (1) illustrate the difficulties of deducing small changes in complex, poorly understood, geographically diverse natural and anthropogenic sources of CH4 from measurements at the remotely-located CMDL sampling sites and (2) emphasize that detailed bottoms-up analyses are necessary to really advance the understanding of changes in source strengths; we are not promoting alternative mechanisms to explain the 1992 decrease in atmospheric CH4.
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Global carbon monoxide cycle: Modeling and data analysis
NASA Astrophysics Data System (ADS)
Arellano, Avelino F., Jr.
The overarching goal of this dissertation is to develop robust, spatially and temporally resolved CO sources, using global chemical transport modeling, CO measurements from Climate Monitoring and Diagnostic Laboratory (CMDL) and Measurement of Pollution In The Troposphere (MOPITT), under the framework of Bayesian synthesis inversion. To rigorously quantify the CO sources, I conducted five sets of inverse analyses, with each set investigating specific methodological and scientific issues. The first two inverse analyses separately explored two different CO observations to estimate CO sources by region and sector. Under a range of scenarios relating to inverse methodology and data quality issues, top-down estimates using CMDL CO surface and MOPITT CO remote-sensed measurements show consistent results particularly on a significantly large fossil fuel/biofuel (FFBF) emission in East Asia than present bottom-up estimates. The robustness of this estimate is strongly supported by forward and inverse modeling studies in the region particularly from TRansport and Chemical Evolution over the Pacific (TRACE-P) campaign. The use of high-resolution measurement for the first time in CO inversion also draws attention to a methodology issue that the range of estimates from the scenarios is larger than posterior uncertainties, suggesting that estimate uncertainties may be underestimated. My analyses highlight the utility of top-down approach to provide additional constraints on present global estimates by also pointing to other discrepancies including apparent underestimation of FFBF from Africa/Latin America and biomass burning (BIOM) sources in Africa, southeast Asia and north-Latin America, indicating inconsistencies on our current understanding of fuel use and land-use patterns in these regions. Inverse analysis using MOPITT is extended to determine the extent of MOPITT information and estimate monthly regional CO sources. A major finding, which is consistent with other atmospheric observations but differ with satellite area-burned observations, is a significant overestimation in southern Africa for June/July relative to satellite-and-model-constrained BIOM emissions of CO. Sensitivity inverse analyses on observation error covariance and structure, and sequential inversion using NOAA CMDL to fully exploit available information, confirm the robustness of the estimates and further recognize the limitations of the approach, implying the need to further improve the methodology and to reconcile discrepancies.
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NASA Astrophysics Data System (ADS)
Deshler, Terry; Butler, James H.; Solomon, Susan; Barnes, John E.; Schnell, Russell C.
2009-12-01
David J. Hofmann, a pioneer in stratospheric aerosol and ozone research, passed away in Boulder, Colo., on 11 August 2009. He was 72. Dave, a frequent contributor to AGU publications and meetings, was elected an AGU Fellow in 2006. His long and prolific scientific career was, as he would say, simple in concept: Make a long-term commitment to specific measurements, pay attention to the details, and focus on the important issues that the measurements raise. This is simple in concept yet challenging to maintain in a world of short-term contracts and budgets. That Dave sustained and led key measurement programs through 25 years at the University of Wyoming (UW), in Laramie, and 17 years with the U.S. National Oceanic and Atmospheric Administration's (NOAA) Climate Monitoring and Diagnostics Laboratory (CMDL, which became the Global Monitoring Division (GMD) of NOAA's Earth System Research Laboratory) in Boulder, speaks volumes about the scientific and societal benefits that have resulted from his work. Most of the measurement programs he initiated, and the instruments he helped develop for them, continue today as testament to the value of his focus and lasting influence.
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NASA Technical Reports Server (NTRS)
Atlas, E.; Ridley, B.; Walega, J.; Greenberg, J.; Kok, G.; Staffelbach, T.; Schauffler, S.; Lind, J.; Huebler, G.; Norton, R.
1996-01-01
During October 19-20, 1991, one flight of the NASA Global Tropospheric Experiment (GTE) Pacific Exploratory Mission (PEM-West A) mission was conducted near Hawaii as an intercomparison with ground-based measurements of the Mauna Loa Observatory Photochemistry Experiment (MLOPEX 2) and the NOAA Climate Modeling and Diagnostics Laboratory (CMDL). Ozone, reactive nitrogen species, peroxides, hydrocarbons, and halogenated hydrocarbons were measured by investigators aboard the DC-8 aircraft and at the ground site. Lidar cross sections of ozone revealed a complex air mass structure near the island of Hawaii which was evidenced by large variation in some trace gas mixing ratios. This variation limited the time and spatial scales for direct measurement intercomparisons. Where differences occurred between measurements in the same air masses, the intercomparison suggested that biases for some trace gases was due to different calibration scales or, in some cases, instrumental or sampling biases. Relatively large uncertainties were associated with those trace gases present in the low parts per trillion by volume range. Trace gas correlations were used to expand the scope of the intercomparison to identify consistent trends between the different data sets.
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NASA Astrophysics Data System (ADS)
Kalhori, A. A. M.; Oechel, W. C.; Goodrich, J. P.; Gioli, B.; Burba, G. G.; Shen, S. S. P.; Murphy, P.; Zona, D.
2016-12-01
To refine understanding of the total annual carbon balance in the Arctic, it is critical to extend long-term site-level CO2 flux data collection. These data are critical to addressing the environmental controls and processes responsible for temporal variability and seasonal patterns of net ecosystem exchange of CO2 (NEE). This dataset represents the longest running eddy covariance tower in the Arctic, which is located in an Alaskan wet sedge tundra ecosystem and is adjacent to the NOAA Climate Monitoring & Diagnostic Laboratory (CMDL). In addition to analyzing the year-to-year controls on NEE and its long-term trends, this work will complement a parallel study of the 40 year record of CO2 concentration measurements from the NOAA Barrow synoptic sampling station. For long-term, retrospective measurements, missing values are unavoidable, resulting from system failure, sensors icing-up during winter, losing network connections due to the harsh conditions, necessary instrument repairs, etc. Therefore, to analyze the annual sums, diurnal patterns, and seasonal vs. annual fluxes, the choice of gap-filling approach is critical and can dominate the magnitude of uncertainties, especially for periods with long gaps (> 1 month). We have applied different gap-filling methods such as artificial neural networks (ANN), and multiple linear regression (MLR) driven by micrometeorological parameters in an effort to minimize the associated uncertainties. Following gap-filling, a stepwise multiple regression against meteorological drivers including average summer PAR, average air and soil temperature, growing season length, duration of the zero curtain, growing degree days (GDD), date of snow melt, date of freeze up, and length of the summer was applied to determine the parameters that best explain the magnitude and sign of NEE in different seasons. These statistical analyses show that growing degree days were strongly correlated with summer NEE, which increased with higher GDD (greater carbon sink). Inter-annual NEE was particularly sensitive to dry conditions in this wet sedge tundra. However, we found that growing season NEE has significantly increased since early 2000, due primarily to increases in CO2 uptake during the initial spring thaw period and the June-August growing season.
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NASA Technical Reports Server (NTRS)
2002-01-01
Astronauts obtained this detailed image of the summit caldera of Mauna Loa volcano, called Mokuaweoweo Caldera. Mauna Loa is the largest volcano on our planet-the summit elevation is 4,170 m (over 13,600 ft), but the volcano's summit rises 9 km above the sea floor. The sharp features of the summit caldera and lava flows that drain outward from the summit are tribute to the fact that Mauna Loa is one of the Earth's most active volcanoes. The most recent eruption was in 1984. The straight line the cuts through the center of the crater from top to bottom is a rift zone-an area that pulls apart as magma reaches the surface. A weather observatory run by NOAA's Climate Monitoring and Diagnostics Lab is on the volcano's north slope at 11,000 ft (3397 m). This facility, known as the Mauna Loa Observatory, is the site where scientists have documented the constantly increasing concentrations of global atmospheric carbon dioxide. Other resources about Mauna Loa: http://wwwhvo.wr.usgs.gov/maunaloa/ http://www.cmdl.noaa.gov/obop/mlo/ http://www.volcano.si.edu/gvp/usgs/vol_archive/maunaloa.htm Astronaut photograph ISS005-E-7002 was provided by the Earth Sciences and Image Analysis Laboratory at Johnson Space Center. Additional images taken by astronauts and cosmonauts can be viewed at the NASA-JSC Gateway to Astronaut Photography of Earth.
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NASA Technical Reports Server (NTRS)
Pagano, Thomas S.; Olsen, Edward T.; Nguyen, Hai
2012-01-01
The Atmospheric Infrared Sounder (AIRS) is a hyperspectral infrared instrument on the Earth Observing System (EOS) Aqua Spacecraft, launched on May 4, 2002 into a near polar sun-synchronous orbit. AIRS has 2378 infrared channels ranging from 3.7 ?m to 15.4 ?m and a 13.5 km footprint at nadir. AIRS, in conjunction with the Advanced Microwave Sounding Unit (AMSU), produces temperature profiles with 1K/km accuracy on a global scale, as well as water vapor profiles and trace gas amounts for CO2, CO, SO2, O3 and CH4. AIRS CO2 climatologies have been shown to be useful for identifying anomalies associated with geophysical events such as El Nino-Southern Oscillation or Madden-Julian oscillation. In this study, monthly representations of mid-tropospheric CO2 are constructed from 10 years of AIRS Version 5 monthly Level 3 data. We compare the AIRS mid-tropospheric CO2 representations to ground-based measurements from the Scripps and National Oceanic and Atmospheric Administration Climate Modeling and Diagnostics Laboratory (NOAA CMDL) ground networks to better understand the phase lag of the CO2 seasonal cycle between the surface and middle troposphere. Results show only a small phase lag in the tropics that grows to approximately two months in the northern latitudes.
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Etchemendy, Pablo E; Spiousas, Ignacio; Calcagno, Esteban R; Abregú, Ezequiel; Eguia, Manuel C; Vergara, Ramiro O
2018-06-01
In this study we evaluated whether a method of direct location is an appropriate response method for measuring auditory distance perception of far-field sound sources. We designed an experimental set-up that allows participants to indicate the distance at which they perceive the sound source by moving a visual marker. We termed this method Cross-Modal Direct Location (CMDL) since the response procedure involves the visual modality while the stimulus is presented through the auditory modality. Three experiments were conducted with sound sources located from 1 to 6 m. The first one compared the perceived distances obtained using either the CMDL device or verbal report (VR), which is the response method more frequently used for reporting auditory distance in the far field, and found differences on response compression and bias. In Experiment 2, participants reported visual distance estimates to the visual marker that were found highly accurate. Then, we asked the same group of participants to report VR estimates of auditory distance and found that the spatial visual information, obtained from the previous task, did not influence their reports. Finally, Experiment 3 compared the same responses that Experiment 1 but interleaving the methods, showing a weak, but complex, mutual influence. However, the estimates obtained with each method remained statistically different. Our results show that the auditory distance psychophysical functions obtained with the CMDL method are less susceptible to previously reported underestimation for distances over 2 m.
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NASA Technical Reports Server (NTRS)
Russell, P. B.; Livingston, J. M.; Dutton, E. G.; Pueschel, R. F.; Reagan, J. A.; Defoor, T. E.; Box, M. A.; Allen, D.; Pilewskie, P.; Herman, B. M.
1993-01-01
The Ames airborne tracking sunphotometer was operated at the National Oceanic and Atmospheric Administration (NOAA) Mauna Loa Observatory (MLO) in 1991 and 1992 along with the NOAA Climate Monitoring and Diagnostics Laboratory (CMDL) automated tracking sunphotometer and lidar. June 1991 measurements provided calibrations, optical-depth spectra, and intercomparisons under relatively clean conditions; later measurements provided spectra and comparisons for the Pinatubo cloud plus calibration checks. June 1991 results are similar to previous MLO springtime measurements, with midvisible particle optical depth at the near-background level of 0.012 +/- 0.006 and no significant wavelength dependence in the measured range (lambda = 0.38 to 1.06 micrometers). The arrival of the Pinatubo cloud in July 1991 increased midvisible particle optical depth by more than an order of magnitude and changed the spectral shape of to an approximate power law with an exponent of about -1.4. By clearly September 1991, the spectrum was broadly peaked near 0.5 micrometers, and by July 1992, it was peaked near 0.8 micrometers. Our optical-depth spectra include corrections for diffuse light. NOAA- and Ames Research Center (ARC)-measured spectra are in good agreement. Columnar size distributions inverted from the spectra show that the initial (July 1991) post-Pinatubo cloud was relatively rich in small particles (r less than 0.25 micrometers), which were progressively depleted in the August-September 1991 and July 1992 periods. Conversely, both of the later periods had more of the optically efficient medium-sized particles (0.25 less than r less than 1 micrometers) than did the fresh July 1991 cloud. These changes are consistent with particle growth by condensation and coagulation. Photometer-inferred column backscatter values agree with those measured by the CMDL lidar on nearby nights. Combining lidar-measured backscatter profiles with photometer-derived backscatter-to-area ratios gives peak particle areas that could cause rapid heterogeneous loss of ozone, given sufficiently low particle acidity and suitable solar zenith angles (achieved at mid- to high latitudes). Top-of-troposphere radiative forcings for the September 1991 and July 1992 optical depths and size distributions over MLO are about -5 and -3 W/sq m, respectively (hence comparable in magnitude but opposite in sign to the radiative forcing caused by the increase in manmade greenhouse gases since the industrial revolution). Heating rates in the Pinatubo layer over MLO are 0.55 +/- 0.13 and 0.41 +/- 0.14 K/d for September 1991 and July 1992, respectively.
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NASA Technical Reports Server (NTRS)
Voemel, Holger
2004-01-01
The main goal of our work was to provide in situ water vapor and ozone profiles in the upper troposphere and lower stratosphere as reference measurements for the validation of SAGE III water vapor and ozone retrievals. We used the NOAA/CMDL frost point hygrometer and ECC ozone sondes on small research balloons to provide continuous profiles between the surface and the mid stratosphere. The NOAA/CMDL frost point hygrometer is currently the only lightweight balloon borne instrument capable of measuring water vapor between the lower troposphere and middle stratosphere. The validation measurements were based in the arctic region of Scandinavia for northern hemisphere observations and in New Zealand for southern hemisphere observations and timed to coincide with overpasses of the SAGE III instrument. In addition to SAGE III validation we also tried to coordinate launches with other instruments and studied dehydration and transport processes in the Arctic stratospheric vortex.
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NASA Technical Reports Server (NTRS)
Heath, D. F.; Ahmad, Z.; Torres, O.; Evans, R. D.; Grass, R. D.; Komhyr, W. A.; Nelson, W.
1994-01-01
Total ozone data obtained during summers at Mauna Loa Observatory, Hawaii, with Dobson Spectrophotometer 83 are routinely compared with overpass total ozone data from the Total Ozone Mapping Spectrometer (TOMS) and the Solar Backscatter Ultraviolet (SBUV) spectrometer launched aboard the Nimbus 7 satellite in 1978. Results from the TOMS/Dobson instrument comparisons through 1990 have been presented by McPeters and Komhyr (1991). Dobson spectrophotometer 83 was established as the standard instrument for the U.S.A. Dobson instrument station network in 1962. In 1980, the instrument was designated by the World Meteorological Organization (WMO) as the Standard Dobson Spectrophotometer for the World. Long-term ozone measurement precision of the instrument has been maintained at plus or minus 0.5 percent (Komhyr et al., 1989). On an absolute scale, the ozone measurement accuracy of the instrument is estimated to plus or minus 3 percent. In early April, 1990, comparison of total ozone and vertical distribution (Umkehr) observations were made for the first time with Dobson spectrophotometer 8.3. The work was conducted at the NOAA Climate Monitoring and Diagnostics Laboratory (CMDL) in Boulder, Colorado, and at the research and instrument manufacturing facility of the Ball Aerospace System Division located about 2 km east of Boulder. (The SBUV-2 S/N-2 instrument, built by Ball Aerospace Systems Division, is scheduled for launch aboard the NOAA-13 satellite). We present results of the comparisons which include ozone vertical distribution data obtained with a balloon-borne electrochemical concentration cell (ECC) ozonesonde (Komhyr, 1969).
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NASA Technical Reports Server (NTRS)
Thompson, Anne
2003-01-01
We have been producing near-real tropical tropospheric ozone ('TTO') data from TOMS since 1997 with Prof. Hudson and students at the University of Maryland. Maps for 1996-2000 for the operational Earth-Probe instrument reside at:
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Inverse Modeling of Tropospheric Methane Constrained by 13C Isotope in Methane
NASA Astrophysics Data System (ADS)
Mikaloff Fletcher, S. E.; Tans, P. P.; Bruhwiler, L. M.
2001-12-01
Understanding the budget of methane is crucial to predicting climate change and managing earth's carbon reservoirs. Methane is responsible for approximately 15% of the anthropogenic greenhouse forcing and has a large impact on the oxidative capacity of Earth's atmosphere due to its reaction with hydroxyl radical. At present, many of the sources and sinks of methane are poorly understood, due in part to the large spatial and temporal variability of the methane flux. Model calculations of methane mixing ratios using most process-based source estimates typically over-predict the inter-hemispheric gradient of atmospheric methane. Inverse models, which estimate trace gas budgets by using observations of atmospheric mixing ratios and transport models to estimate sources and sinks, have been used to incorporate features of the atmospheric observations into methane budgets. While inverse models of methane generally tend to find a decrease in northern hemisphere sources and an increase in southern hemisphere sources relative to process-based estimates,no inverse study has definitively associated the inter-hemispheric gradient difference with a specific source process or group of processes. In this presentation, observations of isotopic ratios of 13C in methane and isotopic signatures of methane source processes are used in conjunction with an inverse model of methane to further constrain the source estimates of methane. In order to investigate the advantages of incorporating 13C, the TM3 three-dimensional transport model was used. The methane and carbon dioxide measurements used are from a cooperative international effort, the Cooperative Air Sampling Network, lead by the Climate Monitoring Diagnostics Laboratory (CMDL) at the National Oceanic and Atmospheric Administration (NOAA). Experiments using model calculations based on process-based source estimates show that the inter-hemispheric gradient of δ 13CH4 is not reproduced by these source estimates, showing that the addition of observations of δ 13CH4 should provide unique insight into the methane problem.
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NASA Technical Reports Server (NTRS)
Russell, P. B.; Livingston, J. M.; Dutton, E. G.; Pueschel, R. F.; Reagan, J. A.; DeFoor, T. E.; Box, M. A.; Pilewskie, P.; Herman, B. M.; Kinne, S. A.;
1993-01-01
The Ames airborne tracking sunphotometer was operated at the National Oceanic and Atmospheric Administration (NOAA) Mauna Loa Observatory (MLO) in 1991 and 1992 along with the NOAA Climate Monitoring and Diagnostics Laboratory (CMDL) automated tracking sunphotometer and lidar. June 1991 measurements provided calibrations, optical-depth spectra, and intercomparisons under relatively clean conditions; later measurements provided spectra and comparisons for the Pinatubo cloud plus calibration checks. June 1991 results are similar to previous MLO springtime measurements, with midvisible particle optical depth tau(sub p)(lambda = 0.526 microns) at the near-background level of 0.012 +/- 0.006 and no significant wavelength dependence in the measured range (lambda = 0.38 to 1.06 microns). The arrival of the Pinatubo cloud in July 1991 increased midvisible particle optical depth by more than an order of magnitude and changed the spectral shape of tau(sub p)(lambda) to an approximate power law with an exponent of about -1.4. By early September 1991, the spectrum was broadly peaked near 0.5 microns, and by July 1992, it was peaked near 0.8 microns. Our optical-depth spectra include corrections for diffuse light which increase postvolcanic midvisible tau(sub p) values by 1 to 3% (i.e., 0.0015 to 0.0023). NOAA- and Ames Research Center (ARC)-measured spectra are in good agreement. Columnar size distributions inverted from the spectra show that the initial (July 1991) post-Pinatubo cloud was relatively rich in small particles (r less than 0.25 microns), which were progressively depleted in the August-September 1991 and July 1992 periods. Conversely, both of the later periods had more of the optically efficient medium-sized particles (0.25 less than r less than 1 micron) than did the fresh July 1991 cloud. These changes are consistent with particle growth by condensation and coagulation. The effective, or area-weighted, radius increased from 0.22 +/- 0.06 micron in July 1991 to 0.56 +/- 0.12 micron in August-September 1991 and to 0.86 +/- 0.29 micron in July 1992. Corresponding column mass values were 4.8 +/- 0.7, 9.1 +/- 2.7, and 5.5 +/- 2 micro g/sq cm, and corresponding column surface areas were 4.4 +/- 0.5, 2.9 +/- 0.2, and 1.1 +/- 0.1 sq micron/sq cm,. Photometer-inferred column backscatter values agree with those measured by the CMDL lidar on nearby nights. Combining lidar-measured backscatter profiles with photometer-derived backscatter-to-area ratios gives peak particle areas that could cause rapid heterogeneous loss of ozone, given sufficiently low particle acidity and suitable solar zenith angles (achieved at mid- to high latitudes). Top-of-troposphere radiative forcings for the September 1991 and July 1992 optical depths and size distributions over MLO are about -5 and -3 W 1/sq m, respectively (hence comparable in magnitude but opposite in sign to the radiative forcing caused by the increase in manmade greenhouse gases since the industrial revolution). Heating rates in Pinatubo layer over MLO are 0.55 +/- 0.13 and 0.41 +/- 0.14 K/d for September 1991 and July 1992, respectively.
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42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 3 2010-10-01 2010-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...
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42 CFR 414.508 - Payment for a new clinical diagnostic laboratory test.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 3 2011-10-01 2011-10-01 false Payment for a new clinical diagnostic laboratory... SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.508 Payment for a new clinical diagnostic laboratory test. For a new clinical diagnostic laboratory test that is assigned a new or...
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[CO2 Budget and Atmospheric Rectification (COBRA) Over North America
NASA Technical Reports Server (NTRS)
2004-01-01
The purpose of the CO2 Budget and Rectification Airborne (COBRA) study was to assess terrestrial sources and sinks of carbon dioxide using an air-borne study. The study was designed to address the measurement gap between plot-scale direct flux measurements and background hemispheric-scale constraints and to refine techniques for measuring terrestrial fluxes at regional to continental scales. The initial funded effort (reported on here) was to involve two air-borne campaigns over North America, one in summer and one in winter. Measurements for COBRA (given the acronym C02BAR in the initial proposal) were conducted from the University of North Dakota Citation 11, a twin-engine jet aircraft capable of profiling from the surface to 12 km and cruising for up to 4 hours and 175m/s. Onboard instrumentation measured concentrations of CO2, CO, and H2O, and meteorological parameters at high rates. In addition, two separate flask sampling systems collected discrete samples for laboratory analysis of CO2,CO, CH4, N2O, SF6, H2, 13CO2, C18O16O,O2/N2, and Ar/N2. The project involved a collaboration between a number of institutions, including (but not limited to) Harvard, NOAA-CMDL, the University of North Dakota, and Scripps.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-10
...] Medicare Program; Section 3113: The Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration... code under the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration. The deadline for... interested parties of an opportunity to participate in the Treatment of Certain Complex Diagnostic Laboratory...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...
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Code of Federal Regulations, 2011 CFR
2011-10-01
... a new clinical diagnostic laboratory test. 414.506 Section 414.506 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory...
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Miller, J Michael; Astles, Rex; Baszler, Timothy; Chapin, Kimberle; Carey, Roberta; Garcia, Lynne; Gray, Larry; Larone, Davise; Pentella, Michael; Pollock, Anne; Shapiro, Daniel S; Weirich, Elizabeth; Wiedbrauk, Danny
2012-01-06
Prevention of injuries and occupational infections in U.S. laboratories has been a concern for many years. CDC and the National Institutes of Health addressed the topic in their publication Biosafety in Microbiological and Biomedical Laboratories, now in its 5th edition (BMBL-5). BMBL-5, however, was not designed to address the day-to-day operations of diagnostic laboratories in human and animal medicine. In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories. The members of this panel recommended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly. These guidelines promote a culture of safety and include recommendations that supplement BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians. Throughout these guidelines, quality laboratory science is reinforced by a common-sense approach to biosafety in day-to-day activities. Because many of the same diagnostic techniques are used in human and animal diagnostic laboratories, the text is presented with this in mind. All functions of the human and animal diagnostic laboratory--microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance--are addressed. A specific section for veterinary diagnostic laboratories addresses the veterinary issues not shared by other human laboratory departments. Recommendations for all laboratories include use of Class IIA2 biological safety cabinets that are inspected annually; frequent hand washing; use of appropriate disinfectants, including 1:10 dilutions of household bleach; dependence on risk assessments for many activities; development of written safety protocols that address the risks of chemicals in the laboratory; the need for negative airflow into the laboratory; areas of the laboratory in which use of gloves is optional or is recommended; and the national need for a central site for surveillance and nonpunitive reporting of laboratory incidents/exposures, injuries, and infections.
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Biosafety principles and practices for the veterinary diagnostic laboratory.
Kozlovac, Joseph; Schmitt, Beverly
2015-01-01
Good biosafety and biocontainment programs and practices are critical components of the successful operation of any veterinary diagnostic laboratory. In this chapter we provide information and guidance on critical biosafety management program elements, facility requirements, protective equipment, and procedures necessary to ensure that the laboratory worker and the environment are adequately protected in the challenging work environment of the veterinary diagnostic laboratory in general and provide specific guidance for those laboratories employing molecular diagnostic techniques.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-04
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-82,379] Abbott Laboratories... February 22, 2013, applicable to workers of Abbott Laboratories, Diagnostic--Hematology division, including... Clara, California location of Abbott Laboratories, Diagnostic--Hematology Division. The Department has...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-27
... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-75,201] Abbott Laboratories..., applicable to workers of Abbott Laboratories, Diagnostics Division, including on-site leased workers from... (clerical) were employed on-site at the Irving, Texas location of Abbott Laboratories, Diagnostics Division...
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Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana
2016-10-15
With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia.
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Nikolaev, N S; Nazarova, V V; Dobrovol'skaia, N Iu; Orlova, A V; Pchelova, N N
2014-10-01
The article presents experience of clinical diagnostic laboratory of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary) in the area of quality management of medical laboratory services on the basis of evaluation of efficacy and effectiveness of processes. The factors effecting quality of functioning of clinical diagnostic laboratory are indicated. The criteria and indicators of efficacy of work of employees of clinical diagnostic laboratory are presented.
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ERIC Educational Resources Information Center
Seaton, Vaughn A.
1980-01-01
The veterinary diagnostic laboratory's prime role has been diagnosis and/or laboratory findings to assist a diagnosis. Interpretation and evaluation and more involvement with decision-making in monitoring groups of animals and their health status are seen as future roles for diagnostic laboratories. (MLW)
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Taylor, Sara; Bennett, Katie M; Deignan, Joshua L; Hendrix, Ericka C; Orton, Susan M; Verma, Shalini; Schutzbank, Ted E
2014-05-01
Molecular diagnostics is a rapidly growing specialty in the clinical laboratory assessment of pathology. Educational programs in medical laboratory science and specialized programs in molecular diagnostics must address the training of clinical scientists in molecular diagnostics, but the educational curriculum for this field is not well defined. Moreover, our understanding of underlying genetic contributions to specific diseases and the technologies used in molecular diagnostics laboratories change rapidly, challenging providers of training programs in molecular diagnostics to keep their curriculum current and relevant. In this article, we provide curriculum recommendations to molecular diagnostics training providers at both the baccalaureate and master's level of education. We base our recommendations on several factors. First, we considered National Accrediting Agency for Clinical Laboratory Sciences guidelines for accreditation of molecular diagnostics programs, because educational programs in clinical laboratory science should obtain its accreditation. Second, the guidelines of several of the best known certifying agencies for clinical laboratory scientists were incorporated into our recommendations. Finally, we relied on feedback from current employers of molecular diagnostics scientists, regarding the skills and knowledge that they believe are essential for clinical scientists who will be performing molecular testing in their laboratories. We have compiled these data into recommendations for a molecular diagnostics curriculum at both the baccalaureate and master's level of education. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.
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Code of Federal Regulations, 2011 CFR
2011-10-01
... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...
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Code of Federal Regulations, 2012 CFR
2012-10-01
... Procedural Terminology published by the American Medical Association. (vii) Diagnostic tests performed by a... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...
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Kuna, Andrea Tešija; Đerek, Lovorka; Kozmar, Ana; Drvar, Vedrana
2016-01-01
Introduction With the trend of increasing incidence of autoimmune diseases, laboratories are faced with exponential growth of the requests for tests relating the diagnosis of these diseases. Unfortunately, the lack of laboratory personnel experienced in this specific discipline of laboratory diagnostic, as well as an unawareness of a method limitation often results in confusion for clinicians. The aim was to gain insight into number and type of Croatian laboratories that perform humoral diagnostics with the final goal to improve and harmonize laboratory diagnostics of autoimmune diseases in Croatia. Materials and methods In order to get insight into current laboratory practice two questionnaires, consisting of 42 questions in total, were created. Surveys were conducted using SurveyMonkey application and were sent to 88 medical biochemistry laboratories in Croatia for the first survey. Out of 33 laboratories that declared to perform diagnostic from the scope, 19 were selected for the second survey based on the tests they pleaded to perform. The survey comprised questions regarding autoantibody hallmarks of systemic autoimmune diseases while regarding organ-specific autoimmune diseases was limited to diseases of liver, gastrointestinal and nervous system. Results Response rate was high with 80 / 88 (91%) laboratories which answered the first questionnaire, and 19 / 19 (1.0) for the second questionnaire. Obtained results of surveys indicate high heterogeneity in the performance of autoantibody testing among laboratories in Croatia. Conclusions Results indicate the need of creating recommendations and algorithms in order to harmonize the approach to laboratory diagnostics of autoimmune diseases in Croatia. PMID:27812306
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Monitoring and investigating natural disease by veterinary pathologists in diagnostic laboratories.
O'Toole, D
2010-01-01
Many emerging diseases in animals are initially recognized by diagnostic pathologists in animal health laboratories using routine laboratory submissions, in conjunction with clinical veterinarians and wildlife biologists. Familiar recent examples are chronic wasting disease, bovine spongiform encephalopathy, West Nile encephalomyelitis in North America, and postweaning multisystemic wasting syndrome in pigs. The recognition of new diseases in animals requires that the curiosity of diagnosticians be articulated with the capacity of animal health laboratories to create effective diagnostic teams, solicit additional cases from the field at minimal cost to clients, and develop relationships with basic researchers. Bovine neosporosis is used as an example to illustrate how a disease investigation triggered by routine clinical accessions can have international ramifications. Between the late 1980s and 1995, diagnosticians with California's animal health laboratory system identified neosporosis as a cause of reproductive wastage in cattle, characterized the lesions, isolated the agent, defined routes of transmission, met Koch's postulates, and developed diagnostic assays. Diagnostic pathologists catalyzed the process. The neosporosis investigation in California suggests useful attributes of veterinary diagnostic laboratories that pursue emerging diseases identified through routine laboratory accessions.
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76 FR 61153 - Robert Raymond Reppy, D.O.; Decision and Order
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-03
... diagnostic and laboratory tests consistent with good medical care,'' ``[f]ormulate[] a therapeutic plan... examination and appropriate diagnostic and laboratory testing.'' Id. In May 2000, the Louisiana State Board of..., examination, physical examination and appropriate diagnostic and laboratory testing; Discussing with the...
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The Development of a Post-Baccalaureate Certificate Program in Molecular Diagnostics
Williams, Gail S.; Brown, Judith D.; Keagle, Martha B.
2000-01-01
A post-baccalaureate certificate program in diagnostic molecular sciences was created in 1995 by the Diagnostic Genetic Sciences Program in the School of Allied Health at the University of Connecticut. The required on-campus lecture and laboratory courses include basic laboratory techniques, health care issues, cell biology, immunology, human genetics, research, management, and molecular diagnostic techniques and laboratory in molecular diagnostics. These courses precede a 6-month, full-time practicum at an affiliated full-service molecular laboratory. The practicum includes amplification and blotting methods, a research project, and a choice of specialized electives including DNA sequencing, mutagenesis, in situ hybridization methods, or molecular diagnostic applications in microbiology. Graduates of the program are immediately eligible to sit for the National Credentialing Agency examination in molecular biology to obtain the credential Clinical Laboratory Specialist in Molecular Biology (CLSp(MB). This description of the University of Connecticut program may assist other laboratory science programs in creating similar curricula. PMID:11232107
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Code of Federal Regulations, 2013 CFR
2013-10-01
... in the 80000 series of the Current Procedural Terminology published by the American Medical... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... Procedural Terminology published by the American Medical Association. (3) Levels of supervision. Except where... & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.32 Diagnostic x-ray tests, diagnostic laboratory...
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Antimicrobial susceptibility testing by Australian veterinary diagnostic laboratories.
Hardefeldt, L Y; Marenda, M; Crabb, H; Stevenson, M A; Gilkerson, J R; Billman-Jacobe, H; Browning, G F
2018-04-01
The national strategy for tackling antimicrobial resistance highlights the need for antimicrobial stewardship in veterinary practice and for surveillance of antimicrobial susceptibility in veterinary pathogens. Diagnostic laboratories have an important role in facilitating both of these processes, but it is unclear whether data from veterinary diagnostic laboratories are similar enough to allow for compilation and if there is consistent promotion of appropriate antimicrobial use embedded in the approaches of different laboratories to susceptibility testing. A cross-sectional study of antimicrobial susceptibility testing and reporting procedures by Australian veterinary diagnostic laboratories was conducted in 2017 using an online questionnaire. All 18 veterinary diagnostic laboratories in Australia completed the questionnaire. Kirby-Bauer disc diffusion was the method predominantly used for antimicrobial susceptibility testing and was used to evaluate 86% of all isolates, although two different protocols were used across the 18 laboratories (CLSI 15/18, CDS 3/18). Minimum inhibitory concentrations were never reported by 61% of laboratories. Common isolates were consistently reported on across all species, except for gram-negative isolates in pigs, for which there was some variation in the approach to reporting. There was considerable diversity in the panels of antimicrobials used for susceptibility testing on common isolates and no consistency was apparent between laboratories for any bacterial species. We recommend that nationally agreed and consistent antimicrobial panels for routine susceptibility testing should be developed and a uniform set of guidelines should be adopted by veterinary diagnostic laboratories in Australia. © 2018 Australian Veterinary Association.
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van Dorp, Sofie M; Notermans, Daan W; Alblas, Jeroen; Gastmeier, Petra; Mentula, Silja; Nagy, Elisabeth; Spigaglia, Patrizia; Ivanova, Katiusha; Fitzpatrick, Fidelma; Barbut, Frédéric; Morris, Trefor; Wilcox, Mark H; Kinross, Pete; Suetens, Carl; Kuijper, Ed J
2016-07-21
Suboptimal laboratory diagnostics for Clostridium difficile infection (CDI) impedes its surveillance and control across Europe. We evaluated changes in local laboratory CDI diagnostics and changes in national diagnostic and typing capacity for CDI during the European C. difficile Infection Surveillance Network (ECDIS-Net) project, through cross-sectional surveys in 33 European countries in 2011 and 2014. In 2011, 126 (61%) of a convenience sample of 206 laboratories in 31 countries completed a survey on local diagnostics. In 2014, 84 (67%) of these 126 laboratories in 26 countries completed a follow-up survey. Among laboratories that participated in both surveys, use of CDI diagnostics deemed 'optimal' or 'acceptable' increased from 19% to 46% and from 10% to 15%, respectively (p < 0.001). The survey of national capacity was completed by national coordinators of 31 and 32 countries in 2011 and 2014, respectively. Capacity for any C. difficile typing method increased from 22/31 countries in 2011 to 26/32 countries in 2014; for PCR ribotyping from 20/31 countries to 23/32 countries, and specifically for capillary PCR ribotyping from 7/31 countries to 16/32 countries. While our study indicates improved diagnostic capability and national capacity for capillary PCR ribotyping across European laboratories between 2011 and 2014, increased use of 'optimal' diagnostics should be promoted. This article is copyright of The Authors, 2016.
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Zenina, L P; Godkov, M A
2013-08-01
The article presents the experience of implementation of system of quality management into the practice of multi-field laboratory of emergency medical care hospital. The analysis of laboratory errors is applied and the modes of their prevention are demonstrated. The ratings of department of laboratory diagnostic of the N. V. Sklifosofskiy research institute of emergency care in the program EQAS (USA) Monthly Clinical Chemistry from 2007 are presented. The implementation of the system of quality management of laboratory analysis into department of laboratory diagnostic made it possible to support physicians of clinical departments with reliable information. The confidence of clinicians to received results increased. The effectiveness of laboratory diagnostic increased due to lowering costs of analysis without negative impact to quality of curative process.
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Jacobsen, Sonja; Patel, Pranav; Schmidt-Chanasit, Jonas; Leparc-Goffart, Isabelle; Teichmann, Anette; Zeller, Herve; Niedrig, Matthias
2016-03-01
Since the re-emergence of Chikungunya virus (CHIKV) in Reunion in 2005 and the recent outbreak in the Caribbean islands with an expansion to the Americas the CHIK diagnostic became very important. We evaluate the performance of laboratories regarding molecular and serological diagnostic of CHIK worldwide. A panel of 12 samples for molecular and 13 samples for serology were provided to 60 laboratories in 40 countries for evaluating the sensitivity and specificity of molecular and serology testing. The panel for molecular diagnostic testing was analysed by 56 laboratories returning 60 data sets of results whereas the 56 and 60 data sets were returned for IgG and IgM diagnostic from the participating laboratories. Twenty-three from 60 data sets performed optimal, 7 acceptable and 30 sets of results require improvement. From 50 data sets only one laboratory shows an optimal performance for IgM detection, followed by 9 data sets with acceptable and the rest need for improvement. From 46 IgG serology data sets 20 provide an optimal, 2 an acceptable and 24 require improvement performance. The evaluation of some of the diagnostic performances allows linking the quality of results to the in-house methods or commercial assays used. The external quality assurance for CHIK diagnostics provides a good overview on the laboratory performance regarding sensitivity and specificity for the molecular and serology diagnostic required for the quick and reliable analysis of suspected CHIK patients. Nearly half of the laboratories have to improve their diagnostic profile to achieve a better performance. Copyright © 2016 Z. Published by Elsevier B.V. All rights reserved.
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Lee, Roy E; Henricks, Walter H; Sirintrapun, Sahussapont J
2016-03-01
Molecular diagnostic testing presents new challenges to information management that are yet to be sufficiently addressed by currently available information systems for the molecular laboratory. These challenges relate to unique aspects of molecular genetic testing: molecular test ordering, informed consent issues, diverse specimen types that encompass the full breadth of specimens handled by traditional anatomic and clinical pathology information systems, data structures and data elements specific to molecular testing, varied testing workflows and protocols, diverse instrument outputs, unique needs and requirements of molecular test reporting, and nuances related to the dissemination of molecular pathology test reports. By satisfactorily addressing these needs in molecular test data management, a laboratory information system designed for the unique needs of molecular diagnostics presents a compelling reason to migrate away from the current paper and spreadsheet information management that many molecular laboratories currently use. This paper reviews the issues and challenges of information management in the molecular diagnostics laboratory.
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The capacity of diagnostic laboratories in Kenya for detecting infectious diseases.
Slotved, H-C; Yatich, Kennedy K; Sam, Shem Otoi; Ndhine, Edwardina Otieno
2017-01-01
The aim of this study is to present data of the diagnostic capacity of Kenyan laboratories to diagnose a number of human pathogens. The study is based on the data obtained from a biosecurity survey conducted in Kenya in 2014/2015 and data from the Statistical Abstract of Kenya for 2015. The biosecurity survey has previously been published; however, the survey also included information on laboratory capacity to handle a number of pathogens, which have not been published. Data were retrieved from the survey on 86 laboratory facilities. The data include information from relevant categories such as training laboratories, human diagnostic laboratories, veterinary diagnostic laboratories, and research laboratories. The disease incidence in Kenya ranges widely from malaria and diarrhea with an incidence rate of around 10.000 per year to diseases such as cholera and yellow fever with an incidence rate of 1 per year or less for all age groups. The data showed that diseases with the highest number of diagnostic facilities were mainly malaria-, HIV-, tuberculosis-, and diarrhea-related infectious diseases. The study generally shows that the laboratory facilities have the capacity of detecting the infectious diseases with the highest incidence rates. Furthermore, it seems that the number of facilities able to detect a particular disease is related to the incidence rate of the disease.
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Code of Federal Regulations, 2011 CFR
2011-10-01
...) or § 414.509(a)(3) that the basis for payment for a new test will be gapfilling, CMS posts interim... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... FOR PART B MEDICAL AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests...
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Aarsand, Aasne K; Villanger, Jørild H; Støle, Egil; Deybach, Jean-Charles; Marsden, Joanne; To-Figueras, Jordi; Badminton, Mike; Elder, George H; Sandberg, Sverre
2011-11-01
The porphyrias are a group of rare metabolic disorders whose diagnosis depends on identification of specific patterns of porphyrin precursor and porphyrin accumulation in urine, blood, and feces. Diagnostic tests for porphyria are performed by specialized laboratories in many countries. Data regarding the analytical and diagnostic performance of these laboratories are scarce. We distributed 5 sets of multispecimen samples from different porphyria patients accompanied by clinical case histories to 18-21 European specialist porphyria laboratories/centers as part of a European Porphyria Network organized external analytical and postanalytical quality assessment (EQA) program. The laboratories stated which analyses they would normally have performed given the case histories and reported results of all porphyria-related analyses available, interpretative comments, and diagnoses. Reported diagnostic strategies initially showed considerable diversity, but the number of laboratories applying adequate diagnostic strategies increased during the study period. We found an average interlaboratory CV of 50% (range 12%-152%) for analytes in absolute concentrations. Result normalization by forming ratios to the upper reference limits did not reduce this variation. Sixty-five percent of reported results were within biological variation-based analytical quality specifications. Clinical interpretation of the obtained analytical results was accurate, and most laboratories established the correct diagnosis in all distributions. Based on a case-based EQA scheme, variations were apparent in analytical and diagnostic performance between European specialist porphyria laboratories. Our findings reinforce the use of EQA schemes as an essential tool to assess both analytical and diagnostic processes and thereby to improve patient care in rare diseases.
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IPY to Mark Expansion of Research Facilities on the North Slope of Alaska
NASA Astrophysics Data System (ADS)
Zak, B. D.; Eicken, H.; Sheehan, G. W.; Glenn, R.
2004-12-01
The Barrow Global Climate Change Research Facility will open to researchers on the North Slope of Alaska during the 2007-08 anniversary of the first IPY. Between 1949 and 1980, arctic researchers were very active on the North Slope and in nearby waters largely because of the Naval Arctic Research Laboratory (NARL) at Barrow. NARL provided easy access, laboratories and logistical support. NARL was closed in 1981, but particularly during this past decade, Barrow-based arctic research projects have been back on the upswing. The National Oceanic and Atmospheric Administration (NOAA) Climate Monitoring and Diagnostics Laboratory (CMDL) Barrow station was founded during the 1970s, and continues as part of NOAA's five station global network for monitoring atmospheric composition. The North Slope Borough's Department of Wildlife Management (DWM) has for the past 20 years conducted its own research. The DWM also served as logistical provider for growing numbers of arctic researchers without other logistical support. In the late 1990s, the Department of Energy Atmospheric Radiation Measurement program (ARM: DOE's principal climate change research effort) created a Cloud and Radiation Testbed on the North Slope with atmospheric instrumentation at Barrow and Atqasuk. It is now part of the ARM Climate Research Facility, a National User Facility. In response to growing researcher needs, the Barrow Arctic Science Consortium (BASC) was formed in the late 1990s as a non-profit logistical support and community coordinating organization, and received the endorsement of Ukpeagvik Inupiat Corporation (UIC), NSB and the local community college. BASC provides logistical support to National Science Foundation (NSF) researchers through a cooperative agreement, and to others on a fee for service basis. UIC also dedicated 11 square miles of its land as the Barrow Environmental Observatory (BEO), and charged BASC with management of the BEO. This land that has been used for research for more than 50 years, and now is available to the larger research community through BASC. It has been protected from development by the NSB Assembly as a Scientific Research District. Since 1981, the remains of the old NARL infrastructure sustained the scientific enterprise on the North Slope. But now, as a result of the rapid ongoing changes in the Arctic, these old inadequate facilities are about to be replaced. The new Barrow facility, although smaller than the old NARL, will serve the needs of modern researchers with first class laboratories, information technology and lodging. It is being designed by the arctic research community itself through a series of workshops held over this past year, and through ongoing feedback (http://scifac.arcticscience.org). Research on the North Slope capitalizes on the history of collaboration between the Native Inupiat Eskimo people and scientists going back to the first IPY. Local native people have served in many support capacities for scientists in the past, and currently serve as managers and technicians for projects like ARM. It is this history of collaboration with scientists that inspired the creation of BASC, of the BEO, and that made the new facility possible. This paper reviews the status of planning for the new Barrow facility. Feedback can be provided through the web site and through the authors, who serve BASC respectively as chairs of advisory committees, Executive Director and President.
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Code of Federal Regulations, 2013 CFR
2013-10-01
...) or § 414.509(a)(3) that the basis for payment for a new test will be gapfilling, CMS posts interim... for a new clinical diagnostic laboratory test. 414.509 Section 414.509 Public Health CENTERS FOR... Laboratory Tests § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic...
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Basic haemoglobinopathy diagnostics in Dutch laboratories; providing an informative test result.
Kaufmann, J O; Smit, J W; Huisman, W; Idema, R N; Bakker, E; Giordano, P C
2013-08-01
After a first survey in 2001, the Dutch Association of Hematological Laboratory Research (VHL) advised its members to adopt a basic protocol for haemoglobinopathy carrier detection and to provide genetic information with all positive results to allow health-care professionals to inform carriers about potential genetic risks. This article reports on the compliance with these recommendations and their consequences. Clinical chemists of all 106 Dutch laboratories were invited to answer a survey on patient population, diagnostic techniques used, (self-reported) knowledge, use and effect of the additional information. The average increase in diagnostic output was over 60% and the recommended basic protocol was applied by 65% of the laboratories. Over 84% of the laboratories reported to be aware of the additional recommendations and 77% to be using them. Most laboratories with limited diagnostic requests were still sending their cases to other laboratories and included the genetic information received from these laboratories in their diagnostic reports. The effect of information on subsequent 'family analysis' was estimated to be between 26 and 50%. The present study shows an increase in diagnostic potential for haemoglobinopathy over the last decade, especially in the larger cities. Low 'family testing' rates were mostly found in areas with lower carrier prevalence or associated with local reluctance to pass the information to carriers. In spite of a dramatic improvement, too many carriers are still not informed because of lack of awareness among health-care providers and more education is needed. © 2012 John Wiley & Sons Ltd.
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Rahmadane, Ibnu; Certoma, Andrea F; Peck, Grantley R; Fitria, Yul; Payne, Jean; Colling, Axel; Shiell, Brian J; Beddome, Gary; Wilson, Susanne; Yu, Meng; Morrissy, Chris; Michalski, Wojtek P; Bingham, John; Gardner, Ian A; Allen, John D
2017-11-01
Rabies continues to pose a significant threat to human and animal health in regions of Indonesia. Indonesia has an extensive network of veterinary diagnostic laboratories and the 8 National laboratories are equipped to undertake diagnostic testing for rabies using the commercially-procured direct fluorescent antibody test (FAT), which is considered the reference (gold standard) test. However, many of the Indonesian Provincial diagnostic laboratories do not have a fluorescence microscope required to undertake the FAT. Instead, certain Provincial laboratories continue to screen samples using a chemical stain-based test (Seller's stain test, SST). This test has low diagnostic sensitivity, with negative SST-tested samples being forwarded to the nearest National laboratory resulting in significant delays for completion of testing and considerable additional costs. This study sought to develop a cost-effective and diagnostically-accurate immunoperoxidase antigen detection (RIAD) test for rabies that can be readily and quickly performed by the resource-constrained Provincial laboratories. This would reduce the burden on the National laboratories and allow more rapid diagnoses and implementation of post-exposure prophylaxis. The RIAD test was evaluated using brain smears fixed with acetone or formalin and its performance was validated by comparison with established rabies diagnostic tests used in Indonesia, including the SST and FAT. A proficiency testing panel was distributed between Provincial laboratories to assess the reproducibility of the test. The performance of the RIAD test was improved by using acetone fixation of brain smears rather than formalin fixation such that it was of equivalent accuracy to that of the World Organisation for Animal Health (OIE)-recommended FAT, with both tests returning median diagnostic sensitivity and specificity values of 0.989 and 0.993, respectively. The RIAD test and FAT had higher diagnostic sensitivity than the SST (median = 0.562). Proficiency testing using a panel of 6 coded samples distributed to 16 laboratories showed that the RIAD test had good reproducibility with an overall agreement of 97%. This study describes the successful development, characterisation and use of a novel RIAD test and its fitness for purpose as a screening test for use in provincial Indonesian veterinary laboratories.
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Kusters, Elske; Kerkhoffs, Jean-Louis H; van Rossum, André P
2014-01-01
The thalassaemias are characterised by quantitative aberrations in the production of the globin chains that make up haemoglobin, and are a subgroup of the haemoglobinopathies. In this LabQuiz we show how thalassaemia carrier status can be indicated in the results of regular laboratory tests, and discuss the laboratory diagnostics that can confirm or rule out thalassaemia. In these two cases we will present a man of Moroccan descent, and two brothers of Filipino descent, all with anaemia and microcytosis. We show it is possible to differentiate between iron-deficiency anaemia and thalassaemia carrier status on the basis of a complete blood count and measurement of ferritin levels, and which laboratory diagnostics can be subsequently performed in order to confirm a suspicion of thalassaemia. The background section discusses the properties and pitfalls of routine laboratory diagnostics for the thalassaemias, and thalassaemia diagnostics in the Dutch newborn screening programme.
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National NIF Diagnostic Program Fiscal Year 2002 Second Quarter Report
DOE Office of Scientific and Technical Information (OSTI.GOV)
MacGowan, B
Since October 2001 the development of the facility diagnostics for NIF has been funded by the NIF Director through the National NIF Diagnostic Program (NNDP). The current emphasis of the NNDP is on diagnostics for the early NIF quad scheduled to be available for experiment commissioning in FY03. During the past six months the NNDP has set in place processes for funding diagnostics, developing requirements for diagnostics, design reviews and monthly status reporting. Those processes are described in an interim management plan for diagnostics (''National NIF Diagnostic Program Interim Plan'', NIF-0081315, April 2002) and a draft Program Execution Plan (''Programmore » Execution Plan for the National NlF Diagnostic Program'', NIF-0072083, October 2001) and documents cited therein. Work has been funded at Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Naval Research Laboratory (NRL), Sandia National Laboratories (SNL), Bechtel Nevada at Los Alamos and Santa Barbara. There are no major technical risks with the early diagnostics. The main concerns relate to integration of the diagnostics into the facility, all such issues are being worked. This report is organized to show the schedule and budget status and a summary of Change Control Board actions for the past six months. The following sections then provide short descriptions of the status of each diagnostic. Where design reviews or requirements documents are cited, the documents are available on the Diagnostics file server or on request.« less
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76 FR 76736 - Agency Forms Undergoing Paperwork Reduction Act Review
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-08
... Project Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Laboratories-NEW--the Office of...). Background and Brief Description The Survey of Rapid Influenza Diagnostic Testing Practices in Laboratories is a national systematic study investigating rapid influenza diagnostic testing practices in clinical...
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Purcell, Maureen K.; Getchell, Rodman G.; McClure, Carol A.; Weber, S.E.; Garver, Kyle A.
2011-01-01
Real-time, or quantitative, polymerase chain reaction (qPCR) is quickly supplanting other molecular methods for detecting the nucleic acids of human and other animal pathogens owing to the speed and robustness of the technology. As the aquatic animal health community moves toward implementing national diagnostic testing schemes, it will need to evaluate how qPCR technology should be employed. This review outlines the basic principles of qPCR technology, considerations for assay development, standards and controls, assay performance, diagnostic validation, implementation in the diagnostic laboratory, and quality assurance and control measures. These factors are fundamental for ensuring the validity of qPCR assay results obtained in the diagnostic laboratory setting.
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Lewis, Suzanna M.; Lansley, Amber; Fraser, Sara; Shieber, Clare; Shah, Sonal; Semper, Amanda; Bailey, Daniel; Busuttil, Jason; Evans, Liz; Carroll, Miles W.; Silman, Nigel J.; Brooks, Tim; Shallcross, Jane A.
2017-01-01
As part of the UK response to the 2013–2016 Ebola virus disease (EVD) epidemic in West Africa, Public Health England (PHE) were tasked with establishing three field Ebola virus (EBOV) diagnostic laboratories in Sierra Leone by the UK Department for International Development (DFID). These provided diagnostic support to the Ebola Treatment Centre (ETC) facilities located in Kerry Town, Makeni and Port Loko. The Novel and Dangerous Pathogens (NADP) Training group at PHE, Porton Down, designed and implemented a pre-deployment Ebola diagnostic laboratory training programme for UK volunteer scientists being deployed to the PHE EVD laboratories. Here, we describe the training, workflow and capabilities of these field laboratories for use in response to disease epidemics and in epidemiological surveillance. We discuss the training outcomes, the laboratory outputs, lessons learned and the legacy value of the support provided. We hope this information will assist in the recruitment and training of staff for future responses and in the design and implementation of rapid deployment diagnostic field laboratories for future outbreaks of high consequence pathogens. This article is part of the themed issue ‘The 2013–2016 West African Ebola epidemic: data, decision-making and disease control’. PMID:28396470
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Condell, Orla; Wasunna, Christine; Kpaka, Jonathan; Zwizwai, Ruth; Nuha, Mahmood; Fallah, Mosoka; Freeman, Maxwell; Harris, Victoria; Miller, Mark; Baller, April; Massaquoi, Moses; Katawera, Victoria; Saindon, John; Bemah, Philip; Hamblion, Esther; Castle, Evelyn; Williams, Desmond; Gasasira, Alex; Nyenswah, Tolbert
2018-01-01
The 2014–16 Ebola Virus Disease (EVD) outbreak in West Africa highlighted the necessity for readily available, accurate and rapid diagnostics. The magnitude of the outbreak and the re-emergence of clusters of EVD cases following the declaration of interrupted transmission in Liberia, reinforced the need for sustained diagnostics to support surveillance and emergency preparedness. We describe implementation of the Xpert Ebola Assay, a rapid molecular diagnostic test run on the GeneXpert platform, at a mobile laboratory in Liberia and the subsequent impact on EVD outbreak response, case management and laboratory system strengthening. During the period of operation, site coordination, management and operational capacity was supported through a successful collaboration between Ministry of Health (MoH), World Health Organization (WHO) and international partners. A team of Liberian laboratory technicians were trained to conduct EVD diagnostics and the laboratory had capacity to test 64–100 blood specimens per day. Establishment of the laboratory significantly increased the daily testing capacity for EVD in Liberia, from 180 to 250 specimens at a time when the effectiveness of the surveillance system was threatened by insufficient diagnostic capacity. During the 18 months of operation, the laboratory tested a total of 9,063 blood specimens, including 21 EVD positives from six confirmed cases during two outbreaks. Following clearance of the significant backlog of untested EVD specimens in November 2015, a new cluster of EVD cases was detected at the laboratory. Collaboration between surveillance and laboratory coordination teams during this and a later outbreak in March 2016, facilitated timely and targeted response interventions. Specimens taken from cases during both outbreaks were analysed at the laboratory with results informing clinical management of patients and discharge decisions. The GeneXpert platform is easy to use, has relatively low running costs and can be integrated into other national diagnostic algorithms. The technology has on average a 2-hour sample-to-result time and allows for single specimen testing to overcome potential delays of batching. This model of a mobile laboratory equipped with Xpert Ebola test, staffed by local laboratory technicians, could serve to strengthen outbreak preparedness and response for future outbreaks of EVD in Liberia and the region. PMID:29304039
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Raftery, Philomena; Condell, Orla; Wasunna, Christine; Kpaka, Jonathan; Zwizwai, Ruth; Nuha, Mahmood; Fallah, Mosoka; Freeman, Maxwell; Harris, Victoria; Miller, Mark; Baller, April; Massaquoi, Moses; Katawera, Victoria; Saindon, John; Bemah, Philip; Hamblion, Esther; Castle, Evelyn; Williams, Desmond; Gasasira, Alex; Nyenswah, Tolbert
2018-01-01
The 2014-16 Ebola Virus Disease (EVD) outbreak in West Africa highlighted the necessity for readily available, accurate and rapid diagnostics. The magnitude of the outbreak and the re-emergence of clusters of EVD cases following the declaration of interrupted transmission in Liberia, reinforced the need for sustained diagnostics to support surveillance and emergency preparedness. We describe implementation of the Xpert Ebola Assay, a rapid molecular diagnostic test run on the GeneXpert platform, at a mobile laboratory in Liberia and the subsequent impact on EVD outbreak response, case management and laboratory system strengthening. During the period of operation, site coordination, management and operational capacity was supported through a successful collaboration between Ministry of Health (MoH), World Health Organization (WHO) and international partners. A team of Liberian laboratory technicians were trained to conduct EVD diagnostics and the laboratory had capacity to test 64-100 blood specimens per day. Establishment of the laboratory significantly increased the daily testing capacity for EVD in Liberia, from 180 to 250 specimens at a time when the effectiveness of the surveillance system was threatened by insufficient diagnostic capacity. During the 18 months of operation, the laboratory tested a total of 9,063 blood specimens, including 21 EVD positives from six confirmed cases during two outbreaks. Following clearance of the significant backlog of untested EVD specimens in November 2015, a new cluster of EVD cases was detected at the laboratory. Collaboration between surveillance and laboratory coordination teams during this and a later outbreak in March 2016, facilitated timely and targeted response interventions. Specimens taken from cases during both outbreaks were analysed at the laboratory with results informing clinical management of patients and discharge decisions. The GeneXpert platform is easy to use, has relatively low running costs and can be integrated into other national diagnostic algorithms. The technology has on average a 2-hour sample-to-result time and allows for single specimen testing to overcome potential delays of batching. This model of a mobile laboratory equipped with Xpert Ebola test, staffed by local laboratory technicians, could serve to strengthen outbreak preparedness and response for future outbreaks of EVD in Liberia and the region.
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The Correlated Lecture Laboratory Series in Diagnostic Radiological Physics.
ERIC Educational Resources Information Center
Lamel, David A.; And Others
This series in diagnostic radiological physics has been designed to provide the physics background requisite for the proper conduct of medical diagnostic x-ray examinations. The basic goal of the series is to bridge physics theory and radiological practice, achieved by combining pertinent lecture material with laboratory exercises that illustrate…
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Diagnostic trends in Clostridium difficile detection in Finnish microbiology laboratories.
Könönen, Eija; Rasinperä, Marja; Virolainen, Anni; Mentula, Silja; Lyytikäinen, Outi
2009-12-01
Due to increased interest directed to Clostridium difficile-associated infections, a questionnaire survey of laboratory diagnostics of toxin-producing C. difficile was conducted in Finland in June 2006. Different aspects pertaining to C. difficile diagnosis, such as requests and criteria used for testing, methods used for its detection, yearly changes in diagnostics since 1996, and the total number of investigations positive for C. difficile in 2005, were asked in the questionnaire, which was sent to 32 clinical microbiology laboratories, including all hospital-affiliated and the relevant private clinical microbiology laboratories in Finland. The situation was updated by phone and email correspondence in September 2008. In June 2006, 28 (88%) laboratories responded to the questionnaire survey; 24 of them reported routinely testing requested stool specimens for C. difficile. Main laboratory methods included toxin detection (21/24; 88%) and/or anaerobic culture (19/24; 79%). In June 2006, 18 (86%) of the 21 laboratories detecting toxins directly from feces, from the isolate, or both used methods for both toxin A (TcdA) and B (TcdB), whereas only one laboratory did so in 1996. By September 2008, all of the 23 laboratories performing diagnostics for C. difficile used methods for both TcdA and TcdB. In 2006, the number of specimens processed per 100,000 population varied remarkably between different hospital districts. In conclusion, culturing C. difficile is common and there has been a favorable shift in toxin detection practice in Finnish clinical microbiology laboratories. However, the variability in diagnostic activity reported in 2006 creates a challenge for national monitoring of the epidemiology of C. difficile and related diseases.
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78 FR 60245 - Privacy Act Systems of Records; LabWare Laboratory Information Management System
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-01
... Services Laboratories (NVSL). Diagnostic testing provides official test results for animal imports, exports.... Diagnostic testing is also done in connection with suspected foreign animal disease investigations and... of Records; LabWare Laboratory Information Management System AGENCY: Animal and Plant Health...
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Dorizzi, R M; Maconi, M; Giavarina, D; Loza, G; Aman, M; Moreira, J; Bisoffi, Z; Gennuso, C
2009-10-01
The adoption of Evidence Based Laboratory Medicine (EBLM) has been hampered until today by the lack of effective tools. The SIMeL EBLM e-Thesaurus (on-line Repertoire of the diagnostic effectiveness of the laboratory, radiology and cardiology test) provides a useful support to clinical laboratory professionals and to clinicians for the interpretation of the diagnostic tests. The e-Thesaurus is an application developed using Microsoft Active Server Pages technology and carried out with Web Server Microsoft Internet Information Server and is available at the SIMeL website using a browser running JavaScript scripts (Internet Explorer is recommended). It contains a database (in Italian, English and Spanish) of the sensitivity and specificity (including the 95% confidence interval), the positive and negative likelihood ratios, the Diagnostic Odds Ratio and the Number Needed to Diagnose of more than 2000 diagnostic (most laboratory but also cardiology and radiology) tests. The e-Thesaurus improves the previous SIMeL paper and CD Thesaurus; its main features are a three languages search and a continuous and an easy updating capability.
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Quality systems in veterinary diagnostics laboratories.
de Branco, Freitas Maia L M
2007-01-01
Quality assurance of services provided by veterinary diagnostics laboratories is a fundamental element promoted by international animal health organizations to establish trust, confidence and transparency needed for the trade of animals and their products at domestic and international levels. It requires, among other things, trained personnel, consistent and rigorous methodology, choice of suitable methods as well as appropriate calibration and traceability procedures. An important part of laboratory quality management is addressed by ISO/IEC 17025, which aims to facilitate cooperation among laboratories and their associated parties by assuring the generation of credible and consistent information derived from analytical results. Currently, according to OIE recommendation, veterinary diagnostics laboratories are only subject to voluntary compliance with standard ISO/IEC 17025; however, it is proposed here that OIE reference laboratories and collaboration centres strongly consider its adoption.
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Measurements of N2O and SF6 for use in Inverse Model Studies
NASA Astrophysics Data System (ADS)
Dlugokencky, E. J.; Peters, W.; Masarie, K. A.; Lang, P. M.; Dutton, G.; Hall, B. D.
2004-12-01
NOAA CMDL makes measurements of atmospheric nitrous oxide (N2O) and sulfur hexafluoride (SF6) mole fractions in discrete air samples from ˜60 surface sites and ˜10 vertical profile sites for use in inverse modeling. Measurements are made by gas chromatography with electron capture detection (ECD) relative to standard scales developed in CMDL's Halocarbons and Other Atmospheric Trace Species (HATS) group. Uncertainties in the standard scales (95% confidence limits) are 0.8 nmol mol-1 for N2O and 0.05 pmol mol-1 for SF6. For N2O, the ECD response is characterized monthly by a second-order polynomial with a suite of 6 secondary standards covering the range 242-343 nmol mol-1. An instrument response function prepared from measurements of the secondary standards relative to a reference cylinder is used to quantify samples. SF6 in air samples is quantified with the reference by assuming a linear response with zero intercept in samples that are free of SF6. Reproducibility of the measurements, based on agreement between two samples collected in series, is ˜0.4 nmol mol-1 for N2O and ˜0.04 pmol mol-1 for SF6. So far, all measurements have been made on a single analytical system. The measurements impose important constraints on the budgets of N2O and SF6 based on observed trends, changes in trends, and spatial gradients. These parameters can be used to determine source/sink imbalances, changes in emission rates over time, and the distribution of emissions. In addition, Peters et al. [JGR, in press, 2004] have used the SF6 measurements to evaluate transport in the two-way nested chemistry transport model, TM5. They found that TM5 captures vertical gradients and synoptic variability in SF6 well at both MBL and continental sampling sites, but it over-estimates the meridional gradient by ˜19%. The SF6 data also suggest that global SF6 emissions increased by ˜20% during late-2002.
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Clinical pathologist in Korea--training program and its roles in laboratories.
Cho, Han-Ik; Lee, Kap No; Park, Jong-Woo; Park, Hyosoon; Kwak, Yun Sik
2002-01-01
A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.
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Payne, Deborah A; Baluchova, Katarina; Peoc'h, Katell H; van Schaik, Ron H N; Chan, K C Allen; Maekawa, Masato; Mamotte, Cyril; Russomando, Graciela; Rousseau, François; Ahmad-Nejad, Parviz
2017-04-01
Multiple organizations produce guidance documents that provide opportunities to harmonize quality practices for diagnostic testing. The International Organization for Standardization ISO 15189 standard addresses requirements for quality in management and technical aspects of the clinical laboratory. One technical aspect addresses the complexities of the pre-examination phase prior to diagnostic testing. The Committee for Molecular Diagnostics of the International Federation for Clinical Chemistry and Laboratory Medicine (also known as, IFCC C-MD) conducted a survey of international molecular laboratories and determined ISO 15189 to be the most referenced guidance document. In this review, the IFCC C-MD provides case-based examples illustrating the value of select pre-examination processes as these processes relate to molecular diagnostic testing. Case-based examples in infectious disease, oncology, inherited disease and pharmacogenomics address the utility of: 1) providing information to patients and users, 2) designing requisition forms, 3) obtaining informed consent and 4) maintaining sample integrity prior to testing. The pre-examination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. The clinical vignettes presented in this paper illustrate the value of applying select ISO 15189 recommendations for general laboratory to the more specialized area of Molecular Diagnostics. Copyright © 2016 Elsevier B.V. All rights reserved.
