Creep Laboratory manual

NASA Astrophysics Data System (ADS)

Osgerby, S.; Loveday, M. S.

1992-06-01

A manual for the NPL Creep Laboratory, a collective name given to two testing laboratories, the Uniaxial Creep Laboratory and the Advanced High Temperature Mechanical Testing Laboratory, is presented. The first laboratory is devoted to uniaxial creep testing and houses approximately 50 high sensitivity creep machines including 10 constant stress cam lever machines. The second laboratory houses a low cycle fatigue testing machine of 100 kN capacity driven by a servo-electric actuator, five machines for uniaxial tensile creep testing of engineering ceramics at temperatures up to 1600C, and an electronic creep machine. Details of the operational procedures for carrying out uniaxial creep testing are given. Calibration procedures to be followed in order to comply with the specifications laid down by British standards, and to provide traceability back to the primary standards are described.

[Laboratory medicine in the obligatory postgraduate clinical training system--common clinical training program in the department of laboratory medicine in our prefectural medical university hospital].

PubMed

Okamoto, Yasuyuki

2003-04-01

I propose a postgraduate common clinical training program to be provided by the department of laboratory medicine in our prefectural medical university hospital. The program has three purposes: first, mastering basic laboratory tests; second, developing the skills necessary to accurately interpret laboratory data; third, learning specific techniques in the field of laboratory medicine. For the first purpose, it is important that medical trainees perform testing of their own patients at bedside or in the central clinical laboratory. When testing at the central clinical laboratory, instruction by expert laboratory technicians is helpful. The teaching doctors in the department of laboratory medicine are asked to advise the trainees on the interpretation of data. Consultation will be received via interview or e-mail. In addition, the trainees can participate in various conferences, seminars, and meetings held at the central clinical laboratory. Finally, in order to learn specific techniques in the field of laboratory medicine, several special courses lasting a few months will be prepared. I think this program should be closely linked to the training program in internal medicine.

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... specific component, drug product container, closure, in-process material, or drug product, and lot tested... product container, closure, in-process material, or drug product tested. (7) The initials or signature of... of any testing and standardization of laboratory reference standards, reagents, and standard...

Calculating cost savings in utilization management.

PubMed

MacMillan, Donna

2014-01-01

A major motivation for managing the utilization of laboratory testing is to reduce the cost of medical care. For this reason it is important to understand the basic principles of cost accounting in the clinical laboratory. The process of laboratory testing includes three distinct components termed the pre-analytic, analytic and post-analytic phases. Utilization management efforts may impact the cost structure of these three phases in different ways depending on the specific details of the initiative. Estimates of cost savings resulting from utilization management programs reported in the literature have often been fundamentally flawed due to a failure to understand basic concepts such as the difference between laboratory costs versus charges and the impact of reducing laboratory test volumes on the average versus marginal cost structure in the laboratory. This article will provide an overview of basic cost accounting principles in the clinical laboratory including both job order and process cost accounting. Specific examples will be presented to illustrate these concepts in various different scenarios. © 2013.

Safety in the Chemical Laboratory: Tested Disposal Methods for Chemical Wastes from Academic Laboratories.

ERIC Educational Resources Information Center

Armour, M. A.; And Others

1985-01-01

Describes procedures for disposing of dichromate cleaning solution, picric acid, organic azides, oxalic acid, chemical spills, and hydroperoxides in ethers and alkenes. These methods have been tested under laboratory conditions and are specific for individual chemicals rather than for groups of chemicals. (JN)

The role of diagnostic laboratories in support of animal disease surveillance systems.

PubMed

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.

Laboratory test methods for evaluating the fire response of aerospace materials

NASA Technical Reports Server (NTRS)

Hilado, C. J.

1979-01-01

The test methods which were developed or evaluated were intended to serve as means of comparing materials on the basis of specific responses under specific sets of test conditions, using apparatus, facilities, and personnel that would be within the capabilities of perhaps the majority of laboratories. Priority was given to test methods which showed promise of addressing the pre-ignition state of a potential fire. These test methods were intended to indicate which materials may present more hazard than others under specific test conditions. These test methods are discussed and arranged according to the stage of a fire to which they are most relevant. Some observations of material performance which resulted from this work are also discussed.

21 CFR 660.26 - Specificity tests and avidity tests.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Specificity tests and avidity tests. 660.26 Section 660.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.26 Specificity tests and avidity test...

Clinical laboratory: bigger is not always better.

PubMed

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.

Laboratory assessment of novel oral anticoagulants: method suitability and variability between coagulation laboratories.

PubMed

Helin, Tuukka A; Pakkanen, Anja; Lassila, Riitta; Joutsi-Korhonen, Lotta

2013-05-01

Laboratory tests to assess novel oral anticoagulants (NOACs) are under evaluation. Routine monitoring is unnecessary, but under special circumstances bioactivity assessment becomes crucial. We analyzed the effects of NOACs on coagulation tests and the availability of specific assays at different laboratories. Plasma samples spiked with dabigatran (Dabi; 120 and 300 μg/L) or rivaroxaban (Riva; 60, 146, and 305 μg/L) were sent to 115 and 38 European laboratories, respectively. International normalized ratio (INR) and activated partial thromboplastin time (APTT) were analyzed for all samples; thrombin time (TT) was analyzed specifically for Dabi and calibrated anti-activated factor X (anti-Xa) activity for Riva. We compared the results with patient samples. Results of Dabi samples were reported by 73 laboratories (13 INR and 9 APTT reagents) and Riva samples by 22 laboratories (5 INR and 4 APTT reagents). Both NOACs increased INR values; the increase was modest, albeit larger, for Dabi, with higher CV, especially with Quick (vs Owren) methods. Both NOACs dose-dependently prolonged the APTT. Again, the prolongation and CVs were larger for Dabi. The INR and APTT results varied reagent-dependently (P < 0.005), with less prolongation in patient samples. TT results (Dabi) and calibrated anti-Xa results (Riva) were reported by only 11 and 8 laboratories, respectively. The screening tests INR and APTT are suboptimal in assessing NOACs, having high reagent dependence and low sensitivity and specificity. They may provide information, if laboratories recognize their limitations. The variation will likely increase and the sensitivity differ in clinical samples. Specific assays measure NOACs accurately; however, few laboratories applied them. © 2013 American Association for Clinical Chemistry.

Study of LTPP laboratory resilient modulus test data and response characteristics.

DOT National Transportation Integrated Search

2002-10-01

The resilient modulus of every unbound structural layer of the Long Term Pavement Performance (LTPP) Specific Pavement and : General Pavement Studies Test Sections is being measured in the laboratory using LTPP test protocol P46. A total of 2,014 : r...

21 CFR 660.26 - Specificity tests and avidity tests.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Specificity tests and avidity tests. 660.26 Section 660.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.26 Specificity tests and avidity...

21 CFR 660.26 - Specificity tests and avidity tests.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Specificity tests and avidity tests. 660.26 Section 660.26 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.26 Specificity tests and avidity...

Misleading biochemical laboratory test results

PubMed Central

Nanji, Amin A.

1984-01-01

This article reviews the general and specific factors that interfere with the performance of common biochemical laboratory tests and the interpretation of their results. The clinical status of the patient, drug interactions, and in-vivo and in-vitro biochemical interactions and changes may alter the results obtained from biochemical analysis of blood constituents. Failure to recognize invalid laboratory test results may lead to injudicious and dangerous management of patients. PMID:6375845

The ACVD task force on canine atopic dermatitis (XVI): laboratory evaluation of dogs with atopic dermatitis with serum-based "allergy" tests.

PubMed

DeBoer, D J; Hillier, A

2001-09-20

Serum-based in vitro "allergy tests" are commercially available to veterinarians, and are widely used in diagnostic evaluation of a canine atopic patient. Following initial clinical diagnosis, panels of allergen-specific IgE measurements may be performed in an attempt to identify to which allergens the atopic dog is hypersensitive. Methodology for these tests varies by laboratory; few critical studies have evaluated performance of these tests, and current inter-laboratory standardization and quality control measures are inadequate. Other areas where information is critically limited include the usefulness of these tests in diagnosis of food allergy, the effect of extrinsic factors such as season of the year on results, and the influence of corticosteroid treatment on test results. Allergen-specific IgE serological tests are never completely sensitive, nor completely specific. There is only partial correlation between the serum tests and intradermal testing; however, the significance of discrepant results is unknown and unstudied. Variation in test methodologies along with the absence of universal standardization and reporting procedures have created confusion, varying study results, and an inability to compare between studies performed by different investigators.

Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

PubMed

Stuart, Lauren N; Volmar, Keith E; Nowak, Jan A; Fatheree, Lisa A; Souers, Rhona J; Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Astles, J Rex; Nakhleh, Raouf E

2017-09-01

- A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. - To establish new benchmark data on IHC laboratory practices. - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. - The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for nonpredictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for nonpredictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

46 CFR 159.010-15 - Contracting inspections and tests or transferrals to another laboratory or person.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Contracting inspections and tests or transferrals to another laboratory or person. 159.010-15 Section 159.010-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Independent Laboratory...

46 CFR 159.010-15 - Contracting inspections and tests or transferrals to another laboratory or person.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Contracting inspections and tests or transferrals to another laboratory or person. 159.010-15 Section 159.010-15 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Independent Laboratory...

Diagnostic Testing and Interpretation of Tests for Autoimmunity

PubMed Central

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

Laboratory testing in hyperthyroidism.

PubMed

Grebe, Stefan K G; Kahaly, George J

2012-09-01

The clinical diagnosis of hypo- or hyperthyroidism is difficult (full text available online: http://education.amjmed.com/pp1/272). Clinical symptoms and signs are often non-specific, and there is incomplete correlation between structural and functional thyroid gland changes. Laboratory testing is therefore indispensible in establishing the diagnosis of thyrotoxicosis. Similar considerations apply to treatment monitoring. Laboratory testing also plays a crucial role in establishing the most likely cause for a patient's hyperthyroidism. Finally, during pregnancy, when isotopic scanning is relatively contraindicated and ultrasound is more difficult to interpret, laboratory testing becomes even more important. Copyright © 2012. Published by Elsevier Inc.

Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

PubMed

Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

2015-01-01

Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

Use of laboratory testing for genital chlamydial infection in Norway.

PubMed Central

Aavitsland, P

1993-01-01

OBJECTIVE--To assess the use of laboratory tests for genital chlamydial infection in Norway. DESIGN--Questionnaire survey of general practitioners' practice in chlamydial testing, retrospective survey of laboratory records, 1986-91, and prospective study of testing in one laboratory during four weeks. SETTING--All 18 microbiological laboratories in Norway (4.2 million population), including one serving all doctors in Vestfold county (0.2 million population). SUBJECTS--302 general practitioners. MAIN MEASURES--GPs' routine practice, methods used for testing, 1986-91, and sex specific and age group specific testing in 1991. RESULTS--201(69%) GPs replied to the questionnaire: 101(51%) would test all women younger than 25 years at routine pelvic examination, 107(54%) all girls at first pelvic examination, 131(66%) all pregnant women, and 106(54%) all men whose female partner had urogenital complaints. Nationwide in 1986, 122,000 tests were performed (2.9 per 100 population); 10% were positive and 51% were cell culture tests. In 1991, 341,000 tests were performed (8.0 per 100 population); 4.5% were positive and 15% were cell culture tests. 13,184 tests were performed in Vestfold in 1991 (6.6 per 100 population). The age group specific rates (per 100 population) among women were: age 15-19 years, 22.0(95% confidence interval 18.2 to 25.8); 20-24 years, 47.2(42.1 to 52.3); 25-29 years, 42.3(37.1 to 47.5); 30-34 years, 29.8(25.4 to 34.2); and 35-39 years, 12.5(9.5 to 15.5). CONCLUSIONS--GPs use liberal indications for testing. The dramatic increase in testing, especially by enzyme immunoassays, in populations with a low prevalence of infection results in low cost effectiveness and low predictive value of positive tests, which in women over 29 years is estimated as 17-36%. IMPLICATIONS--Doctors should be educated about the limitations of enzyme immunoassays in screening low prevalence populations, and laboratories should apply a confirmatory test to specimens testing positive with such assays. PMID:10131639

Evaluation of the Kodak Surecell Chlamydia test for the laboratory diagnosis of adult inclusion conjunctivitis.

PubMed

Tantisira, J G; Kowalski, R P; Gordon, Y J

1995-07-01

The Kodak Surecell Chlamydia test, a rapid enzyme immunoassay, has been reported to be highly sensitive (93%) and specific (96%) for detecting chlamydial lipopolysaccharide antigen in conjunctival specimens from infants, but has not been evaluated previously in adult conjunctival specimens. This study was designed to determine the efficacy of the Kodak Surecell Chlamydia test for the laboratory diagnosis of adult inclusion conjunctivitis. Twenty Chlamydia culture-positive conjunctival specimens from adults (true-positives) and 20 true-negative specimens were tested with the Kodak Surecell Chlamydia test. The Kodak Surecell Chlamydia test was 40% (8/20) sensitive, 100% (20/20) specific, and 70% (28/40) efficient. This study indicates that the Kodak Surecell Chlamydia test, though highly specific, is less sensitive in its ability to diagnose chlamydial conjunctivitis in adults than has been reported previously in infants.

Technical standards and guidelines: molecular genetic testing for ultra-rare disorders.