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External quality assessment of dengue and chikungunya diagnostics in the Asia Pacific region, 2015
Soh, Li Ting; Squires, Raynal C; Tan, Li Kiang; Pok, Kwoon Yong; Yang, HuiTing; Liew, Christina; Shah, Aparna Singh; Aaskov, John; Abubakar, Sazaly; Hasabe, Futoshi; Ng, Lee Ching
2016-01-01
Objective To conduct an external quality assessment (EQA) of dengue and chikungunya diagnostics among national-level public health laboratories in the Asia Pacific region following the first round of EQA for dengue diagnostics in 2013. Methods Twenty-four national-level public health laboratories performed routine diagnostic assays on a proficiency testing panel consisting of two modules. Module A contained serum samples spiked with cultured dengue virus (DENV) or chikungunya virus (CHIKV) for the detection of nucleic acid and DENV non-structural protein 1 (NS1) antigen. Module B contained human serum samples for the detection of anti-DENV antibodies. Results Among 20 laboratories testing Module A, 17 (85%) correctly detected DENV RNA by reverse transcription polymerase chain reaction (RT–PCR), 18 (90%) correctly determined serotype and 19 (95%) correctly identified CHIKV by RT–PCR. Ten of 15 (66.7%) laboratories performing NS1 antigen assays obtained the correct results. In Module B, 18/23 (78.3%) and 20/20 (100%) of laboratories correctly detected anti-DENV IgM and IgG, respectively. Detection of acute/recent DENV infection by both molecular (RT–PCR) and serological methods (IgM) was available in 19/24 (79.2%) participating laboratories. Discussion Accurate laboratory testing is a critical component of dengue and chikungunya surveillance and control. This second round of EQA reveals good proficiency in molecular and serological diagnostics of these diseases in the Asia Pacific region. Further comprehensive diagnostic testing, including testing for Zika virus, should comprise future iterations of the EQA. PMID:27508088
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Human rabies in India: an audit from a rabies diagnostic laboratory.
Mani, Reeta Subramaniam; Anand, Ashwini Manoor; Madhusudana, Shampur Narayan
2016-04-01
Rabies, an acute progressive encephalomyelitis, continues to be a serious public health problem in India and many other countries in Asia and Africa. The low level of commitment to rabies control is partly attributable to challenges in laboratory diagnosis and lack of adequate surveillance to indicate the disease burden. A laboratory audit of human rabies cases was undertaken to disseminate information on the clinical, demographic, prophylactic and most importantly the laboratory diagnostic aspects of rabies. A retrospective analysis of all clinically suspected human rabies cases, whose samples were received at a rabies diagnostic laboratory in South India in the last 3 years, was performed. Clinical and demographic details of patients were obtained. The clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. Various laboratory tests were performed for diagnosis. Clinical samples from 128 patients with suspected rabies, from 11 states in India, were received for diagnostic confirmation. About 94% of the victims reported dog-bites, more than a third of them were children and most of the victims did not receive adequate post-exposure prophylaxis. Antemortem confirmation of rabies by a combination of laboratory diagnostic assays (detection of viral RNA in CSF, skin and saliva, and neutralising antibodies in CSF) could be achieved in 40.6% cases. Increasing awareness about adequate post-exposure prophylaxis, additional rabies diagnostic facilities, and enhanced human and animal rabies surveillance to indicate the true disease burden are essential to control this fatal disease. © 2016 John Wiley & Sons Ltd.
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Atmospheric CO2 Record from In Situ Measurements at Amsterdam Island (1980-1995)
Gaudry, A. [Centre des Faibles Radioactivites, Laboratoire de Modelisation du Climat et de l'Environnement, Centre d'Etudes de Saclay, France; Kazan, V. [Centre des Faibles Radioactivites, Laboratoire de Modelisation du Climat et de l'Environnement, Centre d'Etudes de Saclay, France; Monfray, P. [Centre des Faibles Radioactivites, Laboratoire de Modelisation du Climat et de l'Environnement, Centre d'Etudes de Saclay, France
1996-09-01
Until 1993 air samples were collected continuously through an air intake located at the top of a tower, 9 m above ground and 65 m above mean sea level. Since 1994, the intake has been situated 20 m above ground and 76 m above mean sea level. The tower is located at the north-northwest end of the island on the edge of a 55 m cliff. The air is dried by means of a cryogenic water trap at -60°C. Until 1990, determinations of CO2 were made by using successively two Hartmann-Braun URAS 2T nondispersive infrared (NDIR) analyzers. Since 1991, CO2 determinations have been made using a Siemens ULTRAMAT 5F NDIR. Standard gases in use from October 1980 to December of 1984 were CO2-in-N2 mixtures certified by Scripps Institution of Oceanography (SIO). The N2 scale was corrected for the carrier gas effect to obtain the air scale (WMO mole fraction scale). In 1985, CO2-in-air mixtures expressed in the 1985 WMO mole fraction in air scale were introduced. In 1990, a new series of 12 primary standard gases were gravimetrically prepared, then linearly adjusted at the laboratory and checked several times (i.e., 1990, 1992, and 1993) through intercalibrations with DSIR in New Zealand and NOAA/CMDL, which both used the 1985 mole fraction scale. The agreement was always better than 0.1 ppm (Monfray et al. 1992). Since 1993, the 1993 mole fraction scale has been used thanks to a new series of 10 cylinders provided by SIO.
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Pok, Kwoon Yong; Squires, Raynal C; Tan, Li Kiang; Takasaki, Tomohiko; Abubakar, Sazaly; Hasebe, Futoshi; Partridge, Jeffrey; Lee, Chin Kei; Lo, Janice; Aaskov, John; Ng, Lee Ching; Konings, Frank
2015-01-01
Accurate laboratory testing is a critical component of dengue surveillance and control. The objective of this programme was to assess dengue diagnostic proficiency among national-level public health laboratories in the World Health Organization (WHO) Western Pacific Region. Nineteen national-level public health laboratories performed routine dengue diagnostic assays on a proficiency testing panel consisting of two modules: one containing commercial serum samples spiked with cultured dengue viruses for the detection of nucleic acid and non-structural protein 1 (NS1) (Module A) and one containing human serum samples for the detection of anti-dengue virus antibodies (Module B). A review of logistics arrangements was also conducted. All 16 laboratories testing Module A performed reverse transcriptase polymerase chain reaction (RT-PCR) for both RNA and serotype detection. Of these, 15 had correct results for RNA detection and all 16 correctly serotyped the viruses. All nine laboratories performing NS1 antigen detection obtained the correct results. Sixteen of the 18 laboratories using IgM assays in Module B obtained the correct results as did the 13 laboratories that performed IgG assays. Detection of ongoing/recent dengue virus infection by both molecular (RT-PCR) and serological methods (IgM) was available in 15/19 participating laboratories. This first round of external quality assessment of dengue diagnostics was successfully conducted in national-level public health laboratories in the WHO Western Pacific Region, revealing good proficiency in both molecular and serological testing. Further comprehensive diagnostic testing for dengue virus and other priority pathogens in the Region will be assessed during future rounds.
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The role of diagnostic laboratories in support of animal disease surveillance systems.
Zepeda, C
2007-01-01
Diagnostic laboratories are an essential component of animal disease surveillance systems. To understand the occurrence of disease in populations, surveillance systems rely on random or targeted surveys using three approaches: clinical, serological and virological surveillance. Clinical surveillance is the basis for early detection of disease and is usually centered on the detection of syndromes and clinical findings requiring confirmation by diagnostic laboratories. Although most of the tests applied usually perform to an acceptable standard, several have not been properly validated in terms of their diagnostic sensitivity and specificity. Sensitivity and specificity estimates can vary according to local conditions and, ideally, should be determined by national laboratories where the tests are to be applied. The importance of sensitivity and specificity estimates in the design and interpretation of statistically based surveys and risk analysis is fundamental to establish appropriate disease control and prevention strategies. The World Organisation for Animal Health's (OIE) network of reference laboratories acts as centers of expertise for the diagnosis of OIE listed diseases and have a role in promoting the validation of OIE prescribed tests for international trade. This paper discusses the importance of the epidemiological evaluation of diagnostic tests and the role of the OIE Reference Laboratories and Collaborating Centres in this process.
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Lacbawan, Felicitas L; Weck, Karen E; Kant, Jeffrey A; Feldman, Gerald L; Schrijver, Iris
2012-01-01
The number of clinical laboratories introducing various molecular tests to their existing test menu is continuously increasing. Prior to offering a US Food and Drug Administration-approved test, it is necessary that performance characteristics of the test, as claimed by the company, are verified before the assay is implemented in a clinical laboratory. To provide an example of the verification of a specific qualitative in vitro diagnostic test: cystic fibrosis carrier testing using the Luminex liquid bead array (Luminex Molecular Diagnostics, Inc, Toronto, Ontario). The approach used by an individual laboratory for verification of a US Food and Drug Administration-approved assay is described. Specific verification data are provided to highlight the stepwise verification approach undertaken by a clinical diagnostic laboratory. Protocols for verification of in vitro diagnostic assays may vary between laboratories. However, all laboratories must verify several specific performance specifications prior to implementation of such assays for clinical use. We provide an example of an approach used for verifying performance of an assay for cystic fibrosis carrier screening.
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Manca, Claudia; Hill, Carol; Hujer, Andrea M; Patel, Robin; Evans, Scott R; Bonomo, Robert A; Kreiswirth, Barry N
2017-03-15
The Antibacterial Resistance Leadership Group (ARLG) Laboratory Center (LC) leads the evaluation, development, and implementation of laboratory-based research by providing scientific leadership and supporting standard/specialized laboratory services. The LC has developed a physical biorepository and a virtual biorepository. The physical biorepository contains bacterial isolates from ARLG-funded studies located in a centralized laboratory and they are available to ARLG investigators. The Web-based virtual biorepository strain catalogue includes well-characterized gram-positive and gram-negative bacterial strains published by ARLG investigators. The LC, in collaboration with the ARLG Leadership and Operations Center, developed procedures for review and approval of strain requests, guidance during the selection process, and for shipping strains from the distributing laboratories to the requesting investigators. ARLG strains and scientific and/or technical guidance have been provided to basic research laboratories and diagnostic companies for research and development, facilitating collaboration between diagnostic companies and the ARLG Master Protocol for Evaluating Multiple Infection Diagnostics (MASTERMIND) initiative for evaluation of multiple diagnostic devices from a single patient sampling event. In addition, the LC has completed several laboratory-based studies designed to help evaluate new rapid molecular diagnostics by developing, testing, and applying a MASTERMIND approach using purified bacterial strains. In collaboration with the ARLG's Statistical and Data Management Center (SDMC), the LC has developed novel analytical strategies that integrate microbiologic and genetic data for improved and accurate identification of antimicrobial resistance. These novel approaches will aid in the design of future ARLG studies and help correlate pathogenic markers with clinical outcomes. The LC's accomplishments are the result of a successful collaboration with the ARLG's Leadership and Operations Center, Diagnostics and Devices Committee, and SDMC. This interactive approach has been pivotal for the success of LC projects. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false User fees for other veterinary... FEES USER FEES § 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) User fees for veterinary diagnostics tests performed at the...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false User fees for other veterinary... FEES USER FEES § 130.17 User fees for other veterinary diagnostic laboratory tests performed at NVSL (excluding FADDL) or at authorized sites. (a) User fees for veterinary diagnostics tests performed at the...
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Laboratory activities involving transmissible spongiform encephalopathy causing agents
Leunda, Amaya; Van Vaerenbergh, Bernadette; Baldo, Aline; Roels, Stefan; Herman, Philippe
2013-01-01
Since the appearance in 1986 of epidemic of bovine spongiform encephalopathy (BSE), a new form of neurological disease in cattle which also affected human beings, many diagnostic and research activities have been performed to develop detection and therapeutic tools. A lot of progress was made in better identifying, understanding and controlling the spread of the disease by appropriate monitoring and control programs in European countries. This paper reviews the recent knowledge on pathogenesis, transmission and persistence outside the host of prion, the causative agent of transmissible spongiform encephalopathies (TSE) in mammals with a particular focus on risk (re)assessment and management of biosafety measures to be implemented in diagnostic and research laboratories in Belgium. Also, in response to the need of an increasing number of European diagnostic laboratories stopping TSE diagnosis due to a decreasing number of TSE cases reported in the last years, decontamination procedures and a protocol for decommissioning TSE diagnostic laboratories is proposed. PMID:24055928
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van Asten, Liselotte; van der Lubben, Mariken; van den Wijngaard, Cees; van Pelt, Wilfrid; Verheij, Robert; Jacobi, Andre; Overduin, Pieter; Meijer, Adam; Luijt, Dirk; Claas, Eric; Hermans, Mirjam; Melchers, Willem; Rossen, John; Schuurman, Rob; Wolffs, Petra; Boucher, Charles; Bouchier, Charles; Schirm, Jurjen; Kroes, Louis; Leenders, Sander; Galama, Joep; Peeters, Marcel; van Loon, Anton; Stobberingh, Ellen; Schutten, Martin; Koopmans, Marion
2009-07-01
Experience with a highly pathogenic avian influenza outbreak in the Netherlands (2003) illustrated that the diagnostic demand for respiratory viruses at different biosafety levels (including BSL3), can increase unexpectedly and dramatically. We describe the measures taken since, aimed at strengthening national laboratory surge capacity and improving preparedness for dealing with diagnostic demand during outbreaks of (emerging) respiratory virus infections, including pandemic influenza virus. Academic and peripheral medical-microbiological laboratories collaborated to determine minimal laboratory requirements for the identification of viruses in the early stages of a pandemic or a large outbreak of avian influenza virus. Next, an enhanced collaborative national network of outbreak assistance laboratories (OAL) was set up. An inventory was made of the maximum diagnostic throughput that this network can deliver in a period of intensified demand. For an estimate of the potential magnitude of this surge demand, historical counts were calculated from hospital- and physician-based registries of patients presenting with respiratory symptoms. Number of respiratory physician-visits ranged from 140,000 to 615,000 per month and hospitalizations ranged from 3000 to 11,500 per month. The established OAL-network provides rapid diagnostic response with agreed quality requirements and a maximum throughput capacity of 1275 samples/day (38,000 per month), assuming other routine diagnostic work needs to be maintained. Thus surge demand for diagnostics for hospitalized cases (if not distinguishable from other respiratory illness) could be handled by the OAL network. Assessing etiology of community acquired acute respiratory infection however, may rapidly exceed the capacity of the network. Therefore algorithms are needed for triaging for laboratory diagnostics; currently this is not addressed in pandemic preparedness plans.
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Brzozowski, Amanda K; Silk, Benjamin J; Berkelman, Ruth L; Loveys, Deborah A; Caliendo, Angela M
2012-01-01
Although clinical microbiology testing facilitates both public health surveillance of infectious diseases and patient care, research on testing patterns is scant. We surveyed hospital laboratories in Georgia to assess their diagnostic testing practices. Using e-mail, all directors of hospital laboratories in Georgia were invited to participate. The survey focused on timing and location of diagnostic testing in 2006 for 6 reportable diseases: giardiasis, legionellosis, meningococcal disease, pertussis, Rocky Mountain spotted fever, and West Nile virus disease. Of 141 laboratories, 62 (44%) responded to the survey. Hospitals varied widely in their use of diagnostic testing in 2006, with 95.1% testing for meningococcal disease, but only 66.1% and 63.3% testing for legionellosis and West Nile virus disease, respectively. Most laboratories (91%) performed gram stain/culture to diagnose meningococcal disease in-house and 23% performed ova and parasite panels for giardiasis were conducted in-house. Fewer than 11% of laboratories performed in-house testing for the remaining diseases. Laboratories affiliated with small hospitals (≤100 beds) were more likely to send specimens for outside testing compared with laboratories associated with large hospitals (>250 beds). Median turnaround time for ova and parasite panel testing for giardiasis was significantly shorter for in-house testing (1.0 days) than within-system (2.25 days) or outside laboratory (3.0 days) testing (P = .0003). No laboratories reported in-house testing for meningococcal disease, pertussis, or Rocky Mountain spotted fever using polymerase chain reaction. Many hospitals did not order diagnostic tests for important infectious diseases during 2006, even for relatively common diseases. In addition, hospital laboratories were unlikely to perform diagnostic testing in-house; sending specimens to an outside laboratory may result in substantial delays in receiving results. These unsettling findings have adverse implications for both patient care and public health surveillance; they indicate an immediate need to study nationally the use and timeliness of clinical microbiologic testing.
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Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan.
Elduma, Adel Hussein
2012-01-01
This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too.
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Truszczyński, M J
1998-08-01
Veterinary laboratories which deal with infectious diseases form three groups according to the tasks for which they are responsible. The first group includes central or national veterinary laboratories, national or international reference laboratories, high-security laboratories, district regional or state veterinary diagnostic laboratories. The major role of these laboratories is to assist national Veterinary Services in diagnosing infectious animal diseases. The second group comprises laboratories that produce veterinary diagnostic kits and those that produce veterinary vaccines. The third group is composed of veterinary research laboratories, which generally concentrate on basic research and do not contribute directly to the diagnosis and control of infectious animal diseases. The author describes the objectives of each of the three groups of laboratories.
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Laboratory diagnostics of chronic kidney disease in Croatia: state of the art
Honović, Lorena; Matica, Jasminka; Knežević, Branka; Vojak, Sanela Šimić
2015-01-01
Introduction Early identification and management of chronic kidney disease (CKD) is highly cost-effective and can reduce the risk of kidney failure progression and cardiovascular disease. In 2014, the Joint Croatian Working Group (JCWG) for laboratory diagnostic of CKD on the behalf of Croatian society of medical biochemistry and laboratory medicine (CSMBLM) and Croatian chamber of medical biochemists (CCMB) conducted a survey across Croatian medical-biochemistry laboratories to assess the current practice in this area of laboratory medicine. The aim of this study was to present the data collected through the survey and to give insight about laboratory diagnostics of chronic kidney disease in Croatia. Materials and methods An invitation to participate in the survey was sent to all Croatian medical-biochemistry laboratories (N = 196). The questionnaire was designed in a form of questions and statements, with possible multiple answers, comprising 24 questions. Results The response rate was 80/196 (40.8%). 39 answers were from primary medical-biochemistry laboratories. 31/78 (0.40) laboratories measure creatinine with non-standardized method (uncompensated Jaffe method). 58/78 (0.74) of laboratories that measure creatinine do not report eGFR values. Similar number of laboratories (58/80, 0.73) do not measure urine albumin or protein. Conclusions There is a large heterogeneity among Croatian laboratories regarding measuring methods, reporting units and reference intervals (cut-off values), both for creatinine and urine albumin or protein. The two key prerequisites for CKD screening, automatic reporting of eGFR and albuminuria or proteinuria assessment, are not implemented nationwide. There is a need for harmonization in laboratory diagnostics of CKD in Croatia. PMID:25672470
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Alexander, C L; Currie, S; Pollock, K; Smith-Palmer, A; Jones, B L
2017-06-01
Giardia duodenalis and Cryptosporidium species are protozoan parasites capable of causing gastrointestinal disease in humans and animals through the ingestion of infective faeces. Whereas Cryptosporidium species can be acquired locally or through foreign travel, there is the mis-conception that giardiasis is considered to be largely travel-associated, which results in differences in laboratory testing algorithms. In order to determine the level of variation in testing criteria and detection methods between diagnostic laboratories for both pathogens across Scotland, an audit was performed. Twenty Scottish diagnostic microbiology laboratories were invited to participate with questions on sample acceptance criteria, testing methods, testing rates and future plans for pathogen detection. Reponses were received from 19 of the 20 laboratories representing each of the 14 territorial Health Boards. Detection methods varied between laboratories with the majority performing microscopy, one using a lateral flow immunochromatographic antigen assay, another using a manually washed plate-based enzyme immunoassay (EIA) and one laboratory trialling a plate-based EIA automated with an EIA plate washer. Whereas all laboratories except one screened every stool for Cryptosporidium species, an important finding was that significant variation in the testing algorithm for detecting Giardia was noted with only four laboratories testing all diagnostic stools. The most common criteria were 'travel history' (11 laboratories) and/or 'when requested' (14 laboratories). Despite only a small proportion of stools being examined in 15 laboratories for Giardia (2%-18% of the total number of stools submitted), of interest is the finding that a higher positivity rate was observed for Giardia than Cryptosporidium in 10 of these 15 laboratories. These findings highlight that the underreporting of Giardia in Scotland is likely based on current selection and testing algorithms.
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District, state or regional veterinary diagnostic laboratories.
Gosser, H S; Morehouse, L G
1998-08-01
The district, regional or state laboratory is the local laboratory to which veterinarian practitioners usually submit samples, and consequently these laboratories are usually the first to observe a suspected disease problem. In most countries, these laboratories are under the jurisdiction of the State or region in which they are located. In the United States of America (USA), most veterinary diagnostic laboratories are State-associated and operate under the aegis of either the State Department of Agriculture or a university. The national laboratory provides reference assistance to the State laboratories. In the USA, the national Laboratory (the National Veterinary Services Laboratories) acts as a consultant to confirm difficult diagnoses and administer performance tests for State-associated laboratories. District, state or regional laboratories need to share information regarding technological advances in diagnostic procedures. This need was met in the USA by the formation of the American Association of Veterinary Laboratory Diagnosticians (AAVLD) in the late 1950s. Another requirement of district, state or regional diagnostic laboratories is a method to confirm quality assurance, which was fulfilled in the USA by an accreditation programme established through the AAVLD. The Accreditation Committee evaluates laboratories (on request) in terms of organisation, personnel, physical facilities and equipment, records, finance and budget. Those laboratories which meet the standards as established in the 'Essential Requirements for Accreditation' are given accreditation status, which indicates that they have the expertise and facilities to perform tests on food-producing animals for shipment in national or international commerce and on companion, laboratory or zoo animals. While confidentiality of test records is most important, it is becoming necessary to release certain types of animal disease test information if a country is to participate in the exportation of animals and animal products. As district, state and regional laboratories operate under many different administrative entities (i.e., universities, State governments and the Federal government), various checks at different administrative levels provide safeguards and reduce the possibility of faulty disease reporting.
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Sá, Luísa; Teixeira, Andreia Sofia Costa; Tavares, Fernando; Costa-Santos, Cristina; Couto, Luciana; Costa-Pereira, Altamiro; Hespanhol, Alberto Pinto; Santos, Paulo
2017-01-01
Objectives To characterise the test ordering pattern in Northern Portugal and to investigate the influence of context-related factors, analysing the test ordered at the level of geographical groups of family physicians and at the level of different healthcare organisations. Design Cross-sectional study. Setting Northern Primary Health Care, Portugal. Participants Records about diagnostic and laboratory tests ordered from 2035 family physicians working at the Northern Regional Health Administration, who served approximately 3.5 million Portuguese patients, in 2014. Outcomes To determine the 20 most ordered diagnostic and laboratory tests in the Northern Regional Health Administration; to identify the presence and extent of variations in the 20 most ordered diagnostic and laboratory tests between the Groups of Primary Care Centres and between health units; and to study factors that may explain these variations. Results The 20 most ordered diagnostic and laboratory tests almost entirely comprise laboratory tests and account for 70.9% of the total tests requested. We can trace a major pattern of test ordering for haemogram, glucose, lipid profile, creatinine and urinalysis. There was a significant difference (P<0.001) in test orders for all tests between Groups of Primary Care Centres and for all tests, except glycated haemoglobin (P=0.06), between health units. Generally, the Personalised Healthcare Units ordered more than Family Health Units. Conclusions The results from this study show that the most commonly ordered tests in Portugal are laboratory tests, that there is a tendency for overtesting and that there is a large variability in diagnostic and laboratory test ordering in different geographical and organisational Portuguese primary care practices, suggesting that there may be considerable potential for the rationalisation of test ordering. The existence of Family Health Units seems to be a strong determinant in decreasing test ordering by Portuguese family physicians. Approaches to ensuring more rational testing are needed. PMID:29146654
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Hölzel, W; Baumgarten, R; Fiedler, H; Zimmermann, S
1985-12-01
The optimal utilization of the knowledge and possibilities of pathological and clinical biochemistry presumes a close cooperation between it and the clinical specialties. The common working team of the GDR Society of Internal Medicine and the GDR Society for Clinical Chemistry and Laboratory Diagnostics makes theses of the central points of the cooperation in care, education, further education and postgraduate study and in research a subject for discussion. As essential tasks in the process of medical care are regarded the balance of the examination programme standing at the disposal, the establishment of diagnostic programmes, the establishment of organisational measures, the ascertainment of a use according to indication, the guarantee of the representance of examination material, the control of plausibility and the interpretation of test results. Since the realization of the tasks to a large extent depends on the cooperation of the specialities in education, further education and postgraduate study during the further education the clinician should become acquainted with the possibilities, the limits and the prerequisites for the performance of laboratory diagnostic investigations, the clinical biochemist with the problems of medical care and the value of the laboratory diagnosis in the total process of the treatment. In the field of research the result is a necessary cooperation in the clarification of patho-biochemical mechanisms, in the search for suitable laboratory diagnostic parameters for diagnostics and control of the course as well as in the statement of the validity of laboratory diagnostic parameters and parameter combinations taking into consideration the factors expenses, benefit and risk as well as further diagnostic possibilities.
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Implementation of HIV and Tuberculosis Diagnostics: The Importance of Context
Dominique, Joyelle K.; Ortiz-Osorno, Alberto A.; Fitzgibbon, Joseph; Gnanashanmugam, Devasena; Gilpin, Christopher; Tucker, Timothy; Peel, Sheila; Peter, Trevor; Kim, Peter; Smith, Steven
2015-01-01
Background. Novel diagnostics have been widely applied across human immunodeficiency virus (HIV) and tuberculosis prevention and treatment programs. To achieve the greatest impact, HIV and tuberculosis diagnostic programs must carefully plan and implement within the context of a specific healthcare system and the laboratory capacity. Methods. A workshop was convened in Cape Town in September 2014. Participants included experts from laboratory and clinical practices, officials from ministries of health, and representatives from industry. Results. The article summarizes best practices, challenges, and lessons learned from implementation experiences across sub-Saharan Africa for (1) building laboratory programs within the context of a healthcare system; (2) utilizing experience of clinicians and healthcare partners in planning and implementing the right diagnostic; and (3) evaluating the effects of new diagnostics on the healthcare system and on patient health outcomes. Conclusions. The successful implementation of HIV and tuberculosis diagnostics in resource-limited settings relies on careful consideration of each specific context. PMID:26409272
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Lippi, Giuseppe; Plebani, Mario; Favaloro, Emmanuel J
2015-04-01
The reality of laboratory diagnostics as a whole, and hemostasis testing in particular, is evolving under new paradigms of efficiency. The driving forces of health care and laboratory diagnostics in the third millennium are mainly represented by macro- and microeconomics. In a world with limited resources, shattered by an unprecedented economic crisis, laboratory diagnostics is undergoing a substantial reorganization, with emergence of new models under the imperative of terms, such as bedside testing, consolidation, and networking. The paradigms under which these changes are being developed include a variety of environment, preanalytical, technological, professional, and health-care aspects. The maintenance of continued quality is indeed the major challenge to be faced in the foreseeable future. In fact, some challenges prepotently emerge during a consolidation process, which basically involve delayed testing, centrifugation, transportation, and stability of the specimens, as well as the potential mismatch of sample matrix. This article is aimed to provide an overview of the current economic scenario of laboratory diagnostics and discuss the changing face of hemostasis testing in modern laboratories, providing a synthetic overview about potential drawbacks of actualized solutions. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
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Onishenko, G G; Popova, A Iu; Bragina, I V; Kuz'kin, B P; Ezhlova, E B; Demina, Iu V; Gus'kov, A S; Ivanov, G E; Chikina, L V; Klindukhova, V P; Grechanaia, T V; Tesheva, S Ch; Kulichenko, A N; Efremenko, D B; Manin, E A; Kuznetsova, I V; Parkhomenko, V V; Kulichenko, O A; Rafeenko, G K; Shcherbina, L I; Zavora, D L; Briukhanov, A F; Eldinova, V E; Iunicheva, Iu V; Derliatko, S K; Komarov, N S
2015-01-01
The experience of the organization and functioning of the laboratory network during the XXII Olympic Winter Games and XI Paralympic Winter Games of 2014 in Sochi is considered. Efforts to establish an effective system of laboratory support, the order of work and interaction of diagnostic laboratories involved in diseases control of population during the Olympic Games are analyzed.
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Robinson, P A; Epperson, W B
2013-05-11
Diagnostic sampling of farm animals by private veterinary practitioners can be an important contributing factor towards the discovery of emerging and exotic diseases. This focus group study of farm animal practitioners in Northern Ireland investigated their use and expectations of diagnostic veterinary laboratories, and elicited their opinions on the role of the private practitioner in veterinary surveillance and the protection of rural public health. The veterinarians were enthusiastic users of diagnostic laboratories, and regarded their own role in surveillance as pivotal. They attached great importance to their veterinary public health duties, and called for more collaboration with their medical general practitioner counterparts. The findings of this research can be used to guide future development of veterinary diagnostic services; provide further insights into the mechanics of scanning surveillance; and measure progress towards a 'One Health' approach between veterinarians and physicians in one geographical region of the UK.
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Djangirova, T V; Shabalova, I P; Pronichev, A N; Polyakov, E V
2015-08-01
The article considers application of technology of analysis of cytological slides in external quality control of clinical diagnostic laboratories. The advantages of virtual slides are demonstrated against other applied technologies of external evaluation of quality i.e. slide plate and digital micro-photography. The conditions of formation of virtual slides for external evaluation of quality of clinical diagnostic laboratories. The technology of their application is described. The success of practical application of considered technology in the Federal system of external evaluation of quality is emphasized.
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Integration of Diagnostic Microbiology in a Model of Total Laboratory Automation.
Da Rin, Giorgio; Zoppelletto, Maira; Lippi, Giuseppe
2016-02-01
Although automation has become widely utilized in certain areas of diagnostic testing, its adoption in diagnostic microbiology has proceeded much more slowly. To describe our real-world experience of integrating an automated instrument for diagnostic microbiology (Walk-Away Specimen Processor, WASPLab) within a model of total laboratory automation (TLA). The implementation process was divided into 2 phases. The former period, lasting approximately 6 weeks, entailed the installation of the WASPLab processor to operate as a stand-alone instrumentation, whereas the latter, lasting approximately 2 weeks, involved physical connection of the WASPLab with the automation. Using the WASPLab instrument in conjunction with the TLA model, we obtained a time savings equivalent to the work of 1.2 full-time laboratory technicians for diagnostic microbiology. The connection of WASPLab to TLA allowed its management by a generalist or clinical chemistry technician, with no need for microbiology skills on the part of either worker. Hence, diagnostic microbiology could be performed by the staff that is already using the TLA, extending their activities to include processing urgent clinical chemistry and hematology specimens. The time to result was also substantially improved. According to our experience, using the WASPLab instrument as part of a TLA in diagnostic microbiology holds great promise for optimizing laboratory workflow and improving the quality of testing. © American Society for Clinical Pathology, 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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Clinical Laboratories – Production Factories or Specialized Diagnostic Centers
Tóth, Judit
2016-01-01
Since a large proportion of medical decisions are based on laboratory results, clinical laboratories should meet the increasing demand of clinicians and their patients. Huge central laboratories may process over 10 million tests annually; they act as production factories, measuring emergency and routine tests with sufficient speed and accuracy. At the same time, they also serve as specialized diagnostic centers where well-trained experts analyze and interpret special test results. It is essential to improve and constantly monitor this complex laboratory service, by several methods. Sample transport by pneumatic tube system, use of an advanced laboratory information system and point-of-care testing may result in decreased total turnaround time. The optimization of test ordering may result in a faster and more cost-effective laboratory service. Autovalidation can save time for laboratory specialists, when the analysis of more complex results requires their attention. Small teams of experts responsible for special diagnostic work, and their interpretative reporting according to predetermined principles, may help to minimize subjectivity of these special reports. Although laboratory investigations have become so diversely developed in the past decades, it is essential that the laboratory can provide accurate results relatively quickly, and that laboratory specialists can support the diagnosis and monitoring of patients by adequate interpretation of esoteric laboratory methods. PMID:27683528
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78 FR 20112 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-03
...-related information. The respondents would be clinical laboratory supervisors, nurses, and other.../60 300 Supervisors. Influenza Diagnostic Test Practices in Clinical Laboratories. Nurses Survey of... this notice. Proposed Project Survey of Rapid Influenza Diagnostic Test (RIDT) Practices in Clinical...
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Sá, Luísa; Costa-Santos, Cristina; Teixeira, Andreia; Couto, Luciana; Costa-Pereira, Altamiro; Hespanhol, Alberto; Santos, Paulo; Martins, Carlos
2015-01-01
Background Physicians’ ability to make cost-effective decisions has been shown to be affected by their knowledge of health care costs. This study assessed whether Portuguese family physicians are aware of the costs of the most frequently prescribed diagnostic and laboratory tests. Methods A cross-sectional study was conducted in a representative sample of Portuguese family physicians, using computer-assisted telephone interviews for data collection. A Likert scale was used to assess physician’s level of agreement with four statements about health care costs. Family physicians were also asked to estimate the costs of diagnostic and laboratory tests. Each physician’s cost estimate was compared with the true cost and the absolute error was calculated. Results One-quarter (24%; 95% confidence interval: 23%–25%) of all cost estimates were accurate to within 25% of the true cost, with 55% (95% IC: 53–56) overestimating and 21% (95% IC: 20–22) underestimating the true actual cost. The majority (76%) of family physicians thought they did not have or were uncertain as to whether they had adequate knowledge of diagnostic and laboratory test costs, and only 7% reported receiving adequate education. The majority of the family physicians (82%) said that they had adequate access to information about the diagnostic and laboratory test costs. Thirty-three percent thought that costs did not influence their decision to order tests, while 27% were uncertain. Conclusions Portuguese family physicians have limited awareness of diagnostic and laboratory test costs, and our results demonstrate a need for improved education in this area. Further research should focus on identifying whether interventions in cost knowledge actually change ordering behavior, in identifying optimal methods to disseminate cost information, and on improving the cost-effectiveness of care. PMID:26356625
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External Quality Assessment beyond the analytical phase: an Australian perspective.
Badrick, Tony; Gay, Stephanie; McCaughey, Euan J; Georgiou, Andrew
2017-02-15
External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion.
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External Quality Assessment beyond the analytical phase: an Australian perspective
Gay, Stephanie; McCaughey, Euan J.; Georgiou, Andrew
2017-01-01
External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion. PMID:28392728
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Assessment of biosafety precautions in Khartoum state diagnostic laboratories, Sudan
Elduma, Adel Hussein
2012-01-01
Background This study was conducted to evaluate the biosafety precautions that applied by diagnostic laboratories in Khartoum state, 2009. Methods A total number of 190 laboratories were surveyed about their compliance with standard biosafety precautions. These laboratories included 51 (27%) laboratories from government, 75 (39%) from private sectors and 64 (34%) laboratories belong to organization providing health care services. Results The study found that 32 (16.8%) of laboratories appointed biosafety officers. Only, ten (5.2%) participated in training about response to fire emergency, and 28 (14.7%) reported the laboratory accident occurred during work. 45 (23.7%) laboratories had a written standard operation procedures (SOPs), and 35 (18.4%) had written procedures for the lean-up of spills. Moreover, biosafety cabinet was found in 11 (5.8%) laboratories, autoclave in 28 (14.7%) and incinerator in only two (1.1%) laboratories. Sharp disposable containers were found in 84 (44.2%). Fire alarm system was found in 2 (1.1%) laboratories, fire extinguisher in 39 (20.5%) laboratories, and fire emergency exit found in 14 (7.4%) laboratories. Furthermore, 19 (10%) laboratories had a hepatitis B virus vaccination programme, 5 (6.2%) applied BCG vaccine, and 2 (1.1%0) vaccinated the staff against influenza. Conclusion The study concluded that the standards biosafety precautions adopted by the diagnostic laboratories in Khartoum state was very low. Further, the laboratory personnel awareness towards biosafety principles implementation was very low too. PMID:22514753
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Biljak, Vanja Radišić; Honović, Lorena; Matica, Jasminka; Krešić, Branka; Vojak, Sanela Šimić
2017-01-01
Chronic kidney disease (CKD) is a common clinical condition with significant adverse consequences for the patient and it is recognized as a significant public health problem. The role of laboratory medicine in diagnosis and management of CKD is of great importance: the diagnosis and staging are based on estimation of glomerular filtration rate (eGFR) and assessment of albuminuria (or proteinuria). Therefore, the joint working group of the Croatian society of medical biochemistry and laboratory medicine and Croatian chamber of medical biochemists for laboratory diagnostics in CKD issued this national recommendation regarding laboratory diagnostics of CKD. Key factors for laboratories implementing the national guidelines for the diagnosis and management of CKD are: 1. Ensure good communication between laboratory professionals and clinicians, such as nephrologists or specialists in general/family medicine, 2. Ensure all patients are provided with the same availability of laboratory diagnostics, 3. Ensure creatinine assays are traceable to isotope dilution mass spectrometry (IDMS) method and have minimal bias and acceptable imprecision, 4. Select the appropriate GFR estimating formula. Recommended equation is the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD – EPI) equation, 5. In reporting the key laboratory tests (creatinine, eGFR, urine albumin-to-creatinine ratio, urine protein-to-creatinine ratio) use the appropriate reporting units, 6. Provide adequate information on limitations of creatinine measurement. The manuscript has been organized to identify critical points in laboratory tests used in basic laboratory diagnostics of CKD and is based on the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. PMID:28392738
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Deans, Zandra C; Costa, Jose Luis; Cree, Ian; Dequeker, Els; Edsjö, Anders; Henderson, Shirley; Hummel, Michael; Ligtenberg, Marjolijn Jl; Loddo, Marco; Machado, Jose Carlos; Marchetti, Antonio; Marquis, Katherine; Mason, Joanne; Normanno, Nicola; Rouleau, Etienne; Schuuring, Ed; Snelson, Keeda-Marie; Thunnissen, Erik; Tops, Bastiaan; Williams, Gareth; van Krieken, Han; Hall, Jacqueline A
2017-01-01
The clinical demand for mutation detection within multiple genes from a single tumour sample requires molecular diagnostic laboratories to develop rapid, high-throughput, highly sensitive, accurate and parallel testing within tight budget constraints. To meet this demand, many laboratories employ next-generation sequencing (NGS) based on small amplicons. Building on existing publications and general guidance for the clinical use of NGS and learnings from germline testing, the following guidelines establish consensus standards for somatic diagnostic testing, specifically for identifying and reporting mutations in solid tumours. These guidelines cover the testing strategy, implementation of testing within clinical service, sample requirements, data analysis and reporting of results. In conjunction with appropriate staff training and international standards for laboratory testing, these consensus standards for the use of NGS in molecular pathology of solid tumours will assist laboratories in implementing NGS in clinical services.
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Cheng, Chee Leong; Azhar, Rafay; Sng, Shi Hui Adeline; Chua, Yong Quan; Hwang, Jacqueline Siok Gek; Chin, Jennifer Poi Fun; Seah, Waih Khuen; Loke, Janel Chui Ling; Ang, Roy Hang Leng; Tan, Puay Hoon
2016-09-01
As digital pathology (DP) and whole slide imaging (WSI) technology advance and mature, there is an increasing drive to incorporate DP into the diagnostic environment. However, integration of DP into the diagnostic laboratory is a non-trivial task and filled with unexpected challenges unlike standalone implementations. We share our journey of implementing DP in the diagnostic laboratory setting, highlighting seven key guiding principles that drive the progression through implementation into deployment and beyond. The DP implementation with laboratory information system integration was completed in 8 months, including validation of the solution for diagnostic use in accordance with College of American Pathologists guidelines. We also conducted prospective validation via paired delivery of glass slides and WSI to our pathologists postdeployment. Common themes in our guiding principles included emphasis on workflow and being comprehensive in the approach, looking beyond pathologist user champions and expanding into an extended project team involving laboratory technicians, clerical/data room staff and archival staff. Concordance between glass slides and WSI ranged from 93% to 100% among various applications on validation. We also provided equal opportunities for every pathologist throughout the department to be competent and confident with DP through prospective validation, with overall concordance of 96% compared with glass slides, allowing appreciation of the advantages and limitations of WSI, hence enabling the use of DP as a useful diagnostic modality. Smooth integration of DP into the diagnostic laboratory is possible with careful planning, discipline and a systematic approach adhering to our guiding principles. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
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Argonne Collaborative Center for Energy Storage Science (ACCESS)
Analysis and Diagnostics Laboratory (EADL) Post- Test Facility Access Proven Capabilities Argonne has Analysis, Modeling and Prototyping (CAMP) Electrochemical Analysis and Diagnostics Laboratory (EADL) Post -Test Facility Argonne User Facilities Industries Transportation Consumer Electronics Defense Electric
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Mögling, Ramona; Zeller, Hervé; Revez, Joana; Koopmans, Marion; Reusken, Chantal
2017-01-01
With international travel, Zika virus (ZIKV) is introduced to Europe regularly. A country's ability to robustly detect ZIKV introduction and local transmission is important to minimise the risk for a ZIKV outbreak. Therefore, sufficient expertise and diagnostic capacity and capability are required in European laboratories. To assess the capacity, quality, operational specifics (guidelines and algorithms), technical and interpretation issues and other possible difficulties that were related to ZIKV diagnostics in European countries, a questionnaire was conducted among national reference laboratories in 30 countries in the European Union/European Economic Area (EU/EEA) in May 2016. While the coverage and capacity of ZIKV diagnostics in the EU/EEA national reference laboratories were found to be adequate, the assessment of the quality and needs indicated several crucial points of improvement that will need support at national and EU/EEA level to improve ZIKV preparedness, response and EU/EEA ZIKV surveillance activities. PMID:28920574
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Laboratory development and testing of spacecraft diagnostics
NASA Astrophysics Data System (ADS)
Amatucci, William; Tejero, Erik; Blackwell, Dave; Walker, Dave; Gatling, George; Enloe, Lon; Gillman, Eric
2017-10-01
The Naval Research Laboratory's Space Chamber experiment is a large-scale laboratory device dedicated to the creation of large-volume plasmas with parameters scaled to realistic space plasmas. Such devices make valuable contributions to the investigation of space plasma phenomena under controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. However, in addition to investigations such as plasma wave and instability studies, such devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this talk, we will describe how the laboratory simulation of space plasmas made this development path possible. Work sponsored by the US Naval Research Laboratory Base Program.
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Wildlife specimen collection, preservation, and shipment
White, C. LeAnn; Dusek, Robert J.; Franson, J. Christian; Friend, Milton; Gibbs, Samantha E.J.; Wild, Margaret A.
2015-01-01
Prior to collecting samples, it is important to determine the capabilities and submission criteria of the laboratory receiving the samples. Some laboratories may specialize in a limited number of tests, be equipped to accept only certain types of tissues (instead of entire carcasses), or specialize in particular species or group of animals (e.g., reptiles, birds, mammals). Diagnostic laboratories have specific requirements regarding preparation, labeling, and shipping of samples. Adherence to these requirements helps ensure the usefulness of any submitted specimens. Although laboratories may vary in the cost and turnaround times for diagnostic tests, some laboratories may be able to prioritize samples and accommodate accelerated time frames if communicated at the time of submission. Keeping a prepacked kit with basic carcass-collection supplies, including a paper copy of the specimen history form (available for download from the Web sites of most diagnostic laboratories), in the office or vehicle will decrease the chances of forgetting an essential item and decrease response time for arriving at an event.
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Lumbreras-Lacarra, Blanca; Ramos-Rincón, José Manuel; Hernández-Aguado, Ildefonso
2004-03-01
The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.
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Magnusson, Bertil; Ossowicki, Haakan; Rienitz, Olaf; Theodorsson, Elvar
2012-05-01
Healthcare laboratories are increasingly joining into larger laboratory organizations encompassing several physical laboratories. This caters for important new opportunities for re-defining the concept of a 'laboratory' to encompass all laboratories and measurement methods measuring the same measurand for a population of patients. In order to make measurement results, comparable bias should be minimized or eliminated and measurement uncertainty properly evaluated for all methods used for a particular patient population. The measurement as well as diagnostic uncertainty can be evaluated from internal and external quality control results using GUM principles. In this paper the uncertainty evaluations are described in detail using only two main components, within-laboratory reproducibility and uncertainty of the bias component according to a Nordtest guideline. The evaluation is exemplified for the determination of creatinine in serum for a conglomerate of laboratories both expressed in absolute units (μmol/L) and relative (%). An expanded measurement uncertainty of 12 μmol/L associated with concentrations of creatinine below 120 μmol/L and of 10% associated with concentrations above 120 μmol/L was estimated. The diagnostic uncertainty encompasses both measurement uncertainty and biological variation, and can be estimated for a single value and for a difference. This diagnostic uncertainty for the difference for two samples from the same patient was determined to be 14 μmol/L associated with concentrations of creatinine below 100 μmol/L and 14 % associated with concentrations above 100 μmol/L.
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Bartlett, John M S; Campbell, Fiona M; Ibrahim, Merdol; Thomas, Jeremy; Wencyk, Pete; Ellis, Ian; Kay, Elaine; Connolly, Yvonne; O'Grady, Anthony; Barnett, Sarah; Starczynski, Jane; Cunningham, Paul; Miller, Keith
2010-02-01
To assess a new HER2 fluorescence in situ hybridization (FISH) test and report on multicentre intrasite and intersite variation. HER2 results were scored from 45 breast cancers in eight laboratories using the Kreatech Poseidon HER2 FISH probe (Kreatech Diagnostics, Amsterdam, the Netherlands). Overall, 80.9% of cores were successfully analysed. Mean intrasite variation for HER2 ratio assessment was low (4.74%). Intersite variation in ratio was in line with previous reports (11.9+/-0.8%) for both reference and non-reference laboratories; only one laboratory displayed significantly higher intersite variation (P=0.009) than the remaining seven laboratories. The overall incidence of misclassification of cores was <1.3%, demonstrating an excellent level of concordance (>98.7%) across all eight laboratories, irrespective of whether they were 'reference' or 'routine diagnostic' laboratories. The Kreatech Poseidon HER2 FISH test is robust and reproducible. Highly quantitatively reproducible FISH results were obtained from eight 'diagnostic' and 'reference' laboratories; however, continued quality assessments are essential to good performance.
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Code of Federal Regulations, 2014 CFR
2014-10-01
.... Nonphysician practitioners (that is, clinical nurse specialists, clinical psychologists, clinical social... that do not involve the use of contrast media; and (iii) Diagnostic mammograms if the approved portable...
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Autoimmune diagnostics: the technology, the strategy and the clinical governance.
Bizzaro, Nicola; Tozzoli, Renato; Villalta, Danilo
2015-02-01
In recent years, there has been a profound change in autoimmune diagnostics. From long, tiring and inaccurate manual methods, the art of diagnostics has turned to modern, rapid and automated technology. New antibody tests have been developed, and almost all autoimmune diseases now have some specific diagnostic markers. The current need to make the most of available economic and human resources has led to the production of diagnostic algorithms and guidelines designated for optimal strategic use of the tests and to increase the diagnostic appropriateness. An important role in this scenario was assumed by the laboratory autoimmunologist, whose task is not only to govern the analytical phase, but also to help clinicians in correctly choosing the most suitable test for each clinical situation and provide consultancy support. In this review, we summarize recent advances in technology, describe the diagnostic strategies and highlight the current role of the laboratory autoimmunologist in the clinical governance of autoimmune diagnostics.
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Implementation of HIV and Tuberculosis Diagnostics: The Importance of Context.
Dominique, Joyelle K; Ortiz-Osorno, Alberto A; Fitzgibbon, Joseph; Gnanashanmugam, Devasena; Gilpin, Christopher; Tucker, Timothy; Peel, Sheila; Peter, Trevor; Kim, Peter; Smith, Steven
2015-10-15
Novel diagnostics have been widely applied across human immunodeficiency virus (HIV) and tuberculosis prevention and treatment programs. To achieve the greatest impact, HIV and tuberculosis diagnostic programs must carefully plan and implement within the context of a specific healthcare system and the laboratory capacity. A workshop was convened in Cape Town in September 2014. Participants included experts from laboratory and clinical practices, officials from ministries of health, and representatives from industry. The article summarizes best practices, challenges, and lessons learned from implementation experiences across sub-Saharan Africa for (1) building laboratory programs within the context of a healthcare system; (2) utilizing experience of clinicians and healthcare partners in planning and implementing the right diagnostic; and (3) evaluating the effects of new diagnostics on the healthcare system and on patient health outcomes. The successful implementation of HIV and tuberculosis diagnostics in resource-limited settings relies on careful consideration of each specific context. Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.
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Atmosphere-ocean gas exchange based on radiocarbon data
NASA Astrophysics Data System (ADS)
Byalko, Alexey
2014-05-01
In recent decades, the intensity of global atmospheric convection has accelerated faster than climate warming; it is possible to judge this process from indirect data. Increasing ocean salinity contrasts provide evidence that evaporation has intensified [1]; sea surface wind velocities and wave heights have increased [2]. The CO2 gas exchange between the atmosphere and ocean must also simultaneously increase. Monthly measurements of atmospheric CO2 concentration have been published since 1958 [3], but directly measuring its fluxes from the atmosphere to the ocean and back is hardly possible. We show they can be reconstructed from 14C isotope concentration data. In the past century, two processes influenced the atmospheric 14C concentration in opposite directions: burning fossil fuels and testing nuclear weapons in the atmosphere. We compare the gas exchange theory with measurements of radiocarbon content in the atmosphere [4—6], which allows assessing the gas exchange quantitatively for the ocean to atmosphere and atmosphere to ocean fluxes separately for period 1960—2010 [7]. References 1. Durack P. J. and Wijffels S. E., J. Climate 23, 4342 (2010). 2. Young I. R., Sieger S., and Babanin A.V., Science 332, 451 (2011). 3. NOAA Earth System Research Laboratory Data: ftp://ftp.cmdl.noaa.gov/ccg/co2/trends/co2_mm_mlo.txt. 4. Nydal R., Lövseth K. // J. Geophys. Res. 1983. V. 88. P. 3579. 5. Levin I., Kromer B. // Radiocarbon. 1997. V. 39. P. 205. 6. Miller J.B., Lehman S.J., Montzka S.A., et al. // J. Geophys. Res. 2012. V. 117. D08302. 7. Byalko A.V. Doklady Physics, 2013. V. 58, 267-271.
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Lianidou, Evi; Ahmad-Nejad, Parviz; Ferreira-Gonzalez, Andrea; Izuhara, Kenji; Cremonesi, Laura; Schroeder, Maria-Eugenia; Richter, Karin; Ferrari, Maurizio; Neumaier, Michael
2014-09-25
Molecular techniques are becoming commonplace in the diagnostic laboratory. Their applications influence all major phases of laboratory medicine including predisposition/genetic risk, primary diagnosis, therapy stratification and prognosis. Readily available laboratory hardware and wetware (i.e. consumables and reagents) foster rapid dissemination to countries that are just establishing molecular testing programs. Appropriate skill levels extending beyond the technical procedure are required for analytical and diagnostic proficiency that is mandatory in molecular genetic testing. An international committee (C-CMBC) of the International Federation for Clinical Chemistry (IFCC) was established to disseminate skills in molecular genetic testing in member countries embarking on the respective techniques. We report the ten-year experience with different teaching and workshop formats for beginners in molecular diagnostics. Copyright © 2014 Elsevier B.V. All rights reserved.
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How clinicians should use the diagnostic laboratory in a changing medical world.
Lundberg, G D
1999-02-01
In developed countries, clinicians are faced with a plethora of diagnostic tests to apply to patients to guide their clinical management. The quality, effectiveness, and efficiency of patient care should be foremost in the clinician's mind. Laboratory directors should make every effort to guide clinicians in appropriate laboratory test ordering, interpretation, and resulting actions. Medicine, being at its center a moral enterprise grounded in a covenant of trust, and laboratory medicine being a subset of medicine, must first care and advocate for the patient, and consider clinical outcomes as most important.
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Roles of laboratories and laboratory systems in effective tuberculosis programmes.
Ridderhof, John C; van Deun, Armand; Kam, Kai Man; Narayanan, P R; Aziz, Mohamed Abdul
2007-05-01
Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB.
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Schroeder, Lee F; Elbireer, Ali; Jackson, J Brooks; Amukele, Timothy K
2015-01-01
Diagnostic laboratory tests are routinely defined in terms of their sensitivity, specificity, and ease of use. But the actual clinical impact of a diagnostic test also depends on its availability and price. This is especially true in resource-limited settings such as sub-Saharan Africa. We present a first-of-its-kind report of diagnostic test types, availability, and prices in Kampala, Uganda. Test types (identity) and availability were based on menus and volumes obtained from clinical laboratories in late 2011 in Kampala using a standard questionnaire. As a measure of test availability, we used the Availability Index (AI). AI is the combined daily testing volumes of laboratories offering a given test, divided by the combined daily testing volumes of all laboratories in Kampala. Test prices were based on a sampling of prices collected in person and via telephone surveys in 2015. Test volumes and menus were obtained for 95% (907/954) of laboratories in Kampala city. These 907 laboratories offered 100 different test types. The ten most commonly offered tests in decreasing order were Malaria, HCG, HIV serology, Syphilis, Typhoid, Urinalysis, Brucellosis, Stool Analysis, Glucose, and ABO/Rh. In terms of AI, the 100 tests clustered into three groups: high (12 tests), moderate (33 tests), and minimal (55 tests) availability. 50% and 36% of overall availability was provided through private and public laboratories, respectively. Point-of-care laboratories contributed 35% to the AI of high availability tests, but only 6% to the AI of the other tests. The mean price of the most commonly offered test types was $2.62 (range $1.83-$3.46). One hundred different laboratory test types were in use in Kampala in late 2011. Both public and private laboratories were critical to test availability. The tests offered in point-of-care laboratories tended to be the most available tests. Prices of the most common tests ranged from $1.83-$3.46.
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Sawford, Kate; Vollman, Ardene Robinson; Stephen, Craig
2013-01-01
The animal and public health communities need to address the challenge posed by zoonotic emerging infectious diseases. To minimize the impacts of future events, animal disease surveillance will need to enable prompt event detection and response. Diagnostic laboratory-based surveillance systems targeting domestic animals depend in large part on private veterinarians to submit samples from cases to a laboratory. In contexts where pre-diagnostic laboratory surveillance systems have been implemented, this group of veterinarians is often asked to input data. This scenario holds true in Alberta where private cattle veterinarians have been asked to participate in the Alberta Veterinary Surveillance Network-Veterinary Practice Surveillance, a platform to which pre-diagnostic disease and non-disease case data are submitted. Consequently, understanding the factors that influence these veterinarians to submit cases to a laboratory and the complex of factors that affect their participation in surveillance programs is foundational to interpreting disease patterns reported by laboratories and engaging veterinarians in surveillance. A focused ethnographic study was conducted with ten cattle veterinarians in Alberta. Individual in-depth interviews with participants were recorded and transcribed to enable thematic analysis. Laboratory submissions were biased toward outbreaks of unknown cause, cases with unusual mortality rates, and issues with potential herd-level implications. Decreasing cattle value and government support for laboratory testing have contributed to fewer submissions over time. Participants were willing participants in surveillance, though government support and collaboration were necessary. Changes in the beef industry and veterinary profession, as well as cattle producers themselves, present both challenges and opportunities in surveillance. PMID:23741397
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[Lab-on-a-chip systems in the point-of-care diagnostics].
Szabó, Barnabás; Borbíró, András; Fürjes, Péter
2015-12-27
The need in modern medicine for near-patient diagnostics being able to accelerate therapeutic decisions and possibly replacing laboratory measurements is significantly growing. Reliable and cost-effective bioanalytical measurement systems are required which - acting as a micro-laboratory - contain integrated biomolecular recognition, sensing, signal processing and complex microfluidic sample preparation modules. These micro- and nanofabricated Lab-on-a-chip systems open new perspectives in the diagnostic supply chain, since they are able even for quantitative, high-precision and immediate analysis of special disease specific molecular markers or their combinations from a single drop of sample. Accordingly, crucial requirements regarding the instruments and the analytical methods are the high selectivity, extremely low detection limit, short response time and integrability into the healthcare information networks. All these features can make the hierarchical examination chain shorten, and revolutionize laboratory diagnostics, evolving a brand new situation in therapeutic intervention.
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CLINICAL APPROACH TO THE DIAGNOSTIC EVALUATION OF HERDITARY AND ACQUIRED NEUROMUSCULAR DISEASES
McDonald, Craig M.
2012-01-01
SYNOPSIS In the context of a neuromuscular disease diagnostic evaluation, the clinician still must be able to obtain a relevant patient and family history and perform focused general, musculoskeletal, neurologic and functional physical examinations to direct further diagnostic evaluations. Laboratory studies for hereditary neuromuscular diseases include relevant molecular genetic studies. The EMG and nerve conduction studies remain an extension of the physical examination and help to guide further diagnostic studies such as molecular genetic studies, and muscle and nerve biopsies. All diagnostic information needs to be interpreted not in isolation, but within the context of relevant historical information, family history, physical examination findings, and laboratory data, electrophysiologic findings, pathologic findings, and molecular genetic findings if obtained. PMID:22938875
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Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories.
Jang, Mi Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong Ho; Min, Won Ki; Lee, Ji Sung; Lee, Yong Wha; Lee, You Kyoung
2017-05-01
Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. © The Korean Society for Laboratory Medicine
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Point of care investigations in pediatric care to improve health care in rural areas.
Walia, Kamini
2013-07-01
The good quality laboratory services in developing countries are often limited to major urban centers. As a result, many commercially available high-quality diagnostic tests for infectious diseases are neither accessible nor affordable to patients in the rural areas. Health facilities in rural areas are compromised and this limits the usability and performance of the best medical diagnostic technologies in rural areas as they are designed for air-conditioned laboratories, refrigerated storage of chemicals, a constant supply of calibrators and reagents, stable electrical power, highly trained personnel and rapid transportation of samples. The advent of new technologies have allowed miniaturization and integration of complex functions, which has made it possible for sophisticated diagnostic tools to move out of the developed-world laboratory in the form of a "point of care"(POC) tests. Many diagnostic tests are being developed using these platforms. However, the challenge is to develop diagnostics which are inexpensive, rugged and well suited to the medical and social contexts of the developing world and do not compromise on accuracy and reliability. The already available POC tests which are reliable and affordable, like for HIV infection, malaria, syphilis, and some neglected tropical diseases, and POC tests being developed for other diseases if correctly used and effectively regulated after rigorous evaluation, have the potential to make a difference in clinical management and improve surveillance. In order to use these tests effectively they would need to be supported by technically competent manpower, availability of good-quality reagents, and healthcare providers who value and are able to interpret laboratory results to guide treatment; and a system for timely communication between the laboratory and the healthcare provider. Strengthening the laboratories at the rural level can enable utilization of these diagnostics for improving the diagnosis and management of infectious diseases among children which require prompt treatment and thus, considerably reduce morbidity and mortality among the pediatric age group.
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De Clercq, K; Goris, N; Barnett, P V; MacKay, D K
2008-01-01
The last decade international trade in animals and animal products was liberated and confidence in this global trade can increase only if appropriate control measures are applied. As foot-and-mouth disease (FMD) diagnostics will play an essential role in this respect, the Food and Agriculture Organization European Commission for the Control of Foot-and-Mouth Disease (EUFMD) co-ordinates, in collaboration with the European Commission, several programmes to increase the quality of FMD diagnostics. A quality assurance (QA) system is deemed essential for laboratories involved in certifying absence of FMDV or antibodies against the virus. Therefore, laboratories are encouraged to validate their diagnostic tests fully and to install a continuous quality control (QC) monitoring system. Knowledge of performance characteristics of diagnostics is essential to interpret results correctly and to calculate sample rates in regional surveillance campaigns. Different aspects of QA/QC of classical and new FMD virological and serological diagnostics are discussed in respect to the EU FMD directive (2003/85/EC). We recommended accepting trade certificates only from laboratories participating in international proficiency testing on a regular basis.
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Evaluation of the enterovirus laboratory surveillance system in Denmark, 2010 to 2013.
Condell, Orla; Midgley, Sofie; Christiansen, Claus Bohn; Chen, Ming; Chen Nielsen, Xiaohui; Ellermann-Eriksen, Svend; Mølvadgaard, Mette; Schønning, Kristian; Vermedal Hoegh, Silje; Andersen, Peter Henrik; Voldstedlund, Marianne; Fischer, Thea Kølsen
2016-05-05
The primary aim of the Danish enterovirus (EV) surveillance system is to document absence of poliovirus infection. The conflict in Syria has left many children unvaccinated and movement from areas with polio cases to Europe calls for increased awareness to detect and respond to virus-transmission in a timely manner. We evaluate the national EV laboratory surveillance, to generate recommendations for system strengthening. The system was analysed for completeness of viral typing analysis and clinical information and timeliness of specimen collection, laboratory results and reporting of clinical information. Of 23,720 specimens screened, 2,202 (9.3%) were EV-positive. Submission of cerebrospinal fluid and faecal specimens from primary diagnostic laboratories was 79.5% complete (845/1,063), and varied by laboratory and patient age. EV genotypes were determined in 68.5% (979/1,430) of laboratory-confirmed cases, clinical information was available for 63.1% (903/1,430). Primary diagnostic results were available after a median of 1.4 days, typing results after 17 days, detailed clinical information after 33 days. The large number of samples typed demonstrated continued monitoring of EV-circulation in Denmark. The system could be strengthened by increasing the collection of supplementary faecal specimens, improving communication with primary diagnostic laboratories, adapting the laboratory typing methodology and collecting clinical information with electronic forms.
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Naicker, Serisha D; Govender, Nevashan; Patel, Jaymati; Zietsman, Inge L; Wadula, Jeannette; Coovadia, Yacoob; Kularatne, Ranmini; Seetharam, Sharona; Govender, Nelesh P
2016-11-01
From February 2009 through August 2010, we compared species-level identification of bloodstream Candida isolates and susceptibility to fluconazole, voriconazole, and caspofungin between diagnostic and reference South African laboratories during national surveillance for candidemia. Diagnostic laboratories identified isolates to genus/species level and performed antifungal susceptibility testing, as indicated. At a reference laboratory, viable Candida isolates were identified to species-level using automated systems, biochemical tests, or DNA sequencing; broth dilution susceptibility testing was performed. Categorical agreement (CA) was calculated for susceptibility results of isolates with concordant species identification. Overall, 2172 incident cases were detected, 773 (36%) by surveillance audit. The Vitek 2 YST system (bioMérieux Inc, Marcy l'Etoile, France) was used for identification (360/863, 42%) and susceptibility testing (198/473, 42%) of a large proportion of isolates. For the five most common species (n = 1181), species-level identification was identical in the majority of cases (Candida albicans: 98% (507/517); Candida parapsilosis: 92% (450/488); Candida glabrata: 89% (89/100); Candida tropicalis: 91% (49/54), and Candida krusei: 86% (19/22)). However, diagnostic laboratories were significantly less likely to correctly identify Candida species other than C. albicans versus C. albicans (607/664, 91% vs. 507/517, 98%; P < .001). Susceptibility data were compared for isolates belonging to the five most common species and fluconazole, voriconazole, and caspofungin in 860, 580, and 99 cases, respectively. Diagnostic laboratories significantly under-reported fluconazole resistance in C. parapsilosis (225/393, 57% vs. 239/393, 61%; P < .001) but over-reported fluconazole non-susceptibility in C. albicans (36/362, 10% vs. 3/362, 0.8%; P < .001). Diagnostic laboratories were less likely to correctly identify Candida species other than C. albicans, under-reported fluconazole resistance for C. parapsilosis and over-reported fluconazole resistance for C. albicans. © The Author 2016. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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[Evaluation of quality of HIV diagnostic procedures in Poland].
Parczewski, Miłosz; Madaliński, Kazimierz; Leszczyszyn-Pynka, Magdalena; Boroń-Kaczmarska, Anna
2010-01-01
The aim of this work was quality assessment of HIV diagnostic procedures in Poland, including human and technical resources as well as laboratory practice. Sixty questionnaires were distributed among diagnostic centers to obtain qualitative data. Basing on the survey data serological control using coded panels of HIV-1/2 samples was performed. Thirty-one filled questionnaires were received (50.8%). Surveyed laboratories perform from 350 to 5500 serological screening tests per year. In most of laboratories fourth generation assays are available, while Blood Donation Centers screen the blood both with serological assays and by HIV-RNA detection. Sanitary and Epidemiological Stations and academic laboratories hold the ISO/IEC 17025 or IS0 9001:2001 accreditation, five of the surveyed centers participate in Labquality assurance and two in Quality Control in Molecular Diagnostics programs. Data of control serological testing were received from 21 centers. In the quality control assessment 194 analyses were performed with 91 true negative, 2 false negative, 96 true positive and 5 false positive results. False negative rate of % and false positive rate of 5.2% was noted for this study. Currently, virtually no guidelines related to the HIV-diagnostics quality assurance and control in Poland are in delineated. Development of the national unified quality control system, basing on the central institution is highly desirable. National certification within the frames of the quality control and assurance program should be mandatory for all the diagnostic labs, and aim at improvement of reliability of the result distributed among clinicians and patients.
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DRG Watchdog highlights new financial dimensions of laboratory diagnostics.
2003-01-01
As nebulous as the details of the German diagnosis-oriented case reimbursement rate (G-DRGs) might be, one thing is obvious: rapid and accurate diagnostics will be vital in future to the reimbursement of standard cases that reflect the actual outlay. The laboratory that up to now has always been categorized as a potential for savings, now becomes a source of revenue for hospitals. A study initiated by the VDGH provides evidence for this (Clinical Laboratory 2002, 48, 327).
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Effect of Accreditation on Accuracy of Diagnostic Tests in Medical Laboratories
Jang, Mi-Ae; Yoon, Young Ahn; Song, Junghan; Kim, Jeong-Ho; Min, Won-Ki; Lee, Ji Sung
2017-01-01
Background Medical laboratories play a central role in health care. Many laboratories are taking a more focused and stringent approach to quality system management. In Korea, laboratory standardization efforts undertaken by the Korean Laboratory Accreditation Program (KLAP) and the Korean External Quality Assessment Scheme (KEQAS) may have facilitated an improvement in laboratory performance, but there are no fundamental studies demonstrating that laboratory standardization is effective. We analyzed the results of the KEQAS to identify significant differences between laboratories with or without KLAP and to determine the impact of laboratory standardization on the accuracy of diagnostic tests. Methods We analyzed KEQAS participant data on clinical chemistry tests such as albumin, ALT, AST, and glucose from 2010 to 2013. As a statistical parameter to assess performance bias between laboratories, we compared 4-yr variance index score (VIS) between the two groups with or without KLAP. Results Compared with the group without KLAP, the group with KLAP exhibited significantly lower geometric means of 4-yr VIS for all clinical chemistry tests (P<0.0001); this difference justified a high level of confidence in standardized services provided by accredited laboratories. Confidence intervals for the mean of each test in the two groups (accredited and non-accredited) did not overlap, suggesting that the means of the groups are significantly different. Conclusions These results confirmed that practice standardization is strongly associated with the accuracy of test results. Our study emphasizes the necessity of establishing a system for standardization of diagnostic testing. PMID:28224767
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Medical microbiology: laboratory diagnosis of invasive pneumococcal disease.
Werno, Anja M; Murdoch, David R
2008-03-15
The laboratory diagnosis of invasive pneumococcal disease (IPD) continues to rely on culture-based methods that have been used for many decades. The most significant recent developments have occurred with antigen detection assays, whereas the role of nucleic acid amplification tests has yet to be fully clarified. Despite developments in laboratory diagnostics, a microbiological diagnosis is still not made in most cases of IPD, particularly for pneumococcal pneumonia. The limitations of existing diagnostic tests impact the ability to obtain accurate IPD burden data and to assess the effectiveness of control measures, such as vaccination, in addition to the ability to diagnose IPD in individual patients. There is an urgent need for improved diagnostic tests for pneumococcal disease--especially tests that are suitable for use in underresourced countries.
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Ishengoma, D R S; Rwegoshora, R T; Mdira, K Y; Kamugisha, M L; Anga, E O; Bygbjerg, I C; Rønn, A M; Magesa, S M
2009-07-01
Although critical for good case management and the monitoring of health interventions, the health-laboratory services in sub-Saharan Africa are grossly compromised by poor infrastructures and a lack of trained personnel, essential reagents and other supplies. The availability and quality of diagnostic services in 37 health laboratories in three districts of the Tanga region of Tanzania have recently been assessed. The results of the survey, which involved interviews with health workers, observations and a documentary review, revealed that malaria accounted for >50% of admissions and out-patient visits. Most (92%) of the laboratories were carrying out malaria diagnosis and 89% were measuring haemoglobin concentrations but only one (3%) was conducting culture and sensitivity tests, and those only on urine and pus samples. Only 14 (17%) of the 84 people found working in the visited laboratories were laboratory technologists with a diploma certificate or higher qualification. Sixteen (43%) of the study laboratories each had five or fewer types of equipment and only seven (19%) had more than 11 types each. Although 11 (30%) of the laboratories reported that they conducted internal quality control, none had standard operating procedures (SOP) on display or evidence of such quality assurance. Although malaria was the main health problem, diagnostic services for malaria and other diseases were inadequate and of poor quality because of the limited human resources, poor equipment and shortage of supplies. If the health services in Tanga are not to be overwhelmed by the progressively increasing burden of HIV/AIDS, malaria, tuberculosis and other emerging and re-emerging diseases, more funding and appropriate policies to improve the availability and quality of the area's diagnostic services will clearly be required.
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Ishengoma, Deus S; Kamugisha, Mathias L; Rutta, Acleus S M; Kagaruki, Gibson B; Kilale, Andrew M; Kahwa, Amos; Kamugisha, Erasmus; Baraka, Vito; Mandara, Celine I; Materu, Godlisten S; Massaga, Julius J; Magesa, Stephen M; Lemnge, Martha M; Mboera, Leonard E G
2017-01-23
Roll-out and implementation of antiretroviral therapy (ART) necessitated many countries in Sub-Saharan Africa to strengthen their national health laboratory systems (NHLSs) to provide high quality HIV diagnostic and supportive services. This study was conducted to assess the performance of health laboratories in provision of HIV diagnostic and supportive services in eight districts (from four regions of Iringa, Mtwara, Tabora and Tanga), after nine years of implementation of HIV/AIDS care and treatment plan in Tanzania. In this cross-sectional study, checklists and observations were utilized to collect information from health facilities (HFs) with care and treatment centres (CTCs) for HIV/AIDS patients; on availability of laboratories, CTCs, laboratory personnel, equipment and reagents. A checklist was also used to collect information on implementation of quality assurance (QA) systems at all levels of the NHLS in the study areas. The four regions had 354 HFs (13 hospitals, 41 Health Centres (HCs) and 300 dispensaries); whereby all hospitals had laboratories and 11 had CTCs while 97.5 and 61.0% of HCs had both laboratories and CTCs, respectively. Of the dispensaries, 36.0 and 15.0% had laboratories and CTCs (mainly in urban areas). Thirty nine HFs (12 hospitals, 21 HCs and six dispensaries) were assessed and 56.4% were located in urban areas. The assessed HFs had 199 laboratory staff of different cadres (laboratory assistants = 35.7%; technicians =32.7%; attendants = 22.6%; and others = 9.1%); with >61% of the staff and 72.3% of the technicians working in urban areas. All laboratories were using rapid diagnostic tests for HIV testing. Over 74% of the laboratories were performing internal quality control and 51.4% were participating in external QA programmes. Regional and district laboratories had all key equipment and harmonization was maintained for Fluorescence-Activated Cell Sorting (FACS) machines. Most of the biochemical (58.0%) and haematological analysers (74.1%) were available in urban areas. Although >81% of the equipment were functional with no mechanical faulty, 62.6% had not been serviced in the past three years. Diagnostic and supportive services for HIV were available in most of the HCs and hospitals while few dispensaries were providing the services. Due to limitations such as shortage of staff, serving of equipment and participation in QA programmes, the NHLS should be strengthened to ensure adequate human resource, implementation of QA and sustainable preventive maintenance services of equipment.
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42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 3 2010-10-01 2010-10-01 false Laboratory date of service for clinical laboratory... AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.510 Laboratory date of service for clinical laboratory and pathology specimens. The date of service for either a...
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Maroney, Justin; Khan, Saba; Powell, Wayne; Klein, Lloyd W
2013-01-01
We seek to assess the per-operator volume of diagnostic catheterizations and percutaneous coronary interventions (PCI) among US cardiologists, and its implication for future manpower needs in the catheterization laboratory. The number of annual Medicare PCIs peaked in 2004 and has trended downward since, however the total number of catheterization laboratories nationwide has increased. It is unknown whether these trends have resulted in a dilution of per-operator volumes, and whether the current supply of interventional cardiologists is appropriate to meet future needs. We analyzed the Centers for Medicare and Medicaid Services 2008 Medicare 5% sample file, and extracted the total number of Medicare fee-for-service (Medicare FFS) diagnostic catheterizations and PCIs performed in 2008. We then determined per-physician procedure volumes using National Provider Identifier numbers. There were 1,198,610 Medicare FFS diagnostic catheterizations performed by 11,029 diagnostic cardiologists, and there were 378,372 Medicare FFS PCIs performed by 6,443 interventional cardiologists in 2008. The data reveal a marked difference in the 2008 distribution of diagnostic catheterizations and PCIs among operators. Just over 10% of diagnostic catheterizations were performed by operators performing 40 or fewer Medicare FFS diagnostic catheterizations, contrasted with almost 30% of PCIs performed by operators with 40 of fewer Medicare FFS PCIs. A significant majority of interventional cardiologists (61%) performed 40 or fewer Medicare FFS PCIs in 2008. There is a high percentage of low-volume operators performing PCI, raising questions regarding annual volume recommendations for procedural skill maintenance, and the future manpower requirements in the catheterization laboratory. Copyright © 2012 Wiley Periodicals, Inc.
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Point-of-Care Diagnostics for Niche Applications
Cummins, Brian M.; Ligler, Frances S.; Walker, Glenn M.
2016-01-01
Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. PMID:26837054
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Roles of laboratories and laboratory systems in effective tuberculosis programmes
van Deun, Armand; Kam, Kai Man; Narayanan, PR; Aziz, Mohamed Abdul
2007-01-01
Abstract Laboratories and laboratory networks are a fundamental component of tuberculosis (TB) control, providing testing for diagnosis, surveillance and treatment monitoring at every level of the health-care system. New initiatives and resources to strengthen laboratory capacity and implement rapid and new diagnostic tests for TB will require recognition that laboratories are systems that require quality standards, appropriate human resources, and attention to safety in addition to supplies and equipment. To prepare the laboratory networks for new diagnostics and expanded capacity, we need to focus efforts on strengthening quality management systems (QMS) through additional resources for external quality assessment programmes for microscopy, culture, drug susceptibility testing (DST) and molecular diagnostics. QMS should also promote development of accreditation programmes to ensure adherence to standards to improve both the quality and credibility of the laboratory system within TB programmes. Corresponding attention must be given to addressing human resources at every level of the laboratory, with special consideration being given to new programmes for laboratory management and leadership skills. Strengthening laboratory networks will also involve setting up partnerships between TB programmes and those seeking to control other diseases in order to pool resources and to promote advocacy for quality standards, to develop strategies to integrate laboratories’ functions and to extend control programme activities to the private sector. Improving the laboratory system will assure that increased resources, in the form of supplies, equipment and facilities, will be invested in networks that are capable of providing effective testing to meet the goals of the Global Plan to Stop TB. PMID:17639219
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Kubo, Shoji; Takemura, Shigekazu; Sakata, Chikaharu; Urata, Yorihisa; Nishioka, Takayoshi; Nozawa, Akinori; Kinoshita, Masahiko; Hamano, Genya; Nakanuma, Yasuni; Endo, Ginji
2014-01-01
A cholangiocarcinoma outbreak among workers of an offset color proof-printing department in a printing company was recently reported. It is important to understand the clinical course leading to occupational cholangiocarcinoma development for investigation of the carcinogenesis process and for surveillance and early detection. We evaluated the changes in laboratory test results and diagnostic imaging presentation before the detection of cholangiocarcinoma. We investigated the changes in laboratory test results and diagnostic imaging presentation before the detection of cholangiocarcinoma in 2 patients because the data were available. Results The clinical courses observed in the 2 participating patients showed persistent elevation of serum γ-glutamyl transpeptidase levels with or without elevated serum levels of alanine aminotransferase and/or aspartate aminotransferase before cholangiocarcinoma detection. Dilatation of the bile ducts without tumor-induced stenosis was observed several years before cholangiocarcinoma detection and progressed gradually in both patients. The serum concentration of carbohydrate 19-9 also increased prior to cholangiocarcinoma detection in both patients. Eventually, observation of stenosis of the bile duct and a space-occupying lesion strongly suggested cholangiocarcinoma. Pathological examination of the resected specimens showed chronic bile duct injury and neoplastic lesions, such as "biliary intraepithelial neoplasia" and "intraductal papillary neoplasm of the bile duct" in various sites of the bile ducts, particularly in the dilated bile ducts. The changes in laboratory test results and diagnostic imaging might be related to the development of cholangiocarcinoma. It is important to monitor diagnostic imaging presentation and laboratory test results in workers with extended exposure to organic solvents.
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Alcalá, L; Reigadas, E; Marín, M; Martín, A; Catalán, P; Bouza, E
2015-08-01
A multicenter study of Clostridium difficile infection (CDI) performed during 2008 in Spain revealed that two of every three episodes went undiagnosed or were misdiagnosed owing to nonsensitive diagnostic tests or lack of clinical suspicion and request. Since then, efforts have been made to improve the diagnostic tests used by laboratories and to increase the awareness of this disease among both clinicians and microbiologists. Our objective was to evaluate the impact of these efforts by assessing the current magnitude of underdiagnosis of CDI in Spain using two point-prevalence studies performed on one day each in January and July of 2013. A total of 111 Spanish laboratories selected all unformed stool specimens received for microbiological diagnosis on these days, and toxigenic culture was performed at a central reference laboratory. Toxigenic isolates were characterized both pheno- and genotypically. The reference laboratory detected 103 episodes of CDI in patients aged 2 years or more. Half (50.5 %) of the episodes were not diagnosed in the participating laboratories, owing to insensitive diagnostic tests (15.5 %) or the lack of clinical suspicion and request (35.0 %). The main ribotypes were 014, 078/126, 001/072, and 106. Ribotype 027 caused 2.9 % of all cases. Despite all the interventions undertaken, CDI remains a highly neglected disease because of the lack of sensitive diagnostic tests in some institutions and, especially, the absence of clinical suspicion, mainly in patients with community-associated CDI. Toxigenic C. difficile should be routinely sought in unformed stools sent for microbiological diagnosis, regardless of their origin.
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Chindamporn, Ariya; Chakrabarti, Arunaloke; Li, Ruoyu; Sun, Pei-Lun; Tan, Ban-Hock; Chua, Mitzi; Wahyuningsih, Retno; Patel, Atul; Liu, Zhengyin; Chen, Yee-Chun; Chayakulkeeree, Methee
2018-06-01
An online survey of mycology laboratories in seven Asian countries was conducted to assess the status, competence, and services available. Country representatives from the Asia Fungal Working Group (AFWG) contacted as many laboratories performing mycology diagnosis as possible in their respective countries, requesting that the laboratory heads complete the online survey. In total, 241 laboratories responded, including 71 in China, 104 in India, 11 in Indonesia, 26 in the Philippines, four in Singapore, 18 in Taiwan, and seven in Thailand. Overall, 129/241 (53.5%) surveyed mycology laboratories operate as separate designated mycology laboratories, 75/241 (31.1%) conduct regular formal staff training, 103/241 (42.7%) are accredited, and 88/157 (56.1%) participate in external quality assurance scheme (EQAS) programs. Microscopy and culture methods are available in nearly all laboratories, although few perform DNA sequencing (37/219; 16.9%) or use matrix-assisted laser desorption/ionization time-of-flight mass spectroscopy (MALDI-TOF MS) (27/219; 12.3%) for isolate identification. Antifungal susceptibility testing is performed in 142/241 (58.9%) laboratories, mainly for yeasts. The most commonly performed nonculture diagnostic is cryptococcal antigen testing (66 laboratories), followed by galactomannan testing (55), polymerase chain reaction (PCR) diagnosis (37), and beta-D-glucan testing (24). Therapeutic drug monitoring is conducted in 21 laboratories. There is almost no access to advanced diagnostic tests, like galactomannan, β-D-glucan, and PCR, in the surveyed laboratories in Indonesia, the Philippines, and Thailand. These results highlight the need for development of quality laboratories, accreditation and training of manpower in existing laboratories, and access to advanced non-culture-based diagnostic tests to facilitate the diagnosis of fungal infections in Asia.
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Building Cross-Country Networks for Laboratory Capacity and Improvement.
Schneidman, Miriam; Matu, Martin; Nkengasong, John; Githui, Willie; Kalyesubula-Kibuuka, Simeon; Silva, Kelly Araujo
2018-03-01
Laboratory networks are vital to well-functioning public health systems and disease control efforts. Cross-country laboratory networks play a critical role in supporting epidemiologic surveillance, accelerating disease outbreak response, and tracking drug resistance. The East Africa Public Health Laboratory Network was established to bolster diagnostic and disease surveillance capacity. The network supports the introduction of regional quality standards; facilitates the rollout and evaluation of new diagnostic tools; and serves as a platform for training, research, and knowledge sharing. Participating facilities benefitted from state-of-the art investments, capacity building, and mentorship; conducted multicountry research studies; and contributed to disease outbreak response. Copyright © 2017 Elsevier Inc. All rights reserved.
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[Mathematical model of technical equipment of a clinical-diagnostic laboratory].
Bukin, S I; Busygin, D V; Tilevich, M E
1990-01-01
The paper is concerned with the problems of technical equipment of standard clinico-diagnostic laboratories (CDL) in this country. The authors suggest a mathematic model that may minimize expenditures for laboratory studies. The model enables the following problems to be solved: to issue scientifically-based recommendations for technical equipment of CDL; to validate the medico-technical requirements for newly devised items; to select the optimum types of uniform items; to define optimal technical decisions at the stage of the design; to determine the lab assistant's labour productivity and the cost of some investigations; to compute the medical laboratory engineering requirement for treatment and prophylactic institutions of this country.
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Grolla, A; Jones, S; Kobinger, G; Sprecher, A; Girard, G; Yao, M; Roth, C; Artsob, H; Feldmann, H; Strong, J E
2012-09-01
The mobile laboratory provides a safe, rapid and flexible platform to provide effective diagnosis of Ebola virus as well as additional differential diagnostic agents in remote settings of equatorial Africa. During the 2007 Democratic Republic of Congo outbreak of Ebola-Zaire, the mobile laboratory was set up in two different locations by two separate teams within a day of equipment arriving in each location. The first location was in Mweka where our laboratory took over the diagnostic laboratory space of the local hospital, whereas the second location, approximately 50 km south near Kampungu at the epicentre of the outbreak, required local labour to fabricate a tent structure as a suitable pre-existing structure was not available. In both settings, the laboratory was able to quickly set up, providing accurate and efficient molecular diagnostics (within 3 h of receiving samples) for 67 individuals, including four cases of Ebola, seven cases of Shigella and 13 cases of malaria. This rapid turn-around time provides an important role in the support of patient management and epidemiological surveillance. © 2012 Blackwell Verlag GmbH.
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Thelaus, Johanna; Lindberg, Anna; Thisted Lambertz, Susanne; Byström, Mona; Forsman, Mats; Lindmark, Hans; Knutsson, Rickard; Båverud, Viveca; Bråve, Andreas; Jureen, Pontus; Lundin Zumpe, Annelie; Melefors, Öjar
The Swedish Forum for Biopreparedness Diagnostics (FBD) is a network that fosters collaboration among the 4 agencies with responsibility for the laboratory diagnostics of high-consequence pathogens, covering animal health and feed safety, food safety, public health and biodefense, and security. The aim of the network is to strengthen capabilities and capacities for diagnostics at the national biosafety level-3 (BSL-3) laboratories to improve Sweden's biopreparedness, in line with recommendations from the EU and WHO. Since forming in 2007, the FBD network has contributed to the harmonization of diagnostic methods, equipment, quality assurance protocols, and biosafety practices among the national BSL-3 laboratories. Lessons learned from the network include: (1) conducting joint projects with activities such as method development and validation, ring trials, exercises, and audits has helped to build trust and improve communication among participating agencies; (2) rotating the presidency of the network steering committee has fostered trust and commitment from all agencies involved; and (3) planning for the implementation of project outcomes is important to maintain gained competencies in the agencies over time. Contacts have now been established with national agencies of the other Nordic countries, with an aim to expanding the collaboration, broadening the network, finding synergies in new areas, strengthening the ability to share resources, and consolidating long-term financing in the context of harmonized European biopreparedness.
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Lindberg, Anna; Thisted Lambertz, Susanne; Byström, Mona; Forsman, Mats; Lindmark, Hans; Knutsson, Rickard; Båverud, Viveca; Bråve, Andreas; Jureen, Pontus; Lundin Zumpe, Annelie; Melefors, Öjar
2017-01-01
The Swedish Forum for Biopreparedness Diagnostics (FBD) is a network that fosters collaboration among the 4 agencies with responsibility for the laboratory diagnostics of high-consequence pathogens, covering animal health and feed safety, food safety, public health and biodefense, and security. The aim of the network is to strengthen capabilities and capacities for diagnostics at the national biosafety level-3 (BSL-3) laboratories to improve Sweden's biopreparedness, in line with recommendations from the EU and WHO. Since forming in 2007, the FBD network has contributed to the harmonization of diagnostic methods, equipment, quality assurance protocols, and biosafety practices among the national BSL-3 laboratories. Lessons learned from the network include: (1) conducting joint projects with activities such as method development and validation, ring trials, exercises, and audits has helped to build trust and improve communication among participating agencies; (2) rotating the presidency of the network steering committee has fostered trust and commitment from all agencies involved; and (3) planning for the implementation of project outcomes is important to maintain gained competencies in the agencies over time. Contacts have now been established with national agencies of the other Nordic countries, with an aim to expanding the collaboration, broadening the network, finding synergies in new areas, strengthening the ability to share resources, and consolidating long-term financing in the context of harmonized European biopreparedness. PMID:28805472
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[Medical microbiology laboratories in Dutch hospitals: essential for safe patient care].
Bonten, M J M
2008-12-06
The Netherlands Health Care Inspectorate investigated the quality of medical microbiology laboratories in Dutch hospitals. By and large the laboratories fulfilled the requirements for appropriate care, although some processes were unsatisfactory and some were insufficiently formalised. In the Netherlands, laboratories for medical microbiology are integrated within hospitals and medical microbiologists are responsible for the diagnostic processes as well as for co-treatment of patients, infection prevention and research. This integrated model contrasts to the more industrialised model in many other countries, where such laboratories are physically distinct from hospitals with a strong focus on diagnostics. The Inspectorate also concludes that the current position of medical microbiology in Dutch hospitals is necessary for patient safety and that outsourcing of these facilities is considered unacceptable.
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42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 3 2011-10-01 2011-10-01 false Laboratory date of service for clinical laboratory and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... AND OTHER HEALTH SERVICES Payment for New Clinical Diagnostic Laboratory Tests § 414.510 Laboratory...
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Clinically expedient reporting of rapid diagnostic test information.
Doern, G V
1986-03-01
With the development of rapid diagnostic tests in the clinical microbiology laboratory has come an awareness of the importance of rapid results reporting. Clearly, the potential clinical impact of rapid diagnostic tests is dependent on expeditious reporting. Traditional manual reporting systems are encumbered by the necessity of transcription of test information onto hard copy reports and then the subsequent distribution of such reports into the hands of the user. Laboratory computers when linked directly to CRTs located in nursing stations, ambulatory clinics, or physician's offices, both inside and outside of the hospital, permit essentially instantaneous transfer of test results from the laboratory to the clinician. Computer-assisted results reporting, while representing a significant advance over manual reporting systems is not, however, without problems. Concerns include validation of test information, authorization of users with access to test information, mechanical integrity, and cost. These issues notwithstanding, computerized results reporting will undoubtedly play a central role in optimizing the clinical impact of rapid diagnostic tests.
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The cobas® 6800/8800 System: a new era of automation in molecular diagnostics.
Cobb, Bryan; Simon, Christian O; Stramer, Susan L; Body, Barbara; Mitchell, P Shawn; Reisch, Natasa; Stevens, Wendy; Carmona, Sergio; Katz, Louis; Will, Stephen; Liesenfeld, Oliver
2017-02-01
Molecular diagnostics is a key component of laboratory medicine. Here, the authors review key triggers of ever-increasing automation in nucleic acid amplification testing (NAAT) with a focus on specific automated Polymerase Chain Reaction (PCR) testing and platforms such as the recently launched cobas® 6800 and cobas® 8800 Systems. The benefits of such automation for different stakeholders including patients, clinicians, laboratory personnel, hospital administrators, payers, and manufacturers are described. Areas Covered: The authors describe how molecular diagnostics has achieved total laboratory automation over time, rivaling clinical chemistry to significantly improve testing efficiency. Finally, the authors discuss how advances in automation decrease the development time for new tests enabling clinicians to more readily provide test results. Expert Commentary: The advancements described enable complete diagnostic solutions whereby specific test results can be combined with relevant patient data sets to allow healthcare providers to deliver comprehensive clinical recommendations in multiple fields ranging from infectious disease to outbreak management and blood safety solutions.
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Abdad, Mohammad Yazid; Squires, Raynal C; Cognat, Sebastien; Oxenford, Christopher John
2017-01-01
Arboviruses continue to pose serious public health threats in the World Health Organization (WHO) Western Pacific Region. As such, laboratories need to be equipped for their accurate detection. In 2011, to ensure test proficiency, the WHO Regional Office for the Western Pacific piloted an external quality assessment (EQA) programme for arbovirus diagnostics. By 2016, it had grown into a global programme with participation of 96 laboratories worldwide, including 25 laboratories from 19 countries, territories and areas in the Region. The test performance of the 25 laboratories in the Region in 2016 was high with 23 (92%) reporting correct results in all specimens for dengue and chikungunya viruses. For Zika virus, 18 (72%) of the 25 laboratories reported correct results in all specimens, while seven (28%) demonstrated at least one error. When comparing iterations of this EQA programme in the Region between 2013 and 2016, the number of participating laboratories increased from 18 to 25. The first round only included dengue virus, while the latest round additionally included chikungunya, Zika and yellow fever viruses. Proficiency for molecular detection of dengue virus remained high (83–94%) over the four-year period. The observed proficiency for arbovirus diagnostics between 2013 and 2016 is an indicator of laboratory quality improvement in the Region. PMID:29051839
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Quality in the molecular microbiology laboratory.
Wallace, Paul S; MacKay, William G
2013-01-01
In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical-from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories-particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.
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42 CFR 419.2 - Basis of payment.
Code of Federal Regulations, 2012 CFR
2012-10-01
... prospective payment system establishes a national payment rate, standardized for geographic wage differences...) Capital-related costs; (9) Implantable items used in connection with diagnostic X-ray tests, diagnostic laboratory tests, and other diagnostic tests; (10) Durable medical equipment that is implantable; (11...
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Particles and microfluidics merged: perspectives of highly sensitive diagnostic detection
Bale, Shyam Sundhar; Bhushan, Abhinav; Shen, Keyue; Seker, Erkin; Polyak, Boris
2014-01-01
There is a growing need for diagnostic technologies that provide laboratories with solutions that improve quality, enhance laboratory system productivity, and provide accurate detection of a broad range of infectious diseases and cancers. Recent advances in micro- and nanoscience and engineering, in particular in the areas of particles and microfluidic technologies, have advanced the “lab-on-a-chip” concept towards the development of a new generation of point-of-care diagnostic devices that could significantly enhance test sensitivity and speed. In this review, we will discuss many of the recent advances in microfluidics and particle technologies with an eye towards merging these two technologies for application in medical diagnostics. Although the potential diagnostic applications are virtually unlimited, the most important applications are foreseen in the areas of biomarker research, cancer diagnosis, and detection of infectious microorganisms. PMID:25378716
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Concordance in diagnostic testing for respiratory pathogens of bighorn sheep
Walsh, Daniel P.; Cassirer, E. Frances; Bonds, Michael D.; Brown, Daniel R.; Edwards, William H.; Weiser, Glen C.; Drew, Mark L.; Briggs, Robert E.; Fox, Karen A.; Miller, Michael W.; Shanthalingam, Sudarvili; Srikumaran, Subramaniam; Besser, Thomas E.
2016-01-01
Reliable diagnostic tests are essential for disease investigation and management. This is particularly true for diseases of free-ranging wildlife where sampling is logistically difficult precluding retesting. Clinical assays for wildlife diseases frequently vary among laboratories because of lack of appropriate standardized commercial kits. Results of diagnostic testing may also be called into question when investigators report different etiologies for disease outbreaks, despite similar clinical and pathologic findings. To evaluate reliability of diagnostic testing for respiratory pathogens of bighorn sheep (Ovis canadensis), we conducted a series of ring tests across 6 laboratories routinely involved in detection of Mycoplasma ovipneumoniae, Pasteurellaceae, lktA (the Pasteurellaceae gene encoding leukotoxin), and 3 reference laboratories. Consistency of results for replicate samples within laboratories was high (median agreement = 1.0). Agreement between laboratories was high for polymerase chain reaction (PCR) detection of M. ovipneumoniae and culture isolation of Mannheimia spp. and Bibersteinia trehalosi(median agreement = 0.89–0.95, Kappa = 0.65–0.74), and lower for PCR detection of Mannheimiaspp. lktA (median agreement = 0.58, Kappa = 0.12). Most errors on defined status samples were false negatives, suggesting test sensitivity was a greater problem than specificity. However, tests for M. haemolytica and lktA yielded some false positive results. Despite differences in testing protocols, median agreement among laboratories and correct classification of controls for most agents was ≥0.80, meeting or exceeding the standard required by federal proficiency testing programs. This information is valuable for interpreting test results, laboratory quality assessments, and advancing diagnosis of respiratory disease in wild sheep. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.
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Land Use Effects on Atmospheric C-13 Imply a Sizable Terrestrial CO2 Sink in Tropical Latitudes
NASA Technical Reports Server (NTRS)
Townsend, Alan R.; Asner, Gregory P.; Tans, Pieter P.; White, James W. C.
2000-01-01
Records of atmospheric CO2 and 13-CO2, can be used to distinguish terrestrial vs. oceanic exchanges of CO2 with the atmosphere. However, this approach has proven difficult in the tropics, partly due to extensive land conversion from C-3 to C-4 vegetation. We estimated the effects of such conversion on biosphere-atmosphere C-13 exchange for 1991 through 1999, and then explored how this 'land-use disequilibrium' altered the partitioning of net atmospheric CO2 exchanges between ocean and land using NOAA-CMDL data and a 2D, zonally averaged atmospheric transport model. Our results show sizable CO2 uptake in C-3-dominated tropical regions in seven of the nine years; 1997 and 1998, which included a strong ENSO event, are near neutral. Since these fluxes include any deforestation source, our findings imply either that such sources are smaller than previously estimated, and/or the existence of a large terrestrial CO2 sink in equatorial latitudes.
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Total ozone trends over the USA during 1979-1991 from Dobson spectrophotometer observations
NASA Technical Reports Server (NTRS)
Komhyr, Walter D.; Grass, Robert D.; Koenig, Gloria L.; Quincy, Dorothy M.; Evans, Robert D.; Leonard, R. Kent
1994-01-01
Ozone trends for 1979-1991, determined from Dobson spectrophotometer observations made at eight stations in the United States, are augmented with trend data from four foreign cooperative stations operated by NOAA/CMDL. Results are based on provisional data archived routinely throughout the years at the World Ozone Data Center in Toronto, Canada, with calibration corrections applied to some of the data. Trends through 1990 exhibit values of minus 0.3 percent to minus 0.5 percent yr(exp -1) at mid-to-high latitudes in the northern hemisphere. With the addition of 1991 data, however, the trends become less negative, indicating that ozone increased in many parts of the world during 1991. Stations located within the plus or minus 20 deg N-S latitude band exhibit no ozone trends. Early 1992 data show decreased ozone values at some of the stations. At South Pole, Antarctica, October ozone values have remained low during the past 3 years.
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Metagenomics: The Next Culture-Independent Game Changer
Forbes, Jessica D.; Knox, Natalie C.; Ronholm, Jennifer; Pagotto, Franco; Reimer, Aleisha
2017-01-01
A trend towards the abandonment of obtaining pure culture isolates in frontline laboratories is at a crossroads with the ability of public health agencies to perform their basic mandate of foodborne disease surveillance and response. The implementation of culture-independent diagnostic tests (CIDTs) including nucleic acid and antigen-based assays for acute gastroenteritis is leaving public health agencies without laboratory evidence to link clinical cases to each other and to food or environmental substances. This limits the efficacy of public health epidemiology and surveillance as well as outbreak detection and investigation. Foodborne outbreaks have the potential to remain undetected or have insufficient evidence to support source attribution and may inadvertently increase the incidence of foodborne diseases. Next-generation sequencing of pure culture isolates in clinical microbiology laboratories has the potential to revolutionize the fields of food safety and public health. Metagenomics and other ‘omics’ disciplines could provide the solution to a cultureless future in clinical microbiology, food safety and public health. Data mining of information obtained from metagenomics assays can be particularly useful for the identification of clinical causative agents or foodborne contamination, detection of AMR and/or virulence factors, in addition to providing high-resolution subtyping data. Thus, metagenomics assays may provide a universal test for clinical diagnostics, foodborne pathogen detection, subtyping and investigation. This information has the potential to reform the field of enteric disease diagnostics and surveillance and also infectious diseases as a whole. The aim of this review will be to present the current state of CIDTs in diagnostic and public health laboratories as they relate to foodborne illness and food safety. Moreover, we will also discuss the diagnostic and subtyping utility and concomitant bias limitations of metagenomics and comparable detection techniques in clinical microbiology, food and public health laboratories. Early advances in the discipline of metagenomics, however, have indicated noteworthy challenges. Through forthcoming improvements in sequencing technology and analytical pipelines among others, we anticipate that within the next decade, detection and characterization of pathogens via metagenomics-based workflows will be implemented in routine usage in diagnostic and public health laboratories. PMID:28725217
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The clinical chemistry and immunology of long-duration space missions.
Wu, A H; Taylor, G R; Graham, G A; McKinley, B A
1993-01-01
Clinical laboratory diagnostic capabilities are needed to guide health and medical care of astronauts during long-duration space missions. Clinical laboratory diagnostics, as defined for medical care on Earth, offers a model for space capabilities. Interpretation of laboratory results for health and medical care of humans in space requires knowledge of specific physiological adaptations that occur, primarily because of the absence of gravity, and how these adaptations affect reference values. Limited data from American and Russian missions have indicated shifts of intra- and extracellular fluids and electrolytes, changes in hormone concentrations related to fluid shifts and stresses of the missions, reductions in bone and muscle mass, and a blunting of the cellular immune response. These changes could increase susceptibility to space-related illness or injury during a mission and after return to Earth. We review physiological adaptations and the risk of medical problems that occur during space missions. We describe the need for laboratory diagnostics as a part of health and medical care in space, and how this capability might be delivered.
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Tembuyser, Lien; Dequeker, Elisabeth M C
2016-01-01
Quality assurance is an indispensable element in a molecular diagnostic laboratory. The ultimate goal is to warrant patient safety. Several risks that can compromise high quality procedures are at stake, from sample collection to the test performed by the laboratory, the reporting of test results to clinicians, and the organization of effective external quality assessment schemes. Quality assurance should therefore be safeguarded at each level and should imply a holistic multidisciplinary approach. This review aims to provide an overview of good quality assurance practices and discusses certain risks and recommendations to promote and improve quality assurance for both diagnostic laboratories and for external quality assessment providers. The number of molecular targets is continuously rising, and new technologies are evolving. As this poses challenges for clinical implementation and increases the demand for external quality assessment, the formation of an international association for improving quality assurance in molecular pathology is called for.
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Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.
Parkinson, David R; McCormack, Robert T; Keating, Susan M; Gutman, Steven I; Hamilton, Stanley R; Mansfield, Elizabeth A; Piper, Margaret A; Deverka, Patricia; Frueh, Felix W; Jessup, J Milburn; McShane, Lisa M; Tunis, Sean R; Sigman, Caroline C; Kelloff, Gary J
2014-03-15
This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.
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Recent advances in tuberculosis diagnostics in resource-limited settings.
Seki, Mitsuko; Kim, Chang-Ki; Hayakawa, Satoshi; Mitarai, Satoshi
2018-04-19
Smear-negative and drug-resistant cases of tuberculosis (TB) disease necessitate the development of new diagnostic methods, especially in resource-limited settings. To improve the current TB situations, sensitive and specific TB point-of-care tests (POCTs) should be developed. This review addresses the current status of TB, novel diagnostic methodologies for TB, and the impact of those new diagnostics on TB control in such situations. Moreover, the perspective of TB management based on laboratory examinations is described. Smear microscopy with sputum samples is the only laboratory examination available in many resource-limited settings and is still used globally. Several nucleic acid amplification tests (NATs) have been developed. The World Health Organization (WHO) endorsed novel diagnostics based on NATs and updated their definition of a bacteriologically confirmed case requiring the biological specimen to be positive by smear microscopy, culture, or the WHO-recommended rapid diagnostic protocols. The use of new diagnostics increased the number of bacteriologically confirmed TB cases. Novel diagnostics are now available, but their sensitivity is still lower than that of conventional liquid culture method. To address the increasing incidence of TB, more resources including novel diagnostics as POCTs with higher sensitivity must be allocated to healthcare systems.
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Point-of-care diagnostics for niche applications.
Cummins, Brian M; Ligler, Frances S; Walker, Glenn M
2016-01-01
Point-of-care or point-of-use diagnostics are analytical devices that provide clinically relevant information without the need for a core clinical laboratory. In this review we define point-of-care diagnostics as portable versions of assays performed in a traditional clinical chemistry laboratory. This review discusses five areas relevant to human and animal health where increased attention could produce significant impact: veterinary medicine, space travel, sports medicine, emergency medicine, and operating room efficiency. For each of these areas, clinical need, available commercial products, and ongoing research into new devices are highlighted. Copyright © 2016 Elsevier Inc. All rights reserved.
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Diagnosing Appendicitis: Evidence-Based Review of the Diagnostic Approach in 2014
Shogilev, Daniel J.; Duus, Nicolaj; Odom, Stephen R.; Shapiro, Nathan I.
2014-01-01
Introduction Acute appendicitis is the most common abdominal emergency requiring emergency surgery. However, the diagnosis is often challenging and the decision to operate, observe or further work-up a patient is often unclear. The utility of clinical scoring systems (namely the Alvarado score), laboratory markers, and the development of novel markers in the diagnosis of appendicitis remains controversial. This article presents an update on the diagnostic approach to appendicitis through an evidence-based review. Methods We performed a broad Medline search of radiological imaging, the Alvarado score, common laboratory markers, and novel markers in patients with suspected appendicitis. Results Computed tomography (CT) is the most accurate mode of imaging for suspected cases of appendicitis, but the associated increase in radiation exposure is problematic. The Alvarado score is a clinical scoring system that is used to predict the likelihood of appendicitis based on signs, symptoms and laboratory data. It can help risk stratify patients with suspected appendicitis and potentially decrease the use of CT imaging in patients with certain Alvarado scores. White blood cell (WBC), C-reactive protein (CRP), granulocyte count and proportion of polymorphonuclear (PMN) cells are frequently elevated in patients with appendicitis, but are insufficient on their own as a diagnostic modality. When multiple markers are used in combination their diagnostic utility is greatly increased. Several novel markers have been proposed to aid in the diagnosis of appendicitis; however, while promising, most are only in the preliminary stages of being studied. Conclusion While CT is the most accurate mode of imaging in suspected appendicitis, the accompanying radiation is a concern. Ultrasound may help in the diagnosis while decreasing the need for CT in certain circumstances. The Alvarado Score has good diagnostic utility at specific cutoff points. Laboratory markers have very limited diagnostic utility on their own but show promise when used in combination. Further studies are warranted for laboratory markers in combination and to validate potential novel markers. PMID:25493136
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Glucose-6-phosphate dehydrogenase laboratory assay: How, when, and why?
Minucci, Angelo; Giardina, Bruno; Zuppi, Cecilia; Capoluongo, Ettore
2009-01-01
Glucose 6-phosphate dehydrogenase (G6PD) deficiency is the most common defect of red blood cells. Although some different laboratory techniques or methods are employed for the biochemical screening, a strict relationship between biochemists, clinicians, and molecular biologists is necessary for a definitive diagnosis. This article represents an overview on the current laboratory tests finalized to the screening or to the definitive diagnosis of G6PD-deficiency, underlying the problems regarding the biochemical and molecular identification of heterozygote females other than those regarding the standardization of the clinical and laboratory diagnostic procedures. Finally, this review is aimed to give a flow-chart for the complete diagnostic approach of G6PD-deficiency.
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Laboratory Spectroscopy of Astrophysically-Relevant Materials: Developing Dust as a Diagnostic
NASA Technical Reports Server (NTRS)
Rinehart, Stephen A.
2010-01-01
Over forty years ago, observations in the new field of infrared astronomy showed a broad spectral feature at 10 microns; the feature was quickly associated with the presence of silicate-rich dust. Since that time, improvements in infrared astronomy have led to the discovery of a plethora of additional spectral features attributable to dust. By combining these observations with spectroscopic data acquired in the laboratory, astronomers have a diagnostic tool that can be used to explore underlying astronomical phenomena. As the laboratory data improves, so does our ability to interpret the astronomical observations. Here, we discuss some recent progress in laboratory spectroscopy and attempt to identify future research directions.
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South African Ebola diagnostic response in Sierra Leone: A modular high biosafety field laboratory
Jansen van Vuren, Petrus; Meier, Gunther H.; le Roux, Chantel; Conteh, Ousman S.; Kemp, Alan; Fourie, Cardia; Naidoo, Prabha; Naicker, Serisha; Ohaebosim, Phumza; Storm, Nadia; Hellferscee, Orienka; Ming Sun, Lisa K.; Mogodi, Busisiwe; Prabdial-Sing, Nishi; du Plessis, Desiree; Greyling, Deidre; Loubser, Shayne; Goosen, Mark; McCulloch, Stewart D.; Scott, Terence P.; Moerdyk, Alexandra; Dlamini, Wesley; Konneh, Kelfala; Kamara, Idrissa L.; Sowa, Dauda; Sorie, Samuel; Kargbo, Brima; Madhi, Shabir A.
2017-01-01
Background In August 2014, the National Institute for Communicable Diseases (NICD) in South Africa established a modular high-biosafety field Ebola diagnostic laboratory (SA FEDL) near Freetown, Sierra Leone in response to the rapidly increasing number of Ebola virus disease (EVD) cases. Methods and findings The SA FEDL operated in the Western Area of Sierra Leone, which remained a “hotspot” of the EVD epidemic for months. The FEDL was the only diagnostic capacity available to respond to the overwhelming demand for rapid EVD laboratory diagnosis for several weeks in the initial stages of the EVD crisis in the capital of Sierra Leone. Furthermore, the NICD set out to establish local capacity amongst Sierra Leonean nationals in all aspects of the FEDL functions from the outset. This led to the successful hand-over of the FEDL to the Sierra Leone Ministry of Health and Sanitation in March 2015. Between 25 August 2014 and 22 June 2016, the laboratory tested 11,250 specimens mostly from the Western Urban and Western Rural regions of Sierra Leone, of which 2,379 (21.14%) tested positive for Ebola virus RNA. Conclusions The bio-safety standards and the portability of the SA FEDL, offered a cost-effective and practical alternative for the rapid deployment of a field-operated high biocontainment facility. The SA FEDL teams demonstrated that it is highly beneficial to train the national staff in the course of formidable disease outbreak and accomplished their full integration into all operational and diagnostic aspects of the laboratory. This initiative contributed to the international efforts in bringing the EVD outbreak under control in Sierra Leone, as well as capacitating local African scientists and technologists to respond to diagnostic needs that might be required in future outbreaks of highly contagious pathogens. PMID:28628619
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South African Ebola diagnostic response in Sierra Leone: A modular high biosafety field laboratory.
Paweska, Janusz T; Jansen van Vuren, Petrus; Meier, Gunther H; le Roux, Chantel; Conteh, Ousman S; Kemp, Alan; Fourie, Cardia; Naidoo, Prabha; Naicker, Serisha; Ohaebosim, Phumza; Storm, Nadia; Hellferscee, Orienka; Ming Sun, Lisa K; Mogodi, Busisiwe; Prabdial-Sing, Nishi; du Plessis, Desiree; Greyling, Deidre; Loubser, Shayne; Goosen, Mark; McCulloch, Stewart D; Scott, Terence P; Moerdyk, Alexandra; Dlamini, Wesley; Konneh, Kelfala; Kamara, Idrissa L; Sowa, Dauda; Sorie, Samuel; Kargbo, Brima; Madhi, Shabir A
2017-06-01
In August 2014, the National Institute for Communicable Diseases (NICD) in South Africa established a modular high-biosafety field Ebola diagnostic laboratory (SA FEDL) near Freetown, Sierra Leone in response to the rapidly increasing number of Ebola virus disease (EVD) cases. The SA FEDL operated in the Western Area of Sierra Leone, which remained a "hotspot" of the EVD epidemic for months. The FEDL was the only diagnostic capacity available to respond to the overwhelming demand for rapid EVD laboratory diagnosis for several weeks in the initial stages of the EVD crisis in the capital of Sierra Leone. Furthermore, the NICD set out to establish local capacity amongst Sierra Leonean nationals in all aspects of the FEDL functions from the outset. This led to the successful hand-over of the FEDL to the Sierra Leone Ministry of Health and Sanitation in March 2015. Between 25 August 2014 and 22 June 2016, the laboratory tested 11,250 specimens mostly from the Western Urban and Western Rural regions of Sierra Leone, of which 2,379 (21.14%) tested positive for Ebola virus RNA. The bio-safety standards and the portability of the SA FEDL, offered a cost-effective and practical alternative for the rapid deployment of a field-operated high biocontainment facility. The SA FEDL teams demonstrated that it is highly beneficial to train the national staff in the course of formidable disease outbreak and accomplished their full integration into all operational and diagnostic aspects of the laboratory. This initiative contributed to the international efforts in bringing the EVD outbreak under control in Sierra Leone, as well as capacitating local African scientists and technologists to respond to diagnostic needs that might be required in future outbreaks of highly contagious pathogens.
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[The current clinical laboratory in the public health system and medical science: a lecture].
Men'shikov, V V
2011-11-01
The analytic and diagnostic possibilities of current clinical laboratories are discussed. The roles of laboratory information in the formation of new research directions are characterized. The proposals on the development of economic basics of the development of laboratory medicine.
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Bertolaccini, Maria Laura; Amengual, Olga; Andreoli, Laura; Atsumi, Tatsuya; Chighizola, Cecilia B; Forastiero, Ricardo; de Groot, Philip; Lakos, Gabriella; Lambert, Marc; Meroni, Pierluigi; Ortel, Thomas L; Petri, Michelle; Rahman, Anisur; Roubey, Robert; Sciascia, Savino; Snyder, Melissa; Tebo, Anne E; Tincani, Angela; Willis, Rohan
2014-09-01
Current classification criteria for definite Antiphospholipid Syndrome (APS) require the use of three laboratory assays to detect antiphospholipid antibodies (aCL, anti-β2GPI and LA) in the presence of at least one of the two major clinical manifestations (i.e. thrombosis or pregnancy morbidity) of the syndrome. However, several other autoantibodies shown to be directed to other proteins or their complex with phospholipids have been proposed to be relevant to APS but their clinical utility and their diagnostic value remains elusive. This report summarizes the findings, conclusions and recommendations of the "APS Task Force 3-Laboratory Diagnostics and Trends" meeting that took place during the 14th International Congress on Antiphospholipid Antibodies (APLA 2013, September 18-21, Rio de Janeiro, RJ, Brazil). Copyright © 2014 Elsevier B.V. All rights reserved.
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Vola, Ambra; Tamarozzi, Francesca; Noordin, Rahmah; Yunus, Muhammad Hafiznur; Khanbabaie, Sam; De Silvestri, Annalisa; Brunetti, Enrico; Mariconti, Mara
2018-04-14
Rapid diagnostic tests for cystic echinococcosis (CE) are convenient to support ultrasound diagnosis in uncertain cases, especially in resource-limited settings. We found comparable diagnostic performances of the experimental Hyd Rapid Test and the commercial VIRapid HYDATIDOSIS Test, used in our diagnostic laboratory, using samples from well-characterized hepatic CE cases. Copyright © 2018 Elsevier Inc. All rights reserved.
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42 CFR 419.2 - Basis of payment.
Code of Federal Regulations, 2013 CFR
2013-10-01
... prospective payment system establishes a national payment rate, standardized for geographic wage differences... X-ray tests, diagnostic laboratory tests, and other diagnostic tests; (10) Durable medical equipment...
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Zachar, Erin K; Burgess, Hilary J; Wobeser, Bruce K
2016-06-01
Fine-needle aspiration (FNA) is commonly used to diagnose skin disease in companion animals, but its use in horses appears to be infrequent. Equine veterinarians in western Canada were surveyed to determine their opinions about FNA and 15 years of diagnostic submissions were used to compare the perceived to actual value of FNA in the diagnosis of skin disease in horses. Practitioners viewed FNA as quick, easy, economical, and minimally invasive. However, most veterinarians rarely chose to use FNA due to a perception that sample quality and diagnostic yield were poor and there was a narrow range of diseases the technique could diagnose. Analysis of the FNA cytology samples from a veterinary diagnostic laboratory showed a wide variety of equine skin disease conditions, but the frequency of non-diagnostic results was significantly higher in equine submissions compared to those from dogs and cats.
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Schlaberg, Robert; Mitchell, Michael J; Taggart, Edward W; She, Rosemary C
2012-01-01
US Food and Drug Administration (FDA)-approved diagnostic tests based on molecular genetic technologies are becoming available for an increasing number of microbial pathogens. Advances in technology and lower costs have moved molecular diagnostic tests formerly performed for research purposes only into much wider use in clinical microbiology laboratories. To provide an example of laboratory studies performed to verify the performance of an FDA-approved assay for the detection of Clostridium difficile cytotoxin B compared with the manufacturer's performance standards. We describe the process and protocols used by a laboratory for verification of an FDA-approved assay, assess data from the verification studies, and implement the assay after verification. Performance data from the verification studies conducted by the laboratory were consistent with the manufacturer's performance standards and the assay was implemented into the laboratory's test menu. Verification studies are required for FDA-approved diagnostic assays prior to use in patient care. Laboratories should develop a standardized approach to verification studies that can be adapted and applied to different types of assays. We describe the verification of an FDA-approved real-time polymerase chain reaction assay for the detection of a toxin gene in a bacterial pathogen.
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Giordano, P C
2013-10-01
The consistent multi-ethnic migrations of the last decades have considerably changed the epidemiology of the hemoglobinopathies. Healthy carriers of these conditions are present today in many nonendemic parts of the world, and severely affected children are now born where these diseases were previously rare or unknown. Improving the competence in carrier diagnostics at the laboratory level is one of the first concerns when introducing management and primary prevention of the severe conditions in nonendemic areas. This review describes how and when carriers should be correctly diagnosed and informed. The essential technologies needed for basic carrier diagnostics in different situations are summarized in some detail, and interpretation of the results and a number of related problems are discussed. The role of the hematology laboratory is essential, particularly in nonendemic areas where the first line of health care is often insufficiently aware of hemoglobinopathy management. Carriers living in nonendemic areas can be appropriately diagnosed and informed regarding genetic risk and prevention by well-organized laboratories. Both basic and specialized diagnostics are needed for the correct treatment for the anemic carriers, for primary prevention in couples at risk and for state-of-the art care of severely affected patients. © 2012 John Wiley & Sons Ltd.
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Federal Register 2010, 2011, 2012, 2013, 2014
2015-08-03
...] Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments AGENCY: Food... workshop entitled ``FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data.'' The... to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and...
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Nash, Kevin A.; Wallace, Richard J.
2012-01-01
Summary: Within the past 10 years, treatment and diagnostic guidelines for nontuberculous mycobacteria have been recommended by the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA). Moreover, the Clinical and Laboratory Standards Institute (CLSI) has published and recently (in 2011) updated recommendations including suggested antimicrobial and susceptibility breakpoints. The CLSI has also recommended the broth microdilution method as the gold standard for laboratories performing antimicrobial susceptibility testing of nontuberculous mycobacteria. This article reviews the laboratory, diagnostic, and treatment guidelines together with established and probable drug resistance mechanisms of the nontuberculous mycobacteria. PMID:22763637
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Laboratory Diagnosis of Congenital Toxoplasmosis
Pomares, Christelle
2016-01-01
Recent studies have demonstrated that screening and treatment for toxoplasmosis during gestation result in a decrease of vertical transmission and clinical sequelae. Early treatment was associated with improved outcomes. Thus, laboratory methods should aim for early identification of infants with congenital toxoplasmosis (CT). Diagnostic approaches should include, at least, detection of Toxoplasma IgG, IgM, and IgA and a comprehensive review of maternal history, including the gestational age at which the mother was infected and treatment. Here, we review laboratory methods for the diagnosis of CT, with emphasis on serological tools. A diagnostic algorithm that takes into account maternal history is presented. PMID:27147724
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Ekawati, Lenny L; Herdiana, Herdiana; Sumiwi, Maria E; Barussanah, Cut; Ainun, Cut; Sabri, Sabri; Maulana, Teuku; Rahmadyani, Rahmadyani; Maneh, Cut; Yani, Muhammad; Valenti, Paola; Elyazar, Iqbal R F; Hawley, William A
2015-06-11
The Health Office of Aceh aims to eliminate malaria from Aceh Province, Indonesia by 2015. Malaria was formerly common in Aceh (population 4.5 million), but has declined dramatically in recent years consequent to post-tsunami control efforts. Successful elimination will depend upon rapid and accurate diagnosis and case follow-up at community level. A prerequisite to this is widespread coverage of high quality malaria diagnosis. This study describes the results of a comprehensive assessment of the malaria diagnostic capacity in Aceh as the province moves towards malaria elimination. The study was conducted in 23 districts in Aceh from October 2010 to July 2011. Six types of questionnaires were used to collect data on competency of microscopists and laboratory capacity. Standardized slides were used to evaluate the proficiency of all microscopists. In addition, site visits to 17 primary health centres (PHC) assessed diagnostic practice and logistics capacity. Five hundred and seventy four malaria microscopists have been officially registered and assigned to duty in the 23 districts in Aceh Province. They work in 345 laboratories, predominantly in PHCs (69 %) and hospitals (25 %). Three laboratories were evaluated as adequate for all 30 elements, while 29 laboratories were adequate for less than five of 30 elements. Standardized proficiency tests showed that 413 microscopists were at basic (in training) level, with 10 advanced and 9 reference level. No microscopist achieved expert level. Neither the province nor any of Aceh's districts has a standardized inventory and logistics database for malaria diagnostics, nor did any of the surveyed laboratories operate a quality assurance programme for either microscopy or rapid diagnostic tests. The study highlights the importance of careful assessment of diagnostic capacity when embarking upon a large-scale malaria elimination programme. Aceh's laboratories have minimal infrastructure with nearly all microscopists still in training. On the positive side, a large workforce of microscopists has been assigned to laboratories with the needed equipment. Aceh will need to embark on a large-scale comprehensive quality assurance scheme if it is to achieve malaria elimination.
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Pankhurst, Louise J; del Ojo Elias, Carlos; Votintseva, Antonina A; Walker, Timothy M; Cole, Kevin; Davies, Jim; Fermont, Jilles M; Gascoyne-Binzi, Deborah M; Kohl, Thomas A; Kong, Clare; Lemaitre, Nadine; Niemann, Stefan; Paul, John; Rogers, Thomas R; Roycroft, Emma; Smith, E Grace; Supply, Philip; Tang, Patrick; Wilcox, Mark H; Wordsworth, Sarah; Wyllie, David; Xu, Li; Crook, Derrick W
2016-01-01
Summary Background Slow and cumbersome laboratory diagnostics for Mycobacterium tuberculosis complex (MTBC) risk delayed treatment and poor patient outcomes. Whole-genome sequencing (WGS) could potentially provide a rapid and comprehensive diagnostic solution. In this prospective study, we compare real-time WGS with routine MTBC diagnostic workflows. Methods We compared sequencing mycobacteria from all newly positive liquid cultures with routine laboratory diagnostic workflows across eight laboratories in Europe and North America for diagnostic accuracy, processing times, and cost between Sept 6, 2013, and April 14, 2014. We sequenced specimens once using local Illumina MiSeq platforms and processed data centrally using a semi-automated bioinformatics pipeline. We identified species or complex using gene presence or absence, predicted drug susceptibilities from resistance-conferring mutations identified from reference-mapped MTBC genomes, and calculated genetic distance to previously sequenced UK MTBC isolates to detect outbreaks. WGS data processing and analysis was done by staff masked to routine reference laboratory and clinical results. We also did a microcosting analysis to assess the financial viability of WGS-based diagnostics. Findings Compared with routine results, WGS predicted species with 93% (95% CI 90–96; 322 of 345 specimens; 356 mycobacteria specimens submitted) accuracy and drug susceptibility also with 93% (91–95; 628 of 672 specimens; 168 MTBC specimens identified) accuracy, with one sequencing attempt. WGS linked 15 (16% [95% CI 10–26]) of 91 UK patients to an outbreak. WGS diagnosed a case of multidrug-resistant tuberculosis before routine diagnosis was completed and discovered a new multidrug-resistant tuberculosis cluster. Full WGS diagnostics could be generated in a median of 9 days (IQR 6–10), a median of 21 days (IQR 14–32) faster than final reference laboratory reports were produced (median of 31 days [IQR 21–44]), at a cost of £481 per culture-positive specimen, whereas routine diagnosis costs £518, equating to a WGS-based diagnosis cost that is 7% cheaper annually than are present diagnostic workflows. Interpretation We have shown that WGS has a scalable, rapid turnaround, and is a financially feasible method for full MTBC diagnostics. Continued improvements to mycobacterial processing, bioinformatics, and analysis will improve the accuracy, speed, and scope of WGS-based diagnosis. Funding National Institute for Health Research, Department of Health, Wellcome Trust, British Colombia Centre for Disease Control Foundation for Population and Public Health, Department of Clinical Microbiology, Trinity College Dublin. PMID:26669893
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Diagnostic microbiology in veterinary dermatology: present and future.
Guardabassi, Luca; Damborg, Peter; Stamm, Ivonne; Kopp, Peter A; Broens, Els M; Toutain, Pierre-Louis
2017-02-01
The microbiology laboratory can be perceived as a service provider rather than an integral part of the healthcare team. The aim of this review is to discuss the current challenges of providing a state-of-the-art diagnostic veterinary microbiology service including the identification (ID) and antimicrobial susceptibility testing (AST) of key pathogens in veterinary dermatology. The Study Group for Veterinary Microbiology (ESGVM) of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) identified scientific, technological, educational and regulatory issues impacting the predictive value of AST and the quality of the service offered by microbiology laboratories. The advent of mass spectrometry has significantly reduced the time required for ID of key pathogens such as Staphylococcus pseudintermedius. However, the turnaround time for validated AST methods has remained unchanged for many years. Beyond scientific and technological constraints, AST methods are not harmonized and clinical breakpoints for some antimicrobial drugs are either missing or inadequate. Small laboratories, including in-clinic laboratories, are usually not adequately equipped to run up-to-date clinical microbiologic diagnostic tests. ESGVM recommends the use of laboratories employing mass spectrometry for ID and broth micro-dilution for AST, and offering assistance by expert microbiologists on pre- and post-analytical issues. Setting general standards for veterinary clinical microbiology, promoting antimicrobial stewardship, and the development of new, validated and rapid diagnostic methods, especially for AST, are among the missions of ESGVM. © 2017 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and ACVD.
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Montoya, Pablo J.; Lukehart, Sheila A.; Brentlinger, Paula E.; Blanco, Ana J.; Floriano, Florencia; Sairosse, Josefa; Gloyd, Stephen
2006-01-01
OBJECTIVE: Programmes to control syphilis in developing countries are hampered by a lack of laboratory services, delayed diagnosis, and doubts about current screening methods. We aimed to compare the diagnostic accuracy of an immunochromatographic strip (ICS) test and the rapid plasma reagin (RPR) test with the combined gold standard (RPR, Treponema pallidum haemagglutination assay and direct immunofluorescence stain done at a reference laboratory) for the detection of syphilis in pregnancy. METHODS: We included test results from 4789 women attending their first antenatal visit at one of six health facilities in Sofala Province, central Mozambique. We compared diagnostic accuracy (sensitivity, specificity, and positive and negative predictive values) of ICS and RPR done at the health facilities and ICS performed at the reference laboratory. We also made subgroup comparisons by human immunodeficiency virus (HIV) and malaria status. FINDINGS: For active syphilis, the sensitivity of the ICS was 95.3% at the reference laboratory, and 84.1% at the health facility. The sensitivity of the RPR at the health facility was 70.7%. Specificity and positive and negative predictive values showed a similar pattern. The ICS outperformed RPR in all comparisons (P<0.001). CONCLUSION: The diagnostic accuracy of the ICS compared favourably with that of the gold standard. The use of the ICS in Mozambique and similar settings may improve the diagnosis of syphilis in health facilities, both with and without laboratories. PMID:16501726
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Introduction of the Bethesda System to Mainland China with a Web-based tutorial.
Yuan, Qin; Chang, Alexander Russell; Ng, Ho Keung
2003-01-01
To validate the use of a Web-based tutorial to introduce the Bethesda System (TBS) to Mainland Chinese laboratories. Digitized color images of the diagnostic features in 20 Pap smears were displayed on a Web page. Participants were asked to give each smear a diagnosis using the reporting nomenclature employed in their laboratory or one that was familiar to them. This was followed by teaching images of each smear accompanied by text in English and Chinese that highlighted important features for making a diagnosis using TBS. Participants then reviewed the 20 original Pap smears and rendered a diagnosis using TBS. Pathologists and cytotechnologists at 17 laboratories located in 10 cities completed the exercise. The average diagnostic accuracy for the 20 Pap smears before and after the tutorial was 76% and 88%, respectively. Web-based tutorials can be used for disseminating cytologic information to widely dispersed laboratories in China and help enhance the practice of cytology, currently an underutilized diagnostic technique. However, such difficulties as lack of Internet connections in the laboratory, outdated computers and a lack of interest in cytology need to be overcome to ensure success.
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Tohyama, K
2018-05-01
The Japanese Society for Laboratory Hematology (JSLH) was launched in 2000 and has been developed by a mutual collaboration of hematologists, medical technologists, and the companies involved in hematological laboratory testing. The aim of JSLH is the progress and development of laboratory hematology by academic conferences, periodic publication of academic journal, training and education (in the meeting, the journal, or the website), promotion of the standardization of laboratory hematology, and certification of the laboratory hematology specialists. Among 3 specialized committees organized for the standardization of laboratory hematology, the standardization committee on blood cell morphology has been dealing with the various projects on peripheral/bone marrow blood cells and normal/abnormal morphology. Another independent organization, the Japanese National Research Group on idiopathic bone marrow failure syndromes (BMF), has raised the importance of the dysplasia of myelodysplastic syndromes (MDS) and has been conducting the prospective registration, central review, and follow-up study of MDS. This group recently proposed the grading system for diagnostic accuracy of MDS, and the detailed procedure of morphological diagnosis of MDS is presented in the specialized color atlas with typical photographs of various dysplasia. JSLH has also approved the grading system for diagnostic accuracy of MDS and adopted this standardized diagnostic system to the educational item for certification of the laboratory hematology specialists, aiming at a nationwidely expanding morphological evaluation of myelodysplasia. Further and significant progress in the standardization of blood cell morphology will be expected in Japan through the activity of JSLH. © 2018 John Wiley & Sons Ltd.
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Efficacy of a Virtual Teaching Assistant in an Open Laboratory Environment for Electric Circuits
ERIC Educational Resources Information Center
Saleheen, Firdous; Wang, Zicong; Picone, Joseph; Butz, Brian P.; Won, Chang-Hee
2018-01-01
In order to provide an on-demand, open electrical engineering laboratory, we developed an innovative software-based Virtual Open Laboratory Teaching Assistant (VOLTA). This web-based virtual assistant provides laboratory instructions, equipment usage videos, circuit simulation assistance, and hardware implementation diagnostics. VOLTA allows…
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Udager, Aaron M; Alva, Ajjai; Mehra, Rohit
2014-01-01
The idea that detailed knowledge of molecular oncogenesis will drive diagnostic, prognostic, and therapeutic clinical decision making in an increasingly multidisciplinary practice of oncologic care has been anticipated for many years. With the recent rapid advancement in our understanding of the molecular underpinnings of genitourinary malignancies, this concept is now starting to take shape in the fields of prostate, kidney, bladder, testicular, and penile cancer. Such breakthroughs necessitate the development of robust clinical-grade assays that can be quickly made available for patients to facilitate diagnosis in challenging cases, risk-stratify patients for subsequent clinical management, select the appropriate targeted therapy from among increasingly diverse and numerous options, and enroll patients in advanced clinical trials. This rapid translation of basic and clinical cancer research requires a streamlined, multidisciplinary approach to clinical assay development, termed here the molecular diagnostics service line laboratory. In this review, we summarize the current state and explore the future of molecular diagnostics in genitourinary oncology to conceptualize a genitourinary service line laboratory at a tertiary clinical institution.
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Wong, Joyce Y P; Chin, David; Fung, Henry; Li, Ann; Wong, Marcus M S; Kwok, Henry K H
2014-01-01
Upper limb musculoskeletal complaints are common among certain health professionals. We report two cases, both involving technicians working in a diagnostic tuberculosis laboratory in Hong Kong. A work process evaluation suggest that the need to repeatedly open and close small bottles, as well as to work for prolonged periods of time in confined areas, could be related to the workers' clinical presentation. The cases are also compatible with the diagnosis of repetitive strain injury (RSI) of the upper limb, but this term is not commonly used nowadays because of various definitional issues. A review of the various diagnostic issues in RSI is presented.
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Laboratory hemostasis: milestones in Clinical Chemistry and Laboratory Medicine.
Lippi, Giuseppe; Favaloro, Emmanuel J
2013-01-01
Hemostasis is a delicate, dynamic and intricate system, in which pro- and anti-coagulant forces cooperate for either maintaining blood fluidity under normal conditions, or else will prompt blood clot generation to limit the bleeding when the integrity of blood vessels is jeopardized. Excessive prevalence of anticoagulant forces leads to hemorrhage, whereas excessive activation of procoagulant forces triggers excessive coagulation and thrombosis. The hemostasis laboratory performs a variety of first, second and third line tests, and plays a pivotal role in diagnostic and monitoring of most hemostasis disturbances. Since the leading targets of Clinical Chemistry and Laboratory Medicine include promotion of progress in fundamental and applied research, along with publication of guidelines and recommendations in laboratory diagnostics, this journal is an ideal source of information on current developments in the laboratory technology of hemostasis, and this article is aimed to celebrate some of the most important and popular articles ever published by the journal in the filed of laboratory hemostasis.