PubMed

Maddalena, Anne; Bale, Sherri; Das, Soma; Grody, Wayne; Richards, Sue

2005-10-01

These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

46 CFR 159.007-3 - Production inspections and tests: Independent laboratory's procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Production inspections and tests: Independent laboratory's procedures. 159.007-3 Section 159.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of...

46 CFR 159.007-3 - Production inspections and tests: Independent laboratory's procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests: Independent laboratory's procedures. 159.007-3 Section 159.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of...

Analytical control test plan and microbiological methods for the water recovery test

NASA Technical Reports Server (NTRS)

Traweek, M. S. (Editor); Tatara, J. D. (Editor)

1994-01-01

Qualitative and quantitative laboratory results are important to the decision-making process. In some cases, they may represent the only basis for deciding between two or more given options or processes. Therefore, it is essential that handling of laboratory samples and analytical operations employed are performed at a deliberate level of conscientious effort. Reporting erroneous results can lead to faulty interpretations and result in misinformed decisions. This document provides analytical control specifications which will govern future test procedures related to all Water Recovery Test (WRT) Phase 3 activities to be conducted at the National Aeronautics and Space Administration/Marshall Space Flight Center (NASA/MSFC). This document addresses the process which will be used to verify analytical data generated throughout the test period, and to identify responsibilities of key personnel and participating laboratories, the chains of communication to be followed, and ensure that approved methodology and procedures are used during WRT activities. This document does not outline specifics, but provides a minimum guideline by which sampling protocols, analysis methodologies, test site operations, and laboratory operations should be developed.

Competitive bidding for Medicare Part B clinical laboratory services.

PubMed

Kautter, John; Pope, Gregory C

2014-06-01

The traditional Medicare fee-for-service program may be able to purchase clinical laboratory test services at a lower cost through competitive bidding. Demonstrations of competitive bidding for clinical laboratory tests have been twice mandated or authorized by Congress but never implemented. This article provides a summary and review of the final design of the laboratory competitive bidding demonstration mandated by the Medicare Modernization Act of 2003. The design was analogous to a sealed bid (first price), clearing price auction. Design elements presented include covered laboratory tests and beneficiaries, laboratory bidding and payment status under the demonstration, composite bids, determining bidding winners and the demonstration fee schedule, and quality under the demonstration. Expanded use of competitive bidding in Medicare, including specifically for clinical laboratory tests, has been recommended in some proposals for Medicare reform. The presented design may be a useful point of departure if Medicare clinical laboratory competitive bidding is revived in the future.

46 CFR 164.009-21 - Laboratory report.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Description of the specimens tested if the specimens are prepared from composite material. (i) If the test was... Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for Merchant Vessels § 164.009-21 Laboratory...

46 CFR 160.064-7 - Recognized laboratory.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Recognized laboratory. 160.064-7 Section 160.064-7...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Marine Buoyant Devices § 160.064-7 Recognized laboratory. (a) A... laboratory. The following laboratories are recognized under § 159.010-7 of this part, to perform testing and...

46 CFR 160.064-7 - Recognized laboratory.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Recognized laboratory. 160.064-7 Section 160.064-7...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Marine Buoyant Devices § 160.064-7 Recognized laboratory. (a) A... laboratory. The following laboratories are recognized under § 159.010-7 of this part, to perform testing and...

[Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

PubMed

Ishibashi, Midori

2015-01-01

The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

Diagnostic tests in HIV management: a review of clinical and laboratory strategies to monitor HIV-infected individuals in developing countries.

PubMed Central

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

Laboratory Information Systems in Molecular Diagnostics: Why Molecular Diagnostics Data are Different.

PubMed

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.

Procedure for contact electrical resistance measurements as developed for use at Sandia National Laboratories

DOE Office of Scientific and Technical Information (OSTI.GOV)

Finch, J.L.

1994-06-01

Military Specifications call out general procedures and guidelines for conducting contact resistance measurements on chemical conversion coated panels. This paper deals with a test procedure developed at Sandia National Laboratories used to conduct contact electrical resistance on non-chromated conversion coated test panels. MIL-C-81706 {open_quotes}Chemical Conversion Materials For Coating Aluminum and Aluminum Alloys{close_quotes} was the reference specification used for guidance.

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

21 CFR 226.58 - Laboratory controls.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory controls. 226.58 Section 226.58 Food...: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES Product Quality Control § 226.58 Laboratory controls. Laboratory controls shall include the establishment of adequate specifications and test...

NASA Glenn's Acoustical Testing Laboratory Awarded Accreditation by the National Voluntary Laboratory Accreditation Program

NASA Technical Reports Server (NTRS)

Akers, James C.; Cooper, Beth A.

2004-01-01

NASA Glenn Research Center's Acoustical Testing Laboratory (ATL) provides a comprehensive array of acoustical testing services, including sound pressure level, sound intensity level, and sound-power-level testing per International Standards Organization (ISO)1 3744. Since its establishment in September 2000, the ATL has provided acoustic emission testing and noise control services for a variety of customers, particularly microgravity space flight hardware that must meet International Space Station acoustic emission requirements. The ATL consists of a 23- by 27- by 20-ft (height) convertible hemi/anechoic test chamber and a separate sound-attenuating test support enclosure. The ATL employs a personal-computer-based data acquisition system that provides up to 26 channels of simultaneous data acquisition with real-time analysis (ref. 4). Specialized diagnostic tools, including a scanning sound-intensity system, allow the ATL's technical staff to support its clients' aggressive low-noise design efforts to meet the space station's acoustic emission requirement. From its inception, the ATL has pursued the goal of developing a comprehensive ISO 17025-compliant quality program that would incorporate Glenn's existing ISO 9000 quality system policies as well as ATL-specific technical policies and procedures. In March 2003, the ATL quality program was awarded accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) for sound-power-level testing in accordance with ISO 3744. The NVLAP program is administered by the National Institutes of Standards and Technology (NIST) of the U.S. Department of Commerce and provides third-party accreditation for testing and calibration laboratories. There are currently 24 NVLAP-accredited acoustical testing laboratories in the United States. NVLAP accreditation covering one or more specific testing procedures conducted in accordance with established test standards is awarded upon successful completion of an intensive onsite assessment that includes proficiency testing and documentation review. The ATL NVLAP accreditation currently applies specifically to its ISO 3744 soundpower- level determination procedure (see the photograph) and supporting ISO 17025 quality system, although all ATL operations are conducted in accordance with its quality system. The ATL staff is currently developing additional procedures to adapt this quality system to the testing of space flight hardware in accordance with International Space Station acoustic emission requirements.<

46 CFR 164.009-21 - Laboratory report.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Laboratory report. 164.009-21 Section 164.009-21 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for Merchant Vessels § 164.009-21 Laboratory report. The laboratory report of the test...

46 CFR 163.002-7 - Independent laboratory.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Independent laboratory. 163.002-7 Section 163.002-7...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Hoist § 163.002-7 Independent laboratory. (a) The approval and production tests in this subpart must be conducted by, or under the supervision of, an independent laboratory...

46 CFR 160.151-9 - Independent laboratory.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Independent laboratory. 160.151-9 Section 160.151-9...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Liferafts (SOLAS) § 160.151-9 Independent laboratory. Tests and inspections that this subpart requires to be conducted by an independent laboratory must be...

46 CFR 163.002-7 - Independent laboratory.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Independent laboratory. 163.002-7 Section 163.002-7...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Hoist § 163.002-7 Independent laboratory. (a) The approval and production tests in this subpart must be conducted by, or under the supervision of, an independent laboratory...

46 CFR 160.171-5 - Independent laboratory.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Independent laboratory. 160.171-5 Section 160.171-5...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Immersion Suits § 160.171-5 Independent laboratory. The approval and production tests in this subpart must be conducted by an independent laboratory accepted by the...

46 CFR 163.003-7 - Independent laboratory.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Independent laboratory. 163.003-7 Section 163.003-7...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Ladder § 163.003-7 Independent laboratory. The approval and production tests in this subpart must be conducted by or under the supervision of an independent laboratory...

46 CFR 160.151-9 - Independent laboratory.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Independent laboratory. 160.151-9 Section 160.151-9...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Inflatable Liferafts (SOLAS) § 160.151-9 Independent laboratory. Tests and inspections that this subpart requires to be conducted by an independent laboratory must be...

46 CFR 160.171-5 - Independent laboratory.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Independent laboratory. 160.171-5 Section 160.171-5...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Immersion Suits § 160.171-5 Independent laboratory. The approval and production tests in this subpart must be conducted by an independent laboratory accepted by the...

46 CFR 163.003-7 - Independent laboratory.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Independent laboratory. 163.003-7 Section 163.003-7...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Ladder § 163.003-7 Independent laboratory. The approval and production tests in this subpart must be conducted by or under the supervision of an independent laboratory...

46 CFR 164.009-21 - Laboratory report.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 6 2013-10-01 2013-10-01 false Laboratory report. 164.009-21 Section 164.009-21 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for Merchant Vessels § 164.009-21 Laboratory report. The laboratory report of the test...

46 CFR 164.009-21 - Laboratory report.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 6 2014-10-01 2014-10-01 false Laboratory report. 164.009-21 Section 164.009-21 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for Merchant Vessels § 164.009-21 Laboratory report. The laboratory report of the test...

46 CFR 164.009-21 - Laboratory report.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 6 2012-10-01 2012-10-01 false Laboratory report. 164.009-21 Section 164.009-21 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Noncombustible Materials for Merchant Vessels § 164.009-21 Laboratory report. The laboratory report of the test...

Field and laboratory analyses of water from the Columbia aquifer in Eastern Maryland

USGS Publications Warehouse

Bachman, L.J.

1984-01-01

Field and laboratory analyses of pH, alkalinity, and specific conductance from water samples collected from the Columbia aquifer on the Delmarva Peninsula in eastern Maryland were compared to determine if laboratory analyses could be used for making regional water-quality interpretations. Kruskal-Wallis tests of field and laboratory data indicate that the difference between field and laboratory values is usually not enough to affect the outcome of the statistical tests. Thus, laboratory measurements of these constituents may be adequate for making certain regional water-quality interpretations, although they may result in errors if used for geochemical interpretations.

To test or not to test? Laboratory support for the diagnosis of Lyme borreliosis: a position paper of ESGBOR, the ESCMID study group for Lyme borreliosis.

PubMed

Dessau, R B; van Dam, A P; Fingerle, V; Gray, J; Hovius, J W; Hunfeld, K-P; Jaulhac, B; Kahl, O; Kristoferitsch, W; Lindgren, P-E; Markowicz, M; Mavin, S; Ornstein, K; Rupprecht, T; Stanek, G; Strle, F

2018-02-01

Lyme borreliosis (LB) is a tick-borne infection caused by Borrelia burgdorferi sensu lato. The most frequent clinical manifestations are erythema migrans and Lyme neuroborreliosis. Currently, a large volume of diagnostic testing for LB is reported, whereas the incidence of clinically relevant disease manifestations is low. This indicates overuse of diagnostic testing for LB with implications for patient care and cost-effective health management. The recommendations provided in this review are intended to support both the clinical diagnosis and initiatives for a more rational use of laboratory testing in patients with clinically suspected LB. This is a narrative review combining various aspects of the clinical and laboratory diagnosis with an educational purpose. The literature search was based on existing systematic reviews, national and international guidelines and supplemented with specific citations. The main recommendations according to current European case definitions for LB are as follows. Typical erythema migrans should be diagnosed clinically and does not require laboratory testing. The diagnosis of Lyme neuroborreliosis requires laboratory investigation of the spinal fluid including intrathecal antibody production, and the remaining disease manifestations require testing for serum antibodies to B. burgdorferi. Testing individuals with non-specific subjective symptoms is not recommended, because of a low positive predictive value. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

78 FR 70329 - Modification to the Scopes of Recognition of Several NRTLs; Final Determination

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... determination to delete specific test standards from the scopes of recognition of several Nationally Recognized Testing Laboratories (NRTLs), and to incorporate replacement test standards into the scopes of recognition... proposed to delete specific test standards from the scopes of recognition of several NRTLs, and incorporate...

42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

Code of Federal Regulations, 2014 CFR

2014-10-01

... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

Code of Federal Regulations, 2013 CFR

2013-10-01

... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

Code of Federal Regulations, 2012 CFR

2012-10-01

... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

Code of Federal Regulations, 2011 CFR

2011-10-01

... establish performance specifications for any test system used by the laboratory before April 24, 2003. (b)(1... approved test system must do the following before reporting patient test results: (i) Demonstrate that it... following performance characteristics: (A) Accuracy. (B) Precision. (C) Reportable range of test results for...

Performance indicators and decision making for outsourcing public health laboratory services.