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Hong, Na; Li, Dingcheng; Yu, Yue; Xiu, Qiongying; Liu, Hongfang; Jiang, Guoqian
2016-10-01
Constructing standard and computable clinical diagnostic criteria is an important but challenging research field in the clinical informatics community. The Quality Data Model (QDM) is emerging as a promising information model for standardizing clinical diagnostic criteria. To develop and evaluate automated methods for converting textual clinical diagnostic criteria in a structured format using QDM. We used a clinical Natural Language Processing (NLP) tool known as cTAKES to detect sentences and annotate events in diagnostic criteria. We developed a rule-based approach for assigning the QDM datatype(s) to an individual criterion, whereas we invoked a machine learning algorithm based on the Conditional Random Fields (CRFs) for annotating attributes belonging to each particular QDM datatype. We manually developed an annotated corpus as the gold standard and used standard measures (precision, recall and f-measure) for the performance evaluation. We harvested 267 individual criteria with the datatypes of Symptom and Laboratory Test from 63 textual diagnostic criteria. We manually annotated attributes and values in 142 individual Laboratory Test criteria. The average performance of our rule-based approach was 0.84 of precision, 0.86 of recall, and 0.85 of f-measure; the performance of CRFs-based classification was 0.95 of precision, 0.88 of recall and 0.91 of f-measure. We also implemented a web-based tool that automatically translates textual Laboratory Test criteria into the QDM XML template format. The results indicated that our approaches leveraging cTAKES and CRFs are effective in facilitating diagnostic criteria annotation and classification. Our NLP-based computational framework is a feasible and useful solution in developing diagnostic criteria representation and computerization. Copyright © 2016 Elsevier Inc. All rights reserved.
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Requirements for diagnosis of malaria at different levels of the laboratory network in Africa.
Long, Earl G
2009-06-01
The rapid increase of resistance to cheap, reliable antimalarials, the increasing cost of effective drugs, and the low specificity of clinical diagnosis has increased the need for more reliable diagnostic methods for malaria. The most commonly used and most reliable remains microscopic examination of stained blood smears, but this technique requires skilled personnel, precision instruments, and ideally a source of electricity. Microscopy has the advantage of enabling the examiner to identify the species, stage, and density of an infection. An alternative to microscopy is the rapid diagnostic test (RDT), which uses a labeled monoclonal antibody to detect circulating parasitic antigens. This test is most commonly used to detect Plasmodium falciparum infections and is available in a plastic cassette format. Both microscopy and RDTs should be available at all levels of laboratory service in endemic areas, but in peripheral laboratories with minimally trained staff, the RDT may be a more practical diagnostic method.
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Tazawa, Yoshiaki
2016-01-01
On July 1st, 2013, the Ministry of Health, Labor and Welfare (MHLW) issued an official notification regarding the co-development of companion diagnostics (CDx) with a drug which requires any exclusive diagnostic test or medical device to predict efficacy or adverse reactions to the drug. The main frame and contents in the MHLW's notification are quite similar to the summaries in the final guidance issued by the US Food and Drug Administration (FDA) on August 6th, 2014 Guidance for Industry and Food and Drug Administration Staff (In Vitro Companion Diagnostic Devices, [2014] ), and these recommend industries to develop, study and submit CDx and the corresponding drug contemporaneously as much as possible. Following the MHLW's notification, the Pharmaceutical and Medical Device Agency (PMDA) notified on December 26th, 2013, "the technical guidance for co-development of CDx and the drug" that mentioned the regulatory requirements for clinical trial of the drug and CDx as well as analytical validity of CDx required for the trials. These official notifications from the Ministry and the Agency may be useful for pharmaceutical and diagnostics makers to understand how they should co-develop and validate CDx for clinical trials and regulatory submission. However, since the most anticipated technologies such as the next generation sequencer (NGS) are more complex and its medical risks could be high level, the existing regulatory system focusing on only diagnostics reagents and devices that are developed and manufactured by in vitro diagnostics (IVD) makers may be no longer suitable for the characteristics of CDx for the future.As an increase of clinical needs for multiple biomarkers assay by DNA sequencer, on November 19th, 2013, the FDA cleared 510 K for NGS and its universal kit. On October 3rd, 2014, moreover, the agency notified two drafts of guidance (Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), [2014]; Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratory in FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDT), [2014]) for oversight of laboratory developed tests (LDTs) with medium or high medical risks. These FDA's strategic decisions and new regulatory frameworks may allow the clinical laboratories to develop and perform more easily NGS-based CDx under the certification of Clinical Laboratory Improvement Amendments (CLIA). However, neither law nor regulated quality management system similar to the CLIA exists in Japan. To effectively validate LDTs and NGS for medical practice, Japan should learn more the current regulatory changes and initiatives in the US, as well as to reform the regulatory frameworks and create any regulated quality management system for clinical laboratory testing to be reimbursed.
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Nolte, Thomas; Brander-Weber, Patricia; Dangler, Charles; Deschl, Ulrich; Elwell, Michael R; Greaves, Peter; Hailey, Richard; Leach, Michael W; Pandiri, Arun R; Rogers, Arlin; Shackelford, Cynthia C; Spencer, Andrew; Tanaka, Takuji; Ward, Jerrold M
2016-01-01
The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) project is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP), and North America (STP) to develop an internationally accepted nomenclature and diagnostic criteria for nonproliferative and proliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature and diagnostic criteria for classifying lesions in the digestive system including the salivary glands and the exocrine pancreas of laboratory rats and mice. Most lesions are illustrated by color photomicrographs. The standardized nomenclature, the diagnostic criteria, and the photomicrographs are also available electronically on the Internet (http://www.goreni.org/). Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous and age related lesions as well as lesions induced by exposure to test items. Relevant infectious and parasitic lesions are included as well. A widely accepted and utilized international harmonization of nomenclature and diagnostic criteria for the digestive system will decrease misunderstandings among regulatory and scientific research organizations in different countries and provide a common language to increase and enrich international exchanges of information among toxicologists and pathologists.
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Nolte, Thomas; Brander-Weber, Patricia; Dangler, Charles; Deschl, Ulrich; Elwell, Michael R.; Greaves, Peter; Hailey, Richard; Leach, Michael W.; Pandiri, Arun R.; Rogers, Arlin; Shackelford, Cynthia C.; Spencer, Andrew; Tanaka, Takuji; Ward, Jerrold M.
2016-01-01
The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) project is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP), and North America (STP) to develop an internationally accepted nomenclature and diagnostic criteria for nonproliferative and proliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature and diagnostic criteria for classifying lesions in the digestive system including the salivary glands and the exocrine pancreas of laboratory rats and mice. Most lesions are illustrated by color photomicrographs. The standardized nomenclature, the diagnostic criteria, and the photomicrographs are also available electronically on the Internet (http://www.goreni.org/). Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous and age related lesions as well as lesions induced by exposure to test items. Relevant infectious and parasitic lesions are included as well. A widely accepted and utilized international harmonization of nomenclature and diagnostic criteria for the digestive system will decrease misunderstandings among regulatory and scientific research organizations in different countries and provide a common language to increase and enrich international exchanges of information among toxicologists and pathologists. PMID:26973378
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Model Based Inference for Wire Chafe Diagnostics
NASA Technical Reports Server (NTRS)
Schuet, Stefan R.; Wheeler, Kevin R.; Timucin, Dogan A.; Wysocki, Philip F.; Kowalski, Marc Edward
2009-01-01
Presentation for Aging Aircraft conference covering chafing fault diagnostics using Time Domain Reflectometry. Laboratory setup and experimental methods are presented, along with initial results that summarize fault modeling and detection capabilities.
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Laboratory simulation of space plasma phenomena*
NASA Astrophysics Data System (ADS)
Amatucci, B.; Tejero, E. M.; Ganguli, G.; Blackwell, D.; Enloe, C. L.; Gillman, E.; Walker, D.; Gatling, G.
2017-12-01
Laboratory devices, such as the Naval Research Laboratory's Space Physics Simulation Chamber, are large-scale experiments dedicated to the creation of large-volume plasmas with parameters realistically scaled to those found in various regions of the near-Earth space plasma environment. Such devices make valuable contributions to the understanding of space plasmas by investigating phenomena under carefully controlled, reproducible conditions, allowing for the validation of theoretical models being applied to space data. By working in collaboration with in situ experimentalists to create realistic conditions scaled to those found during the observations of interest, the microphysics responsible for the observed events can be investigated in detail not possible in space. To date, numerous investigations of phenomena such as plasma waves, wave-particle interactions, and particle energization have been successfully performed in the laboratory. In addition to investigations such as plasma wave and instability studies, the laboratory devices can also make valuable contributions to the development and testing of space plasma diagnostics. One example is the plasma impedance probe developed at NRL. Originally developed as a laboratory diagnostic, the sensor has now been flown on a sounding rocket, is included on a CubeSat experiment, and will be included on the DoD Space Test Program's STP-H6 experiment on the International Space Station. In this presentation, we will describe several examples of the laboratory investigation of space plasma waves and instabilities and diagnostic development. *This work supported by the NRL Base Program.
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Williamson, Julie A; Tornquist, Susan J
2014-01-01
There is a huge unmet need for veterinary diagnostic laboratory services in developing nations such as Liberia. One way of bridging the service gap is for visiting experts to provide veterinary laboratory training to technicians in a central location in a short-course format. An intensive 1-week training workshop was organized for 18 student and faculty participants from the College of Agriculture and Integrated Development Studies (CAIDS) at Cuttington University in rural central Liberia. The training was designed and delivered by the non-governmental organization Veterinarians Without Borders US and funded through a Farmer-to-Farmer grant provided by the United States Agency for International Development. Although at the start of training none of the students had any veterinary laboratory experience, by the end of the course over 80% of the students were able to discuss appropriate care and use of a microscope and name at least three important components of laboratory record keeping; over 60% were able to describe how to make and stain a blood smear and how to perform a passive fecal flotation; and over 30% were able to describe what a packed cell volume is and how it is measured and name at least three criteria for classifying bacteria. The intensive training workshop greatly improved the knowledge of trainees about veterinary diagnostic laboratory techniques. The training provided initial skills to students and faculty who are awaiting the arrival of additional grant-funded laboratory equipment to continue their training.
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Langlois, Michel R; Wallemacq, Pierre
2009-01-01
To face the economic pressures arising from the current socio-economic conjuncture, hospital laboratories are endangered by an increasing trend towards the outsourcing of clinical laboratory tests to external (mega-) laboratories. This should allow hospitals to meet their economic requirements, but with an increased risk of loss of medical quality and, mid- to long-term, loss of cost effectiveness of healthcare at the national level. To anticipate current developments (economical and technological) that inevitably will affect the future of laboratory medicine, hospital laboratories should be proactive and enhance efficiency, reduce costs by consolidation, integrate into regional networks, and form alliances or partnerships. To create additional value, the core competency of laboratory professionals must be refocused to provide medical knowledge services (consultative support to clinicians) related to in vitro diagnostic testing. To integrate cost-efficiency with medical quality, implementation of a matricial organization - operational vs. biomedical level - could be an interesting approach. This integrated structure should create total quality of laboratory testing, managing the entire medical diagnostic cycle from the pre-preanalytical to post-postanalytical phase.
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Gilbert, G L
2015-08-01
If routine laboratory safety precautions are followed, the risk of laboratory-acquired infection from handling specimens from patients with Ebolavirus disease (EVD) is very low, especially in the early 'dry' stage of disease. In Australia, border screening to identify travellers returning from EVD-affected west African countries during the 2014-2015 outbreak has made it unlikely that specimens from patients with unrecognised EVD would be sent to a routine diagnostic laboratory. Australian public health and diagnostic laboratories associated with hospitals designated for the care of patients with EVD have developed stringent safety precautions for EVD diagnostic and other tests likely to be required for supportive care of the sickest (and most infectious) patients with EVD, including as wide a range of point-of-care tests as possible. However, it is important that the stringent requirements for packaging, transport and testing of specimens that might contain Ebolavirus--which is a tier 1 security sensitive biology agent--do not delay the diagnosis and appropriate management of other potentially serious but treatable infectious diseases, which are far more likely causes of a febrile illness in people returning from west Africa. If necessary, urgent haematology, biochemistry and microbiological tests can be performed safely, whilst awaiting the results of EVD tests, in a PC-2 laboratory with appropriate precautions including: use of recommended personal protective equipment (PPE) for laboratory staff; handling any unsealed specimens in a class 1 or II biosafety cabinet; using only centrifuges with sealed rotors; and safe disposal or decontamination of all used equipment and laboratory waste.
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Project management: importance for diagnostic laboratories.
Croxatto, A; Greub, G
2017-07-01
The need for diagnostic laboratories to improve both quality and productivity alongside personnel shortages incite laboratory managers to constantly optimize laboratory workflows, organization, and technology. These continuous modifications of the laboratories should be conducted using efficient project and change management approaches to maximize the opportunities for successful completion of the project. This review aims at presenting a general overview of project management with an emphasis on selected critical aspects. Conventional project management tools and models, such as HERMES, described in the literature, associated personal experience, and educational courses on management have been used to illustrate this review. This review presents general guidelines of project management and highlights their importance for microbiology diagnostic laboratories. As an example, some critical aspects of project management will be illustrated with a project of automation, as experienced at the laboratories of bacteriology and hygiene of the University Hospital of Lausanne. It is important to define clearly beforehand the objective of a project, its perimeter, its costs, and its time frame including precise duration estimates of each step. Then, a project management plan including explanations and descriptions on how to manage, execute, and control the project is necessary to continuously monitor the progression of a project to achieve its defined goals. Moreover, a thorough risk analysis with contingency and mitigation measures should be performed at each phase of a project to minimize the impact of project failures. The increasing complexities of modern laboratories mean clinical microbiologists must use several management tools including project and change management to improve the outcome of major projects and activities. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.
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Laboratory Diagnosis of Congenital Toxoplasmosis.
Pomares, Christelle; Montoya, Jose G
2016-10-01
Recent studies have demonstrated that screening and treatment for toxoplasmosis during gestation result in a decrease of vertical transmission and clinical sequelae. Early treatment was associated with improved outcomes. Thus, laboratory methods should aim for early identification of infants with congenital toxoplasmosis (CT). Diagnostic approaches should include, at least, detection of Toxoplasma IgG, IgM, and IgA and a comprehensive review of maternal history, including the gestational age at which the mother was infected and treatment. Here, we review laboratory methods for the diagnosis of CT, with emphasis on serological tools. A diagnostic algorithm that takes into account maternal history is presented. Copyright © 2016 Pomares and Montoya.
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Mussap, Michele
2014-01-01
The rapid escalation in health care costs has led to the idea to deliver better care at lower costs, reshaping the responsibilities of the health care system to achieve the goal of creating value for the patient. The pressure for fiscal containment and the progressive reduction in available health care resources originated very short term strategies consisting of abrupt reductions in expenditure, specifically in the provision of clinical pathology laboratory medicine services. However, the impact of laboratory test results on diagnostic and therapeutic interventions has increased enormously in the past decade, due to advances in personalized medicine and to the strictly correlated requirement to use new biomarkers with increasing sensitivity and specificity in clinical practice. In order to create savings by delivering better care there is the need to invest financial resources in purchasing high technology and new sophisticated tests and to promote the expertise of clinical pathologists and laboratory medicine professionals. This approach to creating value in patient health care is more productive and sustainable ethically, morally and economically as a long-term strategy. It can be successfully achieved by applying defined rules that make public-private cooperation clearer, skipping incompatible solutions such as transforming clinical laboratories to 'industrially productive premises', outsourcing laboratory medicine services and using central acquisition of diagnostic systems. © 2013.
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Laboratory Diagnosis of Tuberculosis in Resource-Poor Countries: Challenges and Opportunities
Parsons, Linda M.; Somoskövi, Ákos; Gutierrez, Cristina; Lee, Evan; Paramasivan, C. N.; Abimiku, Alash'le; Spector, Steven; Roscigno, Giorgio; Nkengasong, John
2011-01-01
Summary: With an estimated 9.4 million new cases globally, tuberculosis (TB) continues to be a major public health concern. Eighty percent of all cases worldwide occur in 22 high-burden, mainly resource-poor settings. This devastating impact of tuberculosis on vulnerable populations is also driven by its deadly synergy with HIV. Therefore, building capacity and enhancing universal access to rapid and accurate laboratory diagnostics are necessary to control TB and HIV-TB coinfections in resource-limited countries. The present review describes several new and established methods as well as the issues and challenges associated with implementing quality tuberculosis laboratory services in such countries. Recently, the WHO has endorsed some of these novel methods, and they have been made available at discounted prices for procurement by the public health sector of high-burden countries. In addition, international and national laboratory partners and donors are currently evaluating other new diagnostics that will allow further and more rapid testing in point-of-care settings. While some techniques are simple, others have complex requirements, and therefore, it is important to carefully determine how to link these new tests and incorporate them within a country's national diagnostic algorithm. Finally, the successful implementation of these methods is dependent on key partnerships in the international laboratory community and ensuring that adequate quality assurance programs are inherent in each country's laboratory network. PMID:21482728
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Bottom-up or top-down: unit cost estimation of tuberculosis diagnostic tests in India.
Rupert, S; Vassall, A; Raizada, N; Khaparde, S D; Boehme, C; Salhotra, V S; Sachdeva, K S; Nair, S A; Hoog, A H Van't
2017-04-01
Of 18 sites that participated in an implementation study of the Xpert® MTB/RIF assay in India, we selected five microscopy centres and two reference laboratories. To obtain unit costs of diagnostic tests for tuberculosis (TB) and drug-resistant TB. Laboratories were purposely selected to capture regional variations and different laboratory types. Both bottom-up and the top-down methods were used to estimate unit costs. At the microscopy centres, mean bottom-up unit costs were respectively US$0.83 (range US$0.60-US$1.10) and US$12.29 (US$11.61-US$12.89) for sputum smear microscopy and Xpert. At the reference laboratories, mean unit costs were US$1.69 for the decontamination procedure, US$9.83 for a solid culture, US$11.06 for a liquid culture, US$29.88 for a drug susceptibility test, and US$18.18 for a line-probe assay. Top-down mean unit cost estimates were higher for all tests, and for sputum smear microscopy and Xpert these increased to respectively US$1.51 and US$13.58. The difference between bottom-up and top-down estimates was greatest for tests performed at the reference laboratories. These unit costs for TB diagnostics can be used to estimate resource requirements and cost-effectiveness in India, taking into account geographical location, laboratory type and capacity utilisation.
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X-ray - head; X-ray - skull; Skull radiography; Head x-ray ... Chernecky CC, Berger BJ. Radiography of skull, chest, and cervical spine - diagnostic. In: Chernecky CC, Berger BJ, eds. Laboratory Tests and Diagnostic Procedures . 6th ed. ...
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Costa, Pedro; Botelho, Ana; Couto, Isabel; Viveiros, Miguel; Inácio, João
2014-01-01
Nucleic acid testing (NAT) designate any molecular approach used for the detection, identification, and characterization of pathogenic microorganisms, enabling the rapid, specific, and sensitive diagnostic of infectious diseases, such as tuberculosis. These assays have been widely used since the 90s of the last century in human clinical laboratories and, subsequently, also in veterinary diagnostics. Most NAT strategies are based in the polymerase chain reaction (PCR) and its several enhancements and variations. From the conventional PCR, real-time PCR and its combinations, isothermal DNA amplification, to the nanotechnologies, here we review how the NAT assays have been applied to decipher if and which member of the Mycobacterium tuberculosis complex is present in a clinical sample. Recent advances in DNA sequencing also brought new challenges and have made possible to generate rapidly and at a low cost, large amounts of sequence data. This revolution with the high-throughput sequencing (HTS) technologies makes whole genome sequencing (WGS) and metagenomics the trendiest NAT strategies, today. The ranking of NAT techniques in the field of clinical diagnostics is rising, and we provide a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis with our view of the use of molecular diagnostics for detecting tuberculosis in veterinary laboratories, notwithstanding the gold standard being still the classical culture of the agent. The complementary use of both classical and molecular diagnostics approaches is recommended to speed the diagnostic, enabling a fast decision by competent authorities and rapid tackling of the disease. PMID:25988157
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Costa, Pedro; Botelho, Ana; Couto, Isabel; Viveiros, Miguel; Inácio, João
2014-01-01
Nucleic acid testing (NAT) designate any molecular approach used for the detection, identification, and characterization of pathogenic microorganisms, enabling the rapid, specific, and sensitive diagnostic of infectious diseases, such as tuberculosis. These assays have been widely used since the 90s of the last century in human clinical laboratories and, subsequently, also in veterinary diagnostics. Most NAT strategies are based in the polymerase chain reaction (PCR) and its several enhancements and variations. From the conventional PCR, real-time PCR and its combinations, isothermal DNA amplification, to the nanotechnologies, here we review how the NAT assays have been applied to decipher if and which member of the Mycobacterium tuberculosis complex is present in a clinical sample. Recent advances in DNA sequencing also brought new challenges and have made possible to generate rapidly and at a low cost, large amounts of sequence data. This revolution with the high-throughput sequencing (HTS) technologies makes whole genome sequencing (WGS) and metagenomics the trendiest NAT strategies, today. The ranking of NAT techniques in the field of clinical diagnostics is rising, and we provide a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis with our view of the use of molecular diagnostics for detecting tuberculosis in veterinary laboratories, notwithstanding the gold standard being still the classical culture of the agent. The complementary use of both classical and molecular diagnostics approaches is recommended to speed the diagnostic, enabling a fast decision by competent authorities and rapid tackling of the disease.
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Delfiner, Matthew S; Martinez, Luis R; Pavia, Charles S
2016-01-01
Laboratory diagnostic tests have an essential role in patient care, and the increasing number of medical and health professions schools focusing on teaching laboratory medicine to pre-clinical students reflects this importance. However, data validating the pedagogical methods that best influence students' comprehension and interpretation of diagnostic tests have not been well described. The Gram stain is a simple yet significant and frequently used diagnostic test in the clinical setting that helps classify bacteria into two major groups, Gram positive and negative, based on their cell wall structure. We used this technique to assess which educational strategies may improve students' learning and competency in medical diagnostic techniques. Hence, in this randomized controlled study, we compared the effectiveness of several educational strategies (e.g. workshop, discussion, or lecture) in first year medical students' competency in comprehension and interpretation of the Gram stain procedure. We demonstrated that a hands-on practical workshop significantly enhances students' competency in memorization and overall comprehension of the technique. Interestingly, most students irrespective of their cohort showed difficulty in answering Gram stain-related analytical questions, suggesting that more emphasis should be allocated by the instructors to clearly explain the interpretation of the diagnostic test results to students in medical and health professional schools. This proof of principle study highlights the need of practical experiences on laboratory medical techniques during pre-clinical training to facilitate future medical doctors' and healthcare professionals' basic understanding and competency in diagnostic testing for better patient care.
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20 CFR 220.113 - Symptoms, signs, and laboratory findings.
Code of Federal Regulations, 2011 CFR
2011-04-01
... are medically demonstrable phenomena which indicate specific abnormalities of behavior, affect... psychological phenomena which can be shown by the use of medically acceptable laboratory diagnostic techniques...
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Diagnosis of Ebola Virus Disease: Past, Present, and Future
Brooks, Tim J. G.
2016-01-01
SUMMARY Laboratory diagnosis of Ebola virus disease plays a critical role in outbreak response efforts; however, establishing safe and expeditious testing strategies for this high-biosafety-level pathogen in resource-poor environments remains extremely challenging. Since the discovery of Ebola virus in 1976 via traditional viral culture techniques and electron microscopy, diagnostic methodologies have trended toward faster, more accurate molecular assays. Importantly, technological advances have been paired with increasing efforts to support decentralized diagnostic testing capacity that can be deployed at or near the point of patient care. The unprecedented scope of the 2014-2015 West Africa Ebola epidemic spurred tremendous innovation in this arena, and a variety of new diagnostic platforms that have the potential both to immediately improve ongoing surveillance efforts in West Africa and to transform future outbreak responses have reached the field. In this review, we describe the evolution of Ebola virus disease diagnostic testing and efforts to deploy field diagnostic laboratories in prior outbreaks. We then explore the diagnostic challenges pervading the 2014-2015 epidemic and provide a comprehensive examination of novel diagnostic tests that are likely to address some of these challenges moving forward. PMID:27413095
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Recent Progress and Future Plans for Fusion Plasma Synthetic Diagnostics Platform
NASA Astrophysics Data System (ADS)
Shi, Lei; Kramer, Gerrit; Tang, William; Tobias, Benjamin; Valeo, Ernest; Churchill, Randy; Hausammann, Loic
2015-11-01
The Fusion Plasma Synthetic Diagnostics Platform (FPSDP) is a Python package developed at the Princeton Plasma Physics Laboratory. It is dedicated to providing an integrated programmable environment for applying a modern ensemble of synthetic diagnostics to the experimental validation of fusion plasma simulation codes. The FPSDP will allow physicists to directly compare key laboratory measurements to simulation results. This enables deeper understanding of experimental data, more realistic validation of simulation codes, quantitative assessment of existing diagnostics, and new capabilities for the design and optimization of future diagnostics. The Fusion Plasma Synthetic Diagnostics Platform now has data interfaces for the GTS and XGC-1 global particle-in-cell simulation codes with synthetic diagnostic modules including: (i) 2D and 3D Reflectometry; (ii) Beam Emission Spectroscopy; and (iii) 1D Electron Cyclotron Emission. Results will be reported on the delivery of interfaces for the global electromagnetic PIC code GTC, the extended MHD M3D-C1 code, and the electromagnetic hybrid NOVAK eigenmode code. Progress toward development of a more comprehensive 2D Electron Cyclotron Emission module will also be discussed. This work is supported by DOE contract #DEAC02-09CH11466.
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Britton, Sumudu; Cheng, Qin; McCarthy, James S
2016-02-16
As malaria transmission continues to decrease, an increasing number of countries will enter pre-elimination and elimination. To interrupt transmission, changes in control strategies are likely to require more accurate identification of all carriers of Plasmodium parasites, both symptomatic and asymptomatic, using diagnostic tools that are highly sensitive, high throughput and with fast turnaround times preferably performed in local health service settings. Currently available immunochromatographic lateral flow rapid diagnostic tests and field microscopy are unlikely to consistently detect infections at parasite densities less than 100 parasites/µL making them insufficiently sensitive for detecting all carriers. Molecular diagnostic platforms, such as PCR and LAMP, are currently available in reference laboratories, but at a cost both financially and in turnaround time. This review describes the recent progress in developing molecular diagnostic tools in terms of their capacity for high throughput and potential for performance in non-reference laboratories for malaria elimination.
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2016-01-01
It is important to consider the role of diagnostics and the critical need for quality diagnostics services in resource-limited settings. Accurate diagnostic tests play a key role in patient management and the prevention and control of most infectious diseases. As countries plan for implementation of HIV early infant diagnosis and viral load point-of-care testing, the London School of Hygiene & Tropical Medicine has worked with countries and partners with an interest in external quality assurance to support quality point-of-care testing on the continent. Through a series of collaborative consultations and workshops, the London School of Hygiene & Tropical Medicine has gathered lessons learned, tools, and resources and developed quality assurance models that will support point-of-care testing. The London School of Hygiene & Tropical Medicine is committed to the continued advancement of laboratory diagnostics in Africa and quality laboratory services and point-of-care testing. PMID:28879132
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[Laboratory diagnostics of urogenital clamidiosis].
Churakov, A A; Kulichenko, A N; Kzakova, E S; Serebrianik, N E; Suvorov, A P; Kutyrev, V V; Glybochko, P V
2005-02-01
Laboratory diagnostic tools of urogenital clamidiosis--PCR, ELISA (IgG and IgM) and direct immunofluorescence (DIF)--were comparatively analyzed. The positive PCR result was checked by another PCR test with a different primer; 5 false positive responses were registered (specificity 99.6%). As against PCR, the sensitivity of ELISA made 53%, its specificity -75.5%, the diagnostic value of positive result -58%, the diagnostic value of negative result -71.6% and the diagnostics accuracy -66.7%. The respective DIF parameters were as follows: 36%, 90%, 81.5%, 54.2% and 60.9%. A high rate of detection (above 90%) of the conditionally pathogenic microflora associated with Chlamydia trachomatis (above 110 microbe cells/ml) was pointed out. Hardnerelli and ureaplasms were more often found in female smears, staphylococci and enterococci--in male sperm. It is underlined as important to hold complex examinations for Chlamidia (PCR, ELISA and DIC as an additional test) combined with bacteriological quantification of the conditionally pathogenic microflora and determination of its resistance to antibiotics.
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Information engineering for molecular diagnostics.
Sorace, J. M.; Ritondo, M.; Canfield, K.
1994-01-01
Clinical laboratories are beginning to apply the recent advances in molecular biology to the testing of patient samples. The emerging field of Molecular Diagnostics will require a new Molecular Diagnostics Laboratory Information System which handles the data types, samples and test methods found in this field. The system must be very flexible in regards to supporting ad-hoc queries. The requirements which are shaping the developments in this field are reviewed and a data model developed. Several queries which demonstrate the data models ability to support the information needs of this area have been developed and run. These results demonstrate the ability of the purposed data model to meet the current and projected needs of this rapidly expanding field. PMID:7949937
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Food and Drug Administration Regulation of in Vitro Diagnostic Devices
Mansfield, Elizabeth; O’Leary, Timothy J.; Gutman, Steven I.
2005-01-01
The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic devices. We discuss the similarities and differences between devices that are not subject to premarket review, and those that are required to undergo either a premarket application or premarket notification [510(k)] pathway. We then discuss the methods that the Food and Drug Administration uses to assess the performance of in vitro diagnostic devices in the marketplace as a component of the total life cycle approach to medical device regulation. PMID:15681468
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-04
...] Notice of Request for Approval of an Information Collection; National Veterinary Services Laboratories... collection associated with the National Veterinary Services Laboratories animal health diagnostic system...: For information on request forms associated with the National Veterinary Services Laboratories animal...
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Missed diagnostic opportunities within South Africa's early infant diagnosis program, 2010-2015.
Haeri Mazanderani, Ahmad; Moyo, Faith; Sherman, Gayle G
2017-01-01
Samples submitted for HIV PCR testing that fail to yield a positive or negative result represent missed diagnostic opportunities. We describe HIV PCR test rejections and indeterminate results, and the associated delay in diagnosis, within South Africa's early infant diagnosis (EID) program from 2010 to 2015. HIV PCR test data from January 2010 to December 2015 were extracted from the National Health Laboratory Service Corporate Data Warehouse, a central data repository of all registered test-sets within the public health sector in South Africa, by laboratory number, result, date, facility, and testing laboratory. Samples that failed to yield either a positive or negative result were categorized according to the rejection code on the laboratory information system, and descriptive analysis performed using Microsoft Excel. Delay in diagnosis was calculated for patients who had a missed diagnostic opportunity registered between January 2013 and December 2015 by means of a patient linking-algorithm employing demographic details. Between 2010 and 2015, 2 178 582 samples were registered for HIV PCR testing of which 6.2% (n = 134 339) failed to yield either a positive or negative result, decreasing proportionally from 7.0% (n = 20 556) in 2010 to 4.4% (n = 21 388) in 2015 (p<0.001). Amongst 76 972 coded missed diagnostic opportunities, 49 585 (64.4%) were a result of pre-analytical error and 27 387 (35.6%) analytical error. Amongst 49 694 patients searched for follow-up results, 16 895 (34.0%) had at least one subsequent HIV PCR test registered after a median of 29 days (IQR: 13-57), of which 8.4% tested positive compared with 3.6% of all samples submitted for the same period. Routine laboratory data provides the opportunity for near real-time surveillance and quality improvement within the EID program. Delay in diagnosis and wastage of resources associated with missed diagnostic opportunities must be addressed and infants actively followed-up as South Africa works towards elimination of mother-to-child transmission.
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Laboratory automation: trajectory, technology, and tactics.
Markin, R S; Whalen, S A
2000-05-01
Laboratory automation is in its infancy, following a path parallel to the development of laboratory information systems in the late 1970s and early 1980s. Changes on the horizon in healthcare and clinical laboratory service that affect the delivery of laboratory results include the increasing age of the population in North America, the implementation of the Balanced Budget Act (1997), and the creation of disease management companies. Major technology drivers include outcomes optimization and phenotypically targeted drugs. Constant cost pressures in the clinical laboratory have forced diagnostic manufacturers into less than optimal profitability states. Laboratory automation can be a tool for the improvement of laboratory services and may decrease costs. The key to improvement of laboratory services is implementation of the correct automation technology. The design of this technology should be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to healthcare delivery and the business and operational processes in the clinical laboratory. Automation design philosophy has evolved from a hardware-based approach to a software-based approach. Process control software to support repeat testing, reflex testing, and transportation management, and overall computer-integrated manufacturing approaches to laboratory automation implementation are rapidly expanding areas. It is clear that hardware and software are functionally interdependent and that the interface between the laboratory automation system and the laboratory information system is a key component. The cost-effectiveness of automation solutions suggested by vendors, however, has been difficult to evaluate because the number of automation installations are few and the precision with which operational data have been collected to determine payback is suboptimal. The trend in automation has moved from total laboratory automation to a modular approach, from a hardware-driven system to process control, from a one-of-a-kind novelty toward a standardized product, and from an in vitro diagnostics novelty to a marketing tool. Multiple vendors are present in the marketplace, many of whom are in vitro diagnostics manufacturers providing an automation solution coupled with their instruments, whereas others are focused automation companies. Automation technology continues to advance, acceptance continues to climb, and payback and cost justification methods are developing.
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Taremwa, Ivan Mugisha; Ampaire, Lucas; Iramiot, Jacob; Muhwezi, Obed; Matte, Aloysius; Itabangi, Herbert; Mbabazi, Hope; Atwebembeire, Jeninah; Kamwine, Monicah; Katawera, Victoria; Mbalibulha, Yona; Orikiriza, Patrick; Boum, Yap
2017-01-01
While the laboratory represents more than 70% of clinical diagnosis and patient management, access to reliable and quality laboratory diagnostics in sub-Saharan Africa remains a challenge. To gain knowledge and suggest evidence based interventions towards laboratory improvement in Southwestern Uganda, we assessed the baseline laboratory quality standards in three medical and research laboratories in Southwestern Uganda. We conducted a cross sectional survey from October, 2013 to April, 2014. Selected laboratories, including one private research, one private for profit and one public laboratory, were assessed using the WHO AFRO_SLIPTA checklist and baseline scores were determined. The three laboratories assessed met basic facility requirements, had trained personnel, and safety measures in place. Sample reception was properly designed and executed with a well designated chain of custody. All laboratories had sufficient equipment for the nature of work they were involved in. However, we found that standard operating procedures were incomplete in all three laboratories, lack of quality audit schemes by two laboratories and only one laboratory enrolled into external quality assurance schemes. The SLIPTA scores were one star for the research laboratory and no star for both the public and private-for-profit laboratories. While most of the laboratory systems were in place, the low scores obtained by the assessed laboratories reflect the need for improvement to reach standards of quality assured diagnostics in the region. Therefore, routine mentorship and regional supportive supervision are necessary to increase the quality of laboratory services.
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The perceived and actual diagnostic utility of veterinary cytological samples.
Skeldon, N; Dewhurst, E
2009-04-01
To establish the proportion of cytology samples sent to a commercial veterinary laboratory that yields diagnostically useful information in the context of current use and perceptions of cytology. Nine hundred and forty-five cytology submissions were retrospectively collected and categorised according to diagnostic utility. A survey into the use and perceptions of cytology was distributed at the British Small Animal Veterinary Association Congress 2008. A specific diagnosis was reached in 23.1 per cent of samples and a cytological diagnosis in 35.3 per cent. 22.4 per cent of samples yielded some useful information, but 19.2 per cent were unacceptable. Seventy-four participants in the survey took an average of 3.9 cytological samples per week, of which they examined 27.0 per cent in-house only, 21.6 per cent in-house before sending to an external laboratory and 51.4 per cent were sent externally without prior examination. "To obtain a definitive diagnosis" was the principal reason cited for performing cytology. Results suggest that cytology is underused and may be applied in an inappropriate context in the UK. It is hoped that illustrating the diagnostic outcome of samples received by a commercial laboratory will encourage increased, appropriate use of cytology.
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Adaptation of LASCA method for diagnostics of malignant tumours in laboratory animals
DOE Office of Scientific and Technical Information (OSTI.GOV)
Ul'yanov, S S; Laskavyi, V N; Glova, Alina B
The LASCA method is adapted for diagnostics of malignant neoplasms in laboratory animals. Tumours are studied in mice of Balb/c inbred line after inoculation of cells of syngeneic myeloma cell line Sp.2/0 Ag.8. The appropriateness of using the tLASCA method in tumour investigations is substantiated; its advantages in comparison with the sLASCA method are demonstrated. It is found that the most informative characteristic, indicating the presence of a tumour, is the fractal dimension of LASCA images.
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Dalley, C; Basarir, H; Wright, J G; Fernando, M; Pearson, D; Ward, S E; Thokula, P; Krishnankutty, A; Wilson, G; Dalton, A; Talley, P; Barnett, D; Hughes, D; Porter, N R; Reilly, J T; Snowden, J A
2015-04-01
Specialist Integrated Haematological Malignancy Diagnostic Services (SIHMDS) were introduced as a standard of care within the UK National Health Service to reduce diagnostic error and improve clinical outcomes. Two broad models of service delivery have become established: 'co-located' services operating from a single-site and 'networked' services, with geographically separated laboratories linked by common management and information systems. Detailed systematic cost analysis has never been published on any established SIHMDS model. We used Activity Based Costing (ABC) to construct a cost model for our regional 'networked' SIHMDS covering a two-million population based on activity in 2011. Overall estimated annual running costs were £1 056 260 per annum (£733 400 excluding consultant costs), with individual running costs for diagnosis, staging, disease monitoring and end of treatment assessment components of £723 138, £55 302, £184 152 and £94 134 per annum, respectively. The cost distribution by department was 28.5% for haematology, 29.5% for histopathology and 42% for genetics laboratories. Costs of the diagnostic pathways varied considerably; pathways for myelodysplastic syndromes and lymphoma were the most expensive and the pathways for essential thrombocythaemia and polycythaemia vera being the least. ABC analysis enables estimation of running costs of a SIHMDS model comprised of 'networked' laboratories. Similar cost analyses for other SIHMDS models covering varying populations are warranted to optimise quality and cost-effectiveness in delivery of modern haemato-oncology diagnostic services in the UK as well as internationally. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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Practical issues in implementing whole-genome-sequencing in routine diagnostic microbiology.
Rossen, J W A; Friedrich, A W; Moran-Gilad, J
2018-04-01
Next generation sequencing (NGS) is increasingly being used in clinical microbiology. Like every new technology adopted in microbiology, the integration of NGS into clinical and routine workflows must be carefully managed. To review the practical aspects of implementing bacterial whole genome sequencing (WGS) in routine diagnostic laboratories. Review of the literature and expert opinion. In this review, we discuss when and how to integrate whole genome sequencing (WGS) in the routine workflow of the clinical laboratory. In addition, as the microbiology laboratories have to adhere to various national and international regulations and criteria for their accreditation, we deliberate on quality control issues for using WGS in microbiology, including the importance of proficiency testing. Furthermore, the current and future place of this technology in the diagnostic hierarchy of microbiology is described as well as the necessity of maintaining backwards compatibility with already established methods. Finally, we speculate on the question of whether WGS can entirely replace routine microbiology in the future and the tension between the fact that most sequencers are designed to process multiple samples in parallel whereas for optimal diagnosis a one-by-one processing of the samples is preferred. Special reference is made to the cost and turnaround time of WGS in diagnostic laboratories. Further development is required to improve the workflow for WGS, in particular to shorten the turnaround time, reduce costs, and streamline downstream data analyses. Only when these processes reach maturity will reliance on WGS for routine patient management and infection control management become feasible, enabling the transformation of clinical microbiology into a genome-based and personalized diagnostic field. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.
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2012-01-01
Background Resource-limited tropical countries are home to numerous infectious pathogens of both human and zoonotic origin. A capability for early detection to allow rapid outbreak containment and prevent spread to non-endemic regions is severely impaired by inadequate diagnostic laboratory capacity, the absence of a “cold chain” and the lack of highly trained personnel. Building up detection capacity in these countries by direct replication of the systems existing in developed countries is not a feasible approach and instead requires “leapfrogging” to the deployment of the newest diagnostic systems that do not have the infrastructure requirements of systems used in developed countries. Methods A laboratory for molecular diagnostics of infectious agents was established in Bo, Sierra Leone with a hybrid solar/diesel/battery system to ensure stable power supply and a satellite modem to enable efficient communication. An array of room temperature stabilization and refrigeration technologies for reliable transport and storage of reagents and biological samples were also tested to ensure sustainable laboratory supplies for diagnostic assays. Results The laboratory demonstrated its operational proficiency by conducting an investigation of a suspected avian influenza outbreak at a commercial poultry farm at Bo using broad range resequencing microarrays and real time RT-PCR. The results of the investigation excluded influenza viruses as a possible cause of the outbreak and indicated a link between the outbreak and the presence of Klebsiella pneumoniae. Conclusions This study demonstrated that by application of a carefully selected set of technologies and sufficient personnel training, it is feasible to deploy and effectively use a broad-range infectious pathogen detection technology in a severely resource-limited setting. PMID:22759725
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Hazardous Waste Cleanup: Ortho-Clinical Diagnostics, Raritan, New Jersey
Ortho-Clinical Diagnostics (OCD) is an administration and manufacturing facility located at 1001 U.S. Route 202 North in Raritan Borough, Somerset County, New Jersey. The facility manufactures hospital and laboratory reagents used primarily for blood
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Painful Shoulder in Swimmers: A Diagnostic Challenge.
ERIC Educational Resources Information Center
McMaster, William C.
1986-01-01
This article discusses the incidence, diagnosis, and treatment of painful shoulder in swimmers, including: regional problems that can cause shoulder pain; physical, clinical, and laboratory tests for diagnostic use; and approaches to management of the problem. (Author/CB)
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Metabolomics for laboratory diagnostics.
Bujak, Renata; Struck-Lewicka, Wiktoria; Markuszewski, Michał J; Kaliszan, Roman
2015-09-10
Metabolomics is an emerging approach in a systems biology field. Due to continuous development in advanced analytical techniques and in bioinformatics, metabolomics has been extensively applied as a novel, holistic diagnostic tool in clinical and biomedical studies. Metabolome's measurement, as a chemical reflection of a current phenotype of a particular biological system, is nowadays frequently implemented to understand pathophysiological processes involved in disease progression as well as to search for new diagnostic or prognostic biomarkers of various organism's disorders. In this review, we discussed the research strategies and analytical platforms commonly applied in the metabolomics studies. The applications of the metabolomics in laboratory diagnostics in the last 5 years were also reviewed according to the type of biological sample used in the metabolome's analysis. We also discussed some limitations and further improvements which should be considered taking in mind potential applications of metabolomic research and practice. Copyright © 2014 Elsevier B.V. All rights reserved.
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Soft x-ray power diagnostic improvements at the Omega Laser Facility
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sorce, C.; Schein, J.; Weber, F.
2006-10-15
Soft x-ray power diagnostics are essential for evaluating high temperature laser plasma experiments. The Dante soft x-ray spectrometer, a core diagnostic for radiation flux and temperature measurements of Hohlraums, installed on the Omega Laser Facility at the Laboratory for Laser Energetics has recently undergone a series of upgrades. Work performed at Brookhaven National Laboratory for the development of the National Ignition Facility (NIF) Dante spectrometer enables the Omega Dante to offer a total of 18 absolutely calibrated channels in the energy range from 50 eV to 20 keV. This feature provides Dante with the capability to measure higher, NIF relevant,more » radiation temperatures with increased accuracy including a differentiation of higher energy radiation such as the Au M and L bands. Diagnostic monitoring using experimental data from directly driven Au spherical shots is discussed.« less
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Status and test report on the LANL-Boeing APLE/HPO flying-wire beam-profile monitor. Status report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Wilke, M.; Barlow, D.; Fortgang, C.
1994-07-01
The High-Power Oscillator (HPO) demonstration of the Average Power Laser Experiment (APLE) is a collaboration by Los Alamos National Laboratory and Boeing to demonstrate a 10 kW average power, 10 {mu}m free electron laser (FEL). As part of the collaboration, Los Alamos National Laboratory (LANL) is responsible for many of the electron beam diagnostics in the linac, transport, and laser sections. Because of the high duty factor and power of the electron beam, special diagnostics are required. This report describes the flying wire diagnostic required to monitor the beam profile during high-power, high-duty operation. The authors describe the diagnostic andmore » prototype tests on the Los Alamos APLE Prototype Experiment (APEX) FEL. They also describe the current status of the flying wires being built for APLE.« less
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... eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier Saunders; 2013:878-880. Klemm ... Diagnosis and Management by Laboratory Methods . 23rd ed. St Louis, MO: Elsevier; 2017:chap 15. Kliegman RM, ...
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Recommendations for accreditation of laboratories in molecular biology of hematologic malignancies.
Flandrin-Gresta, Pascale; Cornillet, Pascale; Hayette, Sandrine; Gachard, Nathalie; Tondeur, Sylvie; Mauté, Carole; Cayuela, Jean-Michel
2015-01-01
Over recent years, the development of molecular biology techniques has improved the hematological diseases diagnostic and follow-up. Consequently, these techniques are largely used in the biological screening of these diseases; therefore the Hemato-oncology molecular diagnostics laboratories must be actively involved in the accreditation process according the ISO 15189 standard. The French group of molecular biologists (GBMHM) provides requirements for the implementation of quality assurance for the medical molecular laboratories. This guideline states the recommendations for the pre-analytical, analytical (methods validation procedures, quality controls, reagents), and post-analytical conditions. In addition, herein we state a strategy for the internal quality control management. These recommendations will be regularly updated.
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Interpreting the Laboratory Reports for Vit D.
Sarmah, Devajit; Sharma, Booloo
2014-09-01
Importance for Vit D estimation has increased in the recent years due to its link to various diseases. Measurements of Vit D by different diagnostic laboratories is however not uniform. There is variation pertaining to assay methodology and also variation in the measurement of different metabolites of Vit D. There are also various confounders which influence Vit D assays and which in most instances are overlooked. Also a matter of concern regarding Vit D assays is the lack of assay standardisation. These factors contribute to the variation in the reports generated by the diagnostic laboratories. Therefore interpretation of Vit D reports needs proper understanding of these interfering factors and further reports need to be correlated substantially with the clinical findings.
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Antonelli, Giorgia; Padoan, Andrea; Aita, Ada; Sciacovelli, Laura; Plebani, Mario
2017-08-28
Background The International Standard ISO 15189 is recognized as a valuable guide in ensuring high quality clinical laboratory services and promoting the harmonization of accreditation programmes in laboratory medicine. Examination procedures must be verified in order to guarantee that their performance characteristics are congruent with the intended scope of the test. The aim of the present study was to propose a practice model for implementing procedures employed for the verification of validated examination procedures already used for at least 2 years in our laboratory, in agreement with the ISO 15189 requirement at the Section 5.5.1.2. Methods In order to identify the operative procedure to be used, approved documents were identified, together with the definition of performance characteristics to be evaluated for the different methods; the examination procedures used in laboratory were analyzed and checked for performance specifications reported by manufacturers. Then, operative flow charts were identified to compare the laboratory performance characteristics with those declared by manufacturers. Results The choice of performance characteristics for verification was based on approved documents used as guidance, and the specific purpose tests undertaken, a consideration being made of: imprecision and trueness for quantitative methods; diagnostic accuracy for qualitative methods; imprecision together with diagnostic accuracy for semi-quantitative methods. Conclusions The described approach, balancing technological possibilities, risks and costs and assuring the compliance of the fundamental component of result accuracy, appears promising as an easily applicable and flexible procedure helping laboratories to comply with the ISO 15189 requirements.
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Laboratory Response to Ebola - West Africa and United States.
Sealy, Tara K; Erickson, Bobbie R; Taboy, Céline H; Ströher, Ute; Towner, Jonathan S; Andrews, Sharon E; Rose, Laura E; Weirich, Elizabeth; Lowe, Luis; Klena, John D; Spiropoulou, Christina F; Rayfield, Mark A; Bird, Brian H
2016-07-08
The 2014-2016 Ebola virus disease (Ebola) epidemic in West Africa highlighted the need to maintain organized laboratory systems or networks that can be effectively reorganized to implement new diagnostic strategies and laboratory services in response to large-scale events. Although previous Ebola outbreaks enabled establishment of critical laboratory practice safeguards and diagnostic procedures, this Ebola outbreak in West Africa highlighted the need for planning and preparedness activities that are better adapted to emerging pathogens or to pathogens that have attracted little commercial interest. The crisis underscored the need for better mechanisms to streamline development and evaluation of new diagnostic assays, transfer of material and specimens between countries and organizations, and improved processes for rapidly deploying health workers with specific laboratory expertise. The challenges and events of the outbreak forced laboratorians to examine not only the comprehensive capacities of existing national laboratory systems to recognize and respond to events, but also their sustainability over time and the mechanisms that need to be pre-established to ensure effective response. Critical to this assessment was the recognition of how response activities (i.e., infrastructure support, logistics, and workforce supplementation) can be used or repurposed to support the strengthening of national laboratory systems during the postevent transition to capacity building and recovery. This report compares CDC's domestic and international laboratory response engagements and lessons learned that can improve future responses in support of the International Health Regulations and Global Health Security Agenda initiatives.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).
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Jacobsen, Sonja; Patel, Pranav; Rieger, Toni; Eickmann, Markus; Becker, Stephan; Günther, Stephan; Naidoo, Dhamari; Schrick, Livia; Keeren, Kathrin; Targosz, Angelina; Teichmann, Anette; Formenty, Pierre; Niedrig, Matthias
2017-01-01
During the recent Ebola outbreak in West Africa several international mobile laboratories were deployed to the mainly affected countries Guinea, Sierra Leone and Liberia to provide ebolavirus diagnostic capacity. Additionally, imported cases and small outbreaks in other countries required global preparedness for Ebola diagnostics. Detection of viral RNA by reverse transcription polymerase chain reaction has proven effective for diagnosis of ebolavirus disease and several assays are available. However, reliability of these assays is largely unknown and requires serious evaluation. Therefore, a proficiency test panel of 11 samples was generated and distributed on a global scale. Panels were analyzed by 83 expert laboratories and 106 data sets were returned. From these 78 results were rated optimal and 3 acceptable, 25 indicated need for improvement. While performance of the laboratories deployed to West Africa was superior to the overall performance there was no significant difference between the different assays applied. PMID:28459810
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Ellerbrok, Heinz; Jacobsen, Sonja; Patel, Pranav; Rieger, Toni; Eickmann, Markus; Becker, Stephan; Günther, Stephan; Naidoo, Dhamari; Schrick, Livia; Keeren, Kathrin; Targosz, Angelina; Teichmann, Anette; Formenty, Pierre; Niedrig, Matthias
2017-05-01
During the recent Ebola outbreak in West Africa several international mobile laboratories were deployed to the mainly affected countries Guinea, Sierra Leone and Liberia to provide ebolavirus diagnostic capacity. Additionally, imported cases and small outbreaks in other countries required global preparedness for Ebola diagnostics. Detection of viral RNA by reverse transcription polymerase chain reaction has proven effective for diagnosis of ebolavirus disease and several assays are available. However, reliability of these assays is largely unknown and requires serious evaluation. Therefore, a proficiency test panel of 11 samples was generated and distributed on a global scale. Panels were analyzed by 83 expert laboratories and 106 data sets were returned. From these 78 results were rated optimal and 3 acceptable, 25 indicated need for improvement. While performance of the laboratories deployed to West Africa was superior to the overall performance there was no significant difference between the different assays applied.
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New Mexico Small Business Assistance (NMSBA) September 2016 Advisory Council Update
DOE Office of Scientific and Technical Information (OSTI.GOV)
Larkin, Ariana Kayla
This is an update on two projects headed by Los Alamos National Laboratory and Sandia National Laboratories. The two projects are: The Electrochemical Based Gas Analyzer for Automotive Diagnostic and Maximizing the Production of High Value and High Demand Guar Gum on Marginal Lands in New Mexico. The Electrochemical Based Gas Analyzer for Automotive Diagnostic NMSBA leveraged project is made up of Albuquerque companies, Automotive Test Solutions, Inc. (ATS), ATS Mobile Diagnostics and Thoma Technologies and Los Alamos small business, VI Control Systems, to develop a new sensor system for the automotive industry. The Guar Gum NMSBA Leveraged Project beganmore » in January 2016 with the goal to develop biotechnology to enable a genetic modification of prairie cordgrass, a renewable feedstock for bioenergy and bio-manufacturing. In the long term, the companies hope to use the technology to bio-manufacture high value products in the stem of the plant. This document describes the laboratories' cooperation with small businesses on these projects.« less
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Glass-Kaastra, Shiona K.; Pearl, David L.; Reid-Smith, Richard J.; McEwen, Beverly; Slavic, Durda; McEwen, Scott A.; Fairles, Jim
2014-01-01
Antimicrobial susceptibility data on Escherichia coli F4, Pasteurella multocida, and Streptococcus suis isolates from Ontario swine (January 1998 to October 2010) were acquired from a comprehensive diagnostic veterinary laboratory in Ontario, Canada. In relation to the possible development of a surveillance system for antimicrobial resistance, data were assessed for ease of management, completeness, consistency, and applicability for temporal and spatial statistical analyses. Limited farm location data precluded spatial analyses and missing demographic data limited their use as predictors within multivariable statistical models. Changes in the standard panel of antimicrobials used for susceptibility testing reduced the number of antimicrobials available for temporal analyses. Data consistency and quality could improve over time in this and similar diagnostic laboratory settings by encouraging complete reporting with sample submission and by modifying database systems to limit free-text data entry. These changes could make more statistical methods available for disease surveillance and cluster detection. PMID:24688133
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Glass-Kaastra, Shiona K; Pearl, David L; Reid-Smith, Richard J; McEwen, Beverly; Slavic, Durda; McEwen, Scott A; Fairles, Jim
2014-04-01
Antimicrobial susceptibility data on Escherichia coli F4, Pasteurella multocida, and Streptococcus suis isolates from Ontario swine (January 1998 to October 2010) were acquired from a comprehensive diagnostic veterinary laboratory in Ontario, Canada. In relation to the possible development of a surveillance system for antimicrobial resistance, data were assessed for ease of management, completeness, consistency, and applicability for temporal and spatial statistical analyses. Limited farm location data precluded spatial analyses and missing demographic data limited their use as predictors within multivariable statistical models. Changes in the standard panel of antimicrobials used for susceptibility testing reduced the number of antimicrobials available for temporal analyses. Data consistency and quality could improve over time in this and similar diagnostic laboratory settings by encouraging complete reporting with sample submission and by modifying database systems to limit free-text data entry. These changes could make more statistical methods available for disease surveillance and cluster detection.
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Point-of-care diagnostics: extending the laboratory network to reach the last mile.
Drain, Paul K; Rousseau, Christine
2017-03-01
More point-of-care (POC) diagnostic tests are becoming available for HIV diagnosis and treatment in resource-limited settings. These novel technologies have the potential to foster decentralized HIV care and treatment for the benefit of clinical laboratories, HIV clinics, and HIV-infected patients. There continue to be many business, technological, and operational challenges that limit product development and regulatory approval, which limits products available for the required operational and cost-effectiveness studies and delays policy adoption and implementation. Although the rapid HIV diagnostic test has been widely successful, the pathways for POC CD4 cell count and HIV viral load assay analyzers have been more challenging. We describe significant hurdles for product development, approval, and implementation, which include the business case, technical development, clinical impact, and integrating laboratory and clinical networks. The objective of this review is to highlight the obstacles for developing and implementing appropriate strategies for POC HIV testing assays to improve the clinical services for HIV-infected patients in resource-limited settings.
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Screening and syndromic approaches to identify gonorrhea and chlamydial infection among women.
Sloan, N L; Winikoff, B; Haberland, N; Coggins, C; Elias, C
2000-03-01
The standard diagnostic tools to identify sexually transmitted infections are often expensive and have laboratory and infrastructure requirements that make them unavailable to family planning and primary health-care clinics in developing countries. Therefore, inexpensive, accessible tools that rely on symptoms, signs, and/or risk factors have been developed to identify and treat reproductive tract infections without the need for laboratory diagnostics. Studies were reviewed that used standard diagnostic tests to identify gonorrhea and cervical chlamydial infection among women and that provided adequate information about the usefulness of the tools for screening. Aggregation of the studies' results suggest that risk factors, algorithms, and risk scoring for syndromic management are poor indicators of gonorrhea and chlamydial infection in samples of both low and high prevalence and, consequently, are not effective mechanisms with which to identify or manage these conditions. The development and evaluation of other approaches to identify gonorrhea and chlamydial infections, including inexpensive and simple laboratory screening tools, periodic universal treatment, and other alternatives must be given priority.
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Ciardo, Diana E; Lucke, Katja; Imhof, Alex; Bloemberg, Guido V; Böttger, Erik C
2010-08-01
The implementation of internal transcribed spacer (ITS) sequencing for routine identification of molds in the diagnostic mycology laboratory was analyzed in a 5-year study. All mold isolates (n = 6,900) recovered in our laboratory from 2005 to 2009 were included in this study. According to a defined work flow, which in addition to troublesome phenotypic identification takes clinical relevance into account, 233 isolates were subjected to ITS sequence analysis. Sequencing resulted in successful identification for 78.6% of the analyzed isolates (57.1% at species level, 21.5% at genus level). In comparison, extended in-depth phenotypic characterization of the isolates subjected to sequencing achieved taxonomic assignment for 47.6% of these, with a mere 13.3% at species level. Optimization of DNA extraction further improved the efficacy of molecular identification. This study is the first of its kind to testify to the systematic implementation of sequence-based identification procedures in the routine workup of mold isolates in the diagnostic mycology laboratory.
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Antidiuretic hormone blood test
... eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier Saunders; 2013:146. Guber HA, ... Diagnosis and Management by Laboratory Methods . 23rd ed. St Louis, MO: Elsevier; 2017:chap 24. Oh MS, ...
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... eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier Saunders; 2013:654-655. Fagoaga ... Diagnosis and Management by Laboratory Methods . 23rd ed. St Louis, MO: Elsevier; 2017:chap 49. Inman RD. ...
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Bonar, Roslyn; Favaloro, Emmanuel; Zebeljan, Diane; Rosenfeld, David; Kershaw, Geoff; Mohammed, Soma; Marsden, Katherine; Hertzberg, Mark
2012-04-01
Laboratory identification of lupus anticoagulants (LA), an important component of the clinical diagnosis of the autoimmune disorder antiphospholipid syndrome (APS), is challenged by the heterogeneity of tests available, the diagnostic and laboratory approach undertaken, and the heterogeneity of the autoantibodies present. : To assess the laboratory approach for investigation of LA, as well as the utility of various tests and test approaches, given a difficult clinical scenario in which LA might or might not be present. Ninety-three participants in the Royal College of Pathologists of Australasia (RCPA) Haematology Quality Assurance Program (QAP) were sent 4 mL of a complex but strongly positive LA sample blinded to the nature of the abnormality. Seventy-three (79%) participants returned results and in most cases diagnostic interpretations. The laboratory approach to LA investigation of this sample was quite varied: 34.7% of participants concluded the sample was LA negative, with 91.7% of these performing dilute Russell viper venom time (dRVVT) testing without mixing, whereas 43.5% of participants identified a strong LA, with 96.7% of these having performed mixing studies. Most laboratories reporting negative LA instead identified the false presence of specific factor inhibitors against a variety of factors, including II, V and VIII. For this difficult challenge, performance of non-mixing dRVVT was associated with a high false negative LA rate. (C) 2012 Royal College of Pathologists of Australasia.
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Messacar, Kevin; Parker, Sarah K; Todd, James K; Dominguez, Samuel R
2017-03-01
New rapid molecular diagnostic technologies for infectious diseases enable expedited accurate microbiological diagnoses. However, diagnostic stewardship and antimicrobial stewardship are necessary to ensure that these technologies conserve, rather than consume, additional health care resources and optimally affect patient care. Diagnostic stewardship is needed to implement appropriate tests for the clinical setting and to direct testing toward appropriate patients. Antimicrobial stewardship is needed to ensure prompt appropriate clinical action to translate faster diagnostic test results in the laboratory into improved outcomes at the bedside. This minireview outlines the roles of diagnostic stewardship and antimicrobial stewardship in the implementation of rapid molecular infectious disease diagnostics. Copyright © 2017 American Society for Microbiology.
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Initial Public Health Laboratory Response After Hurricane Maria - Puerto Rico, 2017.
Concepción-Acevedo, Jeniffer; Patel, Anita; Luna-Pinto, Carolina; Peña, Rafael González; Cuevas Ruiz, Rosa Ivette; Arbolay, Héctor Rivera; Toro, Mayra; Deseda, Carmen; De Jesus, Victor R; Ribot, Efrain; Gonzalez, Jennifer-Quiñones; Rao, Gouthami; De Leon Salazar, Alfonsina; Ansbro, Marisela; White, Brunilís B; Hardy, Margaret C; Georgi, Joaudimir Castro; Stinnett, Rita; Mercante, Alexandra M; Lowe, David; Martin, Haley; Starks, Angela; Metchock, Beverly; Johnston, Stephanie; Dalton, Tracy; Joglar, Olga; Stafford, Cortney; Youngblood, Monica; Klein, Katherine; Lindstrom, Stephen; Berman, LaShondra; Galloway, Renee; Schafer, Ilana J; Walke, Henry; Stoddard, Robyn; Connelly, Robin; McCaffery, Elaine; Rowlinson, Marie-Claire; Soroka, Stephen; Tranquillo, Darin T; Gaynor, Anne; Mangal, Chris; Wroblewski, Kelly; Muehlenbachs, Atis; Salerno, Reynolds M; Lozier, Matthew; Sunshine, Brittany; Shapiro, Craig; Rose, Dale; Funk, Renee; Pillai, Satish K; O'Neill, Eduardo
2018-03-23
Hurricane Maria made landfall in Puerto Rico on September 20, 2017, causing major damage to infrastructure and severely limiting access to potable water, electric power, transportation, and communications. Public services that were affected included operations of the Puerto Rico Department of Health (PRDOH), which provides critical laboratory testing and surveillance for diseases and other health hazards. PRDOH requested assistance from CDC for the restoration of laboratory infrastructure, surveillance capacity, and diagnostic testing for selected priority diseases, including influenza, rabies, leptospirosis, salmonellosis, and tuberculosis. PRDOH, CDC, and the Association of Public Health Laboratories (APHL) collaborated to conduct rapid needs assessments and, with assistance from the CDC Foundation, implement a temporary transport system for shipping samples from Puerto Rico to the continental United States for surveillance and diagnostic and confirmatory testing. This report describes the initial laboratory emergency response and engagement efforts among federal, state, and nongovernmental partners to reestablish public health laboratory services severely affected by Hurricane Maria. The implementation of a sample transport system allowed Puerto Rico to reinitiate priority infectious disease surveillance and laboratory testing for patient and public health interventions, while awaiting the rebuilding and reinstatement of PRDOH laboratory services.
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Dekmezian, Mhair; Beal, Stacy G; Damashek, Mary Jane; Benavides, Raul; Dhiman, Neelam
2015-04-01
Successful performance and execution of rapid diagnostics in a clinical laboratory hinges heavily on careful validation, accurate and timely communication of results, and real-time quality monitoring. Laboratories must develop strategies to integrate diagnostics with stewardship and evidence-based clinical practice guidelines. We present a collaborative SUCCESS model for execution and monitoring of rapid sepsis diagnostics to facilitate timely treatment. Six months after execution of the Verigene Gram-Positive Blood Culture (BC-GP) and the AdvanDx PNA-FISH assays, data were collected on 579 and 28 episodes of bacteremia and fungemia, respectively. Clinical testing was executed using a SUCCESS model comprising the following components: stewardship, utilization of resources, core strategies, concierge services, education, support, and surveillance. Stewardship needs were identified by evaluating the specialty services benefiting from new testing. Utilization of resources was optimized by reviewing current treatment strategies and antibiogram and formulary options. Core strategies consisted of input from infectious disease leadership, pharmacy, and laboratory staff. Concierge services included automated Micro-eUpdate and physician-friendly actionable reports. Education modules were user-specific, and support was provided through a dedicated 24/7 microbiology hotline. Surveillance was performed by daily audit by the director. Using the SUCCESS model, the turnaround time for the detailed report with actionable guidelines to the physician was ∼3 hours from the time of culture positivity. The overall correlation between rapid methods and culture was 94% (546/579). Discrepant results were predominantly contaminants such as a coagulase-negative staphylococci or viridans streptococci in mixed cultures. SUCCESS is a cost-effective and easily adaptable model for clinical laboratories with limited stewardship resources.
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Pine, P S; Boedigheimer, M; Rosenzweig, B A; Turpaz, Y; He, Y D; Delenstarr, G; Ganter, B; Jarnagin, K; Jones, W D; Reid, L H; Thompson, K L
2008-11-01
Effective use of microarray technology in clinical and regulatory settings is contingent on the adoption of standard methods for assessing performance. The MicroArray Quality Control project evaluated the repeatability and comparability of microarray data on the major commercial platforms and laid the groundwork for the application of microarray technology to regulatory assessments. However, methods for assessing performance that are commonly applied to diagnostic assays used in laboratory medicine remain to be developed for microarray assays. A reference system for microarray performance evaluation and process improvement was developed that includes reference samples, metrics and reference datasets. The reference material is composed of two mixes of four different rat tissue RNAs that allow defined target ratios to be assayed using a set of tissue-selective analytes that are distributed along the dynamic range of measurement. The diagnostic accuracy of detected changes in expression ratios, measured as the area under the curve from receiver operating characteristic plots, provides a single commutable value for comparing assay specificity and sensitivity. The utility of this system for assessing overall performance was evaluated for relevant applications like multi-laboratory proficiency testing programs and single-laboratory process drift monitoring. The diagnostic accuracy of detection of a 1.5-fold change in signal level was found to be a sensitive metric for comparing overall performance. This test approaches the technical limit for reliable discrimination of differences between two samples using this technology. We describe a reference system that provides a mechanism for internal and external assessment of laboratory proficiency with microarray technology and is translatable to performance assessments on other whole-genome expression arrays used for basic and clinical research.
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Vallée, Isabelle; Macé, Pauline; Forbes, Lorry; Scandrett, Brad; Durand, Benoit; Gajadhar, Alvin; Boireau, Pascal
2007-07-01
Routine diagnosis of animal trichinellosis for food safety and trade relies on a method of artificial digestion to free Trichinella muscle larvae from meat for subsequent identification by microscopy. As part of a quality control system, the French National Reference Laboratory (NRL) initiated ring trials to determine the sensitivity of the test performed in the 72 routine diagnostic laboratories in France. A method was devised to obtain calibrated meat samples containing known numbers of capsules with Trichinella spiralis muscle larvae. This method was based on an incomplete artificial digestion of Trichinella-infected mice carcasses to allow the collection of intact Trichinella capsules. Capsules were placed into a meatball of 100 +/- 2 g of pork and horsemeat to produce proficiency samples. Three categories of samples were prepared: small (3 to 5 capsules), medium (7 to 10), and large (12 to 15). The sensitivity was expressed as the percentage of muscle larvae recovered from each proficiency sample. Reproducibility was tested with ring trials organized between two NRLs (France and Canada), and a reference sensitivity of 84.9% was established. National ring trials were then organized in France, with the 72 routine diagnostic laboratories each receiving four proficiency samples per session. After five sessions, an improvement in the digest test sensitivity was observed. Results at the fifth session indicated sensitivities of 78.60% +/- 23.70%, 81.19% +/- 19.59%, and 80.52% +/- 14.71% muscle larvae for small, medium, and large samples, respectively. This study supports the use of proficiency samples to accurately evaluate the performance of routine diagnostic laboratories that conduct digestion tests for animal trichinellosis diagnosis.
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OIE Collaborating Centre for Biorisk Management Strategic Plan.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Brass, Van Hildren
Due to efforts by individual nations and the international community to monitor and control natural occurring outbreaks of animal and zoonotic diseases, any number and variety of select agents and especially dangerous pathogens can be found at diagnostic laboratories around the world. Diagnostic testing is a crucial aspect of disease surveillance, but the organized collection and testing of diagnostic samples from the animal and human population at laboratories has created a repository of disease agents and toxins that could cause serious harm if released or acquired by nefarious means. The delicate balance between public health disease surveillance and the managementmore » of biorisks at facilities utilized in surveillance is a necessary goal of veterinary public health.« less
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A review of current and future molecular diagnostic tests for use in the microbiology laboratory.
Jannes, Geert; De Vos, Daniel
2006-01-01
Nucleic acid-based diagnostics gradually are replacing or complementing culture-based, biochemical, and immunological assays in routine microbiology laboratories. Similar to conventional tests, the first-generation deoxyribonucleic acid assays determined only a single analyte. Recent improvements in detection technologies have paved the way for the development of multiparameter assays using macroarrays or micro-arrays, while the introduction of closed-tube real-time polymerase chain reaction systems has resulted in the development of rapid microbial diagnostics with a reduced contamination risk. The use of these new molecular technologies is not restricted to detection and identification of microbial pathogens but also can be used for genotyping, allowing one to determine antibiotic resistance or to perform microbial fingerprinting.
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Point-of-care technologies for molecular diagnostics using a drop of blood.
Song, Yujun; Huang, Yu-Yen; Liu, Xuewu; Zhang, Xiaojing; Ferrari, Mauro; Qin, Lidong
2014-03-01
Molecular diagnostics is crucial for prevention, identification, and treatment of disease. Traditional technologies for molecular diagnostics using blood are limited to laboratory use because they rely on sample purification and sophisticated instruments, are labor and time intensive, expensive, and require highly trained operators. This review discusses the frontiers of point-of-care (POC) diagnostic technologies using a drop of blood obtained from a finger prick. These technologies, including emerging biotechnologies, nanotechnologies, and microfluidics, hold the potential for rapid, accurate, and inexpensive disease diagnostics. Copyright © 2014 Elsevier Ltd. All rights reserved.
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Molecular diagnostics: the changing culture of medical microbiology.
Bullman, Susan; Lucey, Brigid; Sleator, Roy D
2012-01-01
Diagnostic molecular biology is arguably the fastest growing area in current laboratory-based medicine. Growth of the so called 'omics' technologies has, over the last decade, led to a gradual migration away from the 'one test, one pathogen' paradigm, toward multiplex approaches to infectious disease diagnosis, which have led to significant improvements in clinical diagnostics and ultimately improved patient care.
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Goller, K V; Dill, V; Madi, M; Martin, P; Van der Stede, Y; Vandenberge, V; Haas, B; Van Borm, S; Koenen, F; Kasanga, C J; Ndusilo, N; Beer, M; Liu, L; Mioulet, V; Armson, B; King, D P; Fowler, V L
2018-04-01
Highly contagious transboundary animal diseases such as foot-and-mouth disease (FMD) are major threats to the productivity of farm animals. To limit the impact of outbreaks and to take efficient steps towards a timely control and eradication of the disease, rapid and reliable diagnostic systems are of utmost importance. Confirmatory diagnostic assays are typically performed by experienced operators in specialized laboratories, and access to this capability is often limited in the developing countries with the highest disease burden. Advances in molecular technologies allow implementation of modern and reliable techniques for quick and simple pathogen detection either in basic laboratories or even at the pen-side. Here, we report on a study to evaluate a fully automated cartridge-based real-time RT-PCR diagnostic system (Enigma MiniLab ® ) for the detection of FMD virus (FMDV). The modular system integrates both nucleic acid extraction and downstream real-time RT-PCR (rRT-PCR). The analytical sensitivity of this assay was determined using serially diluted culture grown FMDV, and the performance of the assay was evaluated using a selected range of FMDV positive and negative clinical samples of bovine, porcine and ovine origin. The robustness of the assay was evaluated in an international inter-laboratory proficiency test and by deployment into an African laboratory. It was demonstrated that the system is easy to use and can detect FMDV with high sensitivity and specificity, roughly on par with standard laboratory methods. This cartridge-based automated real-time RT-PCR system for the detection of FMDV represents a reliable and easy to use diagnostic tool for the early and rapid disease detection of acutely infected animals even in remote areas. This type of system could be easily deployed for routine surveillance within endemic regions such as Africa or could alternatively be used in the developed world. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.
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Mezzano, Diego; Quiroga, Teresa; Pereira, Jaime
2009-03-01
The major advances from research on platelet molecular and cell biology, physiology, and pathophysiology over the past decades have not been adequately translated to clinical laboratory diagnosis. Hereditary platelet function disorders (PFDs) are at least as prevalent in the general population as von Willebrand disease (VWD) although PFDs tend not be as well recognized or evaluated. Clinical mucous and skin bleeding in patients with PFDs is prototypic of primary hemostasis disorders, and the bleeding pattern is not distinguishable from that of other primary hemostasis disorders such as VWD. However, different treatment needs, between these discrete disorders, make a precise diagnosis mandatory. Currently, clinicians receive reliable laboratory reports when testing patients with severe PFDs, such as Glanzmann thrombasthenia and Bernard-Soulier syndrome, due to the distinctive laboratory defects that these disorders present, together with the availability of differential diagnostic tests. This is not the case for the majority of PFDs generically classified as "platelet secretion disorders," which are a heterogeneous group of "mild bleeding disorders," for which there are not universally accepted diagnostic criteria. An important reason for robust diagnostic tests is the high proportion (more than 50% in some reports) of patients with unequivocal bleeding who have no precise diagnosis established after a complete laboratory workup. It is paradoxical that the current "gold standard" test for PFD diagnosis, light transmission aggregometry (LTA), has not been standardized after more than four decades of worldwide clinical use. This review describes current diagnostic assays for PFD in a clinical hemostasis laboratory, relating these with current knowledge on platelet function and pathophysiology. Special emphasis will be given to LTA and platelet secretion tests, as well as to the reasons why sensitive tests are needed to explore the lesser known participation of platelets in blood clotting and fibrinolytic processes.
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Hunsperger, Elizabeth A.; Yoksan, Sutee; Buchy, Philippe; Nguyen, Vinh Chau; Sekaran, Shamala Devi; Enria, Delia A.; Vazquez, Susana; Cartozian, Elizabeth; Pelegrino, Jose L.; Artsob, Harvey; Guzman, Maria G.; Olliaro, Piero; Zwang, Julien; Guillerm, Martine; Kliks, Susie; Halstead, Scott; Peeling, Rosanna W.; Margolis, Harold S.
2014-01-01
Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60–75% and specificity 71–80%; NS1 RDT sensitivity was 38–71% and specificity 76–80%; the IgM anti-DENV RDTs sensitivity was 30–96%, with a specificity of 86–92%, and IgM anti-DENV ELISA sensitivity was 96–98% and specificity 78–91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88–94%. PMID:25330157
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Kimmel, April D.; Losina, Elena; Freedberg, Kenneth A.; Goldie, Sue J.
2006-01-01
We conducted a systematic review on the performance of diagnostic tests for clinical and laboratory monitoring of HIV-infected adults in developing countries. Diagnostic test information collected from computerized databases, bibliographies and the Internet were categorized as clinical (non-laboratory patient information), immunologic (information from immunologic laboratory tests), or virologic (information from virologic laboratory tests). Of the 51 studies selected for the review 28 assessed immunologic tests, 12 virologic tests and seven clinical and immunologic tests. Methods of performance evaluation were primarily sensitivity and specificity for the clinical category and correlation coefficients for immunologic and virologic categories. In the clinical category, the majority of test performance measures was reported as >70% sensitive and >65% specific. In the immunologic category, correlation coefficients ranged from r=0.54 to r=0.99 for different CD4 count enumeration techniques, while correlation for CD4 and total lymphocyte counts was between r=0.23 and r=0.74. In the virologic category, correlation coefficients for different human immunodeficiency virus (HIV) ribonucleic acid (RNA) quantification techniques ranged from r=0.54 to r=0.90. Future research requires consensus on designing studies, and collecting and reporting data useful for decision-makers. We recommend classifying information into clinically relevant categories, using a consistent definition of disease across studies and providing measures of both association and accuracy. PMID:16878233
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Concordance in diagnostic testing for respiratory pathogens of Bighorn Sheep
USDA-ARS?s Scientific Manuscript database
Reliable diagnostic tests are essential for disease investigation and management. This is particularly true for diseases of free-ranging wildlife where sampling is logistically difficult precluding retesting. Clinical assays for wildlife diseases frequently vary among laboratories because of lack ...
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Clinical laboratory: bigger is not always better.
Plebani, Mario
2018-06-27
Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.
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Molecular diagnostic methods for invasive fungal disease: the horizon draws nearer?
Halliday, C L; Kidd, S E; Sorrell, T C; Chen, S C-A
2015-04-01
Rapid, accurate diagnostic laboratory tests are needed to improve clinical outcomes of invasive fungal disease (IFD). Traditional direct microscopy, culture and histological techniques constitute the 'gold standard' against which newer tests are judged. Molecular diagnostic methods, whether broad-range or fungal-specific, have great potential to enhance sensitivity and speed of IFD diagnosis, but have varying specificities. The use of PCR-based assays, DNA sequencing, and other molecular methods including those incorporating proteomic approaches such as matrix-assisted laser desorption ionisation-time of flight mass spectroscopy (MALDI-TOF MS) have shown promising results. These are used mainly to complement conventional methods since they require standardisation before widespread implementation can be recommended. None are incorporated into diagnostic criteria for defining IFD. Commercial assays may assist standardisation. This review provides an update of molecular-based diagnostic approaches applicable to biological specimens and fungal cultures in microbiology laboratories. We focus on the most common pathogens, Candida and Aspergillus, and the mucormycetes. The position of molecular-based approaches in the detection of azole and echinocandin antifungal resistance is also discussed.
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Talbot-Lau x-ray interferometry for high energy density plasma diagnostic.
Stutman, D; Finkenthal, M
2011-11-01
High resolution density diagnostics are difficult in high energy density laboratory plasmas (HEDLP) experiments due to the scarcity of probes that can penetrate above solid density plasmas. Hard x-rays are one possible probe for such dense plasmas. We study the possibility of applying an x-ray method recently developed for medical imaging, differential phase-contrast with Talbot-Lau interferometers, for the diagnostic of electron density and small-scale hydrodynamic instabilities in HEDLP experiments. The Talbot method uses micro-periodic gratings to measure the refraction and ultra-small angle scatter of x-rays through an object and is attractive for HEDLP diagnostic due to its capability to work with incoherent and polychromatic x-ray sources such as the laser driven backlighters used for HEDLP radiography. Our paper studies the potential of the Talbot method for HEDLP diagnostic, its adaptation to the HEDLP environment, and its extension of high x-ray energy using micro-periodic mirrors. The analysis is illustrated with experimental results obtained using a laboratory Talbot interferometer. © 2011 American Institute of Physics
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[The National Reference Centres and Reference Laboratories. Importance and tasks].
Laude, G; Ammon, A
2005-09-01
Since 1995, the German Federal Ministry for Health and Social Security funds National Reference Centres (NRC) for the laboratory surveillance of important pathogens and syndromes. Which pathogens or syndromes are selected to be covered by a NRC depends on their epidemiological relevance, the special diagnostic tools, problems with antimicrobial resistance and necessary infection control measures. Currently, there are 15 NRC, which are appointed for a period of 3 years (currently from January 2005 through December 2007). Towards the end of their appointment all NRC are evaluated by a group of specialists. The assessment of their achievements is guided by a catalogue of tasks for the NRC. In addition to the NRC, a total of 50 laboratories are appointed which provide specialist expertise for additional pathogens in order to have a broad range of pathogens for which specialist laboratories are available. Their predominant task is to give advice and support for special diagnostic problems. Both NRC and the specialist laboratories are important parts of the network for infectious disease epidemiology.
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Ebola Laboratory Response at the Eternal Love Winning Africa Campus, Monrovia, Liberia, 2014–2015
de Wit, Emmie; Rosenke, Kyle; Fischer, Robert J.; Marzi, Andrea; Prescott, Joseph; Bushmaker, Trenton; van Doremalen, Neeltje; Emery, Shannon L.; Falzarano, Darryl; Feldmann, Friederike; Groseth, Allison; Hoenen, Thomas; Juma, Bonventure; McNally, Kristin L.; Ochieng, Melvin; Omballa, Victor; Onyango, Clayton O.; Owuor, Collins; Rowe, Thomas; Safronetz, David; Self, Joshua; Williamson, Brandi N.; Zemtsova, Galina; Grolla, Allen; Kobinger, Gary; Rayfield, Mark; Ströher, Ute; Strong, James E.; Best, Sonja M.; Ebihara, Hideki; Zoon, Kathryn C.; Nichol, Stuart T.; Nyenswah, Tolbert G.; Bolay, Fatorma K.; Massaquoi, Moses; Feldmann, Heinz; Fields, Barry
2016-01-01
West Africa experienced the first epidemic of Ebola virus infection, with by far the greatest number of cases in Guinea, Sierra Leone, and Liberia. The unprecedented epidemic triggered an unparalleled response, including the deployment of multiple Ebola treatment units and mobile/field diagnostic laboratories. The National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention deployed a joint laboratory to Monrovia, Liberia, in August 2014 to support the newly founded Ebola treatment unit at the Eternal Love Winning Africa (ELWA) campus. The laboratory operated initially out of a tent structure but quickly moved into a fixed-wall building owing to severe weather conditions, the need for increased security, and the high sample volume. Until May 2015, when the laboratory closed, the site handled close to 6000 clinical specimens for Ebola virus diagnosis and supported the medical staff in case patient management. Laboratory operation and safety, as well as Ebola virus diagnostic assays, are described and discussed; in addition, lessons learned for future deployments are reviewed. PMID:27333914
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Wanja, Elizabeth; Achilla, Rachel; Obare, Peter; Adeny, Rose; Moseti, Caroline; Otieno, Victor; Morang'a, Collins; Murigi, Ephantus; Nyamuni, John; Monthei, Derek R; Ogutu, Bernhards; Buff, Ann M
2017-05-25
One objective of the Kenya National Malaria Strategy 2009-2017 is scaling access to prompt diagnosis and effective treatment. In 2013, a quality assurance (QA) pilot was implemented to improve accuracy of malaria diagnostics at selected health facilities in low-transmission counties of Kenya. Trends in malaria diagnostic and QA indicator performance during the pilot are described. From June to December 2013, 28 QA officers provided on-the-job training and mentoring for malaria microscopy, malaria rapid diagnostic tests and laboratory QA/quality control (QC) practices over four 1-day visits at 83 health facilities. QA officers observed and recorded laboratory conditions and practices and cross-checked blood slides for malaria parasite presence, and a portion of cross-checked slides were confirmed by reference laboratories. Eighty (96%) facilities completed the pilot. Among 315 personnel at pilot initiation, 13% (n = 40) reported malaria diagnostics training within the previous 12 months. Slide positivity ranged from 3 to 7%. Compared to the reference laboratory, microscopy sensitivity ranged from 53 to 96% and positive predictive value from 39 to 53% for facility staff and from 60 to 96% and 52 to 80%, respectively, for QA officers. Compared to reference, specificity ranged from 88 to 98% and negative predictive value from 98 to 99% for health-facility personnel and from 93 to 99% and 99%, respectively, for QA officers. The kappa value ranged from 0.48-0.66 for facility staff and 0.57-0.84 for QA officers compared to reference. The only significant test performance improvement observed for facility staff was for specificity from 88% (95% CI 85-90%) to 98% (95% CI 97-99%). QA/QC practices, including use of positive-control slides, internal and external slide cross-checking and recording of QA/QC activities, all increased significantly across the pilot (p < 0.001). Reference material availability also increased significantly; availability of six microscopy job aids and seven microscopy standard operating procedures increased by a mean of 32 percentage points (p < 0.001) and 38 percentage points (p < 0.001), respectively. Significant gains were observed in malaria QA/QC practices over the pilot. However, these advances did not translate into improved accuracy of malaria diagnostic performance perhaps because of the limited duration of the QA pilot implementation.
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Teaching pediatric laboratory medicine to pathology residents.
Pysher, Theodore J; Bach, Philip R; Geaghan, Sharon M; Hamilton, Marilyn S; Laposata, Michael; Lockitch, Gillian; Brugnara, Carlo; Coffin, Cheryl M; Pasquali, Marzia; Rinaldo, Piero; Roberts, William L; Rutledge, Joe C; Ashwood, Edward R; Blaylock, Robert C; Campos, Joseph M; Goldsmith, Barbara; Jones, Patricia M; Lim, Megan; Meikle, A Wayne; Perkins, Sherrie L; Perry, Deborah A; Petti, Cathy A; Rogers, Beverly B; Steele, Paul E; Weiss, Ronald L; Woods, Gail
2006-07-01
Laboratory data are essential to the medical care of fetuses, infants, children, and adolescents. However, the performance and interpretation of laboratory tests on specimens from these patients, which may constitute a significant component of the workload in general hospitals and integrated health care systems as well as specialized perinatal or pediatric centers, present unique challenges to the clinical pathologist and the laboratory. Therefore, pathology residents should receive training in pediatric laboratory medicine. Children's Health Improvement through Laboratory Diagnostics, a group of pathologists and laboratory scientists with interest and expertise in pediatric laboratory medicine, convened a task force to develop a list of curriculum topics, key resources, and training experiences in pediatric laboratory medicine for trainees in anatomic and clinical pathology or straight clinical pathology residency programs and in pediatric pathology fellowship programs. Based on the experiences of 11 training programs, we have compiled a comprehensive list of pediatric topics in the areas of clinical chemistry, endocrinology, hematology, urinalysis, coagulation medicine, transfusion medicine, immunology, microbiology and virology, biochemical genetics, cytogenetics and molecular diagnostics, point of care testing, and laboratory management. This report also includes recommendations for training experiences and a list of key texts and other resources in pediatric laboratory medicine. Clinical pathologists should be trained to meet the laboratory medicine needs of pediatric patients and to assist the clinicians caring for these patients with the selection and interpretation of laboratory studies. This review helps program directors tailor their curricula to more effectively provide this training.
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Clinical Laboratory Values as Early Indicators of Ebola Virus Infection in Nonhuman Primates.
Reisler, Ronald B; Yu, Chenggang; Donofrio, Michael J; Warren, Travis K; Wells, Jay B; Stuthman, Kelly S; Garza, Nicole L; Vantongeren, Sean A; Donnelly, Ginger C; Kane, Christopher D; Kortepeter, Mark G; Bavari, Sina; Cardile, Anthony P
2017-08-01
The Ebola virus (EBOV) outbreak in West Africa during 2013-2016 demonstrated the need to improve Ebola virus disease (EVD) diagnostics and standards of care. This retrospective study compared laboratory values and clinical features of 3 nonhuman primate models of lethal EVD to assess associations with improved survival time. In addition, the study identified laboratory values useful as predictors of survival, surrogates for EBOV viral loads, and triggers for initiation of therapeutic interventions in these nonhuman primate models. Furthermore, the data support that, in nonhuman primates, the Makona strain of EBOV may be less virulent than the Kikwit strain of EBOV. The applicability of these findings as potential diagnostic and management tools for EVD in humans warrants further investigation.
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The clinical and laboratory correlates of an increased urinary 5-hydroxyindoleacetic acid.
Tormey, W. P.; FitzGerald, R. J.
1995-01-01
Over a five-and-a-half-year period, there were 298 laboratory requests for urinary 5-hydroxyindoleacetic acid (5-HIAA). The clinical and laboratory associations of the 24 patients in which there were 43 urinary 5-HIAA 24-h collection results greater than the laboratory upper reference limit are detailed. Four were confirmed carcinoid tumours and two were phaeochromocytomas. Flushing was a prominent symptom in 46% and diarrhoea or altered bowel habit in 37%. Associated with the raised urinary 5-HIAA values were increased levels of 4-hydroxy-3-methoxymandelic acid and homovanillic acid in 14.3% and 21%, respectively, of those collections where the metabolites were requested. Diagnostic imaging was performed in 57%. While the specificity was 88%, 5-HIAA is relatively insensitive in the diagnosis of carcinoid tumours and a more widespread use of diagnostic imaging including isotope scanning with labelled metaiodo-benzylguanidine, vasoactive intestinal peptide and octreotide is suggested. PMID:7479466
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Moore, Andrew; Nelson, Christina; Molins, Claudia; Mead, Paul; Schriefer, Martin
2016-07-01
In the United States, Lyme disease is caused by Borrelia burgdorferi and transmitted to humans by blacklegged ticks. Patients with an erythema migrans lesion and epidemiologic risk can receive a diagnosis without laboratory testing. For all other patients, laboratory testing is necessary to confirm the diagnosis, but proper interpretation depends on symptoms and timing of illness. The recommended laboratory test in the United States is 2-tiered serologic analysis consisting of an enzyme-linked immunoassay or immunofluorescence assay, followed by reflexive immunoblotting. Sensitivity of 2-tiered testing is low (30%-40%) during early infection while the antibody response is developing (window period). For disseminated Lyme disease, sensitivity is 70%-100%. Specificity is high (>95%) during all stages of disease. Use of other diagnostic tests for Lyme disease is limited. We review the rationale behind current US testing guidelines, appropriate use and interpretation of tests, and recent developments in Lyme disease diagnostics.
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Collection, transport and general processing of clinical specimens in Microbiology laboratory.
Sánchez-Romero, M Isabel; García-Lechuz Moya, Juan Manuel; González López, Juan José; Orta Mira, Nieves
2018-02-06
The interpretation and the accuracy of the microbiological results still depend to a great extent on the quality of the samples and their processing within the Microbiology laboratory. The type of specimen, the appropriate time to obtain the sample, the way of sampling, the storage and transport are critical points in the diagnostic process. The availability of new laboratory techniques for unusual pathogens, makes necessary the review and update of all the steps involved in the processing of the samples. Nowadays, the laboratory automation and the availability of rapid techniques allow the precision and turn-around time necessary to help the clinicians in the decision making. In order to be efficient, it is very important to obtain clinical information to use the best diagnostic tools. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
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Economic challenges associated with tuberculosis diagnostic development
Hanrahan, Colleen F.; Shah, Maunank
2015-01-01
Tuberculosis remains a global health crisis in part due to underdiagnosis. Technological innovations are needed to improve diagnostic test accuracy and reduce the reliance on expensive laboratory infrastructure. However, there are significant economic challenges impeding the development and implementation of new diagnostics. The aim of this piece is to examine the current state of TB diagnostics, outline the unmet needs for new tests, and detail the economic challenges associated with development of new tests from the perspective of developers, policy makers and implementers. PMID:24766367
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Economic challenges associated with tuberculosis diagnostic development.
Hanrahan, Colleen F; Shah, Maunank
2014-08-01
Tuberculosis remains a global health crisis in part due to underdiagnosis. Technological innovations are needed to improve diagnostic test accuracy and reduce the reliance on expensive laboratory infrastructure. However, there are significant economic challenges impeding the development and implementation of new diagnostics. The aim of this piece is to examine the current state of TB diagnostics, outline the unmet needs for new tests, and detail the economic challenges associated with development of new tests from the perspective of developers, policy makers and implementers.
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Breast Cancer Diagnostic System Final Report CRADA No. TC02098.0
DOE Office of Scientific and Technical Information (OSTI.GOV)
Rubenchik, A. M.; DaSilva, L. B.
This was a collaborative effort between Lawrence Livermore National Security, LLC (formerly The Regents of the University of California)/Lawrence Liver more National Laboratory (LLNL) and BioTelligent, Inc. together with a Russian Institution (BioFil, Ltd.), to develop a new system ( diagnostic device, operating procedures, algorithms and software) to accurately distinguish between benign and malignant breast tissue (Breast Cancer Diagnostic System, BCDS).
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42 CFR 493.833 - Condition: Diagnostic immunology.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Diagnostic immunology. 493.833 Section 493.833 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... for Laboratories Performing Tests of Moderate Complexity (including the Subcategory), High Complexity...
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42 CFR 493.833 - Condition: Diagnostic immunology.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Diagnostic immunology. 493.833 Section 493.833 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... for Laboratories Performing Tests of Moderate Complexity (including the Subcategory), High Complexity...
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Tularemia without lesions in grey tree squirrels: A diagnostic challenge
USDA-ARS?s Scientific Manuscript database
Fifteen cases of Francisella tularenesis infection (tularemia) were identified in western grey (Sciurus griseus) and eastern grey (Sciurus carolinesis) squirrels submitted to the Washington Animal Disease Diagnostic Laboratory between 2008 and 2011. All of the squirrels originated in Washington stat...
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Interpretation of diagnostic data: 5. How to do it with simple maths.
1983-11-01
The use of simple maths with the likelihood ratio strategy fits in nicely with our clinical views. By making the most out of the entire range of diagnostic test results (i.e., several levels, each with its own likelihood ratio, rather than a single cut-off point and a single ratio) and by permitting us to keep track of the likelihood that a patient has the target disorder at each point along the diagnostic sequence, this strategy allows us to place patients at an extremely high or an extremely low likelihood of disease. Thus, the numbers of patients with ultimately false-positive results (who suffer the slings of labelling and the arrows of needless therapy) and of those with ultimately false-negative results (who therefore miss their chance for diagnosis and, possibly, efficacious therapy) will be dramatically reduced. The following guidelines will be useful in interpreting signs, symptoms and laboratory tests with the likelihood ratio strategy: Seek out, and demand from the clinical or laboratory experts who ought to know, the likelihood ratios for key symptoms and signs, and several levels (rather than just the positive and negative results) of diagnostic test results. Identify, when feasible, the logical sequence of diagnostic tests. Estimate the pretest probability of disease for the patient, and, using either the nomogram or the conversion formulas, apply the likelihood ratio that corresponds to the first diagnostic test result. While remembering that the resulting post-test probability or odds from the first test becomes the pretest probability or odds for the next diagnostic test, repeat the process for all the pertinent symptoms, signs and laboratory studies that pertain to the target disorder. However, these combinations may not be independent, and convergent diagnostic tests, if treated as independent, will combine to overestimate the final post-test probability of disease. You are now far more sophisticated in interpreting diagnostic tests than most of your teachers. In the last part of our series we will show you some rather complex strategies that combine diagnosis and therapy, quantify our as yet nonquantified ideas about use, and require the use of at least a hand calculator.
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Interpretation of diagnostic data: 5. How to do it with simple maths.
1983-01-01
The use of simple maths with the likelihood ratio strategy fits in nicely with our clinical views. By making the most out of the entire range of diagnostic test results (i.e., several levels, each with its own likelihood ratio, rather than a single cut-off point and a single ratio) and by permitting us to keep track of the likelihood that a patient has the target disorder at each point along the diagnostic sequence, this strategy allows us to place patients at an extremely high or an extremely low likelihood of disease. Thus, the numbers of patients with ultimately false-positive results (who suffer the slings of labelling and the arrows of needless therapy) and of those with ultimately false-negative results (who therefore miss their chance for diagnosis and, possibly, efficacious therapy) will be dramatically reduced. The following guidelines will be useful in interpreting signs, symptoms and laboratory tests with the likelihood ratio strategy: Seek out, and demand from the clinical or laboratory experts who ought to know, the likelihood ratios for key symptoms and signs, and several levels (rather than just the positive and negative results) of diagnostic test results. Identify, when feasible, the logical sequence of diagnostic tests. Estimate the pretest probability of disease for the patient, and, using either the nomogram or the conversion formulas, apply the likelihood ratio that corresponds to the first diagnostic test result. While remembering that the resulting post-test probability or odds from the first test becomes the pretest probability or odds for the next diagnostic test, repeat the process for all the pertinent symptoms, signs and laboratory studies that pertain to the target disorder. However, these combinations may not be independent, and convergent diagnostic tests, if treated as independent, will combine to overestimate the final post-test probability of disease. You are now far more sophisticated in interpreting diagnostic tests than most of your teachers. In the last part of our series we will show you some rather complex strategies that combine diagnosis and therapy, quantify our as yet nonquantified ideas about use, and require the use of at least a hand calculator. PMID:6671182
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Laboratory medicine: challenges and opportunities.
Bossuyt, Xavier; Verweire, Kurt; Blanckaert, Norbert
2007-10-01
Technologic innovations have substantially improved the productivity of clinical laboratories, but the services provided by clinical laboratories are increasingly becoming commoditized. We reflect on how current developments may affect the future of laboratory medicine and how to deal with these changes. We argue that to be prepared for the future, clinical laboratories should enhance efficiency and reduce costs by forming alliances and networks; consolidating, integrating, or outsourcing; and more importantly, create additional value by providing knowledge services related to in vitro diagnostics.
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Sawford, Kate; Vollman, Ardene Robinson; Stephen, Craig
2012-01-01
The global public health community is facing the challenge of emerging infectious diseases. Historically, the majority of these diseases have arisen from animal populations at lower latitudes where many nations experience marked resource constraints. In order to minimize the impact of future events, surveillance of animal populations will need to enable prompt event detection and response. Many surveillance systems targeting animals rely on veterinarians to submit cases to a diagnostic laboratory or input clinical case data. Therefore understanding veterinarians’ decision-making process that guides laboratory case submission and their perceptions of infectious disease surveillance is foundational to interpreting disease patterns reported by laboratories and engaging veterinarians in surveillance initiatives. A focused ethnographic study was conducted with twelve field veterinary surgeons that participated in a mobile phone-based surveillance pilot project in Sri Lanka. Each participant agreed to an individual in-depth interview that was recorded and later transcribed to enable thematic analysis of the interview content. Results found that field veterinarians in Sri Lanka infrequently submit cases to laboratories – so infrequently that common case selection principles could not be described. Field veterinarians in Sri Lanka have a diagnostic process that operates independently of laboratories. Participants indicated a willingness to take part in surveillance initiatives, though they highlighted a need for incentives that satisfy a range of motivations that vary among field veterinarians. This study has implications for the future of animal health surveillance, including interpretation of disease patterns reported, system design and implementation, and engagement of data providers. PMID:23133542
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2010-01-01
Background Abnormal results of diagnostic laboratory tests can be difficult to interpret when disease probability is very low. Although most physicians generally do not use Bayesian calculations to interpret abnormal results, their estimates of pretest disease probability and reasons for ordering diagnostic tests may - in a more implicit manner - influence test interpretation and further management. A better understanding of this influence may help to improve test interpretation and management. Therefore, the objective of this study was to examine the influence of physicians' pretest disease probability estimates, and their reasons for ordering diagnostic tests, on test result interpretation, posttest probability estimates and further management. Methods Prospective study among 87 primary care physicians in the Netherlands who each ordered laboratory tests for 25 patients. They recorded their reasons for ordering the tests (to exclude or confirm disease or to reassure patients) and their pretest disease probability estimates. Upon receiving the results they recorded how they interpreted the tests, their posttest probability estimates and further management. Logistic regression was used to analyse whether the pretest probability and the reasons for ordering tests influenced the interpretation, the posttest probability estimates and the decisions on further management. Results The physicians ordered tests for diagnostic purposes for 1253 patients; 742 patients had an abnormal result (64%). Physicians' pretest probability estimates and their reasons for ordering diagnostic tests influenced test interpretation, posttest probability estimates and further management. Abnormal results of tests ordered for reasons of reassurance were significantly more likely to be interpreted as normal (65.8%) compared to tests ordered to confirm a diagnosis or exclude a disease (27.7% and 50.9%, respectively). The odds for abnormal results to be interpreted as normal were much lower when the physician estimated a high pretest disease probability, compared to a low pretest probability estimate (OR = 0.18, 95% CI = 0.07-0.52, p < 0.001). Conclusions Interpretation and management of abnormal test results were strongly influenced by physicians' estimation of pretest disease probability and by the reason for ordering the test. By relating abnormal laboratory results to their pretest expectations, physicians may seek a balance between over- and under-reacting to laboratory test results. PMID:20158908
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Houben, Paul H H; van der Weijden, Trudy; Winkens, Bjorn; Winkens, Ron A G; Grol, Richard P T M
2010-02-16
Abnormal results of diagnostic laboratory tests can be difficult to interpret when disease probability is very low. Although most physicians generally do not use Bayesian calculations to interpret abnormal results, their estimates of pretest disease probability and reasons for ordering diagnostic tests may--in a more implicit manner--influence test interpretation and further management. A better understanding of this influence may help to improve test interpretation and management. Therefore, the objective of this study was to examine the influence of physicians' pretest disease probability estimates, and their reasons for ordering diagnostic tests, on test result interpretation, posttest probability estimates and further management. Prospective study among 87 primary care physicians in the Netherlands who each ordered laboratory tests for 25 patients. They recorded their reasons for ordering the tests (to exclude or confirm disease or to reassure patients) and their pretest disease probability estimates. Upon receiving the results they recorded how they interpreted the tests, their posttest probability estimates and further management. Logistic regression was used to analyse whether the pretest probability and the reasons for ordering tests influenced the interpretation, the posttest probability estimates and the decisions on further management. The physicians ordered tests for diagnostic purposes for 1253 patients; 742 patients had an abnormal result (64%). Physicians' pretest probability estimates and their reasons for ordering diagnostic tests influenced test interpretation, posttest probability estimates and further management. Abnormal results of tests ordered for reasons of reassurance were significantly more likely to be interpreted as normal (65.8%) compared to tests ordered to confirm a diagnosis or exclude a disease (27.7% and 50.9%, respectively). The odds for abnormal results to be interpreted as normal were much lower when the physician estimated a high pretest disease probability, compared to a low pretest probability estimate (OR = 0.18, 95% CI = 0.07-0.52, p < 0.001). Interpretation and management of abnormal test results were strongly influenced by physicians' estimation of pretest disease probability and by the reason for ordering the test. By relating abnormal laboratory results to their pretest expectations, physicians may seek a balance between over- and under-reacting to laboratory test results.
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Denlinger, David S; Creswell, Joseph A; Anderson, J Laine; Reese, Conor K; Bernhardt, Scott A
2016-04-15
Insecticide resistance to synthetic chemical insecticides is a worldwide concern in phlebotomine sand flies (Diptera: Psychodidae), the vectors of Leishmania spp. parasites. The CDC bottle bioassay assesses resistance by testing populations against verified diagnostic doses and diagnostic times for an insecticide, but the assay has been used limitedly with sand flies. The objective of this study was to determine diagnostic doses and diagnostic times for laboratory Lutzomyia longipalpis (Lutz & Nieva) and Phlebotomus papatasi (Scopoli) to ten insecticides, including pyrethroids, organophosphates, carbamates, and DDT, that are used worldwide to control vectors. Bioassays were conducted in 1,000-ml glass bottles each containing 10-25 sand flies from laboratory colonies of L. longipalpis or P. papatasi. Four pyrethroids, three organophosphates, two carbamates and one organochlorine, were evaluated. A series of concentrations were tested for each insecticide, and four replicates were conducted for each concentration. Diagnostic doses were determined only during the exposure bioassay for the organophosphates and carbamates. For the pyrethroids and DDT, diagnostic doses were determined for both the exposure bioassay and after a 24-hour recovery period. Both species are highly susceptible to the carbamates as their diagnostic doses are under 7.0 μg/ml. Both species are also highly susceptible to DDT during the exposure assay as their diagnostic doses are 7.5 μg/ml, yet their diagnostic doses for the 24-h recovery period are 650.0 μg/ml for Lu. longipalpis and 470.0 μg/ml for P. papatasi. Diagnostic doses and diagnostic times can now be incorporated into vector management programs that use the CDC bottle bioassay to assess insecticide resistance in field populations of Lu. longipalpis and P. papatasi. These findings provide initial starting points for determining diagnostic doses and diagnostic times for other sand fly vector species and wild populations using the CDC bottle bioassay.
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[Advances of Molecular Diagnostic Techniques Application in Clinical Diagnosis.
Ying, Bin-Wu
2016-11-01
Over the past 20 years,clinical molecular diagnostic technology has made rapid development,and became the most promising field in clinical laboratory medicine.In particular,with the development of genomics,clinical molecular diagnostic methods will reveal the nature of clinical diseases in a deeper level,thus guiding the clinical diagnosis and treatments.Many molecular diagnostic projects have been routinely applied in clinical works.This paper reviews the advances on application of clinical diagnostic techniques in infectious disease,tumor and genetic disorders,including nucleic acid amplification,biochip,next-generation sequencing,and automation molecular system,and so on.
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42 CFR 493.1264 - Standard: Parasitology.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... Systems § 493.1264 Standard: Parasitology. (a) The laboratory must have available a reference collection... these references in the laboratory for appropriate comparison with diagnostic specimens. (b) The...
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Diagnostic Laboratory and the Molecular Pathology Laboratory. Johns Hopkins Genomics is staffed with clinical molecular geneticists, bioinformaticists, statistical geneticists, clinical geneticists and molecular shape Claes, Peter et al, Nature Genetics, 2018 February GAME-ON & OncoArray: An International
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Robinson, James C; Whaley, Christopher; Brown, Timothy T
2016-09-01
Prices for laboratory and other clinical services vary widely. Employers and insurers increasingly are adopting "reference pricing" policies to create incentives for patients to select lower-priced facilities. To measure the association between implementation of reference pricing and patient choice of laboratory, test prices, patient out-of-pocket spending, and insurer spending. We conducted an observational study of changes in laboratory pricing and selection by employees of a large national grocery firm (n = 30 415) before and after the firm implemented a reference pricing policy for laboratory services and compared the findings with changes over the same period for policy holders of a large national insurer that did not implement reference pricing (n = 181 831). The grocery firm established a maximum payment limit at the 60th percentile of the distribution of prices for each laboratory test in each region. Employees were provided with data on prices at all laboratories through a mobile digital platform. Patients selecting a laboratory that charged more than the payment limit were required to pay the full difference themselves. A total of 2.13 million claims were analyzed for 285 types of in vitro diagnostic tests between 2010 and 2013. Patient choice of laboratory, price paid per test, patient out-of-pocket costs, and employer spending. Compared with trends in prices paid by insurance policy holders not subject to reference pricing, and after adjusting for characteristics of tests and patients, implementation of reference pricing was associated with a 31.9% reduction (95% CI, 20.6%-41.6%) in average price paid per test by the third year of the program. In these 3 years, total spending on laboratory tests declined by $2.57 million (95% CI, $1.59-$3.35 million). Out-of-pocket costs by patients declined by $1.05 million (95% CI, $0.73-$1.37 million). Spending by the employer declined by $1.70 million (95% CI, $0.92-$2.48 million). When combined with access to price information, reference pricing was associated with patient choice of lower-cost laboratories and reductions in prices and payments by both employer and employees.
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Savel'eva, I V; Khatsukov, K X; Savel'eva, E I; Moskvitina, S I; Kovalev, D A; Savel'ev, V N; Kulichenko, A N; Antonenko, A D; Babenyshev, B V
2015-01-01
Improvement of laboratory diagnostics of cholera taking into the account appearance of hybrid variants of cholera vibrio El Tor biovar in the 1990s. Phenotypic and molecular-genetic properties of typical toxigenic (151 strains) and hybrid (102 strains) variants of El Tor biovar cholera vibrios, isolated in the Caucuses in 1970-1990 and 1993-1998, respectively, were studied. Toxigenicity gene DNA fragments, inherent to El Tor biovars or classic, were detected by using a reagent kit "Genes of Vibrio cholerae variant ctxB-rstR-rstC, REF" developed by us. Reagent kit "Genes of V. cholerae variant ctxB-rstR-rstC, REF" is proposed to be used for laboratory diagnostics of cholera during study of material from humans or environmental objects and for identification of V. cholerae 01 on genome level in PCR-analysis as a necessary addition to the classic scheme of bacteriological analysis. Laboratory diagnostics of cholera due to genetically altered (hybrid) variants of cholera vibrio El Tor biovar is based on a complex study of material from humans and environmental objects by routine bacteriologic and PCR-analysis methods with the aim of detection of gene DNA fragments in the studied material, that determine biovar (classic or El Tor), identification of V. cholerae O1 strains with differentiation of El Tor vibrios into typical and altered, as well as determination of enterotoxin, produced by the specific cholera vibrio strain (by the presence ctxB(El) or ctxB(Cl) gene DNA fragment, coding biosynthesis of CT-2 or CT-1, respectively).
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Williams, K; Sinclair, C; McEwan, R; Fleet, K; Balasegaram, S; Manuel, R
2014-07-01
Planning for the London 2012 Olympic and Paralympic Games at the Public Health Laboratory London was based on the requirement to meet potential increased demand with scalable capacity. The aim of this study was to determine the impact on demand for microbiology gastrointestinal diagnostic services during the Games period. Retrospective cross-sectional time-series data analysis was used to assess the number of gastrointestinal specimens received in the laboratory and the number of positive results. There was no increase in the number of gastrointestinal specimens received during the Games period, thus the Games had no impact on demand for microbiology gastrointestinal diagnostic services at the laboratory. There was a decrease in the number of public health specimens received for culture [incidence rate ratio = 0.34, 95% confidence interval (CI) = 0.13-0.86, P = 0.02] and a decrease in the number of culture positive community specimens (odds ratio = 0.59, 95 % CI = 0.40-0.85, P = 0.005), suggesting a decrease in gastrointestinal illness during the Games period. As previous planning assumptions were not based on actual specimen activity, the results of this study may modify the extent of additional planning for microbiological services required for mass gatherings. © 2014 The Authors.
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Olszynko-Gryn, Jesse
2014-01-01
The Aschheim–Zondek reaction is generally regarded as the first reliable hormone test for pregnancy and as a major product of the ‘heroic age’ of reproductive endocrinology. Invented in Berlin in the late 1920s, by the mid 1930s a diagnostic laboratory in Edinburgh was performing thousands of tests every year for doctors around Britain. In her classic history of antenatal care, sociologist Ann Oakley claimed that the Aschheim–Zondek test launched a ‘modern era’ of obstetric knowledge, which asserted its superiority over that of pregnant women. This article reconsiders Oakley’s claim by examining how pregnancy testing worked in practice. It explains the British adoption of the test in terms less of the medicalisation of pregnancy than of clinicians’ increasing general reliance on laboratory services for differential diagnosis. Crucially, the Aschheim–Zondek reaction was a test not directly for the fetus, but for placental tissue. It was used, less as a yes-or-no test for ordinary pregnancy, than as a versatile diagnostic tool for the early detection of malignant tumours and hormonal deficiencies believed to cause miscarriage. This test was as much a product of oncology and the little-explored world of laboratory services as of reproductive medicine. PMID:24388014
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Huang, Qing; Fu, Wei-Ling; You, Jian-Ping; Mao, Qing
2016-10-01
Ebola virus disease (EVD), caused by Ebola virus (EBOV), is a potent acute infectious disease with a high case-fatality rate. Etiological and serological EBOV detection methods, including techniques that involve the detection of the viral genome, virus-specific antigens and anti-virus antibodies, are standard laboratory diagnostic tests that facilitate confirmation or exclusion of EBOV infection. In addition, routine blood tests, liver and kidney function tests, electrolytes and coagulation tests and other diagnostic examinations are important for the clinical diagnosis and treatment of EVD. Because of the viral load in body fluids and secretions from EVD patients, all body fluids are highly contagious. As a result, biosafety control measures during the collection, transport and testing of clinical specimens obtained from individuals scheduled to undergo EBOV infection testing (including suspected, probable and confirmed cases) are crucial. This report has been generated following extensive work experience in the China Ebola Treatment Center (ETC) in Liberia and incorporates important information pertaining to relevant diagnostic standards, clinical significance, operational procedures, safety controls and other issues related to laboratory testing of EVD. Relevant opinions and suggestions are presented in this report to provide contextual awareness associated with the development of standards and/or guidelines related to EVD laboratory testing.
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National Ignition Facility: Experimental plan
NASA Astrophysics Data System (ADS)
1994-05-01
As part of the Conceptual Design Report (CDR) for the National Ignition Facility (NIF), scientists from Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Sandia National Laboratory (SNL), the University of Rochester's Laboratory for Laser Energetics (UR/LLE), and EG&G formed an NIF Target Diagnostics Working Group. The purpose of the Target Diagnostics Working Group is to prepare conceptual designs of target diagnostics for inclusion in the facility CDR and to determine how these specifications impact the CDR. To accomplish this, a subgroup has directed its efforts at constructing an approximate experimental plan for the ignition campaign of the NIF CDR. The results of this effort are contained in this document, the Experimental Plan for achieving fusion ignition in the NIF. This group initially concentrated on the flow-down requirements of the experimental campaign leading to ignition, which will dominate the initial efforts of the NIF. It is envisaged, however, that before ignition, there will be parallel campaigns supporting weapons physics, weapons effects, and other research. This plan was developed by analyzing the sequence of activities required to finally fire the laser at the level of power and precision necessary to achieve the conditions of an ignition hohlraum target, and to then use our experience in activating and running Nova experiments to estimate the rate of completing these activities.
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SODI-COLLOID (Selectable Optical Diagnostics Instrument - Colloid)
2011-10-17
ISS029-E-027431 (17 Oct. 2011) --- In the International Space Station?s Destiny laboratory, Japan Aerospace Exploration Agency astronaut Satoshi Furukawa, Expedition 29 flight engineer, activates the Microgravity Science Glovebox (MSG) in preparation for work with the Selectable Optical Diagnostics Instrument ? Colloid (SODI-COLLOID) hardware.
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SODI-COLLOID (Selectable Optical Diagnostics Instrument - Colloid)
2011-10-17
ISS029-E-027435 (17 Oct. 2011) --- In the International Space Station?s Destiny laboratory, Japan Aerospace Exploration Agency astronaut Satoshi Furukawa, Expedition 29 flight engineer, activates the Microgravity Science Glovebox (MSG) in preparation for work with the Selectable Optical Diagnostics Instrument ? Colloid (SODI-COLLOID) hardware.
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Michaud, Ginette Y
2005-01-01
In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.
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Approximation algorithms for a genetic diagnostics problem.
Kosaraju, S R; Schäffer, A A; Biesecker, L G
1998-01-01
We define and study a combinatorial problem called WEIGHTED DIAGNOSTIC COVER (WDC) that models the use of a laboratory technique called genotyping in the diagnosis of an important class of chromosomal aberrations. An optimal solution to WDC would enable us to define a genetic assay that maximizes the diagnostic power for a specified cost of laboratory work. We develop approximation algorithms for WDC by making use of the well-known problem SET COVER for which the greedy heuristic has been extensively studied. We prove worst-case performance bounds on the greedy heuristic for WDC and for another heuristic we call directional greedy. We implemented both heuristics. We also implemented a local search heuristic that takes the solutions obtained by greedy and dir-greedy and applies swaps until they are locally optimal. We report their performance on a real data set that is representative of the options that a clinical geneticist faces for the real diagnostic problem. Many open problems related to WDC remain, both of theoretical interest and practical importance.
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Advances and challenges in biosensor-based diagnosis of infectious diseases
Sin, Mandy LY; Mach, Kathleen E; Wong, Pak Kin; Liao, Joseph C
2014-01-01
Rapid diagnosis of infectious diseases and timely initiation of appropriate treatment are critical determinants that promote optimal clinical outcomes and general public health. Conventional in vitro diagnostics for infectious diseases are time-consuming and require centralized laboratories, experienced personnel and bulky equipment. Recent advances in biosensor technologies have potential to deliver point-of-care diagnostics that match or surpass conventional standards in regards to time, accuracy and cost. Broadly classified as either label-free or labeled, modern biosensors exploit micro- and nanofabrication technologies and diverse sensing strategies including optical, electrical and mechanical transducers. Despite clinical need, translation of biosensors from research laboratories to clinical applications has remained limited to a few notable examples, such as the glucose sensor. Challenges to be overcome include sample preparation, matrix effects and system integration. We review the advances of biosensors for infectious disease diagnostics and discuss the critical challenges that need to be overcome in order to implement integrated diagnostic biosensors in real world settings. PMID:24524681
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The Roadmap: Future Opportunities for Bioengagement in the MENA Region
2013-12-01
research to improving biosafety and biosecurity training of laboratory staff, enhancing physical security of research and diagnostic facilities, and...enhancing laboratory and institutional capacity to address biological risks according to international standards ; or building scientific capacity...outbreaks. BEP often supports scientific exchanges to enhance laboratory biosafety and biosecurity training; it could enrich its efforts by
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Polish Code of Ethics of a Medical Laboratory Specialist
2014-01-01
Along with the development of medicine, increasingly significant role has been played by the laboratory diagnostics. For over ten years the profession of the medical laboratory specialist has been regarded in Poland as the autonomous medical profession and has enjoyed a status of one of public trust. The process of education of medical laboratory specialists consists of a five-year degree in laboratory medicine, offered at Medical Universities, and of a five-year Vocational Specialization in one of the fields of laboratory medicine such as clinical biochemistry, medical microbiology, medical laboratory toxicology, medical laboratory cytomorphology and medical laboratory transfusiology. An important component of medical laboratory specialists’ identity is awareness of inherited ethos obtained from bygone generations of workers in this particular profession and the need to continue its further development. An expression of this awareness is among others Polish Code of Ethics of a Medical Laboratory Specialist (CEMLS) containing a set of values and a moral standpoint characteristic of this type of professional environment. Presenting the ethos of the medical laboratory specialist is a purpose of this article. Authors focus on the role CEMLS plays in areas of professional ethics and law. Next, they reconstruct the Polish model of ethos of medical diagnostic laboratory personnel. An overall picture consists of a presentation of the general moral principles concerning execution of this profession and rules of conduct in relations with the patient, own professional environment and the rest of the society. Polish model of ethical conduct, which is rooted in Hippocratic medical tradition, harmonizes with the ethos of medical laboratory specialists of other European countries and the world. PMID:27683468
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Polish Code of Ethics of a Medical Laboratory Specialist.
Elżbieta, Puacz; Waldemar, Glusiec; Barbara, Madej-Czerwonka
2014-09-01
Along with the development of medicine, increasingly significant role has been played by the laboratory diagnostics. For over ten years the profession of the medical laboratory specialist has been regarded in Poland as the autonomous medical profession and has enjoyed a status of one of public trust. The process of education of medical laboratory specialists consists of a five-year degree in laboratory medicine, offered at Medical Universities, and of a five-year Vocational Specialization in one of the fields of laboratory medicine such as clinical biochemistry, medical microbiology, medical laboratory toxicology, medical laboratory cytomorphology and medical laboratory transfusiology. An important component of medical laboratory specialists' identity is awareness of inherited ethos obtained from bygone generations of workers in this particular profession and the need to continue its further development. An expression of this awareness is among others Polish Code of Ethics of a Medical Laboratory Specialist (CEMLS) containing a set of values and a moral standpoint characteristic of this type of professional environment. Presenting the ethos of the medical laboratory specialist is a purpose of this article. Authors focus on the role CEMLS plays in areas of professional ethics and law. Next, they reconstruct the Polish model of ethos of medical diagnostic laboratory personnel. An overall picture consists of a presentation of the general moral principles concerning execution of this profession and rules of conduct in relations with the patient, own professional environment and the rest of the society. Polish model of ethical conduct, which is rooted in Hippocratic medical tradition, harmonizes with the ethos of medical laboratory specialists of other European countries and the world.
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Current methods of laboratory diagnosis of Chlamydia trachomatis infections.
Black, C M
1997-01-01
Infections caused by Chlamydia trachomatis are probably the most common sexually transmitted diseases in the United States. Commonly unrecognized and often inadequately treated, chlamydial infections can ascend the reproductive tract and cause pelvic inflammatory disease, which often results in the devastating consequences of infertility, ectopic pregnancy, or chronic pelvic pain. C. trachomatis infections are also known to increase the risk for human immunodeficiency virus infection. The obligate intracellular life cycle of C. trachomatis has traditionally required laboratory diagnostic tests that are technically demanding, labor-intensive, expensive, and difficult to access. In spite of these historical challenges, however, laboratory diagnosis of C. trachomatis has been a rapidly advancing area in which there is presently a wide array of commercial diagnostic technologies, costs, manufacturers. This review describes and compares the diagnostic methods for C. trachomatis infection that are currently approved for use in the United States, including the newest DNA amplification technologies which are yet to be licensed for commercial use. Issues to consider in selecting a test for purposes of screening versus diagnosis based on prevalence, performance, legal, social, and cost issues are also discussed. PMID:8993862
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Application of the MALDI Biotyper to clinical microbiology: progress and potential.
Kostrzewa, Markus
2018-03-01
The introduction of the MALDI Biotyper in laboratories substantially changed microbiology practice, this has been called a revolution. The system accelerated diagnostic while costs were reduced and accuracy was increased. In just a few years MALDI-TOF MS became the first-line identification tool for microorganisms. Ten years after its introduction, more than 2000 MALDI Biotyper systems are installed in laboratories which are performing routine diagnostic, and the number is still increasing. Areas covered: This article summarises changes in clinical microbiology introduced by the MALDI Biotyper and its effects, as it has been published in peer reviewed articles found in PubMed. Further, the potential of novel developments to increase the value of the system is described. Expert commentary: The MALDI Biotyper has significantly improved clinical microbiology in the area of microorganism identification. Now new developments and applications, e.g. for typing and resistance testing, might further increase its value in clinical microbiology. The systems might get the central diagnostic analyser which is getting integrated into the widely automated microbiology laboratories of the future.
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Ciardo, Diana E.; Lucke, Katja; Imhof, Alex; Bloemberg, Guido V.; Böttger, Erik C.
2010-01-01
The implementation of internal transcribed spacer (ITS) sequencing for routine identification of molds in the diagnostic mycology laboratory was analyzed in a 5-year study. All mold isolates (n = 6,900) recovered in our laboratory from 2005 to 2009 were included in this study. According to a defined work flow, which in addition to troublesome phenotypic identification takes clinical relevance into account, 233 isolates were subjected to ITS sequence analysis. Sequencing resulted in successful identification for 78.6% of the analyzed isolates (57.1% at species level, 21.5% at genus level). In comparison, extended in-depth phenotypic characterization of the isolates subjected to sequencing achieved taxonomic assignment for 47.6% of these, with a mere 13.3% at species level. Optimization of DNA extraction further improved the efficacy of molecular identification. This study is the first of its kind to testify to the systematic implementation of sequence-based identification procedures in the routine workup of mold isolates in the diagnostic mycology laboratory. PMID:20573873
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A Biosecurity Survey in Kenya, November 2014 to February 2015.
Ndhine, Edwardina Otieno; Slotved, Hans-Christian; Osoro, Eric Mogaka; Olsen, Katja N; Rugutt, Moses; Wanjohi, Cathryn W; Mwanda, Walter; Kinyagia, Benson Mburu; Steenhard, Nina R; Hansen, John-Erik Stig
2016-01-01
A biosecurity survey was performed to gather information on the biosecurity level and laboratory capacity in Kenya for the purpose of providing information outlining relevant components for biosecurity legislation, biosecurity implementation, and enforcement of biosecurity measures in Kenya. This survey is, to the authors' knowledge, the first to be published from an African country. A total of 86 facilities with laboratories covering relevant categories, such as training laboratories, human diagnostic laboratories, veterinary diagnostic laboratories, and research laboratories, were selected to participate in the survey. Each facility was visited by a survey team and staff were asked to answer 29 groups of questions from a questionnaire. The survey showed that Kenyan laboratory facilities contain biological agents of biosecurity concern. The restrictions for these agents were found to be limited for several of the facilities, in that many laboratory facilities and storage units were open for access by either students or staff who had no need of access to the laboratory. The survey showed a great deal of confusion in the terms biosecurity and biosafety and a generally limited biosecurity awareness among laboratory personnel. The survey showed that the security of biological agents of biosecurity concern in many facilities does not meet the international requirements. The authors recommend developing a legal framework in Kenya for effective controls, including national biosecurity regulations, guidelines, and procedures, thereby reducing the risk that a Kenyan laboratory would be the source of a future biological attack.
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National and international veterinary reference laboratories for infectious diseases.
Edwards, S; Alexander, D
1998-08-01
Reference laboratories play an increasingly important role in the harmonisation of laboratory diagnostic tests and the standardisation of veterinary vaccines. This is particularly important in building confidence between international trading partners. The authors review aspects of the organisation, designation and support of reference laboratories for infectious diseases of animals and discuss the principal activities which such laboratories would normally perform. These activities include advice and consultancy, publications and communication, training, research, disease surveillance, maintenance of culture collections, evaluation of reference methods, preparation of reference materials and organisation of inter-laboratory comparisons.
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76 FR 33303 - Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-08
... comments should be received within 60 days of this notice. Proposed Project Survey of Rapid Influenza... Description The Survey of Rapid Influenza Diagnostic Testing Practices in Clinical Laboratories is a national systematic study investigating rapid influenza diagnostic testing practices in clinical [[Page 33304...
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When BVD doesn't look like BVD
USDA-ARS?s Scientific Manuscript database
Due to the sheer number of different clinical presentations existing under the BVD umbrella, diagnosing BVD based on clinical signs is not advisable. Thus diagnosis relies upon testing of samples in diagnostic laboratories. In the US, most of the diagnostic effort has been focused on identifying a...
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Clinical chemistry through Clinical Chemistry: a journal timeline.
Rej, Robert
2004-12-01
The establishment of the modern discipline of clinical chemistry was concurrent with the foundation of the journal Clinical Chemistry and that of the American Association for Clinical Chemistry in the late 1940s and early 1950s. To mark the 50th volume of this Journal, I chronicle and highlight scientific milestones, and those within the discipline, as documented in the pages of Clinical Chemistry. Amazing progress has been made in the field of laboratory diagnostics over these five decades, in many cases paralleling-as well as being bolstered by-the rapid pace in the development of computer technologies. Specific areas of laboratory medicine particularly well represented in Clinical Chemistry include lipids, endocrinology, protein markers, quality of laboratory measurements, molecular diagnostics, and general advances in methodology and instrumentation.
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[The characteristics of medical technologies in emergency medical care hospital].
Murakhovskiĭ, A G; Babenko, A I; Bravve, Iu I; Tataurova, E A
2013-01-01
The article analyzes the implementation of major 12 diagnostic and 17 treatment technologies applied during medical care of patients with 12 key nosology forms of diseases in departments of the emergency medical care hospital No 2 of Omsk. It is established that key groups of technologies in the implementation of diagnostic process are the laboratory clinical diagnostic analyses and common diagnostic activities at reception into hospital and corresponding departments. The percentage of this kind of activities is about 78.3% of all diagnostic technologies. During the realization of treatment process the priority technologies are common curative and rehabilitation activities, intensive therapy activities and clinical diagnostic monitoring activities. All of them consist 80.1% of all curative technologies.
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Bone sialoprotein in laboratory diagnostic work-up of osteoarthritis.
Lis, Kinga
2008-01-01
Changes in osteoarthritis joint appear in the articular cartilage, synovium and in subchondral bone. It is necessary to find, apart from markers of cartilage destruction, a sensitive and specific biochemical marker which would reflect the metabolism as well as degradation of subchondral bone. Bone sialoprotein is mostly synthesized in osseous tissue found directly under the surface of joint cartilage. As a result, it is being increasingly perceived as a valuable marker of the metabolism rate of this layer of bone. Bone sialoprotein seems to be of use as a marker for subchondral bone degradation rate in laboratory diagnostic work-up of osteoarthritis.
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Laboratory Diagnosis of Infective Endocarditis
Liesman, Rachael M.; Pritt, Bobbi S.; Maleszewski, Joseph J.
2017-01-01
ABSTRACT Infective endocarditis is life-threatening; identification of the underlying etiology informs optimized individual patient management. Changing epidemiology, advances in blood culture techniques, and new diagnostics guide the application of laboratory testing for diagnosis of endocarditis. Blood cultures remain the standard test for microbial diagnosis, with directed serological testing (i.e., Q fever serology, Bartonella serology) in culture-negative cases. Histopathology and molecular diagnostics (e.g., 16S rRNA gene PCR/sequencing, Tropheryma whipplei PCR) may be applied to resected valves to aid in diagnosis. Herein, we summarize recent knowledge in this area and propose a microbiologic and pathological algorithm for endocarditis diagnosis. PMID:28659319
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Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.
Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep
2018-04-20
Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.
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Ogouyèmi-Hounto, A; Kinde-Gazard, D; Keke, C; Gonçalves, E; Alapini, N; Adjovi, F; Adisso, L; Bossou, C; Denon, Y V; Massougbodji, A
2013-02-01
The aim of the study was to determine the accuracy of a rapid diagnostic test (SD Bioline Malaria Ag P.f/ Pan®) and fluorescent microscopy (CyScope®) in confirming presumptive malaria diagnosis in Cotonou. Thick blood smear was used as the reference technique for comparison. Testing was conducted on persons between the ages of 6 months and 70 years at two hospitals from June to October 2010. If malaria was suspected in the sample by the nurse based on clinical findings and sent to laboratory for confirmation, one thick smear, one rapid diagnostic test and one slide for the fluorescent microscopy were performed. All tests were read in hospital laboratories involved with the quality control of thick blood smear in the parasitology laboratory of National University Hospital of Cotonou. A total of 354 patients with clinical diagnosis of malaria were included. Malaria prevalence determined by thick smear, rapid diagnostic test and fluorescent microscopy was 22.8%, 25.4%, and 25.1% respectively. The sensitivity, specificity, positive and negative predictive values compared to the thick smears were 96.3, 95.6, 86.7, and 98.9% for rapid diagnostic test; and 97.5, 96.7, 89.8, and 99.27% for fluorescent microscopy. With these performances, these tests meet acceptability standards recommended by WHO for rapid tests (sensitivity > 95%). These two methods have advantages for the confirmation of malaria diagnosis in peripheral health structures that lack the resources to conduct diagnosis confirmation by the thick blood smear.
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Viral Hemorrhagic Fever Diagnostics
Racsa, Lori D.; Kraft, Colleen S.; Olinger, Gene G.; Hensley, Lisa E.
2016-01-01
There are 4 families of viruses that cause viral hemorrhagic fever (VHF), including Filoviridae. Ebola virus is one virus within the family Filoviridae and the cause of the current outbreak of VHF in West Africa. VHF-endemic areas are found throughout the world, yet traditional diagnosis of VHF has been performed in large reference laboratories centered in Europe and the United States. The large amount of capital needed, as well as highly trained and skilled personnel, has limited the availability of diagnostics in endemic areas except in conjunction with governmental and nongovernmental entities. However, rapid diagnosis of VHF is essential to efforts that will limit outbreaks. In addition, increased global travel suggests VHF diagnoses may be made outside of the endemic areas. Thus, understanding how to diagnose VHF is imperative for laboratories worldwide. This article reviews traditional and current diagnostic modalities for VHF. PMID:26354968
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Tuberculous otitis media: a significant diagnostic challenge.
Vaamonde, Pedro; Castro, Crisanto; García-Soto, Nicolas; Labella, Torcuato; Lozano, Ascensión
2004-06-01
This study was undertaken to revise the diagnostic characteristics of tuberculous otitis media (TOM), a disorder that is often diagnosed late, leading to delay in specific treatment. Retrospective study of a longitudinal series of 10 TOM patients over a 7-year period at an institutional referral center. Most patients showed intractable otorrhea, moderately severe hearing loss, and necrotic eardrums with granulation tissue and single perforations. Multiple perforations, facial palsy, and cervical adenopathies were rare (<10% of patients). CT generally showed soft tissue involvement of the middle ear without bone erosion. The most effective laboratory test microbiological culture of exudate (diagnostic efficacy 71%). Specific antibiotic treatment was effective in all cases. The diagnosis of TOM remains a significant challenge for otorhinolaryngologists. If there are strong clinical grounds for suspicion, standard laboratory tests for tuberculosis should be repeated even if initially negative.
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A real-time PCR diagnostic method for detection of Naegleria fowleri.