PubMed

Santos, Maria Angelica Borges dos; Moraes, Ricardo Montes de; Passos, Sonia Regina Lambert

2012-06-01

To develop performance indicators for outsourcing clinical laboratory services, based on information systems and public administrative records. In the municipality of Rio de Janeiro, Southern Brazil, the public health laboratory network comprised 33 laboratories with automated equipment (but no integrated information system), 90 primary care units (where sample collection was performed) and 983 employees. Information records were obtained from the administrative records of the Budget Information System for Public Health and the Outpatient and Hospital Information System of the Unified Health System. Performance indicators (production, productivity, usage and costs) were generated from data collected routinely from 2006 to 2008. The variations in production, costs and unit prices for tests were analyzed by Laspeyres and Paasche indices, which specifically measure laboratory activity, and by the Consumer Price Index from the Brazilian Institute of Geography and Statistics. A total of 10,359,111 tests were performed in 2008 (10.6% increase over 2006), and the test/employee ratio grew by 8.6%. The costs of supplies, wages and providers increased by 2.3%, 45.4% and 18.3%, respectively. The laboratory tests per visit and hospitalizations increased by 10% and 20%, respectively. The direct costs totaled R$ 63.2 million in 2008, representing an increase of 22.2% in current values during the period analyzed. The direct costs deflated by the Brazilian National Consumer Price Index (9.5% for the period) showed an 11.6% increase in production volumes. The activity-specific volume index, which considers changes in the mix of tests, showed increases of 18.5% in the test price and 3.1% in the production volume. The performance indicators, particularly the specific indices for volume and price of activity, constitute a baseline of performance potential for monitoring private laboratories and contractors. The economic performance indicators demonstrated the need for network information system integration prior to an outsourcing decision.

Point-of-Care Test Equipment for Flexible Laboratory Automation.

PubMed

You, Won Suk; Park, Jae Jun; Jin, Sung Moon; Ryew, Sung Moo; Choi, Hyouk Ryeol

2014-08-01

Blood tests are some of the core clinical laboratory tests for diagnosing patients. In hospitals, an automated process called total laboratory automation, which relies on a set of sophisticated equipment, is normally adopted for blood tests. Noting that the total laboratory automation system typically requires a large footprint and significant amount of power, slim and easy-to-move blood test equipment is necessary for specific demands such as emergency departments or small-size local clinics. In this article, we present a point-of-care test system that can provide flexibility and portability with low cost. First, the system components, including a reagent tray, dispensing module, microfluidic disk rotor, and photometry scanner, and their functions are explained. Then, a scheduler algorithm to provide a point-of-care test platform with an efficient test schedule to reduce test time is introduced. Finally, the results of diagnostic tests are presented to evaluate the system. © 2014 Society for Laboratory Automation and Screening.

Development of criteria for the use of asphalt-rubber as a Stress-Absorbing Membrane Interlayer (SAMI)

NASA Astrophysics Data System (ADS)

Newcomb, D. E.; McKeen, R. G.

1983-12-01

This report documents over 2 years of research efforts to characterize asphalt-rubber mixtures to be used in Stress-Absorbing Membrane Interlayers (SAMI). The purpose of these SAMIs is to retard or prevent reflection cracking in asphalt-concrete overlays. Several laboratory experiments and one field trial were conducted to define significant test methods and parameters for incorporation into construction design and specification documents. Test methods used in this study included a modified softening point test, force-ductility, and Schweyer viscosity. Variables investigated included (1) Laboratory-mixing temperature; (2) Rubber type; (3) Laboratory storage time; (4) Laboratory storage condition; (5) Laboratory batch replication; (6) Laboratory mixing time; (7) Field mixing time; (8) Laboratory test temperature; (9) Force-Ductility elongation rates; and (10) Asphalt grade. It was found that mixing temperature, mixing time, rubber type, and asphalt grade all have significant effects upon the behavior of asphalt-rubber mixtures. Significant variability was also noticed in different laboratory batch replications. Varying laboratory test temperature and force-ductility elongation rate revealed further differences in asphalt-rubber mixtures.

Creating Best Practices for the Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories.

PubMed

Wangsness, Kathryn; Salfinger, Yvonne; Randolph, Robyn; Shea, Shari; Larson, Kirsten

2017-07-01

Laboratory accreditation provides a level of standardization in laboratories and confidence in generated food and feed testing results. For some laboratories, ISO/IEC 17025:2005 accreditation may not be fiscally viable, or a requested test method may be out of the scope of the laboratory's accreditation. To assist laboratories for whom accreditation is not feasible, the Association of Public Health Laboratories Data Acceptance Work Group developed a white paper entitled "Best Practices for Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories." The basic elements of a quality management system, along with other best practices that state and local food and feed testing laboratories should follow, are included in the white paper. It also covers program-specific requirements that may need to be addressed. Communication with programs and end data users is regarded as essential for establishing the reliability and accuracy of laboratory data. Following these suggested best practices can facilitate the acceptance of laboratory data, which can result in swift regulatory action and the quick removal of contaminated product from the food supply, improving public health nationally.

Chronic myelogenous leukemia: laboratory diagnosis and monitoring.

PubMed

Wang, Y L; Bagg, A; Pear, W; Nowell, P C; Hess, J L

2001-10-01

Rapid developments have occurred both in laboratory medicine and in therapeutic interventions for the management of patients with chronic myelogenous leukemia (CML). With a wide array of laboratory tests available, selecting the appropriate test for a specific diagnostic or therapeutic setting has become increasingly difficult. In this review, we first discuss, from the point of view of laboratory medicine, the advantages and disadvantages of several commonly used laboratory assays, including cytogenetics, fluorescence in situ hybridization (FISH), and qualitative and quantitative reverse transcriptase-polymerase chain reaction (RT-PCR). We then discuss, from the point of view of clinical care, the test(s) of choice for the most common clinical scenarios, including diagnosis and monitoring of the therapeutic response and minimal residual disease in patients treated with different therapies. The purpose of this review is to help clinicians and laboratory physicians select appropriate tests for the diagnosis and monitoring of CML, with the ultimate goal of improving the cost-effective usage of clinical laboratories and improving patient care. Copyright 2001 Wiley-Liss, Inc.

Laboratory Diagnostics Market in East Africa: A Survey of Test Types, Test Availability, and Test Prices in Kampala, Uganda.

PubMed

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.

Integration of next-generation sequencing in clinical diagnostic molecular pathology laboratories for analysis of solid tumours; an expert opinion on behalf of IQN Path ASBL.

PubMed

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.

Sensitivity, specificity, and reproducibility of four measures of laboratory turnaround time.

PubMed

Valenstein, P N; Emancipator, K

1989-04-01

The authors studied the performance of four measures of laboratory turnaround time: the mean, median, 90th percentile, and proportion of tests reported within a predetermined cut-off interval (proportion of acceptable tests [PAT]). Measures were examined with the use of turnaround time data from 11,070 stat partial thromboplastin times, 16,761 urine cultures, and 28,055 stat electrolyte panels performed by a single laboratory. For laboratories with long turnaround times, the most important quality of a turnaround time measure is high reproducibility, so that improvement in reporting speed can be distinguished from random variation resulting from sampling. The mean was found to be the most reproducible of the four measures, followed by the median. The mean achieved acceptable precision with sample sizes of 100-500 tests. For laboratories with normally rapid turnaround times, the most important quality of a measure is high sensitivity and specificity for detecting whether turnaround time has dropped below standards. The PAT was found to be the best measure of turnaround time in this setting but required sample sizes of at least 500 tests to achieve acceptable accuracy. Laboratory turnaround time may be measured for different reasons. The method of measurement should be chosen with an eye toward its intended application.

Current practice in laboratory diagnostics of autoimmune diseases in Croatia. 
Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

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.

Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory.

PubMed

Mlinaric, Ana; Milos, Marija; Coen Herak, Désirée; Fucek, Mirjana; Rimac, Vladimira; Zadro, Renata; Rogic, Dunja

2018-02-23

The need to satisfy high-throughput demands for laboratory tests continues to be a challenge. Therefore, we aimed to automate postanalytical phase in hematology and coagulation laboratory by autovalidation of complete blood count (CBC) and routine coagulation test results (prothrombin time [PT], international normalized ratio [PT-INR], activated partial thromboplastin time [APTT], fibrinogen, antithrombin activity [AT] and thrombin time [TT]). Work efficacy and turnaround time (TAT) before and after implementation of automated solutions will be compared. Ordering panels tailored to specific patient populations were implemented. Rerun and reflex testing rules were set in the respective analyzers' software (Coulter DxH Connectivity 1601, Beckman Coulter, FL, USA; AutoAssistant, Siemens Healthcare Diagnostics, Germany), and sample status information was transferred into the laboratory information system. To evaluate if the automation improved TAT and efficacy, data from manually verified results in September and October of 2015 were compared with the corresponding period in 2016 when autovalidation was implemented. Autovalidation rates of 63% for CBC and 65% for routine coagulation test results were achieved. At the TAT of 120 min, the percentage of reported results increased substantially for all analyzed tests, being above 90% for CBC, PT, PT-INR and fibrinogen and 89% for APTT. This output was achieved with three laboratory technicians less compared with the period when the postanalytical phase was not automated. Automation allowed optimized laboratory workflow for specific patient populations, thereby ensuring standardized results reporting. Autovalidation of test results proved to be an efficient tool for improvement of laboratory work efficacy and TAT.

Food-specific serum IgE and IgG reactivity in dogs with and without skin disease: lack of correlation between laboratories.

PubMed

Hardy, Jonathan I; Hendricks, Anke; Loeffler, Anette; Chang, Yu-Mei; Verheyen, Kristien L; Garden, Oliver A; Bond, Ross

2014-10-01

Despite conflicting data on their utility and no reports on interlaboratory reproducibility, serum food-specific antibodies are commonly assayed in first-opinion canine practice. To determine both the variability of test results between two laboratories and the frequencies and magnitudes of food reactivity in dogs of different disease status. Sera were obtained from eight dogs with cutaneous adverse food reaction (Group A), 22 with nonfood-induced atopic dermatitis (Group B), 30 with an allergic/inflammatory phenotype (Group C), 12 with miscellaneous skin diseases (Group D) and nine healthy dogs (Group E). Paired sera were submitted to two laboratories (A and B) for assays of food-specific IgE and IgG antibodies. Numbers of positive IgE and IgG tests determined by each laboratory in Groups A, B, D and E were comparable (Group C not included). Significant differences in the magnitude of IgE reactivity between groups for each allergen were seen only for lamb (Laboratory A, P = 0.003); lamb reactivity in Group D exceeded Group E (P = 0.004) but was comparable between all other groups. Agreement (kappa statistic) between the two laboratories' tests was 'moderate' for one antigen (potato IgE), 'fair' for four (corn IgE, rice IgE and IgG and soya bean IgG), 'slight' for eight (six IgE and two IgG) and 'less than chance' for the remaining six antigens (three IgE and three IgG). These laboratories' tests appear to have dubious predictive clinical utility because they neither correlate nor distinguish between dogs of different disease status. © 2014 ESVD and ACVD.

The cobas® 6800/8800 System: a new era of automation in molecular diagnostics.

PubMed

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.

Launching a Laboratory Testing Process Quality Improvement Toolkit: From the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP).

PubMed

Fernald, Douglas; Hamer, Mika; James, Kathy; Tutt, Brandon; West, David

2015-01-01

Family medicine and internal medicine physicians order diagnostic laboratory tests for nearly one-third of patient encounters in an average week, yet among medical errors in primary care, an estimated 15% to 54% are attributed to laboratory testing processes. From a practice improvement perspective, we (1) describe the need for laboratory testing process quality improvements from the perspective of primary care practices, and (2) describe the approaches and resources needed to implement laboratory testing process quality improvements in practice. We applied practice observations, process mapping, and interviews with primary care practices in the Shared Networks of Colorado Ambulatory Practices and Partners (SNOCAP)-affiliated practice-based research networks that field-tested in 2013 a laboratory testing process improvement toolkit. From the data collected in each of the 22 participating practices, common testing quality issues included, but were not limited to, 3 main testing process steps: laboratory test preparation, test tracking, and patient notification. Three overarching qualitative themes emerged: practices readily acknowledge multiple laboratory testing process problems; practices know that they need help addressing the issues; and practices face challenges with finding patient-centered solutions compatible with practice priorities and available resources. While practices were able to get started with guidance and a toolkit to improve laboratory testing processes, most did not seem able to achieve their quality improvement aims unassisted. Providing specific guidance tools with practice facilitation or other rapid-cycle quality improvement support may be an effective approach to improve common laboratory testing issues in primary care. © Copyright 2015 by the American Board of Family Medicine.

Quality Indicators in Laboratory Medicine: from theory to practice. Preliminary data from the IFCC Working Group Project "Laboratory Errors and Patient Safety".

PubMed

Sciacovelli, Laura; O'Kane, Maurice; Skaik, Younis Abdelwahab; Caciagli, Patrizio; Pellegrini, Cristina; Da Rin, Giorgio; Ivanov, Agnes; Ghys, Timothy; Plebani, Mario

2011-05-01

The adoption of Quality Indicators (QIs) has prompted the development of tools to measure and evaluate the quality and effectiveness of laboratory testing, first in the hospital setting and subsequently in ambulatory and other care settings. While Laboratory Medicine has an important role in the delivery of high-quality care, no consensus exists as yet on the use of QIs focussing on all steps of the laboratory total testing process (TTP), and further research in this area is required. In order to reduce errors in laboratory testing, the IFCC Working Group on "Laboratory Errors and Patient Safety" (WG-LEPS) developed a series of Quality Indicators, specifically designed for clinical laboratories. In the first phase of the project, specific QIs for key processes of the TTP were identified, including all the pre-, intra- and post-analytic steps. The overall aim of the project is to create a common reporting system for clinical laboratories based on standardized data collection, and to define state-of-the-art and Quality Specifications (QSs) for each QI independent of: a) the size of organization and type of activities; b) the complexity of processes undertaken; and c) different degree of knowledge and ability of the staff. The aim of the present paper is to report the results collected from participating laboratories from February 2008 to December 2009 and to identify preliminary QSs. The results demonstrate that a Model of Quality Indicators managed as an External Quality Assurance Program can serve as a tool to monitor and control the pre-, intra- and post-analytical activities. It might also allow clinical laboratories to identify risks that lead to errors resulting in patient harm: identification and design of practices that eliminate medical errors; the sharing of information and education of clinical and laboratory teams on practices that reduce or prevent errors; the monitoring and evaluation of improvement activities.