Madarová, Lucia; Trnková, Katarína; Feiková, Sona; Klement, Cyril; Obernauerová, Margita
2010-09-01
Naegleria fowleri is a free-living amoeba that can cause primary amoebic meningoencephalitis (PAM). While, traditional methods for diagnosing PAM still rely on culture, more current laboratory diagnoses exist based on conventional PCR methods; however, only a few real-time PCR processes have been described as yet. Here, we describe a real-time PCR-based diagnostic method using hybridization fluorescent labelled probes, with a LightCycler instrument and accompanying software (Roche), targeting the Naegleria fowleriMp2Cl5 gene sequence. Using this method, no cross reactivity with other tested epidemiologically relevant prokaryotic and eukaryotic organisms was found. The reaction detection limit was 1 copy of the Mp2Cl5 DNA sequence. This assay could become useful in the rapid laboratory diagnostic assessment of the presence or absence of Naegleria fowleri. Copyright 2009 Elsevier Inc. All rights reserved.
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Turning the Page: Advancing Paper-Based Microfluidics for Broad Diagnostic Application.
Gong, Max M; Sinton, David
2017-06-28
Infectious diseases are a major global health issue. Diagnosis is a critical first step in effectively managing their spread. Paper-based microfluidic diagnostics first emerged in 2007 as a low-cost alternative to conventional laboratory testing, with the goal of improving accessibility to medical diagnostics in developing countries. In this review, we examine the advances in paper-based microfluidic diagnostics for medical diagnosis in the context of global health from 2007 to 2016. The theory of fluid transport in paper is first presented. The next section examines the strategies that have been employed to control fluid and analyte transport in paper-based assays. Tasks such as mixing, timing, and sequential fluid delivery have been achieved in paper and have enabled analytical capabilities comparable to those of conventional laboratory methods. The following section examines paper-based sample processing and analysis. The most impactful advancement here has been the translation of nucleic acid analysis to a paper-based format. Smartphone-based analysis is another exciting development with potential for wide dissemination. The last core section of the review highlights emerging health applications, such as male fertility testing and wearable diagnostics. We conclude the review with the future outlook, remaining challenges, and emerging opportunities.
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Ronald, L A; Ling, D I; FitzGerald, J M; Schwartzman, K; Bartlett-Esquilant, G; Boivin, J-F; Benedetti, A; Menzies, D
2017-05-01
An increasing number of studies are using health administrative databases for tuberculosis (TB) research. However, there are limitations to using such databases for identifying patients with TB. To summarise validated methods for identifying TB in health administrative databases. We conducted a systematic literature search in two databases (Ovid Medline and Embase, January 1980-January 2016). We limited the search to diagnostic accuracy studies assessing algorithms derived from drug prescription, International Classification of Diseases (ICD) diagnostic code and/or laboratory data for identifying patients with TB in health administrative databases. The search identified 2413 unique citations. Of the 40 full-text articles reviewed, we included 14 in our review. Algorithms and diagnostic accuracy outcomes to identify TB varied widely across studies, with positive predictive value ranging from 1.3% to 100% and sensitivity ranging from 20% to 100%. Diagnostic accuracy measures of algorithms using out-patient, in-patient and/or laboratory data to identify patients with TB in health administrative databases vary widely across studies. Use solely of ICD diagnostic codes to identify TB, particularly when using out-patient records, is likely to lead to incorrect estimates of case numbers, given the current limitations of ICD systems in coding TB.
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Leers, M P G; Keuren, J F W; Oosterhuis, W P
2010-12-01
In patients with inflammatory conditions, diagnosing classic iron deficiency or anemia of chronic disease is challenging. In this study, we assessed the diagnostic value of the so-called Thomas'-plot [soluble transferrin receptor (sTfR)/log ferritin (sTfr/log Ferr) and the reticulocyte hemoglobin equivalent (Ret-HE)] in the anemia work up of patients referred by general practitioners. During July 2008-March 2009, 337 consecutive patients were included because of lowered Hb values. The laboratory results of the first 133 consecutive patients were used to determine the cut-off values for the diagnostic plot. The laboratory results of these patients were assessed and interpreted independently by two investigators, blinded from sTfR/log Ferr and Ret-HE values. The following 204 patients were used to test the plot in practice. In 32% of the first 133 patients, no indication of the cause of anemia could be found. However, when using the diagnostic plot in the following 204 patients, this fraction decreased to 14%. The 'Thomas'-plot is of diagnostic value for distinguishing functional iron deficiency from classic iron deficiency in a patient population referred by general practitioners. © 2010 Blackwell Publishing Ltd.
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Adoption of Lean Principles in a High-Volume Molecular Diagnostic Microbiology Laboratory
Mitchell, P. Shawn; Mandrekar, Jayawant N.
2014-01-01
Clinical laboratories are constantly facing challenges to do more with less, enhance quality, improve test turnaround time, and reduce operational expenses. Experience with adopting and applying lean concepts and tools used extensively in the manufacturing industry is described for a high-volume clinical molecular microbiology laboratory, illustrating how operational success and benefits can be achieved. PMID:24829247
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Cost challenges for laboratory medicine automation in Africa.
Tanyanyiwa, Donald Moshen
2010-01-01
Automation in laboratory medicine is inevitable and the only way forward especially in Africa where the staff turnover is high due to migration of experienced staff to Europe and America. Described here are the common issues that laboratory Managers and Directors encounter when upgrading, replacing analytical systems as well as daily running of diagnostic laboratories. The rapid advancement driven by the first world where research facilities, resources and expertise are available has seen changes in the both the hardware and software utilised by analyzers every two to three years. The downside is that in the process of replacing/phasing out old analysers, the first world countries in some cases donate them to second and third world countries as refurbished analysers. Problems in obtaining spares ensue since the production of new analysers results in reduced production or even of old spares. Unavailability or delayed availability of spares results in suspension of diagnostic service by the recipient laboratory. In some areas costly modifications to the analysers or the location/building have had to done to suite local (African) conditions, hence the need for Laboratory managers to understand fully the analysers' operational requirements before purchasing or accepting donations.
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Godfrey, Catherine C.; Michelow, Pamela M.; Godard, Mandana; Sahasrabuddhe, Vikrant V.; Darden, Janice; Firnhaber, Cynthia S.; Wetherall, Neal T.; Bremer, James; Coombs, Robert W.; Wilkin, Timothy
2014-01-01
Objectives To evaluate an external quality assurance (EQA) program for the laboratory diagnosis of human papillomavirus (HPV) disease that was established to improve international research capability within the Division of AIDS at the National Institute of Allergy and Infectious Disease–supported Adult AIDS Clinical Trials Group network. Methods A three-component EQA scheme was devised comprising assessments of diagnostic accuracy of cytotechnologists and pathologists using available EQA packages, review of quality and accuracy of clinical slides from local sites by an outside expert, and HPV DNA detection using the commercially available HPV test kit. Results Seven laboratories and 17 pathologists in Africa, India, and South America participated. EQA scores were suboptimal for standard packages in three of seven laboratories. There was good agreement between the local laboratory and the central reader 70% of the time (90% confidence interval, 42%-98%). Performance on the College of American Pathologists’ HPV DNA testing panel was successful in all laboratories tested. Conclusions The prequalifying EQA round identified correctable issues that will improve the laboratory diagnosis of HPV related cervical disease at the international sites and will provide a mechanism for ongoing education and continuous quality improvement. PMID:24225757
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Background: Laboratory reports of mycobacteria isolation and identification are created during the clinical diagnostic process to differentiate Mycobacterium tuberculosis from nontuberculous mycobacteria (NTM). NTM isolation rates are expected to exceed rates of true NTM infectio...
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Dogs have been studied for many years as a medical diagnostic tool to detect a pre-clinical disease state by sniffing emissions directly from a human or an in vitro biological sample. Some of the studies report high sensitivity and specificity in blinded case-control studies. How...
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ERIC Educational Resources Information Center
Clark, Sherri; Smith, Geoffrey Battle
2004-01-01
Outbreak! is an online, interactive educational game that helps students and teachers learn and evaluate clinical microbiology skills. When the game was used in introductory microbiology laboratories, qualitative evaluation by students showed very positive responses and increased learning. Outbreak! allows students to design diagnostic tests and…
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Giordano, P C; Plancke, A; Van Meir, C A; Janssen, C A H; Kok, P J M J; Van Rooijen-Nijdam, I H; Tanis, B C; van Huisseling, J C M; Versteegh, F G A
2006-08-01
We have offered, for the first time in The Netherlands, carrier diagnostics for hemoglobinopathies (HbP) to early pregnant women. The aim of this study was to establish whether carrier analysis would be welcome by the public and feasible at the outpatient level. One hundred and thirty-nine randomly selected women were informed and offered basic carrier diagnostics at the first pregnancy control. Carrier diagnostics was accepted by 136 women (97.8%). The population consisted of 31% of recent immigrants and 69% of native Dutch. One carrier of HbS and one of beta-thalassemia were found, both among the group of the recent immigrants. In both cases, partners were tested excluding a couple at risk. In addition, five carriers of alpha(+)-thalassemia were diagnosed at the molecular level, one of them in the native Dutch population. Basic carrier analysis was done both at the Hospital Laboratory and at the Reference Laboratory. No discrepancies were found. This pilot study shows that (1) as predicted the prevalence of risk-related HbP and of alpha(+)-thalassemia is high in the immigrant population. (2) The compliance with carrier analysis in both native Dutch and immigrants is virtually total and (3) carrier diagnosis in early pregnancy and partner analysis in Hospital Laboratories is possible and is an effective tool for primary prevention of HbP in The Netherlands.
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Using the arthroscopic surgery skill evaluation tool as a pass-fail examination.
Koehler, Ryan J; Nicandri, Gregg T
2013-12-04
Examination of arthroscopic skill requires evaluation tools that are valid and reliable with clear criteria for passing. The Arthroscopic Surgery Skill Evaluation Tool was developed as a video-based assessment of technical skill with criteria for passing established by a panel of experts. The purpose of this study was to test the validity and reliability of the Arthroscopic Surgery Skill Evaluation Tool as a pass-fail examination of arthroscopic skill. Twenty-eight residents and two sports medicine faculty members were recorded performing diagnostic knee arthroscopy on a left and right cadaveric specimen in our arthroscopic skills laboratory. Procedure videos were evaluated with use of the Arthroscopic Surgery Skill Evaluation Tool by two raters blind to subject identity. Subjects were considered to pass the Arthroscopic Surgery Skill Evaluation Tool when they attained scores of ≥ 3 on all eight assessment domains. The raters agreed on a pass-fail rating for fifty-five of sixty videos rated with an interclass correlation coefficient value of 0.83. Ten of thirty participants were assigned passing scores by both raters for both diagnostic arthroscopies performed in the laboratory. Receiver operating characteristic analysis demonstrated that logging more than eighty arthroscopic cases or performing more than thirty-five arthroscopic knee cases was predictive of attaining a passing Arthroscopic Surgery Skill Evaluation Tool score on both procedures performed in the laboratory. The Arthroscopic Surgery Skill Evaluation Tool is valid and reliable as a pass-fail examination of diagnostic arthroscopy of the knee in the simulation laboratory. This study demonstrates that the Arthroscopic Surgery Skill Evaluation Tool may be a useful tool for pass-fail examination of diagnostic arthroscopy of the knee in the simulation laboratory. Further study is necessary to determine whether the Arthroscopic Surgery Skill Evaluation Tool can be used for the assessment of multiple arthroscopic procedures and whether it can be used to evaluate arthroscopic procedures performed in the operating room.
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Nonanalytic Laboratory Automation: A Quarter Century of Progress.
Hawker, Charles D
2017-06-01
Clinical laboratory automation has blossomed since the 1989 AACC meeting, at which Dr. Masahide Sasaki first showed a western audience what his laboratory had implemented. Many diagnostics and other vendors are now offering a variety of automated options for laboratories of all sizes. Replacing manual processing and handling procedures with automation was embraced by the laboratory community because of the obvious benefits of labor savings and improvement in turnaround time and quality. Automation was also embraced by the diagnostics vendors who saw automation as a means of incorporating the analyzers purchased by their customers into larger systems in which the benefits of automation were integrated to the analyzers.This report reviews the options that are available to laboratory customers. These options include so called task-targeted automation-modules that range from single function devices that automate single tasks (e.g., decapping or aliquoting) to multifunction workstations that incorporate several of the functions of a laboratory sample processing department. The options also include total laboratory automation systems that use conveyors to link sample processing functions to analyzers and often include postanalytical features such as refrigerated storage and sample retrieval.Most importantly, this report reviews a recommended process for evaluating the need for new automation and for identifying the specific requirements of a laboratory and developing solutions that can meet those requirements. The report also discusses some of the practical considerations facing a laboratory in a new implementation and reviews the concept of machine vision to replace human inspections. © 2017 American Association for Clinical Chemistry.
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Zanatta, Lucia; Valori, Laura; Cappelletto, Eleonora; Pozzebon, Maria Elena; Pavan, Elisabetta; Dei Tos, Angelo Paolo; Merkle, Dennis
2015-02-01
In the modern molecular diagnostic laboratory, cost considerations are of paramount importance. Automation of complex molecular assays not only allows a laboratory to accommodate higher test volumes and throughput but also has a considerable impact on the cost of testing from the perspective of reagent costs, as well as hands-on time for skilled laboratory personnel. The following study tracked the cost of labor (hands-on time) and reagents for fluorescence in situ hybridization (FISH) testing in a routine, high-volume pathology and cytogenetics laboratory in Treviso, Italy, over a 2-y period (2011-2013). The laboratory automated FISH testing with the VP 2000 Processor, a deparaffinization, pretreatment, and special staining instrument produced by Abbott Molecular, and compared hands-on time and reagent costs to manual FISH testing. The results indicated significant cost and time saving when automating FISH with VP 2000 when more than six FISH tests were run per week. At 12 FISH assays per week, an approximate total cost reduction of 55% was observed. When running 46 FISH specimens per week, the cost saving increased to 89% versus manual testing. The results demonstrate that the VP 2000 processor can significantly reduce the cost of FISH testing in diagnostic laboratories. © 2014 Society for Laboratory Automation and Screening.
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Halligan, E; Edgeworth, J; Bisnauthsing, K; Bible, J; Cliff, P; Aarons, E; Klein, J; Patel, A; Goldenberg, S
2014-08-01
Laboratory diagnosis and clinical management of inpatients with diarrhoea is complex and time consuming. Tests are often requested sequentially and undertaken in different laboratories. This causes prolonged unnecessary presumptive isolation of patients, because most cases are non-infectious. A molecular multiplex test (Luminex(®) Gastrointestinal Pathogen Panel (GPP)) was compared with conventional testing over 8 months to determine diagnostic accuracy, turnaround times, laboratory costs, use of isolation facilities and user acceptability. A total of 262 (12%) patients had a pathogen detected by conventional methods compared with 483 (22.1%) by GPP. Most additional cases were detected in patients developing symptoms in the first 4 days of admission. Additional cases were detected because of presumed improved diagnostic sensitivity but also because clinicians had not requested the correct pathogen. Turnaround time (41.8 h) was faster than bacterial culture (66.5 h) and parasite investigation (66.5 h) but slower than conventional testing for Clostridium difficile (17.3 h) and viruses (27 h). The test could allow simplified requesting by clinicians and a consolidated laboratory workflow, reducing the overall number of specimens received by the laboratory. A total of 154 isolation days were saved at an estimated cost of £30 800. Consumables and labour were estimated at £150 641 compared with £63 431 for conventional testing. Multiplex molecular testing using a panel of targets allowed enhanced detection and a consolidated laboratory workflow. This is likely to be of greater benefit to cases that present within the first 4 days of hospital admission. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.
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Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak; Kim, Jeong-Ho
2016-03-01
It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections.
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Lee, Mi-Kyung; Kim, Sinyoung; Kim, Mi-Na; Kweon, Oh Joo; Lim, Yong Kwan; Ki, Chang-Seok; Kim, Jae-Seok; Seong, Moon-Woo; Sung, Heungsup; Yong, Dongeun; Lee, Hyukmin; Choi, Jong-Rak
2016-01-01
Background It is crucial to understand the current status of clinical laboratory practices for the largest outbreak of Middle East respiratory syndrome coronavirus (MERS-CoV) infections in the Republic of Korea to be well prepared for future emerging infectious diseases. Methods We conducted a survey of 49 clinical laboratories in medical institutions and referral medical laboratories. A short questionnaire to survey clinical laboratory practices relating to MERS-CoV diagnostic testing was sent by email to the directors and clinical pathologists in charge of the clinical laboratories performing MERS-CoV testing. The survey focused on testing volume, reporting of results, resources, and laboratory safety. Results A total of 40 clinical laboratories responded to the survey. A total of 27,009 MERS-CoV real-time reverse transcription PCR (rRT-PCR) tests were performed. Most of the specimens were sputum (73.5%). The median turnaround time (TAT) was 5.29 hr (first and third quartile, 4.11 and 7.48 hr) in 26 medical institutions. The median TAT of more than a half of the laboratories (57.7%) was less than 6 hr. Many laboratories were able to perform tests throughout the whole week. Laboratory biosafety preparedness included class II biosafety cabinets (100%); separated pre-PCR, PCR, and post-PCR rooms (88.6%); negative pressure pretreatment rooms (48.6%); and negative pressure sputum collection rooms (20.0%). Conclusions Clinical laboratories were able to quickly expand their diagnostic capacity in response to the 2015 MERS-CoV outbreak. Our results show that clinical laboratories play an important role in the maintenance and enhancement of laboratory response in preparation for future emerging infections. PMID:26709263
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Obstacles in the diagnostics and therapy of heparin-induced thrombocytopenia.
Antonijević, Nebojsa M; Radovanović, Nebojsa; Obradović, Slobodan; Vucelić, Dragica; Stojanović, Bojan; Miković, Danijela; Kovac, Mirjana; Kocica, Tina; Tadić, Svetlana; Antonijević, Irina; Drasković, Snezana; Djordjević, Valentina; Calija, Branko; Perunicić, Jovan; Vasiljević, Zorana
2010-01-01
An immune-mediated, severe, acquired prothrombotic disorder, heparin-induced thrombocytopenia type II (HIT II) occurs in 0.5-5% of patients exposed to unfractionated heparin longer than 5-7 days. Arterial and venous thromboses are induced by HIT II in about 35-50% of patients. Typical death rate for HIT is about 29%, while 21% of HIT patients result in amputation of a limb. The trend towards the occurrence of HIT due to the administration of low molecular weight heparins (LMWH) taking ever conspicuous place in the standard venous thromboembolism (VTE) prophylaxis has been more frequently observed recently. It is considered that LMWH may cause HIT II in about 0.25-1%. The need for further modification of HIPA assays with LMWH has been imposed in the HIT laboratory diagnostics, heretofore overburdened with complexity. There are several constantly opposing problems arising in HIT laboratory diagnostics, one of which is that in a certain number of patients immunologic assays detect nonpathogenic antibodies (mainly IgM or IgA heparin-PF4 antibodies) while, on the other hand, the occurrence of HIT pathogenetically mediated by minor antigens (neutrophil-activating peptide 2 or interleukin 8) may be neglected in certain cases. The following factors play an important role in the interpretation of each laboratory HIT assays performed: 1. correlation with HIT clinical probability test, the best known of which is 4T'score, 2. the interpretation of the laboratory findings dependent on the time of the thrombocytopenia onset, as well as 3. the sensitivity and specificity of each test respectively. The HIT diagnostics in the presence of other comorbid states which may also induce thrombocytopenia, more precisely known as pseudo HIT (cancer, sepsis, disseminated intravascular coagulation, pulmonary embolism, antiphospholipid syndrome, etc), represents a specific clinical problem.
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Raven, Stijn; Hautvast, Jeannine; Steenbergen, Jim van; Akkermans, Reinier; Weykamp, Cas; Smits, Francis; Hoebe, Christian; Vossen, Ann
2017-02-01
Post-vaccination testing after hepatitis B vaccination is indispensable to evaluate long-term immunological protection. Using a threshold level of antibodies against hepatitis B surface antigen (anti-HBs) to define serological protection, implies reproducible and valid measurements of different diagnostic assays. In this study we assess the performance of currently used anti-HBs assays. In 2013, 45 laboratories participated in an external quality assessment program using pooled anti-HBs serum samples around the cutoff values 10IU/l and 100IU/l. Laboratories used either Axsym (Abbott Laboratories), Architect (Abbott Laboratories), Access (Beckman-Coulter), ADVIA Centaur anti-HBs2 (Siemens Healthcare Diagnostics), Elecsys, Modular or Cobas (Roche Diagnostics) or Vidas Total Quick (Biomerieux) for anti-HBs titre quantification. We analysed covariance using mixed-model repeated measures. To assess sensitivity/specificity and agreement, a true positive or true negative result was defined as an anti-HBs titre respectively above or below the cutoff value by ≥4 of 6 assays. Different anti-HBs assays were associated with statistically significant (P<0.05) differences in anti-HBs titres in all dilutions. Sensitivity and specificity ranged respectively from 64%-100% and 95%-100%. Agreement between assays around an anti-HBs titre cutoff value of 10IU/l ranged from 93%-100% and was 44% for a cutoff value of 100IU/l. Around a cutoff value of 10IU/l use of the Access assay may result in false-negative results. Concerning the cutoff value of 100IU/l, a sample being classified below or above this cutoff relied heavily on the specific assay used, with both the Architect and the Access resulting in false-negative results. Copyright © 2016 Elsevier B.V. All rights reserved.
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Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility
NASA Technical Reports Server (NTRS)
Hirsch, David; Williams, James H.
2005-01-01
An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.
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77 FR 41188 - Clinical Laboratory Improvement Advisory Committee (CLIAC)
Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-12
... technological advances, such as new test methods and the electronic transmission of laboratory information... potential need for educational materials and resources for sites that test under a Provider-performed Microscopy Certificate; and the increased use of culture-independent microbiology diagnostics and the impact...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-22
... Laboratory Improvement Amendments Categorization AGENCY: Food and Drug Administration, HHS. ACTION: Notice... for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic... techniques, when appropriate, and other forms of information technology. Requests for CLIA Categorization--42...
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Machinery Diagnostic Feature Extraction and Fusion Techniques Using Diverse Sources
2001-04-05
laboratories AMTEC Corporation P.O. Box 077777 500 Wynn Drive, Suite 314 Huntsville, AL 35807-7777 Huntsville, AL 35816-3429 chongchanlee(~hnt.wvlelabs.com...for helicopters. Other distinguished features of JAHUMS system developed by AMTEC Corporation and Wyle Laboratories Incorporated are their data
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Moore, Andrew; Nelson, Christina; Molins, Claudia; Mead, Paul
2016-01-01
In the United States, Lyme disease is caused by Borrelia burgdorferi and transmitted to humans by blacklegged ticks. Patients with an erythema migrans lesion and epidemiologic risk can receive a diagnosis without laboratory testing. For all other patients, laboratory testing is necessary to confirm the diagnosis, but proper interpretation depends on symptoms and timing of illness. The recommended laboratory test in the United States is 2-tiered serologic analysis consisting of an enzyme-linked immunoassay or immunofluorescence assay, followed by reflexive immunoblotting. Sensitivity of 2-tiered testing is low (30%–40%) during early infection while the antibody response is developing (window period). For disseminated Lyme disease, sensitivity is 70%–100%. Specificity is high (>95%) during all stages of disease. Use of other diagnostic tests for Lyme disease is limited. We review the rationale behind current US testing guidelines, appropriate use and interpretation of tests, and recent developments in Lyme disease diagnostics. PMID:27314832
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Munro, Sarah A; Lund, Steven P; Pine, P Scott; Binder, Hans; Clevert, Djork-Arné; Conesa, Ana; Dopazo, Joaquin; Fasold, Mario; Hochreiter, Sepp; Hong, Huixiao; Jafari, Nadereh; Kreil, David P; Łabaj, Paweł P; Li, Sheng; Liao, Yang; Lin, Simon M; Meehan, Joseph; Mason, Christopher E; Santoyo-Lopez, Javier; Setterquist, Robert A; Shi, Leming; Shi, Wei; Smyth, Gordon K; Stralis-Pavese, Nancy; Su, Zhenqiang; Tong, Weida; Wang, Charles; Wang, Jian; Xu, Joshua; Ye, Zhan; Yang, Yong; Yu, Ying; Salit, Marc
2014-09-25
There is a critical need for standard approaches to assess, report and compare the technical performance of genome-scale differential gene expression experiments. Here we assess technical performance with a proposed standard 'dashboard' of metrics derived from analysis of external spike-in RNA control ratio mixtures. These control ratio mixtures with defined abundance ratios enable assessment of diagnostic performance of differentially expressed transcript lists, limit of detection of ratio (LODR) estimates and expression ratio variability and measurement bias. The performance metrics suite is applicable to analysis of a typical experiment, and here we also apply these metrics to evaluate technical performance among laboratories. An interlaboratory study using identical samples shared among 12 laboratories with three different measurement processes demonstrates generally consistent diagnostic power across 11 laboratories. Ratio measurement variability and bias are also comparable among laboratories for the same measurement process. We observe different biases for measurement processes using different mRNA-enrichment protocols.
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Machine learning in laboratory medicine: waiting for the flood?
Cabitza, Federico; Banfi, Giuseppe
2018-03-28
This review focuses on machine learning and on how methods and models combining data analytics and artificial intelligence have been applied to laboratory medicine so far. Although still in its infancy, the potential for applying machine learning to laboratory data for both diagnostic and prognostic purposes deserves more attention by the readership of this journal, as well as by physician-scientists who will want to take advantage of this new computer-based support in pathology and laboratory medicine.
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Compounding diagnostic delays: a qualitative study of point-of-care testing in South Africa.
Engel, Nora; Davids, Malika; Blankvoort, Nadine; Pai, Nitika Pant; Dheda, Keertan; Pai, Madhukar
2015-04-01
Successful point-of-care (POC) testing (completion of test-and-treat cycle in one patient encounter) has immense potential to reduce diagnostic and treatment delays, and improve patient and public health outcomes. We explored what tests are done and how in public/private, rural/urban hospitals and clinics in South Africa and whether they can ensure successful POC testing. This qualitative research study examined POC testing across major diseases in Cape Town, Durban and Eastern Cape. We conducted 101 semi-structured interviews and seven focus group discussions with doctors, nurses, community health workers, patients, laboratory technicians, policymakers, hospital managers and diagnostic manufacturers. In South Africa, diagnostics are characterised by a centralised system. Most tests conducted on the spot can be made to work successfully as POC tests. The majority of public/private clinics and smaller hospitals send samples via couriers to centralised laboratories and retrieve results the same way, via internet, fax or phone. The main challenge to POC testing lies in transporting samples and results, while delays risk patient loss from diagnostic/treatment pathways. Strategies to deal with associated delays create new problems, such as artificially prolonged turnaround times, strains on human resources and quality of testing, compounding additional diagnostic and treatment delays. For POC testing to succeed, particular characteristics of diagnostic ecosystems and adaptations of professional practices to overcome associated challenges must be taken into account. © 2014 John Wiley & Sons Ltd.
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Samoĭlovich, E O; Semeĭko, G V; Ermolovich, M A; Svirchevskaia, E Iu
2010-01-01
To summarize data on laboratory diagnostics of prenatal and postnatal rubella and molecular monitoring of rubella virus circulation in Belarus obtained during implementation of rubella elimination program. Serum samples from 2314 persons were tested on the presence of IgM to rubella virus and measles virus (in case of negative result on rubella) using respective enzyme immunoassays. Virological testing using RT-PCR as well as genotyping on the basis of E1 gene fragment sequencing were also performed. Two viruses isolated in Belarus were set as reference strains of genotypes 1G and 1h. Implementation of laboratory diagnostics allowed to differentiate cases of rubella from other exanthematous infections, significantly increase the number of laboratory-confirmed cases among all reported cases, and show presence of endemic circulation of rubella virus strains of 3 different genotypes (1G, 1E, and 1h) in Belarus (2004-2006). In 2006, when relatively high incidence of rubella was reported in the country (24.39 per 100,000 population), the risk of congenital rubella syndrome was not less than 9 per 100,000 births. Conducted in October 2005-May 2006 additional rounds of immunization against rubella (>1 million people were vaccinated) decreased incidence to single cases. Obtained data show achievability of indigenous rubella elemination by 2010. Revealed genetic diversity of rubella virus strains allowed to update the International classification of wild rubella viruses.
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Standard Mutation Nomenclature in Molecular Diagnostics
Ogino, Shuji; Gulley, Margaret L.; den Dunnen, Johan T.; Wilson, Robert B.
2007-01-01
To translate basic research findings into clinical practice, it is essential that information about mutations and variations in the human genome are communicated easily and unequivocally. Unfortunately, there has been much confusion regarding the description of genetic sequence variants. This is largely because research articles that first report novel sequence variants do not often use standard nomenclature, and the final genomic sequence is compiled over many separate entries. In this article, we discuss issues crucial to clear communication, using examples of genes that are commonly assayed in clinical laboratories. Although molecular diagnostics is a dynamic field, this should not inhibit the need for and movement toward consensus nomenclature for accurate reporting among laboratories. Our aim is to alert laboratory scientists and other health care professionals to the important issues and provide a foundation for further discussions that will ultimately lead to solutions. PMID:17251329
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The main challenges that remain in applying high-throughput sequencing to clinical diagnostics.
Loeffelholz, Michael; Fofanov, Yuriy
2015-01-01
Over the last 10 years, the quality, price and availability of high-throughput sequencing instruments have improved to the point that this technology may be close to becoming a routine tool in the diagnostic microbiology laboratory. Two groups of challenges, however, have to be resolved in order to move this powerful research technology into routine use in the clinical microbiology laboratory. The computational/bioinformatics challenges include data storage cost and privacy concerns, requiring analysis to be performed without access to cloud storage or expensive computational infrastructure. The logistical challenges include interpretation of complex results and acceptance and understanding of the advantages and limitations of this technology by the medical community. This article focuses on the approaches to address these challenges, such as file formats, algorithms, data collection, reporting and good laboratory practices.
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NASA Technical Reports Server (NTRS)
Murphy, Gerald B.; Lonngren, Karl E.
1986-01-01
The discoveries and experiments of the Plasma Diagnostic Package (PDP) on the OSS 1 and Spacelab 2 missions are reviewed, these results are compared with those of other space and laboratory experiments, and the implications for the understanding of large body interactions in a low Earth orbit (LEO) plasma environment are discussed. First a brief review of the PDP investigation, its instrumentation and experiments is presented. Next a summary of PDP results along with a comparison of those results with similar space or laboratory experiments is given. Last of all the implications of these results in terms of understanding fundamental physical processes that take place with large bodies in LEO is discussed and experiments to deal with these vital questions are suggested.
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Changing needs, opportunities and constraints for the 21st century microbiology laboratory.
Van Eldere, J
2005-04-01
Clinical microbiologists and microbiology laboratories are experiencing changes due to evolving views on 'healthcare delivery' as an economic activity, due to changes in the medical environment and the demographics of the workforce, and technical evolution. Cost-effectiveness of laboratory procedures has been achieved through consolidation and integration of laboratories. Consolidation offers economy of scale and reduction in numbers of on-site staff, but also leads to separation of microbiologists from their clinical colleagues. Integration puts different laboratory disciplines under a single management, and leads to reorganisation of laboratories along common work-lines. Cost-savings combined with on-site availability of laboratories are achieved at the expense of a reduction in the influence of microbiologists in the daily running of the laboratory. Medically, there is growing emphasis on evidence-based diagnostics. Because of time-delays inherent in culturing, microbiology through rapid testing is mandatory. There is an increasing shortage in Europe and the USA of trained microbiology laboratory technicians and microbiologists. This reinforces the trend towards more automation and integration. Technological advances, particularly in molecular diagnostics, offer the possibility of rapid reporting and improvement of the impact of clinical microbiology on patient management. Molecular tests, however, fit perfectly the concept of an integrated laboratory and may further loosen the link between microbiologist and microbiology tests. The challenge for clinical microbiology will be to use new techniques to improve its cost-effectiveness and impact on infectious disease management. The future organisation of microbiology laboratories must support this but is itself of secondary importance. The training of future microbiologist must prepare them for this changing environment.
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Interinstitutional review of slides for forensic pathology: types of inconsistencies.
Ersoy, Gokhan; Akyildiz, Elif Ulker; Korkmaz, Gulay; Albek, Emre
2010-09-01
Because of the specific structure of forensic medicine in Turkey, reexamination of histopathologic specimens is a frequent practice. The aim of the present study is the assessment of microscopic diagnostic consistency in forensic pathology between different laboratories. Reports of the Council of Forensic Medicine between 2001 and 2004 were examined, and 150 cases with second pathologic examination were found. Results of histopathologic reports from peripheral laboratories were compared with those made by the Council pathologists with regard to diagnostic consistency. Consistency was assessed in 3 groups and 1 subgroup. Group 1, consistent and minor inconsistency; includes a major consistency subgroup. Group 2, major inconsistency, is the second diagnosis which is lethal; group 3, major inconsistency, is the first diagnosis which is lethal. The lung was found to be the organ with the highest frequency of diagnostic major inconsistency (group 2 and 3) and major consistency. Bronchopneumonia was the most common diagnosis. The brain had the highest frequency of intercenter diagnostic overall consistency (90.2%, group 1). Myocardial infarction was the diagnosis most frequently rejected on reevaluation (group 3). In conclusion, forensic pathology requires different experience than surgical ones. In cases of discrepancy between the anamnesis of the lethal event and pathologic findings, reevaluation of specimen is mandatory to avoid any diagnostic errors. Quality assurance systems with all include internal and external control mechanisms will improve the diagnostic reliability.
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Grunow, Roland; Ippolito, G; Jacob, D; Sauer, U; Rohleder, A; Di Caro, A; Iacovino, R
2014-01-01
Quality assurance exercises and networking on the detection of highly infectious pathogens (QUANDHIP) is a joint action initiative set up in 2011 that has successfully unified the primary objectives of the European Network on Highly Pathogenic Bacteria (ENHPB) and of P4-laboratories (ENP4-Lab) both of which aimed to improve the efficiency, effectiveness, and response capabilities of laboratories directed at protecting the health of European citizens against high consequence bacteria and viruses of significant public health concern. Both networks have established a common collaborative consortium of 37 nationally and internationally recognized institutions with laboratory facilities from 22 European countries. The specific objectives and achievements include the initiation and establishment of a recognized and acceptable quality assurance scheme, including practical external quality assurance exercises, comprising living agents, that aims to improve laboratory performance, accuracy, and detection capabilities in support of patient management and public health responses; recognized training schemes for diagnostics and handling of highly pathogenic agents; international repositories comprising highly pathogenic bacteria and viruses for the development of standardized reference material; a standardized and transparent Biosafety and Biosecurity strategy protecting healthcare personnel and the community in dealing with high consequence pathogens; the design and organization of response capabilities dealing with cross-border events with highly infectious pathogens including the consideration of diagnostic capabilities of individual European laboratories. The project tackled several sensitive issues regarding Biosafety, Biosecurity and "dual use" concerns. The article will give an overview of the project outcomes and discuss the assessment of potential "dual use" issues.
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Discrepancies in reporting the CAG repeat lengths for Huntington's disease
Quarrell, Oliver W; Handley, Olivia; O'Donovan, Kirsty; Dumoulin, Christine; Ramos-Arroyo, Maria; Biunno, Ida; Bauer, Peter; Kline, Margaret; Landwehrmeyer, G Bernhard
2012-01-01
Huntington's disease results from a CAG repeat expansion within the Huntingtin gene; this is measured routinely in diagnostic laboratories. The European Huntington's Disease Network REGISTRY project centrally measures CAG repeat lengths on fresh samples; these were compared with the original results from 121 laboratories across 15 countries. We report on 1326 duplicate results; a discrepancy in reporting the upper allele occurred in 51% of cases, this reduced to 13.3% and 9.7% when we applied acceptable measurement errors proposed by the American College of Medical Genetics and the Draft European Best Practice Guidelines, respectively. Duplicate results were available for 1250 lower alleles; discrepancies occurred in 40% of cases. Clinically significant discrepancies occurred in 4.0% of cases with a potential unexplained misdiagnosis rate of 0.3%. There was considerable variation in the discrepancy rate among 10 of the countries participating in this study. Out of 1326 samples, 348 were re-analysed by an accredited diagnostic laboratory, based in Germany, with concordance rates of 93% and 94% for the upper and lower alleles, respectively. This became 100% if the acceptable measurement errors were applied. The central laboratory correctly reported allele sizes for six standard reference samples, blind to the known result. Our study differs from external quality assessment (EQA) schemes in that these are duplicate results obtained from a large sample of patients across the whole diagnostic range. We strongly recommend that laboratories state an error rate for their measurement on the report, participate in EQA schemes and use reference materials regularly to adjust their own internal standards. PMID:21811303
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Grolla, Allen; Jones, Steven M.; Fernando, Lisa; Strong, James E.; Ströher, Ute; Möller, Peggy; Paweska, Janusz T.; Burt, Felicity; Pablo Palma, Pedro; Sprecher, Armand; Formenty, Pierre; Roth, Cathy; Feldmann, Heinz
2011-01-01
Background Marburg virus (MARV), a zoonotic pathogen causing severe hemorrhagic fever in man, has emerged in Angola resulting in the largest outbreak of Marburg hemorrhagic fever (MHF) with the highest case fatality rate to date. Methodology/Principal Findings A mobile laboratory unit (MLU) was deployed as part of the World Health Organization outbreak response. Utilizing quantitative real-time PCR assays, this laboratory provided specific MARV diagnostics in Uige, the epicentre of the outbreak. The MLU operated over a period of 88 days and tested 620 specimens from 388 individuals. Specimens included mainly oral swabs and EDTA blood. Following establishing on site, the MLU operation allowed a diagnostic response in <4 hours from sample receiving. Most cases were found among females in the child-bearing age and in children less than five years of age. The outbreak had a high number of paediatric cases and breastfeeding may have been a factor in MARV transmission as indicated by the epidemiology and MARV positive breast milk specimens. Oral swabs were a useful alternative specimen source to whole blood/serum allowing testing of patients in circumstances of resistance to invasive procedures but limited diagnostic testing to molecular approaches. There was a high concordance in test results between the MLU and the reference laboratory in Luanda operated by the US Centers for Disease Control and Prevention. Conclusions/Significance The MLU was an important outbreak response asset providing support in patient management and epidemiological surveillance. Field laboratory capacity should be expanded and made an essential part of any future outbreak investigation. PMID:21629730
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International External Quality Assurance for Laboratory Diagnosis of Diphtheria ▿
Neal, S. E.; Efstratiou, A.
2009-01-01
The diphtheria surveillance network (DIPNET) encompassing National Diphtheria Reference Centers from 25 European countries is a Dedicated Surveillance Network recognized by the European Commission. A key DIPNET objective is the quality assessment of microbiological procedures for diphtheria across the European Union and beyond. A detailed questionnaire on the level of reference laboratory services and an external quality assessment (EQA) panel comprising six simulated throat specimens were sent to 34 centers. Twenty-three centers are designated National Diphtheria Reference Centers, with the laboratory in the United Kingdom being the only WHO Collaborating Centre. A variety of screening and identification tests were used, including the cysteinase test (20/34 centers), pyrazinamidase test (17/34 centers), and commercial kits (25/34 centers). The classic Elek test for toxigenicity testing is mostly used (28/34 centers), with variations in serum sources and antitoxin concentrations. Many laboratories reported problems obtaining Elek reagents or media. Only six centers produced acceptable results for all six specimens. Overall, 21% of identification and 13% of toxigenicity reports were unacceptable. Many centers could not isolate the target organism, and most found difficulties with the specimens that contained Corynebacterium striatum as a commensal contaminant. Nineteen centers generated either false-positive or negative toxigenic results, which may have caused inappropriate medical management. The discrepancies in this diphtheria diagnostics EQA alarmingly reflect the urgent need to improve laboratory performance in diphtheria diagnostics in Europe, standardize feasible and robust microbiological methods, and build awareness among public health authorities. Therefore, DIPNET recommends that regular workshops and EQA distributions for diphtheria diagnostics should be supported and maintained. PMID:19828749
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Grunow, Roland; Ippolito, G.; Jacob, D.; Sauer, U.; Rohleder, A.; Di Caro, A.; Iacovino, R.
2014-01-01
Quality assurance exercises and networking on the detection of highly infectious pathogens (QUANDHIP) is a joint action initiative set up in 2011 that has successfully unified the primary objectives of the European Network on Highly Pathogenic Bacteria (ENHPB) and of P4-laboratories (ENP4-Lab) both of which aimed to improve the efficiency, effectiveness, and response capabilities of laboratories directed at protecting the health of European citizens against high consequence bacteria and viruses of significant public health concern. Both networks have established a common collaborative consortium of 37 nationally and internationally recognized institutions with laboratory facilities from 22 European countries. The specific objectives and achievements include the initiation and establishment of a recognized and acceptable quality assurance scheme, including practical external quality assurance exercises, comprising living agents, that aims to improve laboratory performance, accuracy, and detection capabilities in support of patient management and public health responses; recognized training schemes for diagnostics and handling of highly pathogenic agents; international repositories comprising highly pathogenic bacteria and viruses for the development of standardized reference material; a standardized and transparent Biosafety and Biosecurity strategy protecting healthcare personnel and the community in dealing with high consequence pathogens; the design and organization of response capabilities dealing with cross-border events with highly infectious pathogens including the consideration of diagnostic capabilities of individual European laboratories. The project tackled several sensitive issues regarding Biosafety, Biosecurity and “dual use” concerns. The article will give an overview of the project outcomes and discuss the assessment of potential “dual use” issues. PMID:25426479
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Update on diagnostics for Phytophthora ramorum
Philip Berger
2006-01-01
Diagnostics used by the U.S. Department of Agriculture (USDA), to determine absence or presence of Phytophthora ramorum in plant samples, are based on a combination of tests and depend on collaboration with external laboratories. The system currently in place attempts to maximize limited resources and at the same time provide the most scientifically...
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External Quality Assessment for Zika Virus Molecular Diagnostic Testing, Brazil.
Fischer, Carlo; Pedroso, Celia; Mendrone, Alfredo; Bispo de Filippis, Ana Maria; Vallinoto, Antonio Carlos Rosário; Ribeiro, Bergmann Morais; Durigon, Edison Luiz; Marques, Ernesto T A; Campos, Gubio S; Viana, Isabelle F T; Levi, José Eduardo; Scarpelli, Luciano Cesar; Nogueira, Mauricio Lacerda; Bastos, Michele de Souza; Souza, Nathalia C Santiago; Khouri, Ricardo; Lira, Sanny; Komninakis, Shirley Vasconcelos; Baronti, Cécile; Charrel, Rémi N; Kümmerer, Beate M; Drosten, Christian; Brites, Carlos; de Lamballerie, Xavier; Niedrig, Matthias; Netto, Eduardo Martins; Drexler, Jan Felix
2018-05-01
We conducted an external quality assessment of Zika virus molecular diagnostic tests in Brazil using a new Zika virus standard. Of 15 laboratories, 73% showed limited sensitivity and specificity. Viral load estimates varied significantly. Continuous quality assurance is needed to adequately estimate risk for Zika virus-associated disease and determine patient care.
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An Interview with Medical Diagnostics Scientist Bernhard Weigl
ERIC Educational Resources Information Center
Sullivan, Megan
2010-01-01
Medical diagnostics help us evaluate a range of disorders, such as cancer and infectious diseases. In the United States and other developed countries, doctors have access to advanced equipment and laboratories that provide reliable diagnoses. As a result, when we are sick, we feel confident that we will get the treatment we need. Unfortunately,…
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Molecular Methods and Platforms for Infectious Diseases Testing
Emmadi, Rajyasree; Boonyaratanakornkit, Jerry B.; Selvarangan, Rangaraj; Shyamala, Venkatakrishna; Zimmer, Barbara L.; Williams, Laurina; Bryant, Bonita; Schutzbank, Ted; Schoonmaker, Michele M.; Amos Wilson, Jean A.; Hall, Leslie; Pancholi, Preeti; Bernard, Kathryn
2011-01-01
The superior sensitivity and specificity associated with the use of molecular assays has greatly improved the field of infectious disease diagnostics by providing clinicians with results that are both accurate and rapidly obtained. Herein, we review molecularly based infectious disease diagnostic tests that are Food and Drug Administration approved or cleared and commercially available in the United States as of December 31, 2010. We describe specific assays and their performance, as stated in the Food and Drug Administration's Summary of Safety and Effectiveness Data or the Office of In Vitro Diagnostic Device Evaluation and Safety's decision summaries, product inserts, or peer-reviewed literature. We summarize indications for testing, limitations, and challenges related to implementation in a clinical laboratory setting for a wide variety of common pathogens. The information presented in this review will be particularly useful for laboratories that plan to implement or expand their molecular offerings in the near term. PMID:21871973
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2013-01-01
An HIV-1 diagnostic laboratory was established in the Academic Medical Center (AMC) of the University of Amsterdam after the discovery of human immunodeficiency virus (HIV) as the cause of the acquired immunodeficiency syndrome (AIDS). The first AIDS patients were diagnosed here in 1981 and since 1983 we have tested the samples of 50992 patients using a variety of assays that greatly improved over the years. We will describe some of the basic results from this diagnostic laboratory and then focus on the spin-off in terms of the development of novel virus assays to detect super-infections and ultra-sensitive assays to measure the intracellular HIV-1 RNA load. We also review several original research findings in the field of HIV-1 virology that stem from initial observations made in the diagnostic unit. This includes the study of genetic defects in the HIV-1 genome and time trends of the replication fitness over 30 years of viral evolution, but also the description of novel HIV-1 variants in difficult-to-diagnose clinical specimen. PMID:23985078
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van der Kuyl, Antoinette C; Bakker, Margreet; Jurriaans, Suzanne; Back, Nicole K T; Pasternak, Alexander O; Cornelissen, Marion; Berkhout, Ben
2013-08-28
An HIV-1 diagnostic laboratory was established in the Academic Medical Center (AMC) of the University of Amsterdam after the discovery of human immunodeficiency virus (HIV) as the cause of the acquired immunodeficiency syndrome (AIDS). The first AIDS patients were diagnosed here in 1981 and since 1983 we have tested the samples of 50992 patients using a variety of assays that greatly improved over the years. We will describe some of the basic results from this diagnostic laboratory and then focus on the spin-off in terms of the development of novel virus assays to detect super-infections and ultra-sensitive assays to measure the intracellular HIV-1 RNA load. We also review several original research findings in the field of HIV-1 virology that stem from initial observations made in the diagnostic unit. This includes the study of genetic defects in the HIV-1 genome and time trends of the replication fitness over 30 years of viral evolution, but also the description of novel HIV-1 variants in difficult-to-diagnose clinical specimen.
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Strategies in Ebola virus disease (EVD) diagnostics at the point of care.
Coarsey, Chad T; Esiobu, Nwadiuto; Narayanan, Ramswamy; Pavlovic, Mirjana; Shafiee, Hadi; Asghar, Waseem
2017-11-01
Ebola virus disease (EVD) is a devastating, highly infectious illness with a high mortality rate. The disease is endemic to regions of Central and West Africa, where there is limited laboratory infrastructure and trained staff. The recent 2014 West African EVD outbreak has been unprecedented in case numbers and fatalities, and has proven that such regional outbreaks can become a potential threat to global public health, as it became the source for the subsequent transmission events in Spain and the USA. The urgent need for rapid and affordable means of detecting Ebola is crucial to control the spread of EVD and prevent devastating fatalities. Current diagnostic techniques include molecular diagnostics and other serological and antigen detection assays; which can be time-consuming, laboratory-based, often require trained personnel and specialized equipment. In this review, we discuss the various Ebola detection techniques currently in use, and highlight the potential future directions pertinent to the development and adoption of novel point-of-care diagnostic tools. Finally, a case is made for the need to develop novel microfluidic technologies and versatile rapid detection platforms for early detection of EVD.
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Lutz, Barry; Liang, Tinny; Fu, Elain; Ramachandran, Sujatha; Kauffman, Peter; Yager, Paul
2013-07-21
Lateral flow tests (LFTs) are an ingenious format for rapid and easy-to-use diagnostics, but they are fundamentally limited to assay chemistries that can be reduced to a single chemical step. In contrast, most laboratory diagnostic assays rely on multiple timed steps carried out by a human or a machine. Here, we use dissolvable sugar applied to paper to create programmable flow delays and present a paper network topology that uses these time delays to program automated multi-step fluidic protocols. Solutions of sucrose at different concentrations (10-70% of saturation) were added to paper strips and dried to create fluidic time delays spanning minutes to nearly an hour. A simple folding card format employing sugar delays was shown to automate a four-step fluidic process initiated by a single user activation step (folding the card); this device was used to perform a signal-amplified sandwich immunoassay for a diagnostic biomarker for malaria. The cards are capable of automating multi-step assay protocols normally used in laboratories, but in a rapid, low-cost, and easy-to-use format.
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Lutz, Barry; Liang, Tinny; Fu, Elain; Ramachandran, Sujatha; Kauffman, Peter; Yager, Paul
2013-01-01
Lateral flow tests (LFTs) are an ingenious format for rapid and easy-to-use diagnostics, but they are fundamentally limited to assay chemistries that can be reduced to a single chemical step. In contrast, most laboratory diagnostic assays rely on multiple timed steps carried out by a human or a machine. Here, we use dissolvable sugar applied to paper to create programmable flow delays and present a paper network topology that uses these time delays to program automated multi-step fluidic protocols. Solutions of sucrose at different concentrations (10-70% of saturation) were added to paper strips and dried to create fluidic time delays spanning minutes to nearly an hour. A simple folding card format employing sugar delays was shown to automate a four-step fluidic process initiated by a single user activation step (folding the card); this device was used to perform a signal-amplified sandwich immunoassay for a diagnostic biomarker for malaria. The cards are capable of automating multi-step assay protocols normally used in laboratories, but in a rapid, low-cost, and easy-to-use format. PMID:23685876
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van den Beld, Maaike J C; Friedrich, Alexander W; van Zanten, Evert; Reubsaet, Frans A G; Kooistra-Smid, Mirjam A M D; Rossen, John W A
2016-12-01
An inter-laboratory collaborative trial for the evaluation of diagnostics for detection and identification of Shigella species and Entero-invasive Escherichia coli (EIEC) was performed. Sixteen Medical Microbiological Laboratories (MMLs) participated. MMLs were interviewed about their diagnostic methods and a sample panel, consisting of DNA-extracts and spiked stool samples with different concentrations of Shigella flexneri, was provided to each MML. The results of the trial showed an enormous variety in culture-dependent and molecular diagnostic techniques currently used among MMLs. Despite the various molecular procedures, 15 out of 16 MMLs were able to detect Shigella species or EIEC in all the samples provided, showing that the diversity of methods has no effect on the qualitative detection of Shigella flexneri. In contrast to semi quantitative analysis, the minimum and maximum values per sample differed by approximately five threshold cycles (Ct-value) between the MMLs included in the study. This indicates that defining a uniform Ct-value cut-off for notification to health authorities is not advisable. Copyright © 2016 Elsevier B.V. All rights reserved.
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Namatovu, Alice; Wekesa, Sabenzia Nabalayo; Tjørnehøj, Kirsten; Dhikusooka, Moses Tefula; Muwanika, Vincent B; Siegsmund, Hans Redlef; Ayebazibwe, Chrisostom
2013-01-24
Accurate diagnosis is pertinent to any disease control programme. If Eastern Africa is to work towards control of foot-and-mouth disease (FMD) using the Progressive Control Pathway for FMD (PCP-FMD) as a tool, then the capacity of national reference laboratories (NRLs) mandated to diagnose FMD should match this task. This study assessed the laboratory capacity of 14 NRLs of the Eastern Africa Region Laboratory Network member countries using a semi-structured questionnaire and retrospective data from the World Reference Laboratory for FMD annual reports and Genbank® through National Centre for Biotechnology Information for the period 2006-2010. The questionnaire response rate was 13/14 (93%). Twelve out of the 13 countries/regions had experienced at least one outbreak in the relevant five year period. Only two countries (Ethiopia and Kenya) had laboratories at biosecurity level 3 and only three (Ethiopia, Kenya and Sudan) had identified FMD virus serotypes for all reported outbreaks. Based on their own country/region assessment, 12/13 of these countries /regions were below stage 3 of the PCP-FMD. Quarantine (77%) and vaccination (54%) were the major FMD control strategies employed. The majority (12/13) of the NRLs used serological techniques to diagnose FMD, seven used antigen ELISA and three of these (25%) also used molecular techniques which were the tests most frequently requested from collaborating laboratories by the majority (69%) of the NRLs. Only 4/13 (31%) participated in proficiency testing for FMD. Four (31%) laboratories had no quality management systems (QMS) in place and where QMS existed it was still deficient, thus, none of the laboratories had achieved accreditation for FMD diagnosis. This study indicates that FMD diagnostic capacity in Eastern Africa is still inadequate and largely depends on antigen and antibody ELISAs techniques undertaken by the NRLs. Hence, for the region to progress on the PCP-FMD, there is need to: implement regional control measures, improve the serological diagnostic test performance and laboratory capacity of the NRLs (including training of personnel as well as upgrading of equipment and methods, especially strengthening the molecular diagnostic capacity), and to establish a regional reference laboratory to enforce QMS and characterization of FMD virus containing samples.
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2013-01-01
Background Accurate diagnosis is pertinent to any disease control programme. If Eastern Africa is to work towards control of foot-and-mouth disease (FMD) using the Progressive Control Pathway for FMD (PCP-FMD) as a tool, then the capacity of national reference laboratories (NRLs) mandated to diagnose FMD should match this task. This study assessed the laboratory capacity of 14 NRLs of the Eastern Africa Region Laboratory Network member countries using a semi-structured questionnaire and retrospective data from the World Reference Laboratory for FMD annual reports and Genbank® through National Centre for Biotechnology Information for the period 2006–2010. Results The questionnaire response rate was 13/14 (93%). Twelve out of the 13 countries/regions had experienced at least one outbreak in the relevant five year period. Only two countries (Ethiopia and Kenya) had laboratories at biosecurity level 3 and only three (Ethiopia, Kenya and Sudan) had identified FMD virus serotypes for all reported outbreaks. Based on their own country/region assessment, 12/13 of these countries /regions were below stage 3 of the PCP-FMD. Quarantine (77%) and vaccination (54%) were the major FMD control strategies employed. The majority (12/13) of the NRLs used serological techniques to diagnose FMD, seven used antigen ELISA and three of these (25%) also used molecular techniques which were the tests most frequently requested from collaborating laboratories by the majority (69%) of the NRLs. Only 4/13 (31%) participated in proficiency testing for FMD. Four (31%) laboratories had no quality management systems (QMS) in place and where QMS existed it was still deficient, thus, none of the laboratories had achieved accreditation for FMD diagnosis. Conclusions This study indicates that FMD diagnostic capacity in Eastern Africa is still inadequate and largely depends on antigen and antibody ELISAs techniques undertaken by the NRLs. Hence, for the region to progress on the PCP-FMD, there is need to: implement regional control measures, improve the serological diagnostic test performance and laboratory capacity of the NRLs (including training of personnel as well as upgrading of equipment and methods, especially strengthening the molecular diagnostic capacity), and to establish a regional reference laboratory to enforce QMS and characterization of FMD virus containing samples. PMID:23347795
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Exploration Laboratory Analysis FY13
NASA Technical Reports Server (NTRS)
Krihak, Michael; Perusek, Gail P.; Fung, Paul P.; Shaw, Tianna, L.
2013-01-01
The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk, which is stated as the Risk of Inability to Adequately Treat an Ill or Injured Crew Member, and ExMC Gap 4.05: Lack of minimally invasive in-flight laboratory capabilities with limited consumables required for diagnosing identified Exploration Medical Conditions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability in future exploration missions. Mission architecture poses constraints on equipment and procedures that will be available to treat evidence-based medical conditions according to the Space Medicine Exploration Medical Conditions List (SMEMCL), and to perform human research studies on the International Space Station (ISS) that are supported by the Human Health and Countermeasures (HHC) element. Since there are significant similarities in the research and medical operational requirements, ELA hardware development has emerged as a joint effort between ExMC and HHC. In 2012, four significant accomplishments were achieved towards the development of exploration laboratory analysis for medical diagnostics. These achievements included (i) the development of high priority analytes for research and medical operations, (ii) the development of Level 1 functional requirements and concept of operations documentation, (iii) the selection and head-to-head competition of in-flight laboratory analysis instrumentation, and (iv) the phase one completion of the Small Business Innovation Research (SBIR) projects under the topic Smart Phone Driven Blood-Based Diagnostics. To utilize resources efficiently, the associated documentation and advanced technologies were integrated into a single ELA plan that encompasses ExMC and HHC development efforts. The requirements and high priority analytes was used in the selection of the four in-flight laboratory analysis performers. Based upon the competition results, a down select process will be performed in the upcoming year. Looking ahead, this unified effort has positioned each element for an in-flight lab analysis demonstration of select diagnostics measurements in the 2015 timeframe.
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Gephardt, G N; Zarbo, R J
1996-11-01
To develop a multi-institutional reference database of extraneous tissue (contaminants) in surgical pathology. In 1994, participants in the College of American Pathologists Q-Probes quality improvement program performed prospective and retrospective evaluations of extraneous tissue found in surgical pathology microscopic sections for a period of 4 weeks or until 1000 slides were reviewed in each participating laboratory. Two hundred seventy-five surgical pathology laboratories institutions, predominantly from North America. Extraneous tissue contamination rate for slides in prospective and retrospective reviews; staffing and practice procedures; location of extraneous tissue on slides; type of extraneous tissue (normal, abnormal, nonneoplastic, neoplasm, microorganisms, etc); class of extraneous tissue (slide or block contaminants); source of extraneous tissue (different or same case); origin of extraneous tissue (pathology laboratory, physician's office or operating room); and degree of diagnostic difficulty caused by extraneous tissue. Three hundred twenty-one thousand seven hundred fifty-seven slides were reviewed in the prospective study and 57083 slides in the retrospective study. There was an overall extraneous tissue rate of 0.6% of slides (2074/321757) in the prospective study and 2.9% of slides (1653/57083) in the retrospective study. Of those slides with extraneous tissue, the extraneous tissue was located near diagnostic tissue sections in 59.5% of the slides reviewed prospectively and in 25.3% of slides reviewed retrospectively; deeper sections were performed to evaluate extraneous tissue in 12.2% of prospective cases and in 3.1% of retrospective cases. Of the laboratories, 98% had written guidelines for changing solution in tissue processors, and 64.9% had guidelines for maintaining water baths free of extraneous tissue. A total of 98.9% used lens paper, filter bags, or sponges for processing fragmented and small specimens. Written protocols for documentation of extraneous tissue in surgical pathology reports were established in 6.1% of laboratories, for removal of extraneous tissue from blocks in 5.7%, and for removal of extraneous tissue from microscopic slides in 4.7%. In 24% of laboratories no comment or record was kept to document extraneous tissue. Extraneous tissue consisted of neoplasm in 12.7% of the prospectively reviewed slides and in 6.0% of the retrospectively reviewed slides. For the prospective study, 59.4% of extraneous tissue was classified as slide contaminants, and 28.4% was found to be contaminants within the paraffin block; for the retrospective study, 72.9% was classified as slide contaminants and 15.9% as block contaminants. For the prospective study, 63.2% of extraneous tissue was presumed to be from a different case, and in the retrospective study, 48.5% was presumed to be from a different case. Over 90% of extraneous tissue was thought to originate from the pathology laboratory. The degree of diagnostic difficulty caused by extraneous tissue was judged to be severe in 0.4% of slides in the prospective study and 0.1% of slides in the retrospective study. In the prospective study, it could not be determined whether the tissue in the diagnostic sections was extraneous in 0.6% of slides, and in the retrospective study, it could not be determined whether tissue in the diagnostic sections was extraneous in 0.1%. This study has documented the frequency, type, origin, source, and diagnostic difficulty of extraneous tissue and presents benchmarks of extraneous tissue experienced in the general practice of surgical pathology.
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Using cytology to increase small animal practice revenue.
Hodges, Joanne
2013-11-01
Diagnostic cytology is a useful, noninvasive test with practical foundations in high-quality medicine and applications to practice building. Cytology will generate practice revenue whether assessed in-house or sent to a clinical pathologist. Thorough in-house evaluation is adequate in some cases, but expert opinion is important in many cases. Specimen slides should at least be reviewed in-house for assessment of cellularity and potential artifacts before submission to a reference laboratory. Reference laboratories also provide special stains and advanced molecular diagnostics to help further characterize many neoplastic processes, search for organisms, identify pigments, and address other important aspects of the lesion. Copyright © 2013 Elsevier Inc. All rights reserved.
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Laboratory-based validation of the baseline sensors of the ITER diagnostic residual gas analyzer
NASA Astrophysics Data System (ADS)
Klepper, C. C.; Biewer, T. M.; Marcus, C.; Andrew, P.; Gardner, W. L.; Graves, V. B.; Hughes, S.
2017-10-01
The divertor-specific ITER Diagnostic Residual Gas Analyzer (DRGA) will provide essential information relating to DT fusion plasma performance. This includes pulse-resolving measurements of the fuel isotopic mix reaching the pumping ducts, as well as the concentration of the helium generated as the ash of the fusion reaction. In the present baseline design, the cluster of sensors attached to this diagnostic's differentially pumped analysis chamber assembly includes a radiation compatible version of a commercial quadrupole mass spectrometer, as well as an optical gas analyzer using a plasma-based light excitation source. This paper reports on a laboratory study intended to validate the performance of this sensor cluster, with emphasis on the detection limit of the isotopic measurement. This validation study was carried out in a laboratory set-up that closely prototyped the analysis chamber assembly configuration of the baseline design. This includes an ITER-specific placement of the optical gas measurement downstream from the first turbine of the chamber's turbo-molecular pump to provide sufficient light emission while preserving the gas dynamics conditions that allow for \\textasciitilde 1 s response time from the sensor cluster [1].
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Implementation of Cloud based next generation sequencing data analysis in a clinical laboratory.
Onsongo, Getiria; Erdmann, Jesse; Spears, Michael D; Chilton, John; Beckman, Kenneth B; Hauge, Adam; Yohe, Sophia; Schomaker, Matthew; Bower, Matthew; Silverstein, Kevin A T; Thyagarajan, Bharat
2014-05-23
The introduction of next generation sequencing (NGS) has revolutionized molecular diagnostics, though several challenges remain limiting the widespread adoption of NGS testing into clinical practice. One such difficulty includes the development of a robust bioinformatics pipeline that can handle the volume of data generated by high-throughput sequencing in a cost-effective manner. Analysis of sequencing data typically requires a substantial level of computing power that is often cost-prohibitive to most clinical diagnostics laboratories. To address this challenge, our institution has developed a Galaxy-based data analysis pipeline which relies on a web-based, cloud-computing infrastructure to process NGS data and identify genetic variants. It provides additional flexibility, needed to control storage costs, resulting in a pipeline that is cost-effective on a per-sample basis. It does not require the usage of EBS disk to run a sample. We demonstrate the validation and feasibility of implementing this bioinformatics pipeline in a molecular diagnostics laboratory. Four samples were analyzed in duplicate pairs and showed 100% concordance in mutations identified. This pipeline is currently being used in the clinic and all identified pathogenic variants confirmed using Sanger sequencing further validating the software.
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Singh, Harpal; Shimojima, Masayuki; Shiratori, Tomomi; An, Le Van; Sugamata, Masami; Yang, Ming
2015-01-01
Enzyme-linked Immunosorbent Assay (ELISA)-based diagnosis is the mainstay for measuring antibody response in infectious diseases and to support pathogen identification of potential use in infectious disease outbreaks and clinical care of individual patients. The development of laboratory diagnostics using readily available 3D printing technologies provides a timely opportunity for further expansion of this technology into immunodetection systems. Utilizing available 3D printing platforms, a ‘3D well’ was designed and developed to have an increased surface area compared to those of 96-well plates. The ease and rapidity of the development of the 3D well prototype provided an opportunity for its rapid validation through the diagnostic performance of ELISA in infectious disease without modifying current laboratory practices for ELISA. The improved sensitivity of the 3D well of up to 2.25-fold higher compared to the 96-well ELISA provides a potential for the expansion of this technology towards miniaturization and Lab-On-a-Chip platforms to reduce time, volume of reagents and samples needed for such assays in the laboratory diagnosis of infectious and other diseases including applications in other disciplines. PMID:26184194
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Laboratory Diagnostics of Botulism
Lindström, Miia; Korkeala, Hannu
2006-01-01
Botulism is a potentially lethal paralytic disease caused by botulinum neurotoxin. Human pathogenic neurotoxins of types A, B, E, and F are produced by a diverse group of anaerobic spore-forming bacteria, including Clostridium botulinum groups I and II, Clostridium butyricum, and Clostridium baratii. The routine laboratory diagnostics of botulism is based on the detection of botulinum neurotoxin in the patient. Detection of toxin-producing clostridia in the patient and/or the vehicle confirms the diagnosis. The neurotoxin detection is based on the mouse lethality assay. Sensitive and rapid in vitro assays have been developed, but they have not yet been appropriately validated on clinical and food matrices. Culture methods for C. botulinum are poorly developed, and efficient isolation and identification tools are lacking. Molecular techniques targeted to the neurotoxin genes are ideal for the detection and identification of C. botulinum, but they do not detect biologically active neurotoxin and should not be used alone. Apart from rapid diagnosis, the laboratory diagnostics of botulism should aim at increasing our understanding of the epidemiology and prevention of the disease. Therefore, the toxin-producing organisms should be routinely isolated from the patient and the vehicle. The physiological group and genetic traits of the isolates should be determined. PMID:16614251
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Singh, Harpal; Shimojima, Masayuki; Shiratori, Tomomi; An, Le Van; Sugamata, Masami; Yang, Ming
2015-07-08
Enzyme-linked Immunosorbent Assay (ELISA)-based diagnosis is the mainstay for measuring antibody response in infectious diseases and to support pathogen identification of potential use in infectious disease outbreaks and clinical care of individual patients. The development of laboratory diagnostics using readily available 3D printing technologies provides a timely opportunity for further expansion of this technology into immunodetection systems. Utilizing available 3D printing platforms, a '3D well' was designed and developed to have an increased surface area compared to those of 96-well plates. The ease and rapidity of the development of the 3D well prototype provided an opportunity for its rapid validation through the diagnostic performance of ELISA in infectious disease without modifying current laboratory practices for ELISA. The improved sensitivity of the 3D well of up to 2.25-fold higher compared to the 96-well ELISA provides a potential for the expansion of this technology towards miniaturization and Lab-On-a-Chip platforms to reduce time, volume of reagents and samples needed for such assays in the laboratory diagnosis of infectious and other diseases including applications in other disciplines.
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Pathmanathan, Ishani; Date, Anand; Coggin, William L; Nkengasong, John; Piatek, Amy S; Alexander, Heather
2017-03-31
To eliminate preventable deaths, disease and suffering due to tuberculosis (TB), improved diagnostic capacity is critical. The Cepheid Xpert ® MTB/RIF assay is recommended by the World Health Organization as the initial diagnostic test for people with suspected HIV-associated TB. However, despite high expectations, its scale-up in real-world settings has faced challenges, often due to the systems that support it. In this commentary we discuss needs and opportunities for systems strengthening to support widespread scale-up of Xpert ® MTB/RIF as they relate to each step within the TB diagnostic cascade, from finding presumptive patients, to collecting, transporting and testing sputum specimens, to reporting and receiving results, to initiating and monitoring treatment and, ultimately, to ensuring successful and timely treatment and cure. Investments in evidence-based interventions at each step along the cascade and within the system as a whole will augment not only the utility of Xpert ® MTB/RIF, but also the successful implementation of future diagnostic tests. Xpert ® MTB/RIF will only improve patient outcomes if optimally implemented within the context of strong TB programs and systems. Roll-out of this technology to people living with HIV and others in resource-limited settings offers the opportunity to leverage current TB and HIV laboratory, diagnostic and programmatic investments, while also addressing challenges and strengthening coordination between laboratory systems, laboratory-program interfaces, and TB-HIV program interfaces. If successful, the benefits of this tool could extend beyond progress towards global End TB Strategy goals, to improve system-wide capacity for global disease detection and control.
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[Definition of the Diagnosis Osteomyelitis-Osteomyelitis Diagnosis Score (ODS)].
Schmidt, H G K; Tiemann, A H; Braunschweig, R; Diefenbeck, M; Bühler, M; Abitzsch, D; Haustedt, N; Walter, G; Schoop, R; Heppert, V; Hofmann, G O; Glombitza, M; Grimme, C; Gerlach, U-J; Flesch, I
2011-08-01
The disease "osteomyelitis" is characterised by different symptoms and parameters. Decisive roles in the development of the disease are played by the causative bacteria, the route of infection and the individual defense mechanisms of the host. The diagnosis is based on different symptoms and findings from the clinical history, clinical symptoms, laboratory results, diagnostic imaging, microbiological and histopathological analyses. While different osteomyelitis classifications have been published, there is to the best of our knowledge no score that gives information how sure the diagnosis "osteomyelitis" is in general. For any scientific study of a disease a valid definition is essential. We have developed a special osteomyelitis diagnosis score for the reliable classification of clinical, laboratory and technical findings. The score is based on five diagnostic procedures: 1) clinical history and risk factors, 2) clinical examination and laboratory results, 3) diagnostic imaging (ultrasound, radiology, CT, MRI, nuclear medicine and hybrid methods), 4) microbiology, and 5) histopathology. Each diagnostic procedure is related to many individual findings, which are weighted by a score system, in order to achieve a relevant value for each assessment. If the sum of the five diagnostic criteria is 18 or more points, the diagnosis of osteomyelitis can be viewed as "safe" (diagnosis class A). Between 8-17 points the diagnosis is "probable" (diagnosis class B). Less than 8 points means that the diagnosis is "possible, but unlikely" (class C diagnosis). Since each parameter can score six points at a maximum, a reliable diagnosis can only be achieved if at least 3 parameters are scored with 6 points. The osteomyelitis diagnosis score should help to avoid the false description of a clinical presentation as "osteomyelitis". A safe diagnosis is essential for the aetiology, treatment and outcome studies of osteomyelitis. © Georg Thieme Verlag KG Stuttgart · New York.
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Dyatlov, I A; Mironov, A Yu; Shepelin, A P; Aleshkin, V A
2015-08-01
The import substitution becomes one of the strategic tasks of national economy as a result of prolongation of economic sanctions concerning the Russian Federation of part of the USA, EU countries, Japan and number of other countries. It is not proper to be limited in import substitution only by goods because in conditions ofsanctions when access toforeign technologies is complicated Russia is needed to substitute foreign technologies by national designs in faster manner One of directions of effective import substitution is localization of production of laboratory equipment and consumables for clinical and sanitary microbiology on the territory ofthe Russian Federation and countries of Customs union. In Russia, in the field ofdiagnostic of dangerous and socially significant infections, all components for import substitution to implement gene diagnostic, immune diagnostic. bio-sensory and biochip approaches, isolation and storage of live microbial cultures, implementation of high-tech methods of diagnostic are available. At the same time, national diagnostic instrument-making industry for microbiology is factually absent. The few devices of national production more than on 50% consist of import components. The microbiological laboratories are to be equipped only with import devices of open type for applying national components. The most perspective national designs to be implemented are multiplex polimerase chain reaction test-systems and biochips on the basis of national plotters and readers. The modern development of diagnostic equipment and diagnostic instruments requires supplement of national collections of bacterial and viral pathogens and working-through of organizational schemes of supplying collections with strains. The presented data concerning justification of nomenclature of laboratory equipment and consumables permits to satisfy in fill scope the needs of clinical and sanitary microbiology in devices, growth mediums, consumables of national production and to refuse import deliveries without decreasing quality of microbiological analysis. This approach will ensure appropriate response to occurring challenges and new biological dangers and maintenance of biosecurity of the Russian Federation at proper level.
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Vorob'ev, A A; Mironov, A Iu; Istratov, V G; Osman, K A
2005-01-01
In order to estimate possibility of chromatographic criteria application in diagnostics of syphilitic infection, the authors researched in three directions: evaluation of dysmetabolism of carbohydrate, lipid and amino acid components in patients' serum; search of signal compounds that serve as microbe "cooperative sensitivity" activators (lactones, quinolones, furan boron ethers) with evaluation of the risk of luetic infection generalization; indication of organ lesion markers (the brain, liver, bone structures). The factor analysis performed by the researchers allowed to determine priorities of clinical, laboratory and chromatographic data according to their value. The diagnostic value of various diagnostic chromatographic criteria was estimated as follows: the diagnostic sensitivity was 79.6% to 97.2%, the diagnostic specificity was 50.0% to 92.7%, the positive diagnostic predictability was 61.8% to 94.7% and the negative diagnostic predictability was 60.9% to 95.1%.
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Microfluidic technology for molecular diagnostics.
Robinson, Tom; Dittrich, Petra S
2013-01-01
Molecular diagnostics have helped to improve the lives of millions of patients worldwide by allowing clinicians to diagnose patients earlier as well as providing better ongoing therapies. Point-of-care (POC) testing can bring these laboratory-based techniques to the patient in a home setting or to remote settings in the developing world. However, despite substantial progress in the field, there still remain many challenges. Progress in molecular diagnostics has benefitted greatly from microfluidic technology. This chapter aims to summarise the more recent advances in microfluidic-based molecular diagnostics. Sections include an introduction to microfluidic technology, the challenges of molecular diagnostics, how microfluidic advances are working to solve these issues, some alternative design approaches, and detection within these systems.
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Observations on Microbiology Laboratory Instruction for Allied Health Students.
ERIC Educational Resources Information Center
Benathen, Isaiah A.
1993-01-01
The purposes of this paper are (1) to demonstrate that medical microbiology laboratory exercises should be presented with a focus on medical applications, not just traditional microbiology and (2) that exercises devoted to differential diagnostic decision making can be used to enhance the problem solving of students. (PR)
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ERIC Educational Resources Information Center
Grimes, William J.; Chambers, Linda; Kubo, Kenneth M.; Narro, Martha L.
1998-01-01
Describes a laboratory exercise that simulates the spread of an infectious agent among students in a classroom. Uses a modified Enzyme Linked ImmunoSorbent Assay (ELISA) to provide students with experience using an authentic diagnostic tool for detecting human infections. (DDR)
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The CLIA Molecular Diagnostics Laboratory within the Cancer Research Technology Program will perform messenger RNA isolation and expression analysis specific to a 20-gene panel on formalin-fixed paraffin-embedded (FFPE) patient samples using the Nano
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76 FR 38342 - Medicare Program; Clinical Laboratory Fee Schedule: Signature on Requisition
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-30
... cases, the physician may keep abreast of the patient's condition by calling the nursing staff. If a patient's condition indicates that a clinical diagnostic laboratory test is required, the nursing staff... signature on the requisition. Another example that occurs in many settings, including nursing homes, all...
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Lessons learned from additional research analyses of unsolved clinical exome cases.
Eldomery, Mohammad K; Coban-Akdemir, Zeynep; Harel, Tamar; Rosenfeld, Jill A; Gambin, Tomasz; Stray-Pedersen, Asbjørg; Küry, Sébastien; Mercier, Sandra; Lessel, Davor; Denecke, Jonas; Wiszniewski, Wojciech; Penney, Samantha; Liu, Pengfei; Bi, Weimin; Lalani, Seema R; Schaaf, Christian P; Wangler, Michael F; Bacino, Carlos A; Lewis, Richard Alan; Potocki, Lorraine; Graham, Brett H; Belmont, John W; Scaglia, Fernando; Orange, Jordan S; Jhangiani, Shalini N; Chiang, Theodore; Doddapaneni, Harsha; Hu, Jianhong; Muzny, Donna M; Xia, Fan; Beaudet, Arthur L; Boerwinkle, Eric; Eng, Christine M; Plon, Sharon E; Sutton, V Reid; Gibbs, Richard A; Posey, Jennifer E; Yang, Yaping; Lupski, James R
2017-03-21
Given the rarity of most single-gene Mendelian disorders, concerted efforts of data exchange between clinical and scientific communities are critical to optimize molecular diagnosis and novel disease gene discovery. We designed and implemented protocols for the study of cases for which a plausible molecular diagnosis was not achieved in a clinical genomics diagnostic laboratory (i.e. unsolved clinical exomes). Such cases were recruited to a research laboratory for further analyses, in order to potentially: (1) accelerate novel disease gene discovery; (2) increase the molecular diagnostic yield of whole exome sequencing (WES); and (3) gain insight into the genetic mechanisms of disease. Pilot project data included 74 families, consisting mostly of parent-offspring trios. Analyses performed on a research basis employed both WES from additional family members and complementary bioinformatics approaches and protocols. Analysis of all possible modes of Mendelian inheritance, focusing on both single nucleotide variants (SNV) and copy number variant (CNV) alleles, yielded a likely contributory variant in 36% (27/74) of cases. If one includes candidate genes with variants identified within a single family, a potential contributory variant was identified in a total of ~51% (38/74) of cases enrolled in this pilot study. The molecular diagnosis was achieved in 30/63 trios (47.6%). Besides this, the analysis workflow yielded evidence for pathogenic variants in disease-associated genes in 4/6 singleton cases (66.6%), 1/1 multiplex family involving three affected siblings, and 3/4 (75%) quartet families. Both the analytical pipeline and the collaborative efforts between the diagnostic and research laboratories provided insights that allowed recent disease gene discoveries (PURA, TANGO2, EMC1, GNB5, ATAD3A, and MIPEP) and increased the number of novel genes, defined in this study as genes identified in more than one family (DHX30 and EBF3). An efficient genomics pipeline in which clinical sequencing in a diagnostic laboratory is followed by the detailed reanalysis of unsolved cases in a research environment, supplemented with WES data from additional family members, and subject to adjuvant bioinformatics analyses including relaxed variant filtering parameters in informatics pipelines, can enhance the molecular diagnostic yield and provide mechanistic insights into Mendelian disorders. Implementing these approaches requires collaborative clinical molecular diagnostic and research efforts.
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Prognostic and health management of active assets in nuclear power plants
DOE Office of Scientific and Technical Information (OSTI.GOV)
Agarwal, Vivek; Lybeck, Nancy; Pham, Binh T.
This study presents the development of diagnostic and prognostic capabilities for active assets in nuclear power plants (NPPs). The research was performed under the Advanced Instrumentation, Information, and Control Technologies Pathway of the Light Water Reactor Sustainability Program. Idaho National Laboratory researched, developed, implemented, and demonstrated diagnostic and prognostic models for generator step-up transformers (GSUs). The Fleet-Wide Prognostic and Health Management (FW-PHM) Suite software developed by the Electric Power Research Institute was used to perform diagnosis and prognosis. As part of the research activity, Idaho National Laboratory implemented 22 GSU diagnostic models in the Asset Fault Signature Database and twomore » wellestablished GSU prognostic models for the paper winding insulation in the Remaining Useful Life Database of the FW-PHM Suite. The implemented models along with a simulated fault data stream were used to evaluate the diagnostic and prognostic capabilities of the FW-PHM Suite. Knowledge of the operating condition of plant asset gained from diagnosis and prognosis is critical for the safe, productive, and economical long-term operation of the current fleet of NPPs. This research addresses some of the gaps in the current state of technology development and enables effective application of diagnostics and prognostics to nuclear plant assets.« less
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An update on the use of cerebrospinal fluid analysis as a diagnostic tool in multiple sclerosis.
Gastaldi, Matteo; Zardini, Elisabetta; Franciotta, Diego
2017-01-01
Intrathecal B-lymphocyte activation is a hallmark of multiple sclerosis (MS), a multi-factorial inflammatory-demyelinating disease of the central nervous system. Such activation has a counterpart in the cerebrospinal fluid (CSF) oligoclonal IgG bands (OCB), whose diagnostic role in MS has been downgraded within the current McDonald's criteria. With a theoretico-practical approach, the authors review the physiopathological basis of the CSF dynamics, and the state-of-the-art of routine CSF analysis and CSF biomarkers in MS. Areas covered: The authors discuss pros and cons of CSF analysis, including critical evaluations of both well-established, and promising diagnostic and prognostic laboratory tools. New acquisitions on the CSF and cerebral interstitial fluid dynamics are also presented. The authors searched the PubMed database for English-language articles reported between January 2010 and June 2016, using the key words 'multiple sclerosis', 'cerebrospinal fluid', 'oligoclonal bands'. Reference lists of relevant articles were scanned for additional studies. Expert commentary: The availability of performing high-quality, routine CSF tests in specialized laboratories, the emerging potential of novel CSF biomarkers, and the trend for early treatments should induce a reappraisal of CSF analysis for diagnostic and prognostic purposes in MS. Further procedural and methodological improvements seem to be necessary in both research and translational diagnostic CSF settings.
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Prognostic and health management of active assets in nuclear power plants
Agarwal, Vivek; Lybeck, Nancy; Pham, Binh T.; ...
2015-06-04
This study presents the development of diagnostic and prognostic capabilities for active assets in nuclear power plants (NPPs). The research was performed under the Advanced Instrumentation, Information, and Control Technologies Pathway of the Light Water Reactor Sustainability Program. Idaho National Laboratory researched, developed, implemented, and demonstrated diagnostic and prognostic models for generator step-up transformers (GSUs). The Fleet-Wide Prognostic and Health Management (FW-PHM) Suite software developed by the Electric Power Research Institute was used to perform diagnosis and prognosis. As part of the research activity, Idaho National Laboratory implemented 22 GSU diagnostic models in the Asset Fault Signature Database and twomore » wellestablished GSU prognostic models for the paper winding insulation in the Remaining Useful Life Database of the FW-PHM Suite. The implemented models along with a simulated fault data stream were used to evaluate the diagnostic and prognostic capabilities of the FW-PHM Suite. Knowledge of the operating condition of plant asset gained from diagnosis and prognosis is critical for the safe, productive, and economical long-term operation of the current fleet of NPPs. This research addresses some of the gaps in the current state of technology development and enables effective application of diagnostics and prognostics to nuclear plant assets.« less
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van Deursen, F J; Hino, K; Wyatt, D; Molyneaux, P; Yates, P; Wallace, L A; Dow, B C; Carman, W F
1998-01-01
AIMS: To assess the relevance of genetic variants of hepatitis B virus (HBV) and to demonstrate the usefulness of the polymerase chain reaction (PCR) in cases of HBV diagnostic difficulty. METHODS: Five serum samples from patients that presented diagnostic difficulty in routine laboratories were sent to a research laboratory for PCR, and if appropriate, S gene sequencing, in vitro expression, and antigenic analysis. RESULTS: The demonstration of HBV in serum by PCR allowed a definitive diagnosis of current infection. One serum sample with poor reactivity in a diagnostic assay had a minor hepatitis B surface antigen (HBsAg) variant and another with very poor reactivity had multiple variants of HBsAg. Transient HBsAg reactivity was observed in a recently vaccinated patient. A hepatitis Be antigen (HBeAg) false positive reaction was noted in a patient from a well defined risk group for HBV. One patient who was strongly HBsAg/HBeAg positive, but anti-hepatitis B core antibody negative, was viraemic. CONCLUSIONS: PCR may become the gold standard for the diagnosis of current HBV infection. HBV variants are responsible for a proportion of diagnostically difficult cases. Modification of commercial assays is necessary to increase the sensitivity of detection of such variants. PMID:9602690
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Adoption of lean principles in a high-volume molecular diagnostic microbiology laboratory.
Mitchell, P Shawn; Mandrekar, Jayawant N; Yao, Joseph D C
2014-07-01
Clinical laboratories are constantly facing challenges to do more with less, enhance quality, improve test turnaround time, and reduce operational expenses. Experience with adopting and applying lean concepts and tools used extensively in the manufacturing industry is described for a high-volume clinical molecular microbiology laboratory, illustrating how operational success and benefits can be achieved. Copyright © 2014, American Society for Microbiology. All Rights Reserved.
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Ebola Laboratory Response at the Eternal Love Winning Africa Campus, Monrovia, Liberia, 2014-2015.
de Wit, Emmie; Rosenke, Kyle; Fischer, Robert J; Marzi, Andrea; Prescott, Joseph; Bushmaker, Trenton; van Doremalen, Neeltje; Emery, Shannon L; Falzarano, Darryl; Feldmann, Friederike; Groseth, Allison; Hoenen, Thomas; Juma, Bonventure; McNally, Kristin L; Ochieng, Melvin; Omballa, Victor; Onyango, Clayton O; Owuor, Collins; Rowe, Thomas; Safronetz, David; Self, Joshua; Williamson, Brandi N; Zemtsova, Galina; Grolla, Allen; Kobinger, Gary; Rayfield, Mark; Ströher, Ute; Strong, James E; Best, Sonja M; Ebihara, Hideki; Zoon, Kathryn C; Nichol, Stuart T; Nyenswah, Tolbert G; Bolay, Fatorma K; Massaquoi, Moses; Feldmann, Heinz; Fields, Barry
2016-10-15
West Africa experienced the first epidemic of Ebola virus infection, with by far the greatest number of cases in Guinea, Sierra Leone, and Liberia. The unprecedented epidemic triggered an unparalleled response, including the deployment of multiple Ebola treatment units and mobile/field diagnostic laboratories. The National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention deployed a joint laboratory to Monrovia, Liberia, in August 2014 to support the newly founded Ebola treatment unit at the Eternal Love Winning Africa (ELWA) campus. The laboratory operated initially out of a tent structure but quickly moved into a fixed-wall building owing to severe weather conditions, the need for increased security, and the high sample volume. Until May 2015, when the laboratory closed, the site handled close to 6000 clinical specimens for Ebola virus diagnosis and supported the medical staff in case patient management. Laboratory operation and safety, as well as Ebola virus diagnostic assays, are described and discussed; in addition, lessons learned for future deployments are reviewed. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.
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2017-07-07
RESEARCH ARTICLE Self-reported HIV-positive status but subsequent HIV-negative test result using rapid diagnostic testing algorithms among seven sub...America * judith.harbertson.ctr@mail.mil Abstract HIV rapid diagnostic tests (RDTs) combined in an algorithm are the current standard for HIV diagnosis...in many sub-Saharan African countries, and extensive laboratory testing has con- firmed HIV RDTs have excellent sensitivity and specificity. However
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Filter membrane-based automated therapeutic plasma exchange: a report of two cases from Nigeria.
Arogundade, Fatiu A; Sanusi, Abubakr A; Akinbodewa, Akinwunmi A; Hassan, Muzamil O; Omotosho, Bolanle O; Balogun, Rasheed A; Akinsola, Adewale
2013-02-01
These case reports demonstrated the diagnostic dilemma encountered in patients with systemic lupus erythematosus and thrombotic thrombocytopenic purpura particularly in settings with limited diagnostic facilities and laboratory support. The similarities in the diagnostic criteria for both conditions make clear distinction as well as management decisions difficult. We present the difficulties encountered with both the diagnosis and the management of these two patients that were managed in our facility. Copyright © 2013 Wiley Periodicals, Inc.
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Plenoptic Imaging for Three-Dimensional Particle Field Diagnostics.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Guildenbecher, Daniel Robert; Hall, Elise Munz
2017-06-01
Plenoptic imaging is a promising emerging technology for single-camera, 3D diagnostics of particle fields. In this work, recent developments towards quantitative measurements of particle size, positions, and velocities are discussed. First, the technique is proven viable with measurements of the particle field generated by the impact of a water drop on a thin film of water. Next, well cont rolled experiments are used to verify diagnostic uncertainty. Finally, an example is presented of 3D plenoptic imaging of a laboratory scale, explosively generated fragment field.
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Advances in in vitro diagnostics in allergy, asthma, and immunology in 2012.
Renz, Harald
2013-12-01
Laboratory tests play an increasing role in risk assessment, diagnostics, and disease monitoring. Great advances have been achieved lately, particularly in the field of clinical immunology and allergy. These include neonatal screening of immunodeficiencies and asthma biomarkers and investigation into the role of recombinant allergens in in vitro testing. The latter area has implications for the diagnostics of food allergy, pollen-induced allergies, asthma, and insect allergies. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
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Critical components required to improve deployable laboratory biological hazards identification
NASA Astrophysics Data System (ADS)
Niemeyer, Debra M.
2004-08-01
An ever-expanding global military mission necessitates quick and accurate identification of biological hazards, whether naturally occurring or man-made. Coupled with an ever-present threat of biological attack, an expanded U.S. presence in worn-torn locations like Southwest Asia presents unique public health challenges. We must heed modern day "lessons learned" from Operation Desert Shield and the Soviet Afghanistan Campaign and guard against rapid incapacitation of troop strength from endemic disease and biological attack. To minimize readiness impacts, field hygiene is enforced, and research on better medical countermeasures such as antibiotics and vaccines continues. However, there are no preventions or remedies for all military-relevant infectious diseases or biological agents. A deployable, streamlined, self-contained diagnostic and public health surveillance laboratory capability with a reach-back communication is critical to meeting global readiness challenges. Current deployable laboratory packages comprise primarily diagnostic or environmental sample testing capabilities. Discussion will focus on critical components needed to improve existing laboratory assets, and to facilitate deployment of small, specialized packages far forward. The ideal laboratory model described will become an essential tool for the Combatant or Incident Commander to maintain force projection in the expeditionary environment.
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Implementation science: the laboratory as a command centre.
Boeras, Debrah I; Nkengasong, John N; Peeling, Rosanna W
2017-03-01
Recent advances in point-of-care technologies to ensure universal access to affordable quality-assured diagnostics have the potential to transform patient management, surveillance programmes, and control of infectious diseases. Decentralization of testing can put tremendous stresses on fragile health systems if the laboratory is not involved in the planning, introduction, and scale-up strategies. The impact of investments in novel technologies can only be realized if these tests are evaluated, adopted, and scaled up within the healthcare system with appropriate planning and understanding of the local contexts in which these technologies will be used. In this digital age, the laboratory needs to take on the role of the Command Centre for technology introduction and implementation. Implementation science is needed to understand the political, cultural, economic, and behavioural context for technology introduction. The new paradigm should include: building a comprehensive system of laboratories and point-of-care testing sites to provide quality-assured diagnostic services with good laboratory-clinic interface to build trust in test results and linkage to care; building and coordinating a comprehensive national surveillance and communication system for disease control and global health emergencies; conducting research to monitor the impact of new tools and interventions on improving patient care.
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Willingness to pay for diagnostic technologies: a review of the contingent valuation literature.
Lin, Pei-Jung; Cangelosi, Michael J; Lee, David W; Neumann, Peter J
2013-01-01
To understand how people value information from diagnostic technologies, we reviewed and analyzed published willingness-to-pay (WTP) studies on the topic. We searched PubMed for English-language articles related to WTP for diagnostic laboratory tests published from 1985 through 2011. We characterized methodological differences across studies, examined individual- and technology-level factors associated with WTP, and summarized median WTP values across different diagnostic tests. We identified 66 relevant WTP studies. Half focused on oncology, while others analyzed infectious diseases (n = 11, 16.1%) and obstetric or gynecological conditions (n = 8, 11.7%), among others. Most laboratory tests included in studies were biological samples/genetic testing (n = 44, 61.1%) or imaging tests (n = 23, 31.9%). Approximately one third of the analyses (n = 20, 30.3%) used discrete-choice questions to elicit WTP values. Higher income, education, disease severity, perceived disease risk, family history, and more accurate tests were in general associated with higher WTP values for diagnostic information. Of the 44 studies with median WTP values available, most reported a median WTP value below $100. The median WTP value for colon or colorectal cancer screening ranged from below $100 to over $1000. The contingent valuation literature in diagnostics has grown rapidly, and suggests that many respondents place considerable value on diagnostic information. There exists, however, great variation in studies with respect to the type of technologies and diseases assessed, respondent characteristics, and study methodology. The perceived value of diagnostic technologies is also influenced by the study design and elicitation methods. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
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Development of a miRNA-based diagnostic assay for pancreatic ductal adenocarcinoma.
Szafranska-Schwarzbach, Anna E; Adai, Alex T; Lee, Linda S; Conwell, Darwin L; Andruss, Bernard F
2011-04-01
Diagnosis of pancreatic cancer remains a clinical challenge. Both chronic pancreatitis and pancreatic cancer may present with similar symptoms and similar imaging features, often leading to incorrect interpretation. Thus, the use of an objective molecular test that can discriminate between chronic pancreatitis and pancreatic cancer will be a valuable asset in obtaining a definitive diagnosis of pancreatic cancer. Following Clinical Laboratory Improvement Amendments and College of American Pathologists guidelines, Asuragen Clinical Services Laboratory has developed and validated a laboratory-developed test, miRInform(®) Pancreas, to aid in the identification of pancreatic ductal adenocarcinoma. This molecular diagnostic tool uses reverse-transcription quantitative PCR to measure the expression difference between two miRNAs, miR-196a and miR-217, in fixed tissue specimens. This article describes the test validation process as well as determination of performance parameters of miRInform Pancreas.
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Diagnosis of Dengue Infection Using Conventional and Biosensor Based Techniques
Parkash, Om; Hanim Shueb, Rafidah
2015-01-01
Dengue is an arthropod-borne viral disease caused by four antigenically different serotypes of dengue virus. This disease is considered as a major public health concern around the world. Currently, there is no licensed vaccine or antiviral drug available for the prevention and treatment of dengue disease. Moreover, clinical features of dengue are indistinguishable from other infectious diseases such as malaria, chikungunya, rickettsia and leptospira. Therefore, prompt and accurate laboratory diagnostic test is urgently required for disease confirmation and patient triage. The traditional diagnostic techniques for the dengue virus are viral detection in cell culture, serological testing, and RNA amplification using reverse transcriptase PCR. This paper discusses the conventional laboratory methods used for the diagnosis of dengue during the acute and convalescent phase and highlights the advantages and limitations of these routine laboratory tests. Subsequently, the biosensor based assays developed using various transducers for the detection of dengue are also reviewed. PMID:26492265
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Practical diagnostic testing for human immunodeficiency virus.
Jackson, J B; Balfour, H H
1988-01-01
Since the discovery of human immunodeficiency virus (HIV) as the causative agent of acquired immunodeficiency syndrome in 1983, there has been a proliferation of diagnostic tests. These assays can be used to detect the presence of HIV antibody, HIV antigen, HIV ribonucleic and deoxyribonucleic acids, and HIV reverse transcriptase. Enzyme-linked immunosorbent assays, Western blot, radioimmunoprecipitation assays, indirect immunofluorescence assays, reverse transcriptase assays, and several molecular hybridization techniques are currently available. Enzyme-linked immunosorbent, Western blot, and indirect immunofluorescence assays for HIV antibody are very sensitive, specific, and adaptable to most laboratories. An enzyme-linked immunosorbent assay for HIV antigen is also readily adaptable to most laboratories and will be commercially available soon. While the other assays are more tedious, they are valuable confirmatory tests and are suitable for reference laboratories. The biohazards of performing HIV testing can be minimized with proper biosafety measures. Images PMID:3060241
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Systematic Assessment of the Hemolysis Index: Pros and Cons.
Lippi, Giuseppe
2015-01-01
Preanalytical quality is as important as the analytical and postanalytical quality in laboratory diagnostics. After decades of visual inspection to establish whether or not a diagnostic sample may be suitable for testing, automated assessment of hemolysis index (HI) has now become available in a large number of laboratory analyzers. Although most national and international guidelines support systematic assessment of sample quality via HI, there is widespread perception that this indication has not been thoughtfully acknowledged. Potential explanations include concern of increased specimen rejection rate, poor harmonization of analytical techniques, lack of standardized units of measure, differences in instrument-specific cutoff, negative impact on throughput, organization and laboratory economics, and lack of a reliable quality control system. Many of these concerns have been addressed. Evidence now supports automated HI in improving quality and patient safety. These will be discussed. © 2015 Elsevier Inc. All rights reserved.
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Hogue, R; Graves, M; Moler, S; Janda, J M
2007-06-01
Over the past several decades, the appearance of pink-pigmented bacteria in clinical specimens has gone from being a microbiologic curiosity in the clinical laboratory to the recognition of these aerobic microorganisms as etiologic agents of human disease, most notably bloodstream infections. Advances in the fields of molecular taxonomy and phylogenetics indicate that at least four distinct genera and eight different species are associated with clinical infections in susceptible patient populations. However, these bacteria are slow growing and present multiple diagnostic challenges to the microbiology laboratory including culture, isolation, and identification to species rank. This article provides a current review of these unusual non-fermentative chromogenic bacteria including their disease spectrum, taxonomy, and laboratory identification. The review also highlights the pitfalls or shortcomings we currently have in our knowledge of these microbes and their disease-producing capabilities.
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A Regional Atmospheric Continuous CO2 Network In The Rocky Mountains (Rocky RACCOON)
NASA Astrophysics Data System (ADS)
Stephens, B.; de Wekker, S.; Watt, A.; Schimel, D.
2005-12-01
We have established a continuous CO2 observing network in the Rocky Mountains, building on technological and modeling advances made during the Carbon in the Mountains Experiment (CME), to improve our understanding of regional carbon fluxes and to fill key gaps in the North American Carbon Program (NACP). We will present a description of the Rocky RACCOON network and early results from the first three sites. There are strong scientific and societal motivations for determining CO2 exchanges on regional scales. NACP aims to address these concerns through a dramatic expansion in observations and modeling capabilities over North America. Mountain forests in particular represent a significant potential net CO2 sink in the U.S. and are highly sensitive to land-use practices and climate change. However, plans for new continuous CO2 observing sites have omitted the mountain west. This resulted from expensive instrumentation in the face of limited resources, and a perception that current atmospheric transport models are not sophisticated enough to interpret CO2 measurements made in complex terrain. Through our efforts in CME, we have a new autonomous, inexpensive, and robust CO2 analysis system and are developing mountain CO2 modeling tools that will help us to overcome these obstacles. Preliminary observational and modeling results give us confidence that continuous CO2 observations from mountain top observatories will provide useful constraints on regional carbon cycling and will be valuable in the continental inverse modeling efforts planned for NACP. We began at three Colorado sites in August 2005 and hope to add three to six sites in other western states in subsequent years, utilizing existing observatories to the maximum extent possible. The first three sites are at Niwot Ridge, allowing us to have an ongoing intercomparison with flask measurements made by NOAA CMDL; at Storm Peak Laboratory near Steamboat Springs, allowing us to investigate comparisons between these two relatively nearby sites; and at Fraser Experimental Forest, allowing us to investigate nocturnal respiration rates across a large intermountain valley. Our data are available to the public on the internet in near real time to support quality control, local science, and larger scale synthesis efforts.
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The SIV plasma viral load assay performed by the Quantitative Molecular Diagnostics Core (QMDC) utilizes reagents specifically designed to detect and accurately quantify the full range of SIV/SHIV viral variants and clones in common usage in the rese
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Kalinga, Akili K; Mwanziva, Charles; Chiduo, Sarah; Mswanya, Christopher; Ishengoma, Deus I; Francis, Filbert; Temu, Lucky; Mahikwano, Lucas; Mgata, Saidi; Amoo, George; Anova, Lalaine; Wurrapa, Eyako; Zwingerman, Nora; Ferro, Santiago; Bhat, Geeta; Fine, Ian; Vesely, Brian; Waters, Norman; Kreishman-Deitrick, Mara; Hickman, Mark; Paris, Robert; Kamau, Edwin; Ohrt, Colin; Kavishe, Reginald A
2018-05-29
Although microscopy is a standard diagnostic tool for malaria and the gold standard, it is infrequently used because of unavailability of laboratory facilities and the absence of skilled readers in poor resource settings. Malaria rapid diagnostic tests (RDT) are currently used instead of or as an adjunct to microscopy. However, at very low parasitaemia (usually < 100 asexual parasites/µl), the test line on malaria rapid diagnostic tests can be faint and consequently hard to visualize and this may potentially affect the interpretation of the test results. Fio Corporation (Canada), developed an automated RDT reader named Deki Reader™ for automatic analysis and interpretation of rapid diagnostic tests. This study aimed to compare visual assessment and automated Deki Reader evaluations to interpret malaria rapid diagnostic tests against microscopy. Unlike in the previous studies where expert laboratory technicians interpreted the test results visually and operated the device, in this study low cadre health care workers who have not attended any formal professional training in laboratory sciences were employed. Finger prick blood from 1293 outpatients with fever was tested for malaria using RDT and Giemsa-stained microscopy for thick and thin blood smears. Blood samples for RDTs were processed according to manufacturers' instructions automated in the Deki Reader. Results of malaria diagnoses were compared between visual and the automated devise reading of RDT and microscopy. The sensitivity of malaria rapid diagnostic test results interpreted by the Deki Reader was 94.1% and that of visual interpretation was 93.9%. The specificity of malaria rapid diagnostic test results was 71.8% and that of human interpretation was 72.0%. The positive predictive value of malaria RDT results by the Deki Reader and visual interpretation was 75.8 and 75.4%, respectively, while the negative predictive values were 92.8 and 92.4%, respectively. The accuracy of RDT as interpreted by DR and visually was 82.6 and 82.1%, respectively. There was no significant difference in performance of RDTs interpreted by either automated DR or visually by unskilled health workers. However, despite the similarities in performance parameters, the device has proven useful because it provides stepwise guidance on processing RDT, data transfer and reporting.
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Ozkan, Ozhan; Yildiz, Murat; Arslan, Evren; Yildiz, Sedat; Bilgin, Suleyman; Akkus, Selami; Koyuncuoglu, Hasan R; Koklukaya, Etem
2016-03-01
Fibromyalgia syndrome (FMS), usually observed commonly in females over age 30, is a rheumatic disease accompanied by extensive chronic pain. In the diagnosis of the disease non-objective psychological tests and physiological tests and laboratory test results are evaluated and clinical experiences stand out. However, these tests are insufficient in differentiating FMS with similar diseases that demonstrate symptoms of extensive pain. Thus, objective tests that would help the diagnosis are needed. This study analyzes the effect of sympathetic skin response (SSR) parameters on the auxiliary tests used in FMS diagnosis, the laboratory tests and physiological tests. The study was conducted in Suleyman Demirel University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic in Turkey with 60 patients diagnosed with FMS for the first time and a control group of 30 healthy individuals. In the study all participants underwent laboratory tests (blood tests), certain physiological tests (pulsation, skin temperature, respiration) and SSR measurements. The test data and SSR parameters obtained were classified using artificial neural network (ANN). Finally, in the ANN framework, where only laboratory and physiological test results were used as input, a simulation result of 96.51 % was obtained, which demonstrated diagnostic accuracy. This data, with the addition of SSR parameter values obtained increased to 97.67 %. This result including SSR parameters - meaning a higher diagnostic accuracy - demonstrated that SSR could be a new auxillary diagnostic method that could be used in the diagnosis of FMS.
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Zhang, Yi; Gong, Yan; Wang, Chengyu; Liu, Wensen; Wang, Zhongyi; Xia, Zhiping; Bu, Zhaoyang; Lu, Huijun; Sun, Yang; Zhang, Xiaoguang; Cao, Yuxi; Yang, Fan; Su, Haoxiang; Hu, Yi; Deng, Yongqiang; Zhou, Bo; Zhao, Zongzheng; Fu, Yingying; Kargbo, David; Dafae, Foday; Kargbo, Brima; Kanu, Alex; Qian, Jun; Guo, Zhendong
2017-01-01
Background Ebola virus emerged in West Africa in December 2013. The high population mobility and poor public health infrastructure in this region led to the development of the largest Ebola virus disease (EVD) outbreak to date. Methodology/Principal findings On September 26, 2014, China dispatched a Mobile Biosafety Level-3 Laboratory (MBSL-3 Lab) and a well-trained diagnostic team to Sierra Leone to assist in EVD diagnosis using quantitative real-time PCR, which allowed the diagnosis of suspected EVD cases in less than 4 hours from the time of sample receiving. This laboratory was composed of three container vehicles equipped with advanced ventilation system, communication system, electricity and gas supply system. We strictly applied multiple safety precautions to reduce exposure risks. Personnel, materials, water and air flow management were the key elements of the biosafety measures in the MBSL-3 Lab. Air samples were regularly collected from the MBSL-3 Lab, but no evidence of Ebola virus infectious aerosols was detected. Potentially contaminated objects were also tested by collecting swabs. On one occasion, a pipette tested positive for EVD. A total of 1,635 suspected EVD cases (824 positive [50.4%]) were tested from September 28 to November 11, 2014, and no member of the diagnostic team was infected with Ebola virus or other pathogens, including Lassa fever. The specimens tested included blood (69.2%) and oral swabs (30.8%) with positivity rates of 54.2% and 41.9%, respectively. The China mobile laboratory was thus instrumental in the EVD outbreak response by providing timely and reliable diagnostics. Conclusions/Significance The MBSL-3 Lab significantly contributed to establishing a suitable laboratory response capacity during the emergence of EVD in Sierra Leone. PMID:28505171
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Zhang, Yi; Gong, Yan; Wang, Chengyu; Liu, Wensen; Wang, Zhongyi; Xia, Zhiping; Bu, Zhaoyang; Lu, Huijun; Sun, Yang; Zhang, Xiaoguang; Cao, Yuxi; Yang, Fan; Su, Haoxiang; Hu, Yi; Deng, Yongqiang; Zhou, Bo; Zhao, Zongzheng; Fu, Yingying; Kargbo, David; Dafae, Foday; Kargbo, Brima; Kanu, Alex; Liu, Linna; Qian, Jun; Guo, Zhendong
2017-05-01
Ebola virus emerged in West Africa in December 2013. The high population mobility and poor public health infrastructure in this region led to the development of the largest Ebola virus disease (EVD) outbreak to date. On September 26, 2014, China dispatched a Mobile Biosafety Level-3 Laboratory (MBSL-3 Lab) and a well-trained diagnostic team to Sierra Leone to assist in EVD diagnosis using quantitative real-time PCR, which allowed the diagnosis of suspected EVD cases in less than 4 hours from the time of sample receiving. This laboratory was composed of three container vehicles equipped with advanced ventilation system, communication system, electricity and gas supply system. We strictly applied multiple safety precautions to reduce exposure risks. Personnel, materials, water and air flow management were the key elements of the biosafety measures in the MBSL-3 Lab. Air samples were regularly collected from the MBSL-3 Lab, but no evidence of Ebola virus infectious aerosols was detected. Potentially contaminated objects were also tested by collecting swabs. On one occasion, a pipette tested positive for EVD. A total of 1,635 suspected EVD cases (824 positive [50.4%]) were tested from September 28 to November 11, 2014, and no member of the diagnostic team was infected with Ebola virus or other pathogens, including Lassa fever. The specimens tested included blood (69.2%) and oral swabs (30.8%) with positivity rates of 54.2% and 41.9%, respectively. The China mobile laboratory was thus instrumental in the EVD outbreak response by providing timely and reliable diagnostics. The MBSL-3 Lab significantly contributed to establishing a suitable laboratory response capacity during the emergence of EVD in Sierra Leone.
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Service Quality and Patient Satisfaction: An Exploratory Study of Pathology Laboratories in Jaipur.
Agarwal, Anuradha; Singh, Maithili R P
2016-01-01
One of the most important parts of healthcare system is diagnostics. Nowadays, Indians have become more aware of their health, due to improved and better availability of health related information, increase in medical tourism, and expanding health insurance. The demand for better diagnostic facilities have increased with the increase in lifestyle related diseases, excesses use of chemicals in agriculture practices and change in food habits. It is expected that the Indian diagnostic market will grow from USD $5 billion in the year 2012 to USD $32 billion by the year 2020 with 20% CAGR (India Brand Equity Foundation 2015 ). Today patients have easy access of information regarding the health services and they have become more concerned about it as they look forward to receiving the maximum value for their money. To win the confidence of the patients and to maintain that trust, it is required to deliver the right services to the right person at the right time. The purpose of this study was to develop a scale to measure the service quality at pathology laboratory. A thorough review of literature revealed that there are studies related to healthcare service quality but there is no such established scale to measure service quality of pathology laboratory. Thus, the authors strived to develop a reliable and valid instrument to measure the patients' perception toward pathology laboratory service quality. For this exploratory study was conducted on the sample of 80 patients of the laboratories in Jaipur city. The reliability and factor structures were tested to purify the scale. The findings revealed 13 items, comprising of three dimensions of service quality: responsiveness, tangibility, and reliability.
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Pérez, Teresa; Makrestsov, Nikita; Garatt, John; Torlakovic, Emina; Gilks, C Blake; Mallett, Susan
The Canadian Immunohistochemistry Quality Control program monitors clinical laboratory performance for estrogen receptor and progesterone receptor tests used in breast cancer treatment management in Canada. Current methods assess sensitivity and specificity at each time point, compared with a reference standard. We investigate alternative performance analysis methods to enhance the quality assessment. We used 3 methods of analysis: meta-analysis of sensitivity and specificity of each laboratory across all time points; sensitivity and specificity at each time point for each laboratory; and fitting models for repeated measurements to examine differences between laboratories adjusted by test and time point. Results show 88 laboratories participated in quality control at up to 13 time points using typically 37 to 54 histology samples. In meta-analysis across all time points no laboratories have sensitivity or specificity below 80%. Current methods, presenting sensitivity and specificity separately for each run, result in wide 95% confidence intervals, typically spanning 15% to 30%. Models of a single diagnostic outcome demonstrated that 82% to 100% of laboratories had no difference to reference standard for estrogen receptor and 75% to 100% for progesterone receptor, with the exception of 1 progesterone receptor run. Laboratories with significant differences to reference standard identified with Generalized Estimating Equation modeling also have reduced performance by meta-analysis across all time points. The Canadian Immunohistochemistry Quality Control program has a good design, and with this modeling approach has sufficient precision to measure performance at each time point and allow laboratories with a significantly lower performance to be targeted for advice.
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Tribble, David R.; Baqar, Shahida; Pang, Lorrin W.; Mason, Carl; Houng, Huo-Shu H.; Pitarangsi, Chittima; Lebron, Carlos; Armstrong, Adam; Sethabutr, Orntipa; Sanders, John W.
2008-01-01
High rates of Campylobacter fluoroquinolone resistance highlight the need to evaluate diagnostic strategies that can be used to assist with clinical management. Diagnostic tests were evaluated with U.S. soldiers presenting with acute diarrhea during deployment in Thailand. The results of bedside and field laboratory diagnostic tests were compared to stool microbiology findings for 182 enrolled patients. Campylobacter jejuni was isolated from 62% of the cases. Clinical and laboratory findings at the time of presentation were evaluated to determine their impact on the posttest probability, defined as the likelihood of a diagnosis of Campylobacter infection. Clinical findings, the results of tests for inflammation (stool occult blood testing [Hemoccult], fecal leukocytes, fecal lactoferrin, plasma C-reactive protein), and the numbers of Campylobacter-specific antibody-secreting cells in peripheral blood failed to increase the posttest probability above 90% in this setting of Campylobacter hyperendemicity when these findings were present. Positive results by a Campylobacter-specific commercial enzyme immunoassay (EIA) and, less so, a research PCR were strong positive predictors. The negative predictive value for ruling out Campylobacter infection, defined as a posttest probability of less than 10%, was similarly observed with these Campylobacter-specific stool-based tests as well the fecal leukocyte test. Compared to the other tests evaluated, the Campylobacter EIA is a sensitive and specific rapid diagnostic test that may assist with diagnostic evaluation, with consideration of the epidemiological setting, logistics, and cost. PMID:18234869
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Wogu, M N; Nduka, F O
2018-01-01
The World Health Organization's policy on laboratory test of all suspected malaria cases before treatment has not yielded significant effects in several rural areas of Sub-Saharan Africa due to inadequate diagnostic infrastructure, leading to high morbidity and mortality rates. A cross-sectional randomized study was conducted to evaluate the validity of clinical malaria diagnosis through comparison with microscopy and rapid diagnostic test kits (RDTs) using 1000 consenting outpatients of a tertiary hospital in Nigeria. Physicians conducted clinical diagnosis, and blood samples were collected through venous procedure and analyzed for malaria parasites using Giemsa microscopy and RDT kits. Microscopy was considered the diagnostic "gold standard" and all data obtained were statistically analyzed using Chi-square test with a P value <0.05 considered significant. Malaria prevalence values of 20.1%, 43.1%, and 29.7% were obtained for clinical diagnosis, microscopy, and RDTs, respectively ( P < 0.05). Values of 47.2%, 95.9%, and 77.8% were obtained for sensitivity, specificity, and diagnostic accuracy, respectively, in clinical diagnosis, while RDTs had sensitivity, specificity, and diagnostic accuracy values of 73.7%, 97.3%, and 88.3%, respectively, when compared to microscopy ( P < 0.05). Clinical diagnosed malaria cases should be confirmed with a parasite-based laboratory diagnosis and more qualitative research is needed to explore why clinicians still use clinical diagnosis despite reported cases of its ineffectiveness.
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Talundzic, Eldin; Maganga, Mussa; Masanja, Irene M; Peterson, David S; Udhayakumar, Venkatachalam; Lucchi, Naomi W
2014-01-27
Accurate diagnosis of malaria infections remains challenging, especially in the identification of submicroscopic infections. New molecular diagnostic tools that are inexpensive, sensitive enough to detect low-level infections and suitable in laboratory settings of resource-limited countries are required for malaria control and elimination programmes. Here the diagnostic potential of a recently developed photo-induced electron transfer fluorogenic primer (PET) real-time polymerase chain reaction (PCR) called PET-PCR was investigated. This study aimed to (i) evaluate the use of this assay as a method for the detection of both Plasmodium falciparum and other Plasmodium species infections in a developing country's diagnostic laboratory; and, (ii) determine the assay's sensitivity and specificity compared to a nested 18S rRNA PCR. Samples used in this study were obtained from a previous study conducted in the region of Iringa, Tanzania. A total of 303 samples from eight health facilities in Tanzania were utilized for this evaluation. All samples were screened using the multiplex PET-PCR assay designed to detect Plasmodium genus and P. falciparum initially in laboratory in Tanzania and then repeated at a reference laboratory at the CDC in the USA. Microscopy data was available for all the 303 samples. A subset of the samples were tested in a blinded fashion to find the sensitivity and specificity of the PET-PCR compared to the nested 18S rRNA PCR. Compared to microscopy, the PET-PCR assay was 59% more sensitive in detecting P. falciparum infections. The observed sensitivity and specificity were 100% (95% confidence interval (CI0.95) = 94-100%) and (CI0.95 = 96-100%), respectively, for the PET-PCR assay when compared to nested 18S rRNA PCR. When compared to 18S rRNA PCR, microscopy had a low sensitivity of 40% (CI0.95 = 23-61%) and specificity of 100% (CI0.95 = 96-100%). The PET-PCR results performed in the field laboratory in Tanzania were in 100% concordance with the results obtained at the reference laboratory in the USA. The PET-PCR is a new molecular diagnostic tool with similar performance characteristics as commonly used PCR methods that is less expensive, easy to use, and amiable to large scale-surveillance studies in developing country settings.
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Herpes Genitalis: Diagnosis, Treatment and Prevention
Sauerbrei, A.
2016-01-01
Herpes genitalis is caused by the herpes simplex virus type 1 or type 2 and can manifest as primary or recurrent infection. It is one of the most common sexually transmitted infections and due to associated physical and psychological morbidity it constitutes a considerable, often underestimated medical problem. In addition to providing the reader with basic knowledge of the pathogen and clinical presentation of herpes genitalis, this review article discusses important aspects of the laboratory diagnostics, antiviral therapy and prophylaxis. The article is aimed at all health-care workers managing patients with herpes genitalis and attempts to improve the often suboptimal counselling, targeted use of laboratory diagnostics, treatment and preventive measures provided to patients. PMID:28017972
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In recent years molecular indicators, diagnostic for exposure in aquatic systems, have been developed using teleostean models in laboratory and field settings. Our laboratory has previously shown that the gene for vitellogenin, a protein precursor of egg yolk in oviparous animals...
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Studies on the diagnosis and treatment of human filariasis in Rhodesia.
Goldsmid, J M; Rogers, S
1976-07-10
Experiences in Rhodesia with various recovery techniques available for the laboratory diagnosis of infections with Dipetalonema perstans and Wuchereria bancrofti are discussed. A diagnostic laboratory regimen for routine filarial investigations is suggested. Included are preliminary observations on the use of mebendazole (Vermox) for the treatment of D. perstans infections.
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NASA Astrophysics Data System (ADS)
Bravos, Angelo; Hill, Howard; Choca, James; Bresolin, Linda B.; Bresolin, Michael J.
1986-03-01
Computer technology is rapidly becoming an inseparable part of many health science specialties. Recently, a new area of computer technology, namely Artificial Intelligence, has been applied toward assisting the medical experts in their diagnostic and therapeutic decision making process. MOODIS is an experimental diagnostic expert system which assists Psychiatry specialists in diagnosing human Mood Disorders, better known as Affective Disorders. Its diagnostic methodology is patterned after MDX, a diagnostic expert system developed at LAIR (Laboratory for Artificial Intelligence Research) of Ohio State University. MOODIS is implemented in CSRL (Conceptual Structures Representation Language) also developed at LAIR. This paper describes MOODIS in terms of conceptualization and requirements, and discusses why the MDX approach and CSRL were chosen.
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Kubanov, Aleksey; Runina, Anastassia
2017-01-01
The recombinant protein technology considerably promoted the development of rapid and accurate treponema-specific laboratory diagnostics of syphilis infection. For the last ten years, the immunodominant recombinant inner membrane lipoproteins are proved to be sensitive and specific antigens for syphilis screening. However, the development of an enlarged T. pallidum antigen panel for diagnostics of early and late syphilis and differentiation of syphilis stages or cured syphilis remains as actual goal of multidisciplinary expertise. Current review revealed novel recombinant antigens: surface-exposed proteins, adhesins, and periplasmic and flagellar proteins, which are promising candidates for the improved syphilis serological diagnostics. The opportunities and limitations of diagnostic usage of these antigens are discussed and the criteria for selection of optimal antigens panel summarized. PMID:28523273
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Distribution and Availability of Essential Tuberculosis Diagnostic Items in Amhara Region, Ethiopia.
Sinishaw, Mulusew Alemneh; Gebregergs, Gebremedhin Berhe; Shiferaw, Melashu Balew
2015-01-01
Adequate supplies of tuberculosis laboratory reagents and consumables are necessary for tuberculosis diagnosis and monitoring of treatment response. This study assessed the distribution and stock levels of laboratory commodities used in tuberculosis control in health centers of Amhara region, Ethiopia. A cross-sectional study was conducted in 82 health centers, among 801, providing sputum microscopy services. Stock levels were calculated, and distribution of reagents and consumables assessed. Thirty three (40.2%) health centers were under stocked for at least one of the key items for tuberculosis diagnosis at the time of visit. Fifteen (18.3%) health centers had no stocks of at least one of the key items (methylene blue (11%), carbol fuchsin (11%), acid alcohol (8.5%) and sputum cups (3.7%)). Of the 82 health centers, 77 (93.9%) did not fulfill the criteria for effective distribution of tuberculosis laboratory reagents and consumables. There were many health centers that had no or only low stocks of key tuberculosis laboratory reagents and consumables as a result of ineffective distribution system. It is necessary to strengthen supply chain management to ensure uninterrupted TB diagnostic service.
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Distribution and Availability of Essential Tuberculosis Diagnostic Items in Amhara Region, Ethiopia
2015-01-01
Adequate supplies of tuberculosis laboratory reagents and consumables are necessary for tuberculosis diagnosis and monitoring of treatment response. This study assessed the distribution and stock levels of laboratory commodities used in tuberculosis control in health centers of Amhara region, Ethiopia. A cross-sectional study was conducted in 82 health centers, among 801, providing sputum microscopy services. Stock levels were calculated, and distribution of reagents and consumables assessed. Thirty three (40.2%) health centers were under stocked for at least one of the key items for tuberculosis diagnosis at the time of visit. Fifteen (18.3%) health centers had no stocks of at least one of the key items (methylene blue (11%), carbol fuchsin (11%), acid alcohol (8.5%) and sputum cups (3.7%)). Of the 82 health centers, 77 (93.9%) did not fulfill the criteria for effective distribution of tuberculosis laboratory reagents and consumables. There were many health centers that had no or only low stocks of key tuberculosis laboratory reagents and consumables as a result of ineffective distribution system. It is necessary to strengthen supply chain management to ensure uninterrupted TB diagnostic service. PMID:26641097
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An audit of the laboratory diagnosis of cryptosporidiosis in England and Wales.
Chalmers, Rachel M; Atchison, Christina; Barlow, Katrina; Young, Yvonne; Roche, Anita; Manuel, Rohini
2015-07-01
To assess the level of practice consistent with UK national standards for Cryptosporidium testing, an audit was performed of 156 publicly funded clinical microbiology laboratories in England and Wales between August 2013 and April 2014. Responses were received from 85 (54 %) laboratories. First line diagnostic methods used were mainly microscopy with modified Ziehl-Neelsen (mZN) or auramine phenol (AP) staining (68/85, 80 %), enzyme immunoassays (EIAs) (16/85, 19 %) or in-house PCR (1/85, 1 %). The use of EIAs was more widespread than reported previously. Various methods were used for confirmation of positive EIA reactions and laboratories frequently resorted to sending samples to the national reference laboratory for this purpose, indicating that guidance is required for performance monitoring and confirmation of positive reactions. Laboratory positivity rates were related to the diagnostic test used, with highest median rates reported by those using PCR, EIAs or AP microscopy, and the lowest by those using mZN microscopy. One-third of responding laboratories (28/85, 33 %) routinely tested all stools for Cryptosporidium. However, 16 (19 %) laboratories used stool consistency to decide whether to test for this parasite. Other selection criteria included patient age (n = 18; 21 % laboratories), history or clinical details (n = 40; 47 %), duration of hospitalization (n = 18; 21 %) or clinician requests (n = 25; 29 %). To encourage laboratories to test all stools submitted for the investigation of diarrhoeal illness for Cryptosporidium, revision of the guidance in the national standards is under way. This will enable improved assessment of the burden of illness and ability to monitor outbreaks, and measure changes in reported cases.
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Orvain, Corentin; Joly, Philippe; Pissard, Serge; Badiou, Stéphanie; Badens, Catherine; Bonello-Palot, Nathalie; Couque, Nathalie; Gulbis, Béatrice; Aguilar-Martinez, Patricia
2017-02-01
Congenital causes of erythrocytosis are now more easily identified due to the improvement of the molecular characterization of many of them. Among these causes, hemoglobins with high oxygen affinity take a large place. The aim of this work was to reevaluate the diagnostic approach of these disorders. To assess the current practices, we sent a questionnaire to the expert laboratories in the diagnosis of hemoglobinopathies in France and Belgium. In parallel, we gathered the methods used for the diagnosis of the hemoglobins with high oxygen affinity indexed in the international database HbVar. Even though they remain a rare cause of erythrocytosis (1 to 5 positive diagnosis every year in each of the questioned specialized laboratories), hemoglobins with high oxygen affinity are increasingly suspected by clinicians. Phenotypic assessment by laboratory techniques remains a main step in their diagnosis as it enables the finding of 93% of them in the questioned laboratories (28 of the 30 variants diagnosed during the last 5 years). Among the 96 hemoglobin variants with high oxygen affinity indexed in the international database, 87% could be diagnosed with phenotypic techniques. A direct measure of the p50 with the Hemox-Analyzer is included in the diagnostic approach of half of the laboratories only, because of the poor availability of this apparatus. Comparatively, the estimation of p50 by blood gas analyzers on venous blood is a much more convenient and attractive method but due to the lack of proof as to its effectiveness in the diagnosis of hemoglobins with high oxygen affinity, it requires further investigations. Beta- and alphaglobin genes analysis by molecular biology techniques is essential as it either allows a quick and definite identification of the variant or definitely excludes the diagnosis. It is thus systematically performed as a first or second step method, according to the laboratory practice.
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Enhancing case definitions for surveillance of human monkeypox in the Democratic Republic of Congo.
Osadebe, Lynda; Hughes, Christine M; Shongo Lushima, Robert; Kabamba, Joelle; Nguete, Beatrice; Malekani, Jean; Pukuta, Elisabeth; Karhemere, Stomy; Muyembe Tamfum, Jean-Jacques; Wemakoy Okitolonda, Emile; Reynolds, Mary G; McCollum, Andrea M
2017-09-01
Human monkeypox (MPX) occurs at appreciable rates in the Democratic Republic of Congo (DRC). Infection with varicella zoster virus (VZV) has a similar presentation to that of MPX, and in areas where MPX is endemic these two illnesses are commonly mistaken. This study evaluated the diagnostic utility of two surveillance case definitions for MPX and specific clinical characteristics associated with laboratory-confirmed MPX cases. Data from a cohort of suspect MPX cases (identified by surveillance over the course of a 42 month period during 2009-2014) from DRC were used; real-time PCR diagnostic test results were used to establish MPX and VZV diagnoses. A total of 333 laboratory-confirmed MPX cases, 383 laboratory-confirmed VZV cases, and 36 cases that were determined to not be either MPX or VZV were included in the analyses. Significant (p<0.05) differences between laboratory-confirmed MPX and VZV cases were noted for several signs/symptoms including key rash characteristics. Both surveillance case definitions had high sensitivity and low specificities for individuals that had suspected MPX virus infections. Using 12 signs/symptoms with high sensitivity and/or specificity values, a receiver operator characteristic analysis showed that models for MPX cases that had the presence of 'fever before rash' plus at least 7 or 8 of the 12 signs/symptoms demonstrated a more balanced performance between sensitivity and specificity. Laboratory-confirmed MPX and VZV cases presented with many of the same signs and symptoms, and the analysis here emphasized the utility of including 12 specific signs/symptoms when investigating MPX cases. In order to document and detect endemic human MPX cases, a surveillance case definition with more specificity is needed for accurate case detection. In the absence of a more specific case definition, continued emphasis on confirmatory laboratory-based diagnostics is warranted.
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Strategies in Ebola virus disease (EVD) diagnostics at the point of care
Coarsey, Chad T.; Esiobu, Nwadiuto; Narayanan, Ramswamy; Pavlovic, Mirjana; Shafiee, Hadi; Asghar, Waseem
2017-01-01
Ebola virus disease (EVD) is a devastating, highly infectious illness with a high mortality rate. The disease is endemic to regions of Central and West Africa, where there is limited laboratory infrastructure and trained staff. The recent 2014 West African EVD outbreak has been unprecedented in case numbers and fatalities, and has proven that such regional outbreaks can become a potential threat to global public health, as it became the source for the subsequent transmission events in Spain and the USA. The urgent need for rapid and affordable means of detecting Ebola is crucial to control the spread of EVD and prevent devastating fatalities. Current diagnostic techniques include molecular diagnostics and other serological and antigen detection assays; which can be time-consuming, laboratory-based, often require trained personnel and specialized equipment. In this review, we discuss the various Ebola detection techniques currently in use, and highlight the potential future directions pertinent to the development and adoption of novel point-of-care diagnostic tools. Finally, a case is made for the need to develop novel microfluidic technologies and versatile rapid detection platforms for early detection of EVD. PMID:28440096
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Modeling Complex Workflow in Molecular Diagnostics
Gomah, Mohamed E.; Turley, James P.; Lu, Huimin; Jones, Dan
2010-01-01
One of the hurdles to achieving personalized medicine has been implementing the laboratory processes for performing and reporting complex molecular tests. The rapidly changing test rosters and complex analysis platforms in molecular diagnostics have meant that many clinical laboratories still use labor-intensive manual processing and testing without the level of automation seen in high-volume chemistry and hematology testing. We provide here a discussion of design requirements and the results of implementation of a suite of lab management tools that incorporate the many elements required for use of molecular diagnostics in personalized medicine, particularly in cancer. These applications provide the functionality required for sample accessioning and tracking, material generation, and testing that are particular to the evolving needs of individualized molecular diagnostics. On implementation, the applications described here resulted in improvements in the turn-around time for reporting of more complex molecular test sets, and significant changes in the workflow. Therefore, careful mapping of workflow can permit design of software applications that simplify even the complex demands of specialized molecular testing. By incorporating design features for order review, software tools can permit a more personalized approach to sample handling and test selection without compromising efficiency. PMID:20007844
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Trichinella diagnostics and control: mandatory and best practices for ensuring food safety.
Gajadhar, Alvin A; Pozio, Edoardo; Gamble, H Ray; Nöckler, Karsten; Maddox-Hyttel, Charlotte; Forbes, Lorry B; Vallée, Isabelle; Rossi, Patrizia; Marinculić, Albert; Boireau, Pascal
2009-02-23
Because of its role in human disease, there are increasing global requirements for reliable diagnostic and control methods for Trichinella in food animals to ensure meat safety and to facilitate trade. Consequently, there is a need for standardization of methods, programs, and best practices used in the control of Trichinella and trichinellosis. This review article describes the biology and epidemiology of Trichinella, and describes recommended test methods as well as modified and optimized procedures that are used in meat inspection programs. The use of ELISA for monitoring animals for infection in various porcine and equine pre- and post-slaughter programs, including farm or herd certification programs is also discussed. A brief review of the effectiveness of meat processing methods, such as freezing, cooking and preserving is provided. The importance of proper quality assurance and its application in all aspects of a Trichinella diagnostic system is emphasized. It includes the use of international quality standards, test validation and standardization, critical control points, laboratory accreditation, certification of analysts and proficiency testing. Also described, are the roles and locations of international and regional reference laboratories for trichinellosis where expert advice and support on research and diagnostics are available.
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Diagnostic Pathology and Laboratory Medicine in the Age of “Omics”
Finn, William G.
2007-01-01
Functional genomics and proteomics involve the simultaneous analysis of hundreds or thousands of expressed genes or proteins and have spawned the modern discipline of computational biology. Novel informatic applications, including sophisticated dimensionality reduction strategies and cancer outlier profile analysis, can distill clinically exploitable biomarkers from enormous experimental datasets. Diagnostic pathologists are now charged with translating the knowledge generated by the “omics” revolution into clinical practice. Food and Drug Administration-approved proprietary testing platforms based on microarray technologies already exist and will expand greatly in the coming years. However, for diagnostic pathology, the greatest promise of the “omics” age resides in the explosion in information technology (IT). IT applications allow for the digitization of histological slides, transforming them into minable data and enabling content-based searching and archiving of histological materials. IT will also allow for the optimization of existing (and often underused) clinical laboratory technologies such as flow cytometry and high-throughput core laboratory functions. The state of pathology practice does not always keep up with the pace of technological advancement. However, to use fully the potential of these emerging technologies for the benefit of patients, pathologists and clinical scientists must embrace the changes and transformational advances that will characterize this new era. PMID:17652635
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Ko, Fiona; Drews, Steven J
2017-10-01
Acute respiratory tract infections due to influenza A/B and respiratory syncytial virus (RSV) are major causes of morbidity and mortality globally. Rapid tests for detection of these pathogens include antigen detection point of care tests (POC) and newer easy to use molecular tests. From experience, these assays improve both laboratory workflow and assay interpretation issues. However, the question of the benefits of using rapid test technology compared to routine laboratory testing for respiratory viral pathogens is still often asked. Areas covered: Specifically, this review aims to; 1) identify clinical/patient indicators that can be measured prior to and following the implementation of rapid diagnostic test for influenza and RSV, 2) provide multiple perspectives on the extent of impact of a rapid diagnostic test, including direct and indirect outcomes, and 3) identify the technological advancements in the development of rapid testing, demonstrating a timeline that transitions from antigen-based assays to molecular assays. Expert commentary: Key benefits to the use of either antigen-based or molecular rapid tests for patient care, patient flow within institutions, as well as laboratory utilization are identified. Due to improved test characteristics, the authors feel that rapid molecular tests have greater benefits than antigen-based detection methods.
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Prospects for Nonlinear Laser Diagnostics in the Jet Noise Laboratory
NASA Technical Reports Server (NTRS)
Herring, Gregory C.; Hart, Roger C.; Fletcher, mark T.; Balla, R. Jeffrey; Henderson, Brenda S.