21 CFR 660.44 - Specificity.

Code of Federal Regulations, 2014 CFR

2014-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.44 Specificity. Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by...

21 CFR 660.44 - Specificity.

Code of Federal Regulations, 2012 CFR

2012-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.44 Specificity. Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by...

21 CFR 660.44 - Specificity.

Code of Federal Regulations, 2013 CFR

2013-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.44 Specificity. Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by...

21 CFR 660.44 - Specificity.

Code of Federal Regulations, 2010 CFR

2010-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.44 Specificity. Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by...

Making Sense of Fear Testing - Validating Common Behavioral Tests used in Swine

USDA-ARS?s Scientific Manuscript database

Tests to assess fear are commonly used in laboratory animals, such as mice and rats, when researchers wish to understand the implications of specific drugs, such as anxiolytics, or specific environments which may be used to house experimental animals. Researchers who study the welfare of livestock ...

Performance Assessment of Internal Quality Control (IQC) Products in Blood Transfusion Compatibility Testing in China

PubMed Central

Li, Jing-Jing; Gao, Qi; Liu, Zhi-Dong; Kang, Qiong-Hua; Hou, Yi-Jun; Zhang, Luo-Chuan; Hu, Xiao-Mei; Li, Jie; Zhang, Juan

2015-01-01

Internal quality control (IQC) is a critical component of laboratory quality management, and IQC products can determine the reliability of testing results. In China, given the fact that most blood transfusion compatibility laboratories do not employ IQC products or do so minimally, there is a lack of uniform and standardized IQC methods. To explore the reliability of IQC products and methods, we studied 697 results from IQC samples in our laboratory from 2012 to 2014. The results showed that the sensitivity and specificity of the IQCs in anti-B testing were 100% and 99.7%, respectively. The sensitivity and specificity of the IQCs in forward blood typing, anti-A testing, irregular antibody screening, and cross-matching were all 100%. The reliability analysis indicated that 97% of anti-B testing results were at a 99% confidence level, and 99.9% of forward blood typing, anti-A testing, irregular antibody screening, and cross-matching results were at a 99% confidence level. Therefore, our IQC products and methods are highly sensitive, specific, and reliable. Our study paves the way for the establishment of a uniform and standardized IQC method for pre-transfusion compatibility testing in China and other parts of the world. PMID:26488582

Laboratory evaluation of suspected motor neuron disease: A survey of physicians.

PubMed

Sanderson, Alan B; Novak, John C; Nash, Steven M; Kolb, Stephen J; Kissel, John T

2015-07-01

The clinical diagnosis of amyotrophic lateral sclerosis (ALS) relies on exclusion of mimic syndromes, but there are no specific guidelines regarding the extent of laboratory testing required. A survey was sent to 274 physicians listed in the Neuromuscular Section of the American Academy of Neurology. The survey asked how often they order 21 different laboratory tests in patients suspected of having ALS. Ninety-nine responses were received (36% response rate). Greater than 75% ordered serum creatine kinase, chemistry panel, and thyroid functions often or always. Fewer than 25% tested for serum complement, hexosaminidase A, spinal muscular atrophy, Kennedy disease, heavy metals, or human T-cell lymphotrophic virus often or always. Twelve other tests had intermediate responses. There is a lack of consensus among respondents regarding the laboratory evaluation of suspected ALS. Prospective studies are needed to define the diagnostic yield and cost-effectiveness of laboratory testing in this population. © 2015 Wiley Periodicals, Inc.

Filtrates and Residues: Qualitative Analysis of Some Transition Metals.

ERIC Educational Resources Information Center

Kilner, Cary

1985-01-01

Describes a qualitative analysis laboratory in which students examine specific precipitates that can be used to identify copper, cobalt, nickel, and iron cations. The objective of the laboratory is to determine which test or sequence of tests unambiguously identifies each cation and to use the results to identify several unknowns. (JN)

Laboratory and field tests of the Sutron RLR-0003-1 water level sensor

USGS Publications Warehouse

Fulford, Janice M.; Bryars, R. Scott

2015-01-01

Three Sutron RLR-0003-1 water level sensors were tested in laboratory conditions to evaluate the accuracy of the sensor over the manufacturer’s specified operating temperature and distance-to-water ranges. The sensor was also tested for compliance to SDI-12 communication protocol and in field conditions at a U.S. Geological Survey (USGS) streamgaging site. Laboratory results were compared to the manufacturer’s accuracy specification for water level and to the USGS Office of Surface Water (OSW) policy requirement that water level sensors have a measurement uncertainty of no more than 0.01 foot or 0.20 percent of the indicated reading. Except for one sensor, the differences for the temperature testing were within 0.05 foot and the average measurements for the sensors were within the manufacturer’s accuracy specification. Two of the three sensors were within the manufacturer’s specified accuracy and met the USGS accuracy requirements for the laboratory distance to water testing. Three units passed a basic SDI-12 communication compliance test. Water level measurements made by the Sutron RLR-0003-1 during field testing agreed well with those made by the bubbler system and a Design Analysis Associates (DAA) H3613 radar, and they met the USGS accuracy requirements when compared to the wire-weight gage readings.

Impact of Laboratory Test Use Strategies in a Turkish Hospital

PubMed Central

Yılmaz, Fatma Meriç; Kahveci, Rabia; Aksoy, Altan; Özer Kucuk, Emine; Akın, Tezcan; Mathew, Joseph Lazar; Meads, Catherine; Zengin, Nurullah

2016-01-01

Objectives Eliminating unnecessary laboratory tests is a good way to reduce costs while maintain patient safety. The aim of this study was to define and process strategies to rationalize laboratory use in Ankara Numune Training and Research Hospital (ANH) and calculate potential savings in costs. Methods A collaborative plan was defined by hospital managers; joint meetings with ANHTA and laboratory professors were set; the joint committee invited relevant staff for input, and a laboratory efficiency committee was created. Literature was reviewed systematically to identify strategies used to improve laboratory efficiency. Strategies that would be applicable in local settings were identified for implementation, processed, and the impact on clinical use and costs assessed for 12 months. Results Laboratory use in ANH differed enormously among clinics. Major use was identified in internal medicine. The mean number of tests per patient was 15.8. Unnecessary testing for chloride, folic acid, free prostate specific antigen, hepatitis and HIV testing were observed. Test panel use was pinpointed as the main cause of overuse of the laboratory and the Hospital Information System test ordering page was reorganized. A significant decrease (between 12.6–85.0%) was observed for the tests that were taken to an alternative page on the computer screen. The one year study saving was equivalent to 371,183 US dollars. Conclusion Hospital-based committees including laboratory professionals and clinicians can define hospital based problems and led to a standardized approach to test use that can help clinicians reduce laboratory costs through appropriate use of laboratory tests. PMID:27077653

HCG blood test - qualitative

MedlinePlus

... pregnancy. Other HCG tests include: HCG urine test Quantitative pregnancy test (checks specific level of HCG in ... eds. Henry's Clinical Diagnosis and Management by Laboratory Methods . 23rd ed. Philadelphia, PA: Elsevier; 2017:chap 74. ...

A laboratory comparison of individual Targis/Vectris posts with standard fiberglass posts.

PubMed

Corsalini, Massimo; Genovese, Katia; Lamberti, Luciano; Pappalettere, Carmine; Carella, Mauro; Carossa, Stefano

2007-01-01

This article presents an in vitro analysis of a specific occlusal loading test on endodontically treated teeth restored with 2 different composite post materials. Individual, customized posts (IFPs) were compared to standard fiberglass posts (SFPs). The selected IFPs (standard cylindric Targis/Vectris posts) were compared to SFPs (Conic 6% Post, Ghimas). The posts were first subjected to a 3-point bending test to compare their flexural elastic properties. They were then used to restore 22 endodontically treated artificial maxillary central incisors and subjected to a specific occlusal loading simulation test. The loading test showed that IFP restorations performed better than SFP restorations. A clinical evaluation of this laboratory observation is suggested.

21 CFR 660.5 - Specificity.

Code of Federal Regulations, 2014 CFR

2014-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.5 Specificity. Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as...

21 CFR 660.5 - Specificity.

Code of Federal Regulations, 2012 CFR

2012-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.5 Specificity. Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as...

21 CFR 660.5 - Specificity.

Code of Federal Regulations, 2013 CFR

2013-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.5 Specificity. Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as...

21 CFR 660.5 - Specificity.

Code of Federal Regulations, 2010 CFR

2010-04-01

... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.5 Specificity. Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as...

Pretreatment Engineering Platform Phase 1 Final Test Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kurath, Dean E.; Hanson, Brady D.; Minette, Michael J.

2009-12-23

Pacific Northwest National Laboratory (PNNL) was tasked by Bechtel National Inc. (BNI) on the River Protection Project, Hanford Tank Waste Treatment and Immobilization Plant (RPP-WTP) project to conduct testing to demonstrate the performance of the WTP Pretreatment Facility (PTF) leaching and ultrafiltration processes at an engineering-scale. In addition to the demonstration, the testing was to address specific technical issues identified in Issue Response Plan for Implementation of External Flowsheet Review Team (EFRT) Recommendations - M12, Undemonstrated Leaching Processes.( ) Testing was conducted in a 1/4.5-scale mock-up of the PTF ultrafiltration system, the Pretreatment Engineering Platform (PEP). Parallel laboratory testing wasmore » conducted in various PNNL laboratories to allow direct comparison of process performance at an engineering-scale and a laboratory-scale. This report presents and discusses the results of those tests.« less

Current practice in laboratory diagnostics of autoimmune diseases in Croatia. 
Survey of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine

PubMed Central

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

HIF evaluation of In-Situ Aqua TROLL 400

USGS Publications Warehouse

Tillman, Evan F.

2017-10-18

The In-Situ Aqua TROLL 400 (Aqua TROLL 400) was tested at the U.S. Geological Survey (USGS) Hydrologic Instrumentation Facility (HIF) against known standards over the Aqua TROLL 400’s operating temperature to verify the manufacturer’s stated accuracy specifications and the USGS recommendations for pH, dissolved oxygen (DO), and specific conductance (SC). The Aqua TROLL 400 manufacturer’s specifications are within the USGS recommendations for all parameters tested, except for DO, which is outside the USGS recommendation at DO concentrations of 8.0 milligrams per liter (mg/L) and higher. The Aqua TROLL 400 was compliant with Serial Digital Interface at 1200 baud (SDI-12) version 1.3. During laboratory testing of pH, the Aqua TROLL 400 sonde met the U.S. Geological Survey “National Field Manual for the Collection of Water-Quality Data” (NFM) recommendations for pH at all values tested, except at 4 degrees Celsius (°C) at pH 9.395 and pH 3.998. The Aqua TROLL 400 met the manufacturer specifications for pH at all values tested, except for pH buffers 3.998, 9.395, and 10.245 at 4 °C; pH 2.990 and 3.998 at 15 °C; and pH 3.040 at 40 °C. The Aqua TROLL 400 met the NFM recommendations at 93.7 percent of the SC values tested and met the manufacturer’s accuracy specifications at 56.3 percent of the SC values tested. During the laboratory testing for DO, the Aqua TROLL 400 met the manufacturer specifications, except at 5.55 mg/L, and met the NFM recommendations at all concentrations tested. An Aqua TROLL 400 was field tested at USGS Station 02492620, National Space Technology Laboratories (NSTL) Station, Mississippi, on the Pearl River for 6 weeks and showed good agreement with the well-maintained site sonde data for pH, DO, temperature, and SC.

Microbiological methods for the water recovery systems test, revision 1.1

NASA Technical Reports Server (NTRS)

Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

1990-01-01

Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

Body fluid analysis: clinical utility and applicability of published studies to guide interpretation of today's laboratory testing in serous fluids.

PubMed

Block, Darci R; Algeciras-Schimnich, Alicia

2013-01-01

Requests for testing various analytes in serous fluids (e.g., pleural, peritoneal, pericardial effusions) are submitted daily to clinical laboratories. Testing of these fluids deviates from assay manufacturers' specifications, as most laboratory assays are optimized for testing blood or urine specimens. These requests add a burden to clinical laboratories, which need to validate assay performance characteristics in these fluids to exclude matrix interferences (given the different composition of body fluids) while maintaining regulatory compliance. Body fluid testing for a number of analytes has been reported in the literature; however, understanding the clinical utility of these analytes is critical because laboratories must address the analytic and clinical validation requirements, while educating clinicians on proper test utilization. In this article, we review the published data to evaluate the clinical utility of testing for numerous analytes in body fluid specimens. We also highlight the pre-analytic and analytic variables that need to be considered when reviewing published studies in body fluid testing. Finally, we provide guidance on how published studies might (or might not) guide interpretation of test results in today's clinical laboratories.

Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease, United States.

PubMed

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.

Shield evaluation and performance testing at the USMB`s Strategic Structures Testing Laboratory

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barczak, T.M.; Gearhart, D.F.

1996-12-31

Historically, shield performance testing is conducted by the support manufacturers at European facilities. The U.S. Bureau of Mines (USBM) has conducted extensive research in shield Mechanics and is now opening its Strategic Structures Testing (SST) Laboratory to the mining industry for shield performance testing. The SST Laboratory provides unique shield testing capabilities using the Mine Roof Simulator (MRS) load frame. The MRS provides realistic and cost-effective shield evaluation by combining both vertical and horizontal loading into a single load cycle; whereas, several load cycles would be required to obtain this loading in a static frame. In addition to these advantages,more » the USBM acts as an independent research organization to provide an unbiased assessment of shield performance. This paper describes the USBM`s shield testing program that is designed specifically to simulate in-service mining conditions using the unique the capabilities of the SST Laboratory.« less

Approaches to quality management and accreditation in a genetic testing laboratory

PubMed Central

Berwouts, Sarah; Morris, Michael A; Dequeker, Elisabeth

2010-01-01

Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement. PMID:20720559

Utility of NIST Whole-Genome Reference Materials for the Technical Validation of a Multigene Next-Generation Sequencing Test.

PubMed

Shum, Bennett O V; Henner, Ilya; Belluoccio, Daniele; Hinchcliffe, Marcus J

2017-07-01

The sensitivity and specificity of next-generation sequencing laboratory developed tests (LDTs) are typically determined by an analyte-specific approach. Analyte-specific validations use disease-specific controls to assess an LDT's ability to detect known pathogenic variants. Alternatively, a methods-based approach can be used for LDT technical validations. Methods-focused validations do not use disease-specific controls but use benchmark reference DNA that contains known variants (benign, variants of unknown significance, and pathogenic) to assess variant calling accuracy of a next-generation sequencing workflow. Recently, four whole-genome reference materials (RMs) from the National Institute of Standards and Technology (NIST) were released to standardize methods-based validations of next-generation sequencing panels across laboratories. We provide a practical method for using NIST RMs to validate multigene panels. We analyzed the utility of RMs in validating a novel newborn screening test that targets 70 genes, called NEO1. Despite the NIST RM variant truth set originating from multiple sequencing platforms, replicates, and library types, we discovered a 5.2% false-negative variant detection rate in the RM truth set genes that were assessed in our validation. We developed a strategy using complementary non-RM controls to demonstrate 99.6% sensitivity of the NEO1 test in detecting variants. Our findings have implications for laboratories or proficiency testing organizations using whole-genome NIST RMs for testing. Copyright © 2017 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Laboratory and clinical evaluation of on-site urine drug testing.

PubMed

Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter

2014-11-01

Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

'Multiple-test' approach to the laboratory diagnosis of tuberculosis -perception of medical doctors from Ujjain, India.

PubMed

Purohit, Manju Raj; Sharma, Megha; Rosales-Klintz, Senia; Lundborg, Cecilia Stålsby

2015-08-11

Delay in diagnosis is one of the most important factors for the control of tuberculosis (TB) in endemic countries like India. As laboratory diagnosis is the mainstay for identification of active disease, we aim to explore and understand the opinions of medical doctors about the laboratory diagnosis of TB in Ujjain, India. Sixteen qualified specialist medical doctors from Ujjain were purposefully selected for the study. Individual interviews with the doctors (13 men and 3 women), were conducted. As one interview could not be completed, data from 15 interviews were analyzed using manifest and latent content analysis. Based on perception of the doctors, the theme; 'challenges and need for the laboratory diagnosis of TB' emerged from the following subthemes: (i) Relationship between basic element of the TB diseases process such as 'Symptoms prior to diagnoses' and 'Clinical characteristics of TB', which were not specific enough to diagnose TB (ii) The prevailing conditions such as lack of explicit diagnostic tools, lead to the doctors using the 'multiple tests' or 'empiric treatment' approach (iii) The doctors proposed that there is a need for access to a rapid, single and simple diagnostic test, and a need for awareness and knowledge of the practitioners regarding specific TB investigations, and early referral to improve the situation at resource-limited settings. The medical specialists use a 'multiple test' or 'empiric treatment' approach to diagnose TB. According to the participants, there is a low dependence and uptake of the available laboratory TB investigations by medical practitioners. There is an urgent need to have a specific, simple and reliable test, and a protocol, to improve diagnosis of TB and to prevent development of resistant TB.

Experience with specifications applicable to certification. [of photovoltaic modules for large-scale application

NASA Technical Reports Server (NTRS)

Ross, R. G., Jr.

1982-01-01

The Jet Propulsion Laboratory has developed a number of photovoltaic test and measurement specifications to guide the development of modules toward the requirements of future large-scale applications. Experience with these specifications and the extensive module measurement and testing that has accompanied their use is examined. Conclusions are drawn relative to three aspects of product certification: performance measurement, endurance testing and safety evaluation.

Donating Blood Questions and Answers

MedlinePlus

... isolated laboratory test results should not be considered equivalent to a history of viral hepatitis. In particular, ... transfusion. This test was intended as a surrogate non-specific test for hepatitis C (formerly called non- ...

Repeatability and validity of a field kit for estimation of cholinesterase in whole blood.

PubMed Central

London, L; Thompson, M L; Sacks, S; Fuller, B; Bachmann, O M; Myers, J E

1995-01-01

OBJECTIVES--To evaluate a spectrophotometric field kit (Test-Mate-OP) for repeatability and validity in comparison with reference laboratory methods and to model its anticipated sensitivity and specificity based on these findings. METHODS--76 farm workers between the age of 20 and 55, of whom 30 were pesticide applicators exposed to a range of organophosphates in the preceding 10 days, had blood taken for plasma cholinesterase (PCE) and erythrocyte cholinesterase (ECE) measurement by field kit or laboratory methods. Paired blinded duplicate samples were taken from subgroups in the sample to assess repeatability of laboratory and field kit methods. Field kits were also used to test venous blood in one subgroup. The variance obtained for the field kit tests was then applied to two hypothetical scenarios that used published action guidelines to model the kit's sensitivity and specificity. RESULTS--Repeatability for PCE was much poorer and for ECE slightly poorer than that of laboratory measures. A substantial upward bias for field kit ECE relative to laboratory measurements was found. Sensitivity of the kit to a 40% drop in PCE was 67%, whereas that for ECE was 89%. Specificity of the kit with no change in mean of the population was 100% for ECE and 91% for PCE. CONCLUSION--Field kit ECE estimation seems to be sufficiently repeatable for surveillance activities, whereas PCE does not. Repeatability of both tests seems to be too low for use in epidemiological dose-response investigations. Further research is indicated to characterise the upward bias in ECE estimation on the kit. PMID:7697143

Computer listing of the effects of drugs on laboratory data

PubMed Central

Young, D. S.; Thomas, D. W.; Friedman, R. B.

1972-01-01

A listing of approximately 10000 effects of drugs on tests performed in clinical laboratories has been developed in a time-shared computer. The list contains a directory for matching proprietary and generic names of drugs and an explanation for the mode of action of the drug on each test. Each entry is supported by a bibliographical reference that contains the author's names, and the title of the article and journal. It is possible to search for specific `character strings' (word or words, number, etc) to obtain all the effects of a particular drug, or all drugs that affect a particular test, or even to search for a specific explanation for an effect. The system is undergoing trial in the Department's own computer to permit of automatic correlation of the effects of drugs with laboratory data from patients in one hospital ward. PMID:4648544

Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

PubMed Central

Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

2006-01-01

Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

Draft Test Guideline: Site-Specific Aquatic Microcosm Test, Laboratory

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Evaluation of the Radar Stage Sensor manufactured by Forest Technology Systems—Results of laboratory and field testing

USGS Publications Warehouse

Kunkle, Gerald A.

2018-01-31

Two identical Radar Stage Sensors from Forest Technology Systems were evaluated to determine if they are suitable for U.S. Geological Survey (USGS) hydrologic data collection. The sensors were evaluated in laboratory conditions to evaluate the distance accuracy of the sensor over the manufacturer’s specified operating temperatures and distance to water ranges. Laboratory results were compared to the manufacturer’s accuracy specification of ±0.007 foot (ft) and the USGS Office of Surface Water (OSW) policy requirement that water-level sensors have a measurement uncertainty of no more than 0.01 ft or 0.20 percent of the indicated reading. Both of the sensors tested were within the OSW policy requirement in both laboratory tests and within the manufacturer’s specification in the distance to water test over tested distances from 3 to 15 ft. In the temperature chamber test, both sensors were within the manufacturer’s specification for more than 90 percent of the data points collected over a temperature range of –40 to +60 degrees Celsius at a fixed distance of 8 ft. One sensor was subjected to an SDI-12 communication test, which it passed. A field test was conducted on one sensor at a USGS field site near Landon, Mississippi, from February 5 to March 29, 2016. Water-level measurements made by the radar during the field test were in agreement with those made by the Sutron Accubar Constant Flow Bubble Gauge.Upon the manufacturer’s release of updated firmware version 1.09, additional SDI-12 and temperature testing was performed to evaluate added SDI-12 functions and verify that performance was unaffected by the update. At this time, an Axiom data logger is required to perform a firmware update on this sensor. The data confirmed the results of the original test. Based on the test results, the Radar Stage Sensor is a suitable choice for USGS hydrologic data collection.

Accuracy of a point-of-care ELISA test kit for predicting the presence of protective canine parvovirus and canine distemper virus antibody concentrations in dogs.

PubMed

Litster, A L; Pressler, B; Volpe, A; Dubovi, E

2012-08-01

Canine parvovirus (CPV) and canine distemper virus (CDV) are highly infectious and often fatal diseases with worldwide distributions, and are important population management considerations in animal shelters. A point-of-care ELISA test kit is available to detect serum antibodies to CPV and CDV, and presumptively to predict protective status. The aim of this study was to determine the diagnostic accuracy of the test compared to CPV hemagglutination inhibition titers and CDV serum neutralization titers determined by a reference laboratory, using sera collected from dogs housed at animal shelters. The ELISA test was used under both field and laboratory conditions and duplicate specimens were processed using an extra wash step. The test kit yielded accurate results (CPV: sensitivity 92.3%, specificity 93.5%; CDV: sensitivity 75.7%, specificity 91.8%) under field conditions. CDV sensitivity was improved by performing the test under laboratory conditions and using an optical density (OD) meter (laboratory performed 94.0%; OD 88.1%). Point-of-care ELISA testing for serum CPV and CDV antibody titers was demonstrated to be a useful tool for determining antibody status when making decisions regarding the need for CPV and/or CDV vaccination and also in animal shelters for population management. Copyright © 2012 Elsevier Ltd. All rights reserved.

12. "SITE PLAN." Test Area 1100. Specifications No. OC35973; Drawing ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

12. "SITE PLAN." Test Area 1-100. Specifications No. OC359-73; Drawing No. 5841-C-1; D.O. SERIES AW1525/7 Rev. A. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Leuhman Ridge near Highways 58 & 395, Boron, Kern County, CA

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

PubMed

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.

FIELD CHECK MANUAL FOR LANGUAGE LABORATORIES, A SERIES OF TESTS WHICH A NON-TECHNICAL PERSON CAN CONDUCT TO VERIFY SPECIFICATIONS.

ERIC Educational Resources Information Center

GRITTNER, FRANK; PAVLAT, RUSSELL

IN ORDER TO ASSIST NON-TECHNICAL PEOPLE IN SCHOOLS TO CONDUCT A FIELD CHECK OF LANGUAGE LABORATORY EQUIPMENT BEFORE THEY MAKE FINAL PAYMENTS, THIS MANUAL OFFERS CRITERIA, TESTS, AND METHODS OF SCORING THE QUALITY OF THE EQUIPMENT. CHECKLISTS ARE PROVIDED FOR EVALUATING CONSOLE FUNCTIONS, TAPE RECORDERS, AMPLIFIERS, SOUND QUALITY (INCLUDING…

26. "TEST STAND, STRUCTURAL, FOUNDATION PLAN." Specifications No. ENG043535572; Drawing ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

26. "TEST STAND, STRUCTURAL, FOUNDATION PLAN." Specifications No. ENG-04-353-55-72; Drawing No. 60-0912; sheet 25 of 148; file no. 1320/76. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

Laboratory tests for diagnosis of food allergy: advantages, disadvantages and future perspectives.

PubMed

Moneret-Vautrin, D A; Kanny, G; Frémont, S

2003-04-01

Numerous biological tests point to the diagnosis of food sensitization: detection of specific IgEs by Rast techniques, multi-detection assays, immunoblotting, screening of basophil activation (BAT or FAST), assays for leukotriene LTC4 release (CAST), measurement of plasma histamine, serum tryptase, serum ECP, urinary EDN, completed by mannitol-lactulose test evaluating intestinal permeability, assay of fecal IgEs, Rast for specific IgG4. Primary screening for anti-food IgEs by multi-detection assays seeks justification from insufficient clinical data and false positive tests are common in patients sensitized to pollens or latex, on account of in vitro cross reactivities (CR). Multiple CR explain positive Rast to vegetal food allergens in such patients. Biological tests should not be performed as the first line of diagnosis. In vivo sensitisation is assessed by positive prick-tests, demonstrating the bivalence of allergens, as well as the affinity of specific IgEs, two conditions necessary to bridge membrane bound specific IgEs, leading to the release of mediators. Prick-tests are closer to clinical symptoms than biological tests. However, the diagnosis of food allergy is based on standardised oral challenges. Exceptions are high levels of specific IgEs to egg (> 6 kUl/l), peanut (> 15 kUl/l), fish (> 20 kUl/l) and milk (> 32 kUl/l), reaching a 95% predictive positive value. Rast inhibition tests are useful to identify masked allergens in foods. Research developments will have impact on the development of new diagnostic tools: allergen mixes reinforcing a food extract by associated recombinant major allergens, multiple combination of recombinant allergens (chips) or tests with synthetic epitopes aimed a the prediction of recovery. Laboratory tests take place in the decision free for the diagnosis for the food allergy and the follow-up of the levels specific IgEs is a tool to assess outcome and contributes to predict recovery or persistent allergy. Up to now the significance of positive laboratory tests showing the implication of IgEs is at the crossroads of the allergist's and biologist's expertise.

An effective utilization management strategy by dual approach of influencing physician ordering and gate keeping.

PubMed

Elnenaei, Manal O; Campbell, Samuel G; Thoni, Andrea J; Lou, Amy; Crocker, Bryan D; Nassar, Bassam A

2016-02-01

There is increasing recognition of the importance of appropriate laboratory test utilization. We investigate the effect of a multifaceted educational approach that includes physician feedback on individual test ordering, in conjunction with targeted restriction, on the utilization of selected laboratory tests. Scientific evidence was compiled on the usefulness and limitations of tests suspected of being over utilized in our laboratories. A variety of approaches were used to deliver education on each of the targeted tests, with greater focus on primary care physicians (PCPs). Feedback on requesting behavior of these tests was also communicated to the latter group which included an educational component. Laboratory based restriction of testing was also exercised, including the unbundling of our electrolyte panel. PCP requesting patterns for the selected tests were found to be markedly skewed. The interventions implemented over the study period resulted in a substantial 51% reduction in overall ordering of five of the targeted tests equating to an annual marginal cost saving of $60,124. Unbundling of the electrolyte panel resulted in marginal cost savings that equated annually to $42,500 on chloride and $48,000 on total CO2. A multifaceted educational approach combined with feedback on utilization and laboratory driven gate-keeping significantly reduced the number of laboratory tests suspected of being redundant or unjustifiably requested. Laboratory professionals are well positioned to manage demand on laboratory tests by utilizing evidence base in developing specific test ordering directives and gate-keeping rules. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

Laboratory evaluations of erectile dysfunction: an evidence based approach.

PubMed

Bodie, Joshua; Lewis, Jean; Schow, Doug; Monga, Manoj

2003-06-01

We evaluate the prevalence of laboratory abnormalities in men presenting for initial evaluation and therapy of erectile dysfunction. The computerized charts of men receiving treatment for erectile dysfunction from 1987 to 2002 were retrospectively reviewed. We pooled laboratory data for 3,547 men with erectile dysfunction to assess the prevalence of laboratory abnormalities. Values of the common laboratory screening tests for erectile dysfunction were recorded for testosterone, prolactin, luteinizing hormone, thyroid-stimulating hormone, hemoglobin A(Ic), prostate specific antigen, hemoglobin, cholesterol and creatinine. Of those patients evaluated 18.7% had low testosterone, 4.6% had increased prolactin, 14.6% had abnormal luteinizing hormone, 4.0% had increased thyroid-stimulating hormone, 8.3% had increased prostate specific antigen, 26.5% had anemia and 11.9% tested had renal insufficiency. A high percentage of patients presenting with a primary complaint of erectile dysfunction had increased hemoglobin A(Ic) and total serum cholesterol levels (52.9% and 48.4%, respectively). An evidence based approach to standardization of laboratory evaluations for men presenting with erectile dysfunction is recommended. Laboratory screening should be directed to identify those risk factors that may benefit from lifestyle modification and pharmacological intervention.

Development of an evidence-based approach to external quality assurance for breast cancer hormone receptor immunohistochemistry: comparison of reference values.

PubMed

Makretsov, Nikita; Gilks, C Blake; Alaghehbandan, Reza; Garratt, John; Quenneville, Louise; Mercer, Joel; Palavdzic, Dragana; Torlakovic, Emina E

2011-07-01

External quality assurance and proficiency testing programs for breast cancer predictive biomarkers are based largely on traditional ad hoc design; at present there is no universal consensus on definition of a standard reference value for samples used in external quality assurance programs. To explore reference values for estrogen receptor and progesterone receptor immunohistochemistry in order to develop an evidence-based analytic platform for external quality assurance. There were 31 participating laboratories, 4 of which were previously designated as "expert" laboratories. Each participant tested a tissue microarray slide with 44 breast carcinomas for estrogen receptor and progesterone receptor and submitted it to the Canadian Immunohistochemistry Quality Control Program for analysis. Nuclear staining in 1% or more of the tumor cells was a positive score. Five methods for determining reference values were compared. All reference values showed 100% agreement for estrogen receptor and progesterone receptor scores, when indeterminate results were excluded. Individual laboratory performance (agreement rates, test sensitivity, test specificity, positive predictive value, negative predictive value, and κ value) was very similar for all reference values. Identification of suboptimal performance by all methods was identical for 30 of 31 laboratories. Estrogen receptor assessment of 1 laboratory was discordant: agreement was less than 90% for 3 of 5 reference values and greater than 90% with the use of 2 other reference values. Various reference values provide equivalent laboratory rating. In addition to descriptive feedback, our approach allows calculation of technical test sensitivity and specificity, positive and negative predictive values, agreement rates, and κ values to guide corrective actions.

Developing a customised approach for strengthening tuberculosis laboratory quality management systems toward accreditation

PubMed Central

Trollip, Andre; Erni, Donatelle; Kao, Kekeletso

2017-01-01

Background Quality-assured tuberculosis laboratory services are critical to achieve global and national goals for tuberculosis prevention and care. Implementation of a quality management system (QMS) in laboratories leads to improved quality of diagnostic tests and better patient care. The Strengthening Laboratory Management Toward Accreditation (SLMTA) programme has led to measurable improvements in the QMS of clinical laboratories. However, progress in tuberculosis laboratories has been slower, which may be attributed to the need for a structured tuberculosis-specific approach to implementing QMS. We describe the development and early implementation of the Strengthening Tuberculosis Laboratory Management Toward Accreditation (TB SLMTA) programme. Development The TB SLMTA curriculum was developed by customizing the SLMTA curriculum to include specific tools, job aids and supplementary materials specific to the tuberculosis laboratory. The TB SLMTA Harmonized Checklist was developed from the World Health Organisation Regional Office for Africa Stepwise Laboratory Quality Improvement Process Towards Accreditation checklist, and incorporated tuberculosis-specific requirements from the Global Laboratory Initiative Stepwise Process Towards Tuberculosis Laboratory Accreditation online tool. Implementation Four regional training-of-trainers workshops have been conducted since 2013. The TB SLMTA programme has been rolled out in 37 tuberculosis laboratories in 10 countries using the Workshop approach in 32 laboratories in five countries and the Facility-based approach in five tuberculosis laboratories in five countries. Conclusion Lessons learnt from early implementation of TB SLMTA suggest that a structured training and mentoring programme can build a foundation towards further quality improvement in tuberculosis laboratories. Structured mentoring, and institutionalisation of QMS into country programmes, is needed to support tuberculosis laboratories to achieve accreditation. PMID:28879165

Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

PubMed

2012-04-06

Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn screening laboratories. The recommended practices address the benefits of using a quality management system approach, factors to consider before introducing new tests, establishment and verification of test performance specifications, the total laboratory testing process (which consists of the preanalytic, analytic, and postanalytic phases), confidentiality of patient information and test results, and personnel qualifications and responsibilities for laboratory testing for inherited metabolic diseases. These recommendations are intended for laboratories that perform biochemical genetic testing to improve the quality of laboratory services and for newborn screening laboratories to ensure the quality of laboratory practices for inherited metabolic disorders. These recommendations also are intended as a resource for medical and public health professionals who evaluate laboratory practices, for users of laboratory services to facilitate their collaboration with newborn screening systems and use of biochemical genetic tests, and for standard-setting organizations and professional societies in developing future laboratory quality standards and practice recommendations. This report complements Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions (CDC. Good laboratory practices for molecular genetic testing for heritable diseases and conditions. MMWR 2009;58 [No. RR-6]) to provide guidance for ensuring and improving the quality of genetic laboratory services and public health outcomes. Future recommendations for additional areas of genetic testing will be considered on the basis of continued monitoring and evaluation of laboratory practices, technology advancements, and the development of laboratory standards and guidelines.

Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

PubMed

Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

2017-02-01

Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed, along with variables that influence test results and interpretation.Genet Med 19 2, 256-263.

Field evaluation of a rapid, visually-read colloidal dye immunofiltration assay for Schistosoma japonicum for screening in areas of low transmission.

PubMed Central

Xiao, Xiang; Wang, Tianping; Ye, Hongzhuan; Qiang, Guangxiang; Wei, Haiming; Tian, Zhigang

2005-01-01

OBJECTIVE: To determine the validity of a recently developed rapid test--a colloidal dye immunofiltration assay (CDIFA)--used by health workers in field settings to identify villagers infected with Schistosoma japonicum. METHODS: Health workers in the field used CDIFA to test samples from 1553 villagers in two areas of low endemicity and an area where S. japonicum was not endemic in Anhui, China. All the samples were then tested in the laboratory by laboratory staff using a standard parasitological method (Kato-Katz), an indirect haemagglutination assay (IHA), and CDIFA. The results of CDIFA performed by health workers were compared with those obtained by Kato-Katz and IHA. FINDINGS: Concordance between the results of CDIFA performed in field settings and in the laboratory was high (kappa index, 0.95; 95% confidence interval, 0.93-0.97). When Kato-Katz was used as the reference test, the overall sensitivity and specificity of CDIFA were 98.5% and 83.6%, respectively in the two villages in areas of low endemicity, while the specificity was 99.8% in the nonendemic village. Compared with IHA, the overall specificity and sensitivity of CDIFA were greater than 99% and 96%, respectively. With the combination of Kato-Katz and IHA as the reference standard, CDIFA had a sensitivity of 95.8% and a specificity of 99.5%, and an accuracy of 98.6% in the two areas of low endemicity. CONCLUSION: CDIFA is a specific, sensitive, and reliable test that can be used for rapid screening for schistosomiasis by health workers in field settings. PMID:16175827

The quality and scope of information provided by medical laboratories to patients before laboratory testing: Survey of the Working Group for Patient Preparation of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

PubMed

Nikolac, Nora; Simundic, Ana-Maria; Kackov, Sanja; Serdar, Tihana; Dorotic, Adrijana; Fumic, Ksenija; Gudasic-Vrdoljak, Jelena; Klenkar, Kornelija; Sambunjak, Jadranka; Vidranski, Valentina

2015-10-23

The aim of this work was to evaluate to what extent the scope and content of information provided to patients is standardized across medical biochemistry laboratories in Croatia. Two on-line self-report surveys were sent out: Survey A regarding attitudes on importance of patient preparation and Survey B on the contents of patient preparation instructions. 13/118 laboratories (11%) do not provide written instructions to patients on how to prepare for laboratory testing, and 36 (40%) do not include information about water intake in their instructions. Only half of laboratories provide instructions for prostate-specific antigen (53.8%), female sex hormones (53.7%) and therapeutic drug monitoring (TDM) (52.5%). Inadequate information about fasting status (55.0%) and 24 hour urine collection (77.9%) were frequent errors with high severity and were associated with the greatest potential to cause patient harm. Laboratory professionals in Croatia have a positive attitude towards the importance of patient preparation for laboratory testing. However, the information for laboratory testing is not standardized and frequently lacks guidance for tests related to TDM, coagulation and endocrinology. This study highlights the need for standardized, updated and evidence-based recommendations for patient preparation in order to minimize the risk for patients. Copyright © 2015 Elsevier B.V. All rights reserved.

Quality assurance of laboratory work and clinical use of laboratory tests in general practice in norway: a survey.

PubMed

Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre

2011-09-01

Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices. In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests. Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests. Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.

Current Guidelines, Common Clinical Pitfalls, and Future Directions for Laboratory Diagnosis of Lyme Disease, United States

PubMed Central

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

Evaluating diagnostic tests for bovine tuberculosis in the southern part of Germany: A latent class analysis

PubMed Central

Knubben-Schweizer, Gabriela; Döpfer, Dörte; Groll, Andreas; Hafner-Marx, Angela; Hörmansdorfer, Stefan; Sauter-Louis, Carola; Straubinger, Reinhard K.; Zimmermann, Pia; Hartnack, Sonja

2017-01-01

Germany has been officially free of bovine tuberculosis since 1996. However, in the last years there has been an increase of bovine tuberculosis cases, particularly in the southern part of Germany, in the Allgäu region. As a consequence a one-time tuberculosis surveillance program was revisited with different premortal and postmortal tests. The aim of this paper was to estimate diagnostic sensitivities and specificities of the different tests used within this surveillance program. In the absence of a perfect test with 100% sensitivity and 100% specificity, thus in the absence of a gold standard, a Bayesian latent class approach with two different datasets was performed. The first dataset included 389 animals, tested with single intra-dermal comparative cervical tuberculin (SICCT) test, PCR and pathology; the second dataset contained 175 animals, tested with single intra-dermal cervical tuberculin (SICT) test, Bovigam® assay, pathology and culture. Two-way conditional dependencies were considered within the models. Additionally, inter-laboratory agreement (five officially approved laboratories) of the Bovigam® assay was assessed with Cohen's kappa test (21 blood samples). The results are given in posterior means and 95% credibility intervals. The specificities of the SICT test, SICCT test, PCR and pathology ranged between 75.8% [68.8–82.2%] and 99.0% [96.8–100%]. The Bovigam® assay stood out with a very low specificity (6.9% [3.6–11.1%]), though it had the highest sensitivity (95.7% [91.3–99.2%]). The sensitivities of the SICCT test, PCR, SICT test, pathology and culture varied from 57.8% [48.0–67.6%] to 88.9% [65.5–99.7%]. The prevalences were 19.8% [14.6–26.5%] (three-test dataset) and 7.7% [4.2–12.3%] (four-test dataset). Among all pairwise comparisons the highest agreement was 0.62 [0.15–1]). In conclusion, the specificity of the Bovigam® assay and the inter-laboratory agreement were lower than expected. PMID:28640908

Factitious diarrhea induced by stimulant laxatives: accuracy of diagnosis by a clinical reference laboratory using thin layer chromatography.

PubMed

Shelton, Joseph H; Santa Ana, Carol A; Thompson, Donald R; Emmett, Michael; Fordtran, John S

2007-01-01

Surreptitious ingestion of laxatives can lead to serious factitious diseases that are difficult to diagnose. Most cases involve ingestion of bisacodyl or senna. Thin layer chromatography (TLC) of urine or stool is the only commercially available test for these laxatives. Such testing is considered highly reliable, but its accuracy in clinical practice is unknown. Our aim was to evaluate the reliability of TLC laxative testing by a clinical reference laboratory in the United States. Diarrhea was induced in healthy volunteers by ingestion of bisacodyl, senna, or a control laxative (n = 11 for each laxative group). Samples of urine and diarrheal stool were sent in blinded fashion to the clinical reference laboratory for bisacodyl and senna analysis. TLC testing for bisacodyl-induced diarrhea revealed a sensitivity of 73% and specificity of 91% when urine was tested and sensitivity and specificity of 91% and 96%, respectively, when stool was analyzed. When diarrhea was induced by senna, the TLC assay for senna failed to identify even a single urine or stool specimen as positive (zero% sensitivity). Considering the expected prevalence of surreptitious laxative abuse in patients with chronic idiopathic diarrhea (2.4%-25%, depending on the clinical setting), TLC of urine or stool for bisacodyl by this reference laboratory would often produce misleading results, and testing for senna would have no clinical value. The major problems are false-positive tests for bisacodyl and false-negative tests for senna.

Improving communication skill training in patient centered medical practice for enhancing rational use of laboratory tests: The core of bioinformation for leveraging stakeholder engagement in regulatory science.

PubMed

Moura, Josemar de Almeida; Costa, Bruna Carvalho; de Faria, Rosa Malena Delbone; Soares, Taciana Figueiredo; Moura, Eliane Perlatto; Chiappelli, Francesco

2013-01-01

Requests for laboratory tests are among the most relevant additional tools used by physicians as part of patient's health problemsolving. However, the overestimation of complementary investigation may be linked to less reflective medical practice as a consequence of a poor physician-patient communication, and may impair patient-centered care. This scenario is likely to result from reduced consultation time, and a clinical model focused on the disease. We propose a new medical intervention program that specifically targets improving the patient-centered communication of laboratory tests results, the core of bioinformation in health care. Expectations are that medical students training in communication skills significantly improve physicians-patient relationship, reduce inappropriate use of laboratorial tests, and raise stakeholder engagement.

Comparison of the diagnostic accuracy of a rapid immunochromatographic test and the rapid plasma reagin test for antenatal syphilis screening in Mozambique.

PubMed Central

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

Total laboratory automation: Do stat tests still matter?

PubMed

Dolci, Alberto; Giavarina, Davide; Pasqualetti, Sara; Szőke, Dominika; Panteghini, Mauro

2017-07-01

During the past decades the healthcare systems have rapidly changed and today hospital care is primarily advocated for critical patients and acute treatments, for which laboratory test results are crucial and need to be always reported in predictably short turnaround time (TAT). Laboratories in the hospital setting can face this challenge by changing their organization from a compartmentalized laboratory department toward a decision making-based laboratory department. This requires the implementation of a core laboratory, that exploits total laboratory automation (TLA) using technological innovation in analytical platforms, track systems and information technology, including middleware, and a number of satellite specialized laboratory sections cooperating with care teams for specific medical conditions. In this laboratory department model, the short TAT for all first-line tests performed by TLA in the core laboratory represents the key paradigm, where no more stat testing is required because all samples are handled in real-time and (auto)validated results dispatched in a time that fulfills clinical needs. To optimally reach this goal, laboratories should be actively involved in managing all the steps covering the total examination process, speeding up also extra-laboratory phases, such sample delivery. Furthermore, to warrant effectiveness and not only efficiency, all the processes, e.g. specimen integrity check, should be managed by middleware through a predefined set of rules defined in light of the clinical governance. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Airworthiness and Flight Characteristics Test (A&FC) of the CH-47D helicopter

DTIC Science & Technology

1984-02-01

Development Specification which were evaluated during this test. The Advanced Flight Control System heading select capability and the pressure refueling...determine compliance with the CH-47D Prime Item Development Specification (PIDS). 2. This Directorate agrees with the report conclusions and...Evaluations (PAE) (refs 1 and 2. app A), climatic laboratory tests (ref 3), and icing tests (ref 4). The US Army Aviation Research and Development

8. "TEST STAND, ARCHITECTURAL, FLOOR PLANS AND SCHEDULES." Specifications No. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

8. "TEST STAND, ARCHITECTURAL, FLOOR PLANS AND SCHEDULES." Specifications No. ENG-04-353-55-72; Drawing No. 60-0912; sheet 22 of 148; file no. 1320/73. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A Terminal Room, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

Laboratory Assays in Evaluation of Lynch Syndrome in Patients with Endometrial Carcinoma.

PubMed

Djordjevic, Bojana; Broaddus, Russell R

2016-06-01

This article reviews the main tissue testing modalities for Lynch Syndrome in the pathology laboratory, such as immunohistochemistry and PCR based analyses, and discusses their routine application, interpretation pitfalls, and troubleshooting of common technical performance issues. Discrepancies between laboratory and genetic testing may arise, and are examined in the context of the complexity of molecular abnormalities associated with Lynch Syndrome. The merits of targeted versus universal screening in a changing healthcare climate are addressed. In the absence of comprehensive screening programs, specific tumor topography and histological features that may prompt pathologist-initiated molecular tumor testing are outlined. Copyright © 2016 Elsevier Inc. All rights reserved.

Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?--A pilot study and a proposal.

PubMed

Jassam, Nuthar; Yundt-Pacheco, John; Jansen, Rob; Thomas, Annette; Barth, Julian H

2013-08-01

The implementation of national and international guidelines is beginning to standardise clinical practice. However, since many guidelines have decision limits based on laboratory tests, there is an urgent need to ensure that different laboratories obtain the same analytical result on any sample. A scientifically-based quality control process will be a pre-requisite to provide this level of analytical performance which will support evidence-based guidelines and movement of patients across boundaries while maintaining standardised outcomes. We discuss the finding of a pilot study performed to assess UK clinical laboratories readiness to work to a higher grade quality specifications such as biological variation-based quality specifications. Internal quality control (IQC) data for HbA1c, glucose, creatinine, cholesterol and high density lipoprotein (HDL)-cholesterol were collected from UK laboratories participating in the Bio-Rad Unity QC programme. The median of the coefficient of variation (CV%) of the participating laboratories was evaluated against the CV% based on biological variation. Except creatinine, the other four analytes had a variable degree of compliance with the biological variation-based quality specifications. More than 75% of the laboratories met the biological variation-based quality specifications for glucose, cholesterol and HDL-cholesterol. Slightly over 50% of the laboratories met the analytical goal for HBA1c. Only one analyte (cholesterol) had a performance achieving the higher quality specifications consistent with 5σ. Our data from IQC do not consistently demonstrate that the results from clinical laboratories meet evidence-based quality specifications. Therefore, we propose that a graded scale of quality specifications may be needed at this stage.

Laboratory practice at the periphery in developing countries.

PubMed

Lewis, S M

2002-08-01

An effective national health service structure requires a comprehensive programme for primary health care in peripheral and rural areas. This is especially important in under-resourced countries where facilities are sparse, the population is widely dispersed and transport is limited. Haematology has a key role in diagnosis and patient management by selecting tests for their clinical relevance and utility for the specific circumstances, and ensuring their technical reliability when used in health clinics and point-of-care testing. WHO has proposed a basic menu of tests in three categories: (a) tests such as haemoglobin screen which can be performed by nurses, midwives, health-aides or community doctors, (b) tests such as haemoglobinometry, microhaematocrit and microscopic examination of stained preparations which can be performed by a technician or laboratory assistant in a health centre, (c) tests requiring greater technical expertise of a laboratory technician or trained doctor. The peripheral health clinics and district laboratories must be familiar with the guidelines on standardized methods for collecting and storing specimens and transporting them to a regional laboratory or a reference centre. A training syllabus should be provided at the health centres and district laboratories, and this should include on-site instruction from supervisors and access to training manuals and distance-learning material. A co-ordinated programme of quality assurance and standardization of test methods should be established by a reference centre or national health authority with a network which encompasses all laboratories and health clinics undertaking any tests. Each regional laboratory should foster lower level laboratories or clinics within its neighbourhood. Of particular concern is the reliable diagnosis and management of anaemia. WHO reports indicate that 40% of the world population suffer from anaemia, especially affecting pregnant women, and a high proportion of infants and children in developing countries. The Haemoglobin Colour Scale (HCS) was recently developed for WHO as a simple, cheap and portable device which reads haemoglobin within 1 g/dl of the true value. It has been validated in a number of studies and is now manufactured commercially in accordance with WHO specifications under control of a WHO Collaborating Centre. It has an important potential role in the resource-limited environment where anaemia screening presently usually depends on unreliable clinical examination.

Development and validation of an immunoperoxidase antigen detection test for improved diagnosis of rabies in Indonesia.

PubMed

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.

Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory-based testing.

PubMed

Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M; Hampton, Robert R

2013-05-01

Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory-housed monkeys (Laboratory). The Field station animals shared access to four touch-screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching-to-sample memory test. Despite the differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments.

Automated cognitive testing of monkeys in social groups yields results comparable to individual laboratory based testing

PubMed Central

Gazes, Regina Paxton; Brown, Emily Kathryn; Basile, Benjamin M.; Hampton, Robert R.

2013-01-01

Cognitive abilities likely evolved in response to specific environmental and social challenges and are therefore expected to be specialized for the life history of each species. Specialized cognitive abilities may be most readily engaged under conditions that approximate the natural environment of the species being studied. While naturalistic environments might therefore have advantages over laboratory settings for cognitive research, it is difficult to conduct certain types of cognitive tests in these settings. We implemented methods for automated cognitive testing of monkeys (Macaca mulatta) in large social groups (Field station) and compared the performance to that of laboratory housed monkeys (Laboratory). The Field station animals shared access to four touch screen computers in a large naturalistic social group. Each Field station subject had an RFID chip implanted in each arm for computerized identification and individualized assignment of cognitive tests. The Laboratory group was housed and tested in a typical laboratory setting, with individual access to testing computers in their home cages. Monkeys in both groups voluntarily participated at their own pace for food rewards. We evaluated performance in two visual psychophysics tests, a perceptual classification test, a transitive inference test, and a delayed matching to sample memory test. Despite differences in housing, social environment, age, and sex, monkeys in the two groups performed similarly in all tests. Semi-free ranging monkeys living in complex social environments are therefore viable subjects for cognitive testing designed to take advantage of the unique affordances of naturalistic testing environments. PMID:23263675

Quality assurance practices in Europe: a survey of molecular genetic testing laboratories

PubMed Central

Berwouts, Sarah; Fanning, Katrina; Morris, Michael A; Barton, David E; Dequeker, Elisabeth

2012-01-01

In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (P<0.0001), use of RMs (P=0.0014) and availability of continuous education (CE) on medical/scientific subjects (P=0.023), specific tasks (P=0.0018), and quality assurance (P<0.0001) were significantly higher than in non-accredited laboratories. Non-accredited laboratories expect higher restriction of development of new techniques (P=0.023) and improvement of work satisfaction (P=0.0002) than accredited laboratories. By using a quality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, P<0.001), and certified laboratories better than other laboratories (average score 44, P<0.001), with regard to the implementation of quality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured. PMID:22739339

42 CFR 493.901 - Approval of proficiency testing programs.

Code of Federal Regulations, 2010 CFR

2010-10-01

... when possible and that samples are homogeneous, except for specific subspecialties such as cytology... gynecologic cytology and on individual laboratory performance on testing events, cumulative reports and scores...

42 CFR 493.901 - Approval of proficiency testing programs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... when possible and that samples are homogeneous, except for specific subspecialties such as cytology... gynecologic cytology and on individual laboratory performance on testing events, cumulative reports and scores...

42 CFR 493.901 - Approval of proficiency testing programs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... when possible and that samples are homogeneous, except for specific subspecialties such as cytology... gynecologic cytology and on individual laboratory performance on testing events, cumulative reports and scores...

42 CFR 493.901 - Approval of proficiency testing programs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... when possible and that samples are homogeneous, except for specific subspecialties such as cytology... gynecologic cytology and on individual laboratory performance on testing events, cumulative reports and scores...

42 CFR 493.901 - Approval of proficiency testing programs.

Code of Federal Regulations, 2011 CFR

2011-10-01

... when possible and that samples are homogeneous, except for specific subspecialties such as cytology... gynecologic cytology and on individual laboratory performance on testing events, cumulative reports and scores...

Estimating rotavirus gastroenteritis hospitalisations by using hospital episode statistics before and after the introduction of rotavirus vaccine in Australia.

PubMed

Jayasinghe, Sanjay; Macartney, Kristine

2013-01-30

Hospital discharge records and laboratory data have shown a substantial early impact from the rotavirus vaccination program that commenced in 2007 in Australia. However, these assessments are affected by the validity and reliability of hospital discharge coding and stool testing to measure the true incidence of hospitalised disease. The aim of this study was to assess the validity of these data sources for disease estimation, both before and after, vaccine introduction. All hospitalisations at a major paediatric centre in children aged <5 years from 2000 to 2009 containing acute gastroenteritis (AGE) ICD 10 AM diagnosis codes were linked to hospital laboratory stool testing data. The validity of the rotavirus-specific diagnosis code (A08.0) and the incidence of hospitalisations attributable to rotavirus by both direct estimation and with adjustments for non-testing and miscoding were calculated for pre- and post-vaccination periods. A laboratory record of stool testing was available for 36% of all AGE hospitalisations (n=4948) the rotavirus code had high specificity (98.4%; 95% CI, 97.5-99.1%) and positive predictive value (96.8%; 94.8-98.3%), and modest sensitivity (61.6%; 58-65.1%). Of all rotavirus test positive hospitalisations only a third had a rotavirus code. The estimated annual average number of rotavirus hospitalisations, following adjustment for non-testing and miscoding was 5- and 6-fold higher than identified, respectively, from testing and coding alone. Direct and adjusted estimates yielded similar percentage reductions in annual average rotavirus hospitalisations of over 65%. Due to the limited use of stool testing and poor sensitivity of the rotavirus-specific diagnosis code routine hospital discharge and laboratory data substantially underestimate the true incidence of rotavirus hospitalisations and absolute vaccine impact. However, this data can still be used to monitor vaccine impact as the effects of miscoding and under-testing appear to be comparable between pre and post vaccination periods. Copyright © 2012 Elsevier Ltd. All rights reserved.

EVOKED POTENTIALS, PHYSIOLOGICAL METHODS WITH HUMAN APPLICATIONS

EPA Science Inventory

A number of tests and test batteries have been developed and implemented for detecting potential neurotoxicity in humans. n some cases test results may suggest specific dysfunction. hile tests in laboratory animals are often used to project the potential for adverse health effect...

Staffing benchmarks for clinical laboratories: a College of American Pathologists Q-Probes study of laboratory staffing at 98 institutions.

PubMed

Jones, Bruce A; Darcy, Teresa; Souers, Rhona J; Meier, Frederick A

2012-02-01

Publicly available information concerning laboratory staffing benchmarks is scarce. One of the few publications on this topic summarized the findings of a Q-Probes study performed in 2004. This publication reports a similar survey with data collected in 2010. To assess the relationship between staffing levels in specified laboratory sections and test volumes in these sections and quantify management span of control. The study defined 4 laboratory sections: anatomic pathology (including cytology), chemistry/hematology/immunology, microbiology, and transfusion medicine. It divided staff into 3 categories: management, nonmanagement (operational or bench staff), and doctoral (MD, PhD) supervisory staff. People in these categories were tabulated as full-time equivalents and exclusions specified. Tests were counted in uniform formats, specified for each laboratory section, according to Medicare rules for the bundling and unbundling of tests. Ninety-eight participating institutions provided data that showed significant associations between test volumes and staffing for all 4 sections. There was wide variation in productivity based on volume. There was no relationship between testing volume per laboratory section and management span of control. Higher productivity in chemistry/hematology/immunology was associated with a higher fraction of tests coming from nonacute care patients. In both the 2004 and 2010 studies, productivity was inseparably linked to test volume. Higher test volume was associated with higher productivity ratios in chemistry/hematology/immunology and transfusion medicine sections. The impact of various testing services on productivity is section-specific.

Small Optics Laser Damage Test Procedure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wolfe, Justin

2017-10-19

This specification defines the requirements and procedure for laser damage testing of coatings and bare surfaces designated for small optics in the National Ignition Facility (NIF) at Lawrence Livermore National Laboratory (LLNL).

Evaluation of Minimum Asphalt Concrete Thickness Criteria

DTIC Science & Technology

2008-10-01

9 Figure 6. Dry density versus moisture content for CH material... density measurements. ............................ 24 Figure 18. EPC installation in a crushed gravel base course layer...Construction Materials Materials Characterization Laboratory Testing Field Testing Test Section Construction Hydrometer, Modified Proctor , Specific

Toxicity of materials in fire situations: Laboratory data obtained at the University of San Francisco

NASA Technical Reports Server (NTRS)

Hilado, C. J.; Casey, C. J.; Kourtides, D. A.; Parker, J. A.

1977-01-01

Approximately 300 materials were evaluated using a specific set of test conditions. Materials tested included wood, fibers, fabrics and synthetic polymers. Data obtained using 10 different sets of test conditions are presented.

International Space Station Carbon Dioxide Removal Assembly Testing

NASA Technical Reports Server (NTRS)

Knox, James C.

2000-01-01

Performance testing of the International Space Station Carbon Dioxide Removal Assembly flight hardware in the United States Laboratory during 1999 is described. The CDRA exceeded carbon dioxide performance specifications and operated flawlessly. Data from this test is presented.

Public health consequences of a false-positive laboratory test result for Brucella--Florida, Georgia, and Michigan, 2005.

PubMed

2008-06-06

Human brucellosis, a nationally notifiable disease, is uncommon in the United States. Most human cases have occurred in returned travelers or immigrants from regions where brucellosis is endemic, or were acquired domestically from eating illegally imported, unpasteurized fresh cheeses. In January 2005, a woman aged 35 years who lived in Nassau County, Florida, received a diagnosis of brucellosis, based on results of a Brucella immunoglobulin M (IgM) enzyme immunoassay (EIA) performed in a commercial laboratory using analyte specific reagents (ASRs); this diagnosis prompted an investigation of dairy products in two other states. Subsequent confirmatory antibody testing by Brucella microagglutination test (BMAT) performed at CDC on the patient's serum was negative. The case did not meet the CDC/Council of State and Territorial Epidemiologists' (CSTE) definition for a probable or confirmed brucellosis case, and the initial EIA result was determined to be a false positive. This report summarizes the case history, laboratory findings, and public health investigations. CDC recommends that Brucella serology testing only be performed using tests cleared or approved by the Food and Drug Administration (FDA) or validated under the Clinical Laboratory Improvement Amendments (CLIA) and shown to reliably detect the presence of Brucella infection. Results from these tests should be considered supportive evidence for recent infection only and interpreted in the context of a clinically compatible illness and exposure history. EIA is not considered a confirmatory Brucella antibody test; positive screening test results should be confirmed by Brucella-specific agglutination (i.e., BMAT or standard tube agglutination test) methods.

Importance of supply integrity for in vitro fertilization and embryo culture.

PubMed

Morbeck, Dean E

2012-06-01

The quality of in vitro culture conditions is a key component of a successful clinical embryology laboratory. Many, but not all, supplies used in the embryology laboratory are screened by the supplier with a bioassay. Embryology laboratories use a variety of approaches to verify the quality of mineral oil, protein, and disposables before clinical use; however, a best practice has not been determined. Some laboratories test every supply, even those already screened by the supplier, whereas other laboratories perform as little testing as possible. Despite screening by the supplier, recent reports of embryo toxicity, specifically with mineral oil, highlight that the integrity of the supply system has gaps. This review describes current bioassay quality control testing and discusses how it applies to screening of products with documented lot-to-lot variation. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Molecular genetic testing for cystic fibrosis: laboratory performance on the College of American Pathologists external proficiency surveys.

PubMed

Lyon, Elaine; Schrijver, Iris; Weck, Karen E; Ferreira-Gonzalez, Andrea; Richards, C Sue; Palomaki, Glenn E

2015-03-01

Molecular testing for cystic fibrosis mutations is widespread and routine in reproductive decision making and diagnosis. Our objective was to assess the level of performance of laboratories for this test. The College of American Pathologists administers external proficiency testing with multiple DNA samples distributed biannually. RESULTS are analyzed, reviewed, and graded by the joint College of American Pathologists/American College of Medical Genetics and Genomics Biochemical and Molecular Genetics Committee. Assessment is based on genotype and associated clinical interpretation. Overall, 357 clinical laboratories participated in the proficiency testing survey between 2003 and 2013 (322 in the United States and 35 international). In 2013, US participants reported performing nearly 120,000 tests monthly. Analytical sensitivity and specificity of US laboratories were 98.8% (95% confidence interval: 98.4-99.1%) and 99.6% (95% confidence interval: 99.4-99.7%), respectively. Analytical sensitivity improved between 2003 and 2008 (from 97.9 to 99.3%; P = 0.007) and remained steady thereafter. Clinical interpretation matched the intended response for 98.8, 86.0, and 91.0% of challenges with no, one, or two mutations, respectively. International laboratories performed similarly. Laboratory testing for cystic fibrosis in the United States has improved since 2003, and these data demonstrate a high level of quality. Neither the number of samples tested nor test methodology affected performance.

Evaluation of the HISCL Anti-Treponema pallidum Assay as a Screening Test for Syphilis

PubMed Central

An, Jingna; Chen, Qixia; Liu, Qianqian; Rao, Chenli; Li, Dongdong; Wang, Tingting

2015-01-01

The resurgence of syphilis in recent years has become a serious threat to public health worldwide, and the serological detection of specific antibodies against Treponema pallidum remains the most reliable method for laboratory diagnosis of syphilis. This study examined the performance of the recently launched HISCL anti-Treponema pallidum (anti-TP) assay as a screening test for syphilis in a high-volume laboratory. The HISCL anti-TP assay was tested in 300 preselected syphilis-positive samples, 704 fresh syphilis-negative samples, 48 preselected potentially interfering samples, and 30 “borderline” samples and was compared head to head with the commercially available Lumipulse G TP-N. In this study, the HISCL anti-TP assay was in perfect agreement with the applied testing algorithms with an overall agreement of 100%, comparable to that of Lumipulse G TP-N (99.63%). The sensitivity and specificity of the HISCL anti-TP assay were 100% (95% confidence interval [CI], 98.42% to 100%) and 100% (95% CI, 99.37% to 100%), respectively. Considering the excellent ease of use and automation, high throughput, and its favorable sensitivity and specificity, the HISCL anti-TP assay may represent a new choice for syphilis screening in high-volume laboratories. PMID:25972403

Evaluation of the HISCL Anti-Treponema pallidum Assay as a Screening Test for Syphilis.

PubMed

An, Jingna; Chen, Qixia; Liu, Qianqian; Rao, Chenli; Li, Dongdong; Wang, Tingting; Tao, Chuanmin; Wang, Lanlan

2015-07-01

The resurgence of syphilis in recent years has become a serious threat to public health worldwide, and the serological detection of specific antibodies against Treponema pallidum remains the most reliable method for laboratory diagnosis of syphilis. This study examined the performance of the recently launched HISCL anti-Treponema pallidum (anti-TP) assay as a screening test for syphilis in a high-volume laboratory. The HISCL anti-TP assay was tested in 300 preselected syphilis-positive samples, 704 fresh syphilis-negative samples, 48 preselected potentially interfering samples, and 30 "borderline" samples and was compared head to head with the commercially available Lumipulse G TP-N. In this study, the HISCL anti-TP assay was in perfect agreement with the applied testing algorithms with an overall agreement of 100%, comparable to that of Lumipulse G TP-N (99.63%). The sensitivity and specificity of the HISCL anti-TP assay were 100% (95% confidence interval [CI], 98.42% to 100%) and 100% (95% CI, 99.37% to 100%), respectively. Considering the excellent ease of use and automation, high throughput, and its favorable sensitivity and specificity, the HISCL anti-TP assay may represent a new choice for syphilis screening in high-volume laboratories. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Serne, R.J.; Wood, M.I.

1990-05-01

This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196more » refs., 4 figs., 36 tabs.« less

The role of postictal laboratory blood analyses in the diagnosis and prognosis of seizures.

PubMed

Nass, Robert D; Sassen, Robert; Elger, Christian E; Surges, Rainer

2017-04-01

Epileptic seizures (ES) lead to alterations in the blood laboratory values and reflect changes in different organ systems. Here, we review the diagnostic and prognostic value of various blood laboratory values within the context of epilepsy. Narrative review and literature search on PubMed using the term, "seizure" and various laboratory values. Laboratory markers can help clinicians determine whether an unwitnessed event was more likely to be epileptic or non-epileptic. Prolactin testing helps differentiate ES from psychogenic non-epileptic seizures (PNES) in adults and adolescents, and is associated with high specificity and moderate sensitivity. Elevations in the creatine kinase (CK) levels are common after generalized