2007-01-01
Two experiments were conducted to test whether optical methods, which rely on laser beam coherence, would be viable for off-body flow measurement in high-density, compressible-flow wind tunnels. These tests measured the effects of large, unsteady density gradients on laser diagnostics like laser-induced thermal acoustics (LITA). The first test was performed in the Low Speed Aeroacoustics Wind Tunnel (LSAWT) of NASA Langley Research Center's Jet Noise Laboratory (JNL). This flow facility consists of a dual-stream jet engine simulator (with electric heat and propane burners) exhausting into a simulated flight stream, reaching Mach numbers up to 0.32. A laser beam transited the LSAWT flow field and was imaged with a high-speed gated camera to measure beam steering and transverse mode distortion. A second, independent test was performed on a smaller laboratory jet (Mach number < 1.2 and mass flow rate < 0.1 kg/sec). In this test, time-averaged LITA velocimetry and thermometry were performed at the jet exit plane, where the effect of unsteady density gradients is observed on the LITA signal. Both experiments show that LITA (and other diagnostics relying on beam overlap or coherence) faces significant hurdles in the high-density, compressible, and turbulent flow environments similar to those of the JNL.
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Oliveira, E; Oliveira, D; Cardoso, F A; Barbosa, J R; Marcelino, A P; Dutra, T; Araujo, T; Fernandes, L; Duque, D; Rabello, A
2017-12-01
In this study, we assessed the sensitivity, specificity, and diagnostic accuracy of a previously developed direct agglutination test (DAT) using a freeze-dried antigen derived from Leishmania infantum promastigotes and composed in a prototype kit for visceral leishmaniasis (VL) diagnosis, named DAT-LPC. To evaluate DAT-LPC reproducibility, the kit was used to analyse 207 serum samples from VL patients and 80 serum samples from patients with other parasitic infections or healthy subjects in four laboratories from different public health institutions in Brazil. DAT-LPC showed sensitivity between 96·2 and 99·5% (P = 0·14), specificity ranging from 96·2 to 97·5% (P = 0·95), and diagnostic accuracy ranging from 96·5 to 99% (P = 0·34). The inter-laboratory reproducibility of qualitative results was classified as excellent (κ index: 0·94-0·97). The reproducibility of the end-titre results in relation to the reference laboratory, ranged from 31 to 85%. These results demonstrate an excellent performance of the DAT-LPC, and validate it for the diagnosis of VL that could replace the immunofluorescent antibody test as the routine diagnostic test in the Brazilian public health system.
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An overview of beam diagnostic and control systems for 50 MeV AREAL Linac
NASA Astrophysics Data System (ADS)
Sargsyan, A. A.; Amatuni, G. A.; Sahakyan, V. V.; Zanyan, G. S.; Martirosyan, N. W.; Vardanyan, V. V.; Grigoryan, B. A.
2017-03-01
Advanced Research Electron Accelerator Laboratory (AREAL) is an electron linear accelerator project with a laser driven RF gun being constructed at CANDLE Synchrotron Research Institute. After the successful operation of the gun section at 5 MeV, a program of facility energy enhancement up to 50 MeV is launched. In this paper the current status of existing diagnostic and control systems, as well as the results of electron beam parameter measurements are presented. The approaches of intended diagnostic and control systems for the upgrade program are also described.
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[Peculiarities of the early diagnostics of malignant nasopharyngal neoplasms].
Baryshev, V V; Andreev, V G; Sevryukov, F E; Buyakova, M E; Akki, E D
The authors consider the risk factors and the specific clinical symptoms of the malignant nasopharyngal neoplasms as well as the methods for instrumental, laboratory, and pathomorphological diagnostics of this pathology. The full scale implementation of the recommendations for the timely detection of the tumours using the aforementioned diagnostic procedures and tests makes it possible to reduce to a minimum the interval between the establishment of the diagnosis and the onset of the relevant treatment at the early stages of the disease and thereby to ensure the improvement of its long-term outcomes.
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Current approach in the diagnosis and management of posterior uveitis
Sudharshan, S; Ganesh, Sudha K; Biswas, Jyotrimay
2010-01-01
Posterior uveitic entities are varied entities that are infective or non-infective in etiology. They can affect the adjacent structures such as the retina, vitreous, optic nerve head and retinal blood vessels. Thorough clinical evaluation gives a clue to the diagnosis while ancillary investigations and laboratory tests assist in confirming the diagnosis. Newer evolving techniques in the investigations and management have increased the diagnostic yield. In case of diagnostic dilemma, intraocular fluid evaluation for polymerase chain testing for the genome and antibody testing against the causative agent provide greater diagnostic ability. PMID:20029144
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Perry, John D
2017-04-01
In the last 25 years, chromogenic culture media have found widespread application in diagnostic clinical microbiology. In the last decade, the range of media available to clinical laboratories has expanded greatly, allowing specific detection of additional pathogens, including Pseudomonas aeruginosa, group B streptococci, Clostridium difficile, Campylobacter spp., and Yersinia enterocolitica. New media have also been developed to screen for pathogens with acquired antimicrobial resistance, including vancomycin-resistant enterococci, carbapenem-resistant Acinetobacter spp., and Enterobacteriaceae with extended-spectrum β-lactamases and carbapenemases. This review seeks to explore the utility of chromogenic media in clinical microbiology, with particular attention given to media that have been commercialized in the last decade. The impact of laboratory automation and complementary technologies such as matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is also assessed. Finally, the review also seeks to demarcate the role of chromogenic media in an era of molecular diagnostics. © Crown copyright 2017.
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Spectroscopic Analysis and Thomson Scattering Diagnostics of Wire Produced Plasma
NASA Astrophysics Data System (ADS)
Plechaty, Christopher; Sotnikov, Vladimir; Main, Daniel; Caplinger, James; Wallerstein, Austin; Kim, Tony
2014-10-01
The Lower Hybrid Drift Instability (LHDI) in plasma is driven by the presence of inhomogeneities in density, temperature, or magnetic field (Krall 1971, Davidson 1977), and occurs in systems where the electrons are magnetized and the ions are effectively unmagnetized. The LHDI is thought to occur in magnetic reconnection (Huba 1977), and has also been investigated as a mitigation technique which can allow for communications to take place through the plasma formed around hypersonic aircraft (Sotnikov 2010). To further understand the phenomenology of the LHDI, we plan to carry out experiments at the Air Force Research Laboratory, in the newly formed Plasma Physics Sensors Laboratory. In experiment, a pulsed power generator is employed to produce plasma by passing current through single, or dual-wire configurations. To characterize the plasma, a Thomson scattering diagnostic is employed, along with a visible spectroscopy diagnostic. This work was performed under the auspices of the U.S. Department of Defense by Riverside Research under Contract BAA-FA8650-13-C-1539.
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2017-01-01
SUMMARY In the last 25 years, chromogenic culture media have found widespread application in diagnostic clinical microbiology. In the last decade, the range of media available to clinical laboratories has expanded greatly, allowing specific detection of additional pathogens, including Pseudomonas aeruginosa, group B streptococci, Clostridium difficile, Campylobacter spp., and Yersinia enterocolitica. New media have also been developed to screen for pathogens with acquired antimicrobial resistance, including vancomycin-resistant enterococci, carbapenem-resistant Acinetobacter spp., and Enterobacteriaceae with extended-spectrum β-lactamases and carbapenemases. This review seeks to explore the utility of chromogenic media in clinical microbiology, with particular attention given to media that have been commercialized in the last decade. The impact of laboratory automation and complementary technologies such as matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) is also assessed. Finally, the review also seeks to demarcate the role of chromogenic media in an era of molecular diagnostics. PMID:28122803
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[An evaluation of the effectiveness of laboratory diagnostic methods for brucellosis].
Gandara, B; Zheludkov, M M; Chernysheva, M I
1994-01-01
The diagnostic value of bacteriological and serological methods for the laboratory diagnosis of brucellosis was studied. In the analysis of milk and cheese specimens Brucella cultures were isolated and differentiated as B.melitensis, biovar I, and B.abortus, biovar 4. In 25.6% of cases B.melitensis culture, biovar 1, was isolated from the blood of persons suspected for brucellosis. The isolation of B.melitensis culture from milk showed that this infective agent migrated from small animals to cattle, which was indicative of a high risk of human infection in the state of Zacatecas, Mexico. The comparative evaluation of serological diagnostic methods (the agglutination test in test tubes, Huddleson's slide test, the acidic rose bengal test and the 2-mercaptoethanol test) showed high sensitivity of rapid tests (Huddleson's test and the rose bengal test in 93.7% and 87.9% of cases respectively). The 2-mercaptoethanol test which gave positive results in 63.8% of cases provided additional information characterizing the course of infections process.
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Sa-Ngamuang, Chaitawat; Haddawy, Peter; Luvira, Viravarn; Piyaphanee, Watcharapong; Iamsirithaworn, Sopon; Lawpoolsri, Saranath
2018-06-18
Differentiating dengue patients from other acute febrile illness patients is a great challenge among physicians. Several dengue diagnosis methods are recommended by WHO. The application of specific laboratory tests is still limited due to high cost, lack of equipment, and uncertain validity. Therefore, clinical diagnosis remains a common practice especially in resource limited settings. Bayesian networks have been shown to be a useful tool for diagnostic decision support. This study aimed to construct Bayesian network models using basic demographic, clinical, and laboratory profiles of acute febrile illness patients to diagnose dengue. Data of 397 acute undifferentiated febrile illness patients who visited the fever clinic of the Bangkok Hospital for Tropical Diseases, Thailand, were used for model construction and validation. The two best final models were selected: one with and one without NS1 rapid test result. The diagnostic accuracy of the models was compared with that of physicians on the same set of patients. The Bayesian network models provided good diagnostic accuracy of dengue infection, with ROC AUC of 0.80 and 0.75 for models with and without NS1 rapid test result, respectively. The models had approximately 80% specificity and 70% sensitivity, similar to the diagnostic accuracy of the hospital's fellows in infectious disease. Including information on NS1 rapid test improved the specificity, but reduced the sensitivity, both in model and physician diagnoses. The Bayesian network model developed in this study could be useful to assist physicians in diagnosing dengue, particularly in regions where experienced physicians and laboratory confirmation tests are limited.
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Dafotakis, M; Heckelmann, J; Zechbauer, S; Litmathe, J; Brokmann, J; Willmes, K; Surges, R; Matz, O
2018-03-21
Laboratory parameters can help in the differential diagnostics of acute episodes of transient loss of consciousness. Especially serum lactate and serum creatine kinase (CK) levels may provide valuable hints to distinguish generalized tonic-clonic seizures (GTCS) from syncope. Serum lactate levels at admission and CK levels 10-48 h after the episodes that led to admission were compared between patients with GTCS (n = 30) and those with syncope (n = 15). In addition, sensitivity and specificity of lactate and CK as diagnostic markers for syncope and GTCS were determined. The serum lactate and serum CK levels were significantly increased in patients with GTCS as compared to syncope patients (serum lactate: p < 0.001; CK: p < 0.005). The area under the curve (AUC) for serum lactate as an indicator for GTCS was 0.94 (95% confidence interval [CI] 0.88-1.0). For CK the receiver operating characteristics (ROC) analysis produced an AUC of only 0.77 (95% CI: 0.63-0.9). The determination of the lactate value as point-of-care diagnostics appears to be highly relevant in the rapid clarification of unclear episodes with transient loss of consciousness. The CK level at follow-up is also suitable for distinguishing GTCS from syncope but is inferior to the serum lactate value.
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Krasowski, Matthew D.; Grieme, Caleb V.; Cassady, Brian; Dreyer, Nicholas R.; Wanat, Karolyn A.; Hightower, Maia; Nepple, Kenneth G.
2017-01-01
Background: Electronic health records (EHRs) are commonplace in industrialized countries. Many hospitals are granting their patients access to their medical information through online patient portals. In this report, we describe a retrospective analysis of patient access to diagnostic test results released through the patient portal (MyChart; Epic, Inc.) at a state academic medical center. Methods: We analyzed 6 months of data for anatomic pathology, clinical laboratory, and radiology test results to evaluate variations in results release (automated vs. manual) and subsequent patient access to the institutional patient portal. During this period, diagnostic test results were released for all patient encounters including inpatient units, outpatient clinics, and the emergency department. Results: Manual results release by providers before automated release time occurred most commonly in the outpatient setting. The highest rates of access of diagnostic test results occurred for outpatients (about 30% overall view rate), females (two times or more compared to males in nearly every age bracket), and 20–45-year-old. Access rates of diagnostic tests in the emergency department or inpatient units were <10% across all populations. Access of diagnostic test results was very low for 12–17-year-old, likely influenced by institutional policies limiting parental proxy access within this pediatric age range. Approximately 20% of outpatient laboratory results were viewed by patients within 8 h of release from the EHR to the patient portal and 10% within 2 h of release. Conclusions: Patient accessing of diagnostic test results were generally higher for females, outpatients, and 20–45-year-old. Approximately, 20% of outpatient results were viewed quickly by patients after release to the EHR. PMID:29226008
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Krasowski, Matthew D; Grieme, Caleb V; Cassady, Brian; Dreyer, Nicholas R; Wanat, Karolyn A; Hightower, Maia; Nepple, Kenneth G
2017-01-01
Electronic health records (EHRs) are commonplace in industrialized countries. Many hospitals are granting their patients access to their medical information through online patient portals. In this report, we describe a retrospective analysis of patient access to diagnostic test results released through the patient portal (MyChart; Epic, Inc.) at a state academic medical center. We analyzed 6 months of data for anatomic pathology, clinical laboratory, and radiology test results to evaluate variations in results release (automated vs. manual) and subsequent patient access to the institutional patient portal. During this period, diagnostic test results were released for all patient encounters including inpatient units, outpatient clinics, and the emergency department. Manual results release by providers before automated release time occurred most commonly in the outpatient setting. The highest rates of access of diagnostic test results occurred for outpatients (about 30% overall view rate), females (two times or more compared to males in nearly every age bracket), and 20-45-year-old. Access rates of diagnostic tests in the emergency department or inpatient units were <10% across all populations. Access of diagnostic test results was very low for 12-17-year-old, likely influenced by institutional policies limiting parental proxy access within this pediatric age range. Approximately 20% of outpatient laboratory results were viewed by patients within 8 h of release from the EHR to the patient portal and 10% within 2 h of release. Patient accessing of diagnostic test results were generally higher for females, outpatients, and 20-45-year-old. Approximately, 20% of outpatient results were viewed quickly by patients after release to the EHR.
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Vandenberg, Olivier; Kozlakidis, Zisis; Schrenzel, Jacques; Struelens, Marc Jean; Breuer, Judith
2018-01-01
Many new innovative diagnostic approaches have been made available during the last 10 years with major impact on patient care and public health surveillance. In parallel, to enhance the cost-effectiveness of the clinical microbiology laboratories (CMLs), European laboratory professionals have streamlined their organization leading to amalgamation of activities and restructuring of their professional relationships with clinicians and public health specialists. Through this consolidation process, an operational model has emerged that combines large centralized clinical laboratories performing most tests on one high-throughput analytical platform connected to several distal laboratories dealing locally with urgent analyses at near point of care. The centralization of diagnostic services over a large geographical region has given rise to the concept of regional-scale "microbiology laboratories network." Although the volume-driven cost savings associated with such laboratory networks seem self-evident, the consequence(s) for the quality of patient care and infectious disease surveillance and control remain less obvious. In this article, we describe the range of opportunities that the changing landscape of CMLs in Europe can contribute toward improving the quality of patient care but also the early detection and enhanced surveillance of public health threats caused by infectious diseases. The success of this transformation of health services is reliant on the appropriate preparation in terms of staff, skills, and processes that would be inclusive of stakeholders. In addition, rigorous metrics are needed to set out more concrete laboratory service performance objectives and assess the expected benefits to society in terms of saving lives and preventing diseases.
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Centralization of a regional clinical microbiology service: The Calgary experience
Church, Deirdre L; Hall, Paula
1999-01-01
Diagnostic laboratory services in Alberta have been dramatically restructured over the past five years. In 1994, Alberta Health embarked on an aggressive laboratory restructuring that cut back approximately 30% of the overall monies previously paid to the laboratory service sector in Calgary. A unique service delivery model consolidated all institutional and community-based diagnostic testing in a company called Calgary Laboratory Services (CLS) in late 1996. CLS was formed by a public/private partnership between the Calgary Regional Health Care Authority (CRHA) and MDS-Kasper Laboratories. By virtue of its customer service base and scope of testing, CLS provides comprehensive regional laboratory services to the entire populace. Regional microbiology services within CLS have been successfully consolidated over the past three years into a centralized high volume laboratory (HVL). Because the HVL is not located in a hospital, rapid response laboratories (RRLs) are operated at each acute care site. Although the initial principle behind the proposed test menus for the RRLs was that only procedures requiring a clinical turnaround time of more than 2 h stay on-site, many other principles had to be used to develop and implement an efficient and clinically relevant RRL model for microbiology. From these guiding principles, a detailed assessment of the needs of each institution and extensive networking with user groups, the functions of the microbiology RRLs were established and a detailed implementation plan drawn up. The experience at CLS with regards to restructuring a regional microbiology service is described herein. A post-hoc analysis provides the pros and cons of directing and operating a regionalized microbiology service. PMID:22346397
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Chernecky CC, Berger BJ. Porphyrins, quantitative - blood. In: Chernecky CC, Berger BJ, eds. Laboratory Tests and Diagnostic Procedures . 6th ed. Philadelphia, PA: Elsevier Saunders; 2013:891-892. ...
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Acid hemolysin test; Paroxysmal nocturnal hemoglobinuria - Ham test; PNH - Ham test ... BJ. In: Chernecky CC, Berger BJ, eds. Laboratory Tests and Diagnostic Procedures . 6th ed. Philadelphia, PA: Elsevier ...
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Nanopore Sequencing as a Rapidly Deployable Ebola Outbreak Tool.
Hoenen, Thomas; Groseth, Allison; Rosenke, Kyle; Fischer, Robert J; Hoenen, Andreas; Judson, Seth D; Martellaro, Cynthia; Falzarano, Darryl; Marzi, Andrea; Squires, R Burke; Wollenberg, Kurt R; de Wit, Emmie; Prescott, Joseph; Safronetz, David; van Doremalen, Neeltje; Bushmaker, Trenton; Feldmann, Friederike; McNally, Kristin; Bolay, Fatorma K; Fields, Barry; Sealy, Tara; Rayfield, Mark; Nichol, Stuart T; Zoon, Kathryn C; Massaquoi, Moses; Munster, Vincent J; Feldmann, Heinz
2016-02-01
Rapid sequencing of RNA/DNA from pathogen samples obtained during disease outbreaks provides critical scientific and public health information. However, challenges exist for exporting samples to laboratories or establishing conventional sequencers in remote outbreak regions. We successfully used a novel, pocket-sized nanopore sequencer at a field diagnostic laboratory in Liberia during the current Ebola virus outbreak.
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Alphus D. Wilson
2012-01-01
The rapid development of new electronic technologies and instruments, utilized to perform many current clinical operations in the biomedical field, is changing the way medical health care is delivered to patients. The majority of test results from laboratory analyses, performed with these analytical instruments often prior to clinical examinations, are frequently used...
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ERIC Educational Resources Information Center
Reyer, Ronald
A project was conducted to analyze, design, develop, implement, and evaluate an instructional unit intended to improve the diagnostic skills of operating personnel in responding to abnormal and emergency conditions at the High Flux Beam Reactor at Brookhaven National Laboratory. Research was conducted on the occurrence of emergencies at similar…
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MSG in the Columbus Laboratory during Expedition 22
2010-01-28
ISS022-E-041766 (28 Jan. 2010) --- Japan Aerospace Exploration Agency (JAXA) astronaut Soichi Noguchi, Expedition 22 flight engineer, works with the European Space Agency (ESA) science payload Selectable Optical Diagnostics Instrument / Influence of Vibration on Diffusion in Liquids (SODI/IVIDIL) hardware in the Microgravity Science Glovebox (MSG) facility located in the Columbus laboratory of the International Space Station.
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MSG in the Columbus Laboratory during Expedition 22
2010-01-28
ISS022-E-041767 (28 Jan. 2010) --- Japan Aerospace Exploration Agency (JAXA) astronaut Soichi Noguchi, Expedition 22 flight engineer, works with the European Space Agency (ESA) science payload Selectable Optical Diagnostics Instrument / Influence of Vibration on Diffusion in Liquids (SODI/IVIDIL) hardware in the Microgravity Science Glovebox (MSG) facility located in the Columbus laboratory of the International Space Station.
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MSG in the Columbus Laboratory during Expedition 22
2010-01-28
ISS022-E-041769 (28 Jan. 2010) --- Japan Aerospace Exploration Agency (JAXA) astronaut Soichi Noguchi, Expedition 22 flight engineer, works with the European Space Agency (ESA) science payload Selectable Optical Diagnostics Instrument / Influence of Vibration on Diffusion in Liquids (SODI/IVIDIL) hardware in the Microgravity Science Glovebox (MSG) facility located in the Columbus laboratory of the International Space Station.
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Modular workcells: modern methods for laboratory automation.
Felder, R A
1998-12-01
Laboratory automation is beginning to become an indispensable survival tool for laboratories facing difficult market competition. However, estimates suggest that only 8% of laboratories will be able to afford total laboratory automation systems. Therefore, automation vendors have developed alternative hardware configurations called 'modular automation', to fit the smaller laboratory. Modular automation consists of consolidated analyzers, integrated analyzers, modular workcells, and pre- and post-analytical automation. These terms will be defined in this paper. Using a modular automation model, the automated core laboratory will become a site where laboratory data is evaluated by trained professionals to provide diagnostic information to practising physicians. Modem software information management and process control tools will complement modular hardware. Proper standardization that will allow vendor-independent modular configurations will assure success of this revolutionary new technology.
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NASA Technical Reports Server (NTRS)
Thompson, Anne M.; Witte, Jacquelyn C.; Schmidlin, Francis J.; Oltmans, Samuel J.; McPeters, Richard D.; Einaudi, Franco (Technical Monitor)
2000-01-01
In the past 5 years, new tropical ozone data products have been developed from TOMS and other satellites, During this period, global chemical-transport models have been used for ozone assessment studies. However, there has been a lack of independent ozone profiles in the tropics for evaluation of the data sets and models. In 1998, NASA's Goddard Space Flight Center, Wallops Flight Facility and NOAA's CMDL (Climate Monitoring and Diagnostics Lab), began a 2-year project to collect a consistent data set by augmenting ozonesonde launches at southern hemisphere tropical sites The measurements are available to the scientific community at a single electronic location - the SHADOZ website at NASA/Goddard: http://code9l6.gsfc.nasa.gov/Data services/Shadoz/shadoz hmpg2.html. Stations in SHADOZ include four islands in the Pacific: Fiji, Tahiti, San Cristobal (Galapagos) and American Samoa. Two sites are at and in the Atlantic: Natal (Brazil) and Ascension Island. Three other sites span Africa (Nairobi and Irene, South Africa) and the Indian Ocean (Reunion Island and Watukosek in Java, Indonesia). All SHADOZ sites are using ECC-type sondes, with the conversion from JMD sondes at Java in 1999, but there are variations in sonde preparation technique and data processing. During the 1998-1999 period, more than 550 sondes were incorporated into the SHADOZ data base. Examples from these measurements illustrate the tropical wave-one pattern in total ozone which is easily detectable by satellite. They also show that the wave-one pattern appears to be in the troposphere, as assumed in creating the modified-residual tropospheric ozone data product from TOMS. SHADOZ will add data from intensive field campaigns from time to time. Recent contributions to the SHADOZ archive are from the INDOEX (Indian Ocean Experiment January-March 1999)sondes at the Maldives (5N, 73E) and 27 sondes on the US NOAA oceanographic vessel, the FIN Ronald H Brown between Virginia (US) and Mauritius via CapeTown, during a cruise in January and February 1999. In 2000, as part of the SAFARI-2000 experiment and a validation project called Southern African Validation for EOS (SAVE), enhancement of ozonesonde launches at Irene (South Africa) will extend the data set from this site beyond the 1998-1999 period.
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Performance specifications for the extra-analytical phases of laboratory testing: Why and how.
Plebani, Mario
2017-07-01
An important priority in the current healthcare scenario should be to address errors in laboratory testing, which account for a significant proportion of diagnostic errors. Efforts made in laboratory medicine to enhance the diagnostic process have been directed toward improving technology, greater volumes and more accurate laboratory tests being achieved, but data collected in the last few years highlight the need to re-evaluate the total testing process (TTP) as the unique framework for improving quality and patient safety. Valuable quality indicators (QIs) and extra-analytical performance specifications are required for guidance in improving all TTP steps. Yet in literature no data are available on extra-analytical performance specifications based on outcomes, and nor is it possible to set any specification using calculations involving biological variability. The collection of data representing the state-of-the-art based on quality indicators is, therefore, underway. The adoption of a harmonized set of QIs, a common data collection and standardised reporting method is mandatory as it will not only allow the accreditation of clinical laboratories according to the International Standard, but also assure guidance for promoting improvement processes and guaranteeing quality care to patients. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
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Caya, James G; Agni, Rashmi; Miller, Joan E
2004-06-01
This review article is designed to thoroughly familiarize all health care professionals with the history, classification, epidemiology, clinical characteristics, differential diagnosis, diagnostic evaluation (including laboratory-based testing), treatment, and prognosis of botulism. It is especially targeted toward clinical laboratorians and includes a detailed enumeration of the important clinical laboratory contributions to the diagnosis, treatment, and monitoring of patients with botulism. Finally, the bioterrorism potential for botulism is discussed, with an emphasis on the clinical laboratory ramifications of this possibility. Included medical periodicals and textbooks accessioned from computerized and manual medical literature searches. More than 1000 medical works published from the 1800s through 2003 were retrieved and reviewed in this process. Pertinent data are presented in textual and tabular formats, the latter including 6 tables presenting detailed information regarding the clinical parameters, differential diagnosis, diagnostic studies, laboratory testing, and therapeutic approaches to botulism. Because botulism is such a rare disease, a keen awareness of its manifestations and prompt diagnosis are absolutely crucial for its successful treatment. The bioterrorism potential of botulism adds further urgency to the need for all health care professionals to be familiar with this disease, its proper evaluation, and timely treatment; the need for such urgency clearly includes the clinical laboratory.
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Birnie, Kate; Hay, Alastair D; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O'Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C; Sterne, Jonathan A C
2017-01-01
To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test"), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Theys, M.
1994-05-06
Beamlet is a high power laser currently being built at Lawrence Livermore National Lab as a proof of concept for the National Ignition Facility (NIF). Beamlet is testing several areas of laser advancements, such as a 37cm Pockels cell, square amplifier, and propagation of a square beam. The diagnostics on beamlet tell the operators how much energy the beam has in different locations, the pulse shape, the energy distribution, and other important information regarding the beam. This information is being used to evaluate new amplifier designs, and extrapolate performance to the NIF laser. In my term at Lawrence Livermore Nationalmore » Laboratory I have designed and built a diagnostic, calibrated instruments used on diagnostics, setup instruments, hooked up communication lines to the instruments, and setup computers to control specific diagnostics.« less
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Lerner-Ellis, Jordan; Wang, Marina; White, Shana; Lebo, Matthew S
2015-07-01
The Canadian Open Genetics Repository is a collaborative effort for the collection, storage, sharing and robust analysis of variants reported by medical diagnostics laboratories across Canada. As clinical laboratories adopt modern genomics technologies, the need for this type of collaborative framework is increasingly important. A survey to assess existing protocols for variant classification and reporting was delivered to clinical genetics laboratories across Canada. Based on feedback from this survey, a variant assessment tool was made available to all laboratories. Each participating laboratory was provided with an instance of GeneInsight, a software featuring versioning and approval processes for variant assessments and interpretations and allowing for variant data to be shared between instances. Guidelines were established for sharing data among clinical laboratories and in the final outreach phase, data will be made readily available to patient advocacy groups for general use. The survey demonstrated the need for improved standardisation and data sharing across the country. A variant assessment template was made available to the community to aid with standardisation. Instances of the GeneInsight tool were provided to clinical diagnostic laboratories across Canada for the purpose of uploading, transferring, accessing and sharing variant data. As an ongoing endeavour and a permanent resource, the Canadian Open Genetics Repository aims to serve as a focal point for the collaboration of Canadian laboratories with other countries in the development of tools that take full advantage of laboratory data in diagnosing, managing and treating genetic diseases. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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A Structural Health Monitoring Software Tool for Optimization, Diagnostics and Prognostics
2011-01-01
A Structural Health Monitoring Software Tool for Optimization, Diagnostics and Prognostics Seth S . Kessler1, Eric B. Flynn2, Christopher T...technology more accessible, and commercially practical. 1. INTRODUCTION Currently successful laboratory non- destructive testing and monitoring...PROGRAM ELEMENT NUMBER 6. AUTHOR( S ) 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME( S ) AND ADDRESS(ES
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Biomarker Discovery in Gulf War Veterans: Development of a War Illness Diagnostic Panel
2016-12-01
with GWI reflect a persistent disruption in central nervous system (CNS) proinflammatory and neuroendocrine parameters. These processes can...differences in these systems are more subtle than the frank “abnormalities” identified with standard diagnostic tests (e.g., measures indicating...the coagulation system in Gulf War Illness: a potential pathophysiologic link with chronic fatigue syndrome. A laboratory approach to diagnosis. Blood
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Genzen, Jonathan R.; Kenney, Barton
2009-01-01
Aspergillus terreus was identified in an intra-dural spinal biopsy specimen from an African female with recurrent headache and hydrocephalus. Prior laboratory testing of cerebrospinal fluid (CSF) was non-diagnostic, despite extensive central nervous system (CNS) involvement. CNS Aspergillus infection presents a diagnostic and therapeutic challenge and is reviewed in the context of this particularly instructive and difficult case. PMID:19717262
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Alfa, Michelle J; Sepehri, Shadi
2013-01-01
BACKGROUND: There has been a growing interest in developing an appropriate laboratory diagnostic algorithm for Clostridium difficile, mainly as a result of increases in both the number and severity of cases of C difficile infection in the past decade. A C difficile diagnostic algorithm is necessary because diagnostic kits, mostly for the detection of toxins A and B or glutamate dehydrogenase (GDH) antigen, are not sufficient as stand-alone assays for optimal diagnosis of C difficile infection. In addition, conventional reference methods for C difficile detection (eg, toxigenic culture and cytotoxin neutralization [CTN] assays) are not routinely practiced in diagnostic laboratory settings. OBJECTIVE: To review the four-step algorithm used at Diagnostic Services of Manitoba sites for the laboratory diagnosis of toxigenic C difficile. RESULT: One year of retrospective C difficile data using the proposed algorithm was reported. Of 5695 stool samples tested, 9.1% (n=517) had toxigenic C difficile. Sixty per cent (310 of 517) of toxigenic C difficile stools were detected following the first two steps of the algorithm. CTN confirmation of GDH-positive, toxin A- and B-negative assays resulted in detection of an additional 37.7% (198 of 517) of toxigenic C difficile. Culture of the third specimen, from patients who had two previous negative specimens, detected an additional 2.32% (12 of 517) of toxigenic C difficile samples. DISCUSSION: Using GDH antigen as the screening and toxin A and B as confirmatory test for C difficile, 85% of specimens were reported negative or positive within 4 h. Without CTN confirmation for GDH antigen and toxin A and B discordant results, 37% (195 of 517) of toxigenic C difficile stools would have been missed. Following the algorithm, culture was needed for only 2.72% of all specimens submitted for C difficile testing. CONCLUSION: The overview of the data illustrated the significance of each stage of this four-step C difficile algorithm and emphasized the value of using CTN assay and culture as parts of an algorithm that ensures accurate diagnosis of toxigenic C difficile. PMID:24421808
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Significance and integration of molecular diagnostics in the framework of veterinary practice.
Aranaz, Alicia
2015-01-01
The field of molecular diagnostics in veterinary practice is rapidly evolving. An array of molecular techniques of different complexity is available to facilitate the fast and specific diagnosis of animal diseases. The choice for the adequate technique is dependent on the mission and attributions of the laboratory and requires both a knowledge of the molecular biology basis and of its limitations. The ability to quickly detect pathogens and their characteristics would allow for precise decision-making and target measures such as prophylaxis, appropriate therapy, and biosafety plans to control disease outbreaks. In practice, taking benefit of the huge amount of data that can be obtained using molecular techniques highlights the need of collaboration between veterinarians in the laboratory and practitioners.
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Veterinary Forensic Toxicology.
Gwaltney-Brant, S M
2016-09-01
Veterinary pathologists working in diagnostic laboratories are sometimes presented with cases involving animal poisonings that become the object of criminal or civil litigation. Forensic veterinary toxicology cases can include cases involving animal cruelty (malicious poisoning), regulatory issues (eg, contamination of the food supply), insurance litigation, or poisoning of wildlife. An understanding of the appropriate approach to these types of cases, including proper sample collection, handling, and transport, is essential so that chain of custody rules are followed and proper samples are obtained for toxicological analysis. Consultation with veterinary toxicologists at the diagnostic laboratory that will be processing the samples before, during, and after the forensic necropsy can help to ensure that the analytical tests performed are appropriate for the circumstances and findings surrounding the individual case. © The Author(s) 2016.
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Risin, Semyon A; Chang, Brian N; Welsh, Kerry J; Kidd, Laura R; Moreno, Vanessa; Chen, Lei; Tholpady, Ashok; Wahed, Amer; Nguyen, Nghia; Kott, Marylee; Hunter, Robert L
2015-01-01
As the USA Health Care System undergoes transformation and transitions to value-based models it is critical for laboratory medicine/clinical pathology physicians to explore opportunities and find new ways to deliver value, become an integral part of the healthcare team. This is also essential for ensuring financial health and stability of the profession when the payment paradigm changes from fee-for-service to fee-for-performance. About 5 years ago we started searching for ways to achieve this goal. Among other approaches, the search included addressing the laboratory work-ups for specialists' referrals in the HarrisHealth System, a major safety net health care organization serving mostly indigent and underserved population of Harris County, TX. We present here our experience in improving the efficiency of laboratory testing for the referral process and in building a prototype of a diagnostic e-consult service using rheumatologic diseases as a starting point. The service incorporates algorithmic testing, integration of clinical, laboratory and imaging data, issuing structured comprehensive consultation reports, incorporating all the relevant information, and maintaining personal contacts and an e-line of communications with the primary providers and referral center personnel. Ongoing survey of providers affords testimony of service value in terms of facilitating their work and increasing productivity. Analysis of the cost effectiveness and of other value indicators is currently underway. We also discuss our pioneering experience in building pathology residents and fellows training in integrated diagnostic consulting service. © 2015 by the Association of Clinical Scientists, Inc.
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Strother, R. Matthew; Ndiangui, Francis; Chumba, David; Jacobson, William; Dodson, Cecelia; Resnic, Murray B.; Strate, Randall W.; Smith, James W.
2016-01-01
Background Cancer is becoming a major cause of mortality in low- and middle-income countries. Unlike infectious disease, malignancy and other chronic conditions require significant supportive infrastructure for diagnostics, staging and treatment. In addition to morphologic diagnosis, diagnostic pathways in oncology frequently require immunohistochemistry (IHC) for confirmation. We present the experience of a tertiary-care hospital serving rural western Kenya, which developed and validated an IHC laboratory in support of a growing cancer care service. Objectives, methods and outcomes Over the past decade, in an academic North-South collaboration, cancer services were developed for the catchment area of Moi Teaching and Referral Hospital in western Kenya. A major hurdle to treatment of cancer in a resource-limited setting has been the lack of adequate diagnostic services. Building upon the foundations of a histology laboratory, strategic investment and training were used to develop IHC services. Key elements of success in this endeavour included: translation of resource-rich practices to a resource-limited setting, such as using manual, small-batch IHC instead of disposable- and maintenance-intensive automated machinery, engagement of outside expertise to develop reagent-efficient protocols and supporting all levels of staff to meet the requirements of an external quality assurance programme. Conclusion Development of low- and middle-income country models of services, such as the IHC laboratory presented in this paper, is critical for the infrastructure in resource-limited settings to address the growing cancer burden. We provide a low-cost model that effectively develops these necessary services in a challenging laboratory environment. PMID:28879100
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Williams, Jason; Umaru, Farouk; Edgil, Dianna; Kuritsky, Joel
2016-09-28
In 2014, the Joint United Nations Programme on HIV/AIDS released its 90-90-90 targets, which make laboratory diagnostics a cornerstone for measuring efforts toward the epidemic control of HIV. A data-driven laboratory harmonization and standardization approach is one way to create efficiencies and ensure optimal laboratory procurements. Following the 2008 "Maputo Declaration on Strengthening of Laboratory Systems"-a call for government leadership in harmonizing tiered laboratory networks and standardizing testing services-several national ministries of health requested that the United States Government and in-country partners help implement the recommendations by facilitating laboratory harmonization and standardization workshops, with a primary focus on improving HIV laboratory service delivery. Between 2007 and 2015, harmonization and standardization workshops were held in 8 African countries. This article reviews progress in the harmonization of laboratory systems in these 8 countries. We examined agreed-upon instrument lists established at the workshops and compared them against instrument data from laboratory quantification exercises over time. We used this measure as an indicator of adherence to national procurement policies. We found high levels of diversity across laboratories' diagnostic instruments, equipment, and services. This diversity contributes to different levels of compliance with expected service delivery standards. We believe the following challenges to be the most important to address: (1) lack of adherence to procurement policies, (2) absence or limited influence of a coordinating body to fully implement harmonization proposals, and (3) misalignment of laboratory policies with minimum packages of care and with national HIV care and treatment guidelines. Overall, the effort to implement the recommendations from the Maputo Declaration has had mixed success and is a work in progress. Program managers should continue efforts to advance the principles outlined in the Maputo Declaration. Quantification exercises are an important method of identifying instrument diversity, and provide an opportunity to measure efforts toward standardization. © Williams et al.
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AST Combustion Workshop: Diagnostics Working Group Report
NASA Technical Reports Server (NTRS)
Locke, Randy J.; Hicks, Yolanda R.; Hanson, Ronald K.
1996-01-01
A workshop was convened under NASA's Advanced Subsonics Technologies (AST) Program. Many of the principal combustion diagnosticians from industry, academia, and government laboratories were assembled in the Diagnostics/Testing Subsection of this workshop to discuss the requirements and obstacles to the successful implementation of advanced diagnostic techniques to the test environment of the proposed AST combustor. The participants, who represented the major relevant areas of advanced diagnostic methods currently applied to combustion and related fields, first established the anticipated AST combustor flowfield conditions. Critical flow parameters were then examined and prioritized as to their importance to combustor/fuel injector design and manufacture, environmental concerns, and computational interests. Diagnostic techniques were then evaluated in terms of current status, merits and obstacles for each flow parameter. All evaluations are presented in tabular form and recommendations are made on the best-suited diagnostic method to implement for each flow parameter in order of applicability and intrinsic value.
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[Recurrent epidemics of gastroenteritis caused by norovirus GI.3 in a small hotel].
Soini, Jani; Hemminki, Kaisa; Pirnes, Aija; Roivainen, Merja; Al-Hello, Haider; Maunula, Leena; Kauppinen, Ari; Miettinen, Likka; Smit, Pieter W; Huusko, Sari; Toikkanen, Salla; Rimhanen-Finne, Ruska
2016-01-01
Recurrent cases of gastroenteritis occurred in a small hotel. The causative agent of disease could not be detected. The cause and the source of the disease were established through epidemiological investigations and laboratory diagnosis. The causative agent of the disease was norovirus GI.3. Norovirus GI was detected in the water from the well and on surfaces at the hotel. Both epidemiological investigations and laboratory diagnostics are needed in resolving epidemics. Continuous development of laboratory methods is important.
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Laboratory identification of arthropod ectoparasites.
Mathison, Blaine A; Pritt, Bobbi S
2014-01-01
The collection, handling, identification, and reporting of ectoparasitic arthropods in clinical and reference diagnostic laboratories are discussed in this review. Included are data on ticks, mites, lice, fleas, myiasis-causing flies, and bed bugs. The public health importance of these organisms is briefly discussed. The focus is on the morphological identification and proper handling and reporting of cases involving arthropod ectoparasites, particularly those encountered in the United States. Other arthropods and other organisms not of public health concern, but routinely submitted to laboratories for identification, are also briefly discussed.
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Factoring quality laboratory diagnosis into the malaria control agenda for sub-Saharan Africa.
Aidoo, Michael
2013-09-01
Recent progress in malaria control in sub-Saharan Africa has been achieved primarily through provision of insecticide-treated nets, indoor residual spraying, and antimalarial drugs. Although these interventions are important, proper case identification and accurate measurement of their impact depend on quality diagnostic testing. Current availability of diagnostic testing for malaria in sub-Saharan Africa is inadequate to support disease management, prevention programs, and surveillance needs. Challenges faced include a dearth of skilled workforce, inadequate health systems infrastructure, and lack of political will. A coordinated approach to providing pre-service clinical and laboratory training together with systems that support a scale-up of laboratory services could provide means not only for effective malaria case management but also, management of non-malaria febrile illnesses, disease surveillance, and accurate control program evaluation. A synthesis of the challenges faced in ensuring quality malaria testing and how to include this information in the malaria control and elimination agenda are presented.
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History of the preanalytical phase: a personal view
Guder, Walter G.
2014-01-01
In the 70ies of the last century, ther term “preanalytical phase” was introduced in the literature. This term describes all actions and aspects of the “brain to brain circle” of the medical laboratory diagnostic procedure happening before the analytical phase. The author describes his personal experiences in the early seventies and the following history of increasing awareness of this phase as the main cause of “laboratory errors”. This includes the definitions of influence and interference factors as well as the first publications in book, internet, CD-Rom and recent App form over the past 40 years. In addition, a short summary of previous developments as prerequesits of laboratory diagnostic actions is described from the middle age matula for urine collection to the blood collection tubes, anticoagulants and centrifuges. The short review gives a personal view on the possible causes of missing awareness of preanalytical causes of error and future aspects of new techniques in regulation of requests to introduction of quality assurance programs for preanalytical factors. PMID:24627712
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NASA Technical Reports Server (NTRS)
Uhran, M. L.; Youngblood, W. W.; Georgekutty, T.; Fiske, M. R.; Wear, W. O.
1986-01-01
Taking advantage of the microgravity environment of space NASA has initiated the preliminary design of a permanently manned space station that will support technological advances in process science and stimulate the development of new and improved materials having applications across the commercial spectrum. Previous studies have been performed to define from the researcher's perspective, the requirements for laboratory equipment to accommodate microgravity experiments on the space station. Functional requirements for the identified experimental apparatus and support equipment were determined. From these hardware requirements, several items were selected for concept designs and subsequent formulation of development plans. This report documents the concept designs and development plans for two items of experiment apparatus - the Combustion Tunnel and the Advanced Modular Furnace, and two items of support equipment the Laser Diagnostic System and the Integrated Electronics Laboratory. For each concept design, key technology developments were identified that are required to enable or enhance the development of the respective hardware.
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Combining PCR with Microscopy to Reduce Costs of Laboratory Diagnosis of Buruli Ulcer
Yeboah-Manu, Dorothy; Asante-Poku, Adwoa; Asan-Ampah, Kobina; Ampadu, Emelia Danso Edwin; Pluschke, Gerd
2011-01-01
The introduction of antibiotic therapy as first-line treatment of Buruli ulcer underlines the importance of laboratory confirmation of clinical diagnosis. Because smear microscopy has very limited sensitivity, the technically demanding and more expensive IS2404 diagnostic polymerase chain reaction (PCR) has become the main method for confirmation. By optimization of the release of mycobacteria from swab specimen and concentration of bacterial suspensions before smearing, we were able to improve the detection rate of acid-fast bacilli by microscopy after Ziehl–Neelsen staining. Compared with IS2404 PCR, which is the gold standard diagnostic method, the sensitivity and specificity of microscopy with 100 concentrated specimens were 58.4% and 95.7%, respectively. We subsequently evaluated a stepwise laboratory confirmation algorithm with detection of AFB as first-line method and IS2404 PCR performed only with those samples that were negative in microscopic analysis. This stepwise approach reduced unit cost by more than 50% to $5.41, and the total costs were reduced from $917 to $433. PMID:22049046
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Kontis, Alexios-Patapios; Siassiakos, Konstantinos; Kaimakamis, Georgios; Lazakidou, Athina
2010-01-01
The field of the Laboratory Diagnostics (in vitro), a sector of the field of health services, constitutes an industrial market that includes activities of research, development, production and products distribution that are designated for laboratory use. These products are defined as techno-medical products including various categories of products such as simple medicines, advanced technological systems, etc. Despite the high performance, the enlargement and the increasing trends of the field, it is not recorded the expected progress in the methods and the ways of promotion, trading and supporting of these products in the market. The present paper aims at the investigation of the consumers' opinion and the specification of those services that are possible to be implemented in electronic services and commerce for a strongly competitive advantage for the enterprises of the sector. The analysis of the findings from the Consumer Purchase Decision Centres (CPDC) shows how important it is to implement web-based applications in the proposed services.
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[Laboratory accreditation and proficiency testing].
Kuwa, Katsuhiko
2003-05-01
ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.
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Clinical laboratory analytics: Challenges and promise for an emerging discipline.
Shirts, Brian H; Jackson, Brian R; Baird, Geoffrey S; Baron, Jason M; Clements, Bryan; Grisson, Ricky; Hauser, Ronald George; Taylor, Julie R; Terrazas, Enrique; Brimhall, Brad
2015-01-01
The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and "meaningful use." The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the "big data" clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed.
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Clinical laboratory analytics: Challenges and promise for an emerging discipline
Shirts, Brian H.; Jackson, Brian R.; Baird, Geoffrey S.; Baron, Jason M.; Clements, Bryan; Grisson, Ricky; Hauser, Ronald George; Taylor, Julie R.; Terrazas, Enrique; Brimhall, Brad
2015-01-01
The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and “meaningful use.” The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the “big data” clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed. PMID:25774320
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75 FR 1029 - International Trade Administration
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-08
... manufacturers (equipment and devices including laboratory, emergency, diagnostic, physiotherapy, and orthopedic... in Chennai, and Wockhard and the Tata Institute of Fundamental Research in Mumbai. The three cities...
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Informatics applied to cytology
Hornish, Maryanne; Goulart, Robert A.
2008-01-01
Automation and emerging information technologies are being adopted by cytology laboratories to augment Pap test screening and improve diagnostic accuracy. As a result, informatics, the application of computers and information systems to information management, has become essential for the successful operation of the cytopathology laboratory. This review describes how laboratory information management systems can be used to achieve an automated and seamless workflow process. The utilization of software, electronic databases and spreadsheets to perform necessary quality control measures are discussed, as well as a Lean production system and Six Sigma approach, to reduce errors in the cytopathology laboratory. PMID:19495402
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The role of the independent clinical laboratory in new assay development and commercialization.
Ellis, David G
2003-01-01
Most would agree that these are exciting times in the field of laboratory medicine. As the body of scientific knowledge expands and research activities, such as those catalyzed by the sequencing of the human genome, bring us closer to the promise of personalized medicine, the clinical laboratory industry will have increasing opportunities to partner with owners of intellectual property to develop and commercialize new diagnostic tests. The large, independent clinical laboratories are particularly well positioned to commercialize important new tests, with their broad market penetration, infrastructure, and the scale to run esoteric tests cost-effectively.
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Diagnostic Testing and Interpretation of Tests for Autoimmunity
Castro, Christine; Gourley, Mark
2010-01-01
Laboratory testing is of great value when evaluating a patient with a suspected autoimmune disease. The results can confirm a diagnosis, estimate disease severity, aid in assessing prognosis and are useful to follow disease activity. Components of the laboratory exam include complete blood count with differential, comprehensive metabolic panel, inflammatory markers, autoantibodies, and flow cytometry. This chapter discusses these components and includes a discussion about organ-specific immunologic diseases where immunological laboratory testing is employed. Comprehensive laboratory evaluation of a suspected autoimmune illness in conjunction with a thorough clinical evaluation provides a better understanding of a patient's immunologic disease. PMID:20061009
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Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A
2015-12-01
The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.
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Synthetic biology devices for in vitro and in vivo diagnostics.
Slomovic, Shimyn; Pardee, Keith; Collins, James J
2015-11-24
There is a growing need to enhance our capabilities in medical and environmental diagnostics. Synthetic biologists have begun to focus their biomolecular engineering approaches toward this goal, offering promising results that could lead to the development of new classes of inexpensive, rapidly deployable diagnostics. Many conventional diagnostics rely on antibody-based platforms that, although exquisitely sensitive, are slow and costly to generate and cannot readily confront rapidly emerging pathogens or be applied to orphan diseases. Synthetic biology, with its rational and short design-to-production cycles, has the potential to overcome many of these limitations. Synthetic biology devices, such as engineered gene circuits, bring new capabilities to molecular diagnostics, expanding the molecular detection palette, creating dynamic sensors, and untethering reactions from laboratory equipment. The field is also beginning to move toward in vivo diagnostics, which could provide near real-time surveillance of multiple pathological conditions. Here, we describe current efforts in synthetic biology, focusing on the translation of promising technologies into pragmatic diagnostic tools and platforms.
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Synthetic biology devices for in vitro and in vivo diagnostics
Slomovic, Shimyn; Pardee, Keith; Collins, James J.
2015-01-01
There is a growing need to enhance our capabilities in medical and environmental diagnostics. Synthetic biologists have begun to focus their biomolecular engineering approaches toward this goal, offering promising results that could lead to the development of new classes of inexpensive, rapidly deployable diagnostics. Many conventional diagnostics rely on antibody-based platforms that, although exquisitely sensitive, are slow and costly to generate and cannot readily confront rapidly emerging pathogens or be applied to orphan diseases. Synthetic biology, with its rational and short design-to-production cycles, has the potential to overcome many of these limitations. Synthetic biology devices, such as engineered gene circuits, bring new capabilities to molecular diagnostics, expanding the molecular detection palette, creating dynamic sensors, and untethering reactions from laboratory equipment. The field is also beginning to move toward in vivo diagnostics, which could provide near real-time surveillance of multiple pathological conditions. Here, we describe current efforts in synthetic biology, focusing on the translation of promising technologies into pragmatic diagnostic tools and platforms. PMID:26598662
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Liu, Jie; Kabir, Furqan; Manneh, Jainaba; Lertsethtakarn, Paphavee; Begum, Sharmin; Gratz, Jean; Becker, Steve M; Operario, Darwin J; Taniuchi, Mami; Janaki, Lalitha; Platts-Mills, James A; Haverstick, Doris M; Kabir, Mamun; Sobuz, Shihab U; Nakjarung, Kaewkanya; Sakpaisal, Pimmada; Silapong, Sasikorn; Bodhidatta, Ladaporn; Qureshi, Shahida; Kalam, Adil; Saidi, Queen; Swai, Ndealilia; Mujaga, Buliga; Maro, Athanasia; Kwambana, Brenda; Dione, Michel; Antonio, Martin; Kibiki, Gibson; Mason, Carl J; Haque, Rashidul; Iqbal, Najeeha; Zaidi, Anita K M; Houpt, Eric R
2014-08-01
Childhood diarrhoea can be caused by many pathogens that are difficult to assay in the laboratory. Molecular diagnostic techniques provide a uniform method to detect and quantify candidate enteropathogens. We aimed to develop and assess molecular tests for identification of enteropathogens and their association with disease. We developed and assessed molecular diagnostic tests for 15 enteropathogens across three platforms-PCR-Luminex, multiplex real-time PCR, and TaqMan array card-at five laboratories worldwide. We judged the analytical and clinical performance of these molecular techniques against comparator methods (bacterial culture, ELISA, and PCR) using 867 diarrhoeal and 619 non-diarrhoeal stool specimens. We also measured molecular quantities of pathogens to predict the association with diarrhoea, by univariate logistic regression analysis. The molecular tests showed very good analytical and clinical performance at all five laboratories. Comparator methods had limited sensitivity compared with the molecular techniques (20-85% depending on the target) but good specificity (median 97·3%, IQR 96·5-98·9; mean 95·2%, SD 9·1). Positive samples by comparator methods usually had higher molecular quantities of pathogens than did negative samples, across almost all platforms and for most pathogens (p<0·05). The odds ratio for diarrhoea at a given quantity (measured by quantification cycle, Cq) showed that for most pathogens associated with diarrhoea-including Campylobacter jejuni and Campylobacter coli, Cryptosporidium spp, enteropathogenic Escherichia coli, heat-stable enterotoxigenic E coli, rotavirus, Shigella spp and enteroinvasive E coli, and Vibrio cholerae-the strength of association with diarrhoea increased at higher pathogen loads. For example, Shigella spp at a Cq range of 15-20 had an odds ratio of 8·0 (p<0·0001), but at a Cq range of 25-30 the odds ratio fell to 1·7 (p=0·043). Molecular diagnostic tests can be implemented successfully and with fidelity across laboratories around the world. In the case of diarrhoea, these techniques can detect pathogens with high sensitivity and ascribe diarrhoeal associations based on quantification, including in mixed infections, providing rich and unprecedented measurements of infectious causes. Bill & Melinda Gates Foundation Next Generation Molecular Diagnostics Project. Copyright © 2014 Elsevier Ltd. All rights reserved.
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Nanopore Sequencing as a Rapidly Deployable Ebola Outbreak Tool
Groseth, Allison; Rosenke, Kyle; Fischer, Robert J.; Hoenen, Andreas; Judson, Seth D.; Martellaro, Cynthia; Falzarano, Darryl; Marzi, Andrea; Squires, R. Burke; Wollenberg, Kurt R.; de Wit, Emmie; Prescott, Joseph; Safronetz, David; van Doremalen, Neeltje; Bushmaker, Trenton; Feldmann, Friederike; McNally, Kristin; Bolay, Fatorma K.; Fields, Barry; Sealy, Tara; Rayfield, Mark; Nichol, Stuart T.; Zoon, Kathryn C.; Massaquoi, Moses; Munster, Vincent J.; Feldmann, Heinz
2016-01-01
Rapid sequencing of RNA/DNA from pathogen samples obtained during disease outbreaks provides critical scientific and public health information. However, challenges exist for exporting samples to laboratories or establishing conventional sequencers in remote outbreak regions. We successfully used a novel, pocket-sized nanopore sequencer at a field diagnostic laboratory in Liberia during the current Ebola virus outbreak. PMID:26812583
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Food Microbiology--Design and Testing of a Virtual Laboratory Exercise
ERIC Educational Resources Information Center
Flint, Steve; Stewart, Terry
2010-01-01
A web-based virtual laboratory exercise in identifying an unknown microorganism was designed for use with a cohort of 3rd-year university food-technology students. They were presented with a food-contamination case, and then walked through a number of diagnostic steps to identify the microorganism. At each step, the students were asked to select 1…
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Laboratory Innovation Towards Quality Program Sustainability.
Abimiku, Alash'le; Timperi, Ralph; Blattner, William
2016-08-01
Laboratory innovation significantly affects program sustainability of HIV programs in low and middle income countries (LMICs) far beyond its immediate sphere of impact. Innovation in rapid development of diagnostic technologies, improved quality management systems, strengthened laboratory management, affordable external quality assurance and accreditation schemes, and building local capacity have reduced costs, brought quality improvement to point-of-care testing, increased access to testing services, reduced treatment and prevention costs and opened the door to the real possibility of ending the AIDS epidemic. However, for effectively implemented laboratory innovation to contribute to HIV quality program sustainability, it must be implemented within the overall context of the national strategic plan and HIV treatment programs. The high quality of HIV rapid diagnostic test was a breakthrough that made it possible for more persons to learn their HIV status, receive counseling, and if infected to receive treatment. Likewise, the use of dried blood spots made the shipment of samples easier for the assessment of different variables of HIV infection-molecular diagnosis, CD4+ cell counts, HIV antibodies, drug resistance surveillance, and even antiretroviral drug level measurements. Such advancement is critical for to reaching the UNAIDS target of 90-90-90 and for bringing the AIDS epidemic to an end, especially in LMICs.
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Caliendo, Angela M; Couturier, Marc R; Ginocchio, Christine C; Hanson, Kimberly E; Miller, Melissa B; Walker, Kimberly E; Frank, Gregory M
2016-07-15
In 2014, the US Food and Drug Administration (FDA) proposed to regulate laboratory-developed tests (LDTs)-diagnostics designed, manufactured, and used within a single laboratory. The Infectious Diseases Society of America, the American Society for Microbiology, and the Pan American Society for Clinical Virology recognize that the FDA is committed to protecting patients. However, our societies are concerned that the proposed regulations will limit access to testing and negatively impact infectious diseases (ID) LDTs. In this joint commentary, our societies discuss why LDTs are critical for ID patient care, hospital infection control, and public health responses. We also highlight how the FDA's proposed regulation of LDTs could impair patient access to life-saving tests and stifle innovation in ID diagnostics. Finally, our societies make specific recommendations for the FDA's consideration to reduce the burden of the proposed new rules on clinical laboratories and protect patients' access to state-of-the art, quality LDTs. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.
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9 CFR 147.21 - Flock sanitation.
Code of Federal Regulations, 2011 CFR
2011-01-01
..., by private carrier, to a diagnostic laboratory for complete examination. All Salmonella cultures... effective Salmonella control program. (g) Introduction of started or mature birds should be avoided to...
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CP - serum ... Chernecky CC, Berger BJ. Ceruloplasmin (CP) - serum. In: Chernecky CC, Berger BJ, eds. Laboratory Tests and Diagnostic Procedures . 6th ed. St Louis, MO: Elsevier; 2013:321. McPherson ...
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Williams, Jason; Umaru, Farouk; Edgil, Dianna; Kuritsky, Joel
2016-01-01
ABSTRACT In 2014, the Joint United Nations Programme on HIV/AIDS released its 90-90-90 targets, which make laboratory diagnostics a cornerstone for measuring efforts toward the epidemic control of HIV. A data-driven laboratory harmonization and standardization approach is one way to create efficiencies and ensure optimal laboratory procurements. Following the 2008 “Maputo Declaration on Strengthening of Laboratory Systems”—a call for government leadership in harmonizing tiered laboratory networks and standardizing testing services—several national ministries of health requested that the United States Government and in-country partners help implement the recommendations by facilitating laboratory harmonization and standardization workshops, with a primary focus on improving HIV laboratory service delivery. Between 2007 and 2015, harmonization and standardization workshops were held in 8 African countries. This article reviews progress in the harmonization of laboratory systems in these 8 countries. We examined agreed-upon instrument lists established at the workshops and compared them against instrument data from laboratory quantification exercises over time. We used this measure as an indicator of adherence to national procurement policies. We found high levels of diversity across laboratories’ diagnostic instruments, equipment, and services. This diversity contributes to different levels of compliance with expected service delivery standards. We believe the following challenges to be the most important to address: (1) lack of adherence to procurement policies, (2) absence or limited influence of a coordinating body to fully implement harmonization proposals, and (3) misalignment of laboratory policies with minimum packages of care and with national HIV care and treatment guidelines. Overall, the effort to implement the recommendations from the Maputo Declaration has had mixed success and is a work in progress. Program managers should continue efforts to advance the principles outlined in the Maputo Declaration. Quantification exercises are an important method of identifying instrument diversity, and provide an opportunity to measure efforts toward standardization. PMID:27688718
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NASA Astrophysics Data System (ADS)
Neu, J. L.; Daube, B. C.; Moore, F. L.; Dutton, G. S.; Hall, B. D.; Elkins, J. W.
2003-12-01
In September 2002, we began work on the development and construction of an automated, 3 channel gas chromatograph (GC) with a mass selective detector (MSD) and two electron capture detectors (ECDs). The instrument will be placed at a Pacific CMDL station (Mauna Loa or Trinidad Head), and will make continuous measurements of a variety of chemical species with a wide range of lifetimes, including chloroflourocarbons (CFCs), hydrochlorofluorocarbons (HCFCs), hydrofluorocarbons (HFCs), methyl halides, non-methane hydrocarbons (NMHCs), peroxyacetyl nitrate (PAN), nitrous oxide, and sulfur hexafluoride. The primary goal is to characterize the episodic long-range transport of pollution from Asia. We have completed development of a cryogenic trapping system for pre-concentrating samples for the MSD channel. We present a comparison and characterization of two types of traps, one with a one-inch section of Porapak Q as the adsorbent material, and one with 6 mg of Carboxen 1003 and 4 mg of Carboxen 1000. We discuss the suitability of each of these traps for our intended research. We also present our progress on other aspects of the measurement system, including a dynamic dilution system for calibration of PAN measurements on one of the ECD channels, and a discussion of the science issues involved in choosing the deployment location.
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NASA Technical Reports Server (NTRS)
McDonald, Kyle C.; Kimball, John S.; Zhao, Maosheng; Njoku, Eni; Zimmermann, Reiner; Running, Steven W.
2004-01-01
Landscape transitions between seasonally frozen and thawed conditions occur each year over roughly 50 million square kilometers of Earth's Northern Hemisphere. These relatively abrupt transitions represent the closest analog to a biospheric and hydrologic on/off switch existing in nature, affecting surface meteorological conditions, ecological trace gas dynamics, energy exchange and hydrologic activity profoundly. We utilize time series satellite-borne microwave remote sensing measurements from the Special Sensor Microwave Imager (SSM/I) to examine spatial and temporal variability in seasonal freeze/thaw cycles for the pan-Arctic basin and Alaska. Regional measurements of spring thaw timing are derived using daily brightness temperature measurements from the 19 GHz, horizontally polarized channel, separately for overpasses with 6 AM and 6 PM equatorial crossing times. Spatial and temporal patterns in regional freeze/thaw dynamics show distinct differences between North America and Eurasia, and boreal forest and Arctic tundra biomes. Annual anomalies in the timing of thawing in spring also correspond closely to seasonal atmospheric CO2 concentration anomalies derived from NOAA CMDL arctic and subarctic monitoring stations. Classification differences between AM and PM overpass data average approximately 5 days for the region, though both appear to be effective surrogates for monitoring annual growing seasons at high latitudes.
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NASA Technical Reports Server (NTRS)
McDonald, Kyle C.; Kimball, John S.; Zhao, Maosheng; Njoku, Eni; Zimmermann, Reiner; Running, Steven W.
2004-01-01
Landscape transitions between seasonally frozen and thawed conditions occur each year over roughly 50 million square kilometers of Earth's Northern Hemisphere. These relatively abrupt transitions represent the closest analog to a biospheric and hydrologic on/off switch existing in nature, affecting surface meteorological conditions, ecological trace gas dynamics, energy exchange and hydrologic activity profoundly. We utilize time series satellite-borne microwave remote sensing measurements from the Special Sensor Microwave Imager (SSM/I) to examine spatial and temporal variability in seasonal freeze/thaw cycles for the pan-Arctic basin and Alaska. Regional measurements of spring thaw timing are derived using daily brightness temperature measurements from the 19 GHz, horizontally polarized channel, separately for overpasses with 6 AM and 6 PM equatorial crossing times. Spatial and temporal patterns in regional freeze/thaw dynamics show distinct differences between North America and Eurasia, and boreal forest and Arctic tundra biomes. Annual anomalies in the timing of thawing in spring also correspond closely to seasonal atmospheric CO2 concentration anomalies derived from NOAA CMDL arctic and subarctic monitoring stations. Classification differences between AM and PM overpass data average approximately 5 days for the region, though both appear to be effective surrogates for monitoring annual growing seasons at high latitudes.
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Advances in molecular-based diagnostics in meeting crop biosecurity and phytosanitary issues.
Schaad, Norman W; Frederick, Reid D; Shaw, Joe; Schneider, William L; Hickson, Robert; Petrillo, Michael D; Luster, Douglas G
2003-01-01
Awareness of crop biosecurity and phytosanitation has been heightened since 9/11 and the unresolved anthrax releases in October 2001. Crops are highly vulnerable to accidental or deliberate introductions of crop pathogens from outside U.S. borders. Strategic thinking about protection against deliberate or accidental release of a plant pathogen is an urgent priority. Rapid detection will be the key to success. This review summarizes recent progress in the development of rapid real-time PCR protocols and evaluates their effectiveness in a proposed nationwide network of diagnostic laboratories that will facilitate rapid diagnostics and improved communication.
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Ren, Guomin; Krawetz, Roman
2015-01-01
The data explosion in the last decade is revolutionizing diagnostics research and the healthcare industry, offering both opportunities and challenges. These high-throughput "omics" techniques have generated more scientific data in the last few years than in the entire history of mankind. Here we present a brief summary of how "big data" have influenced early diagnosis of complex diseases. We will also review some of the most commonly used "omics" techniques and their applications in diagnostics. Finally, we will discuss the issues brought by these new techniques when translating laboratory discoveries to clinical practice.
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Designing high speed diagnostics
NASA Astrophysics Data System (ADS)
Veliz Carrillo, Gerardo; Martinez, Adam; Mula, Swathi; Prestridge, Kathy; Extreme Fluids Team Team
2017-11-01
Timing and firing for shock-driven flows is complex because of jitter in the shock tube mechanical drivers. Consequently, experiments require dynamic triggering of diagnostics from pressure transducers. We explain the design process and criteria for setting up re-shock experiments at the Los Alamos Vertical Shock Tube facility, and the requirements for particle image velocimetry and planar laser induced fluorescence measurements necessary for calculating Richtmeyer-Meshkov variable density turbulent statistics. Dynamic triggering of diagnostics allows for further investigation of the development of the Richtemeyer-Meshkov instability at both initial shock and re-shock. Thanks to the Los Alamos National Laboratory for funding our project.
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Image-Capture Devices Extend Medicine's Reach
NASA Technical Reports Server (NTRS)
2009-01-01
Johnson Space Center, Henry Ford Hospital in Detroit, and Houston-based Wyle Laboratories collaborated on NASA's Advanced Diagnostic Ultrasound in Microgravity (ADUM) experiment, which developed revolutionary medical ultrasound diagnostic techniques for long-distance use. Mediphan, a Canadian company with U.S. operations in Springfield, New Jersey drew on NASA expertise to create frame-grabber and data archiving technology that enables ultrasound users with minimal training to send diagnostic-quality ultrasound images and video to medical professionals via the Internet in near real time allowing patients as varied as professional athletes, Olympians, and mountain climbers to receive medical attention as soon as it is needed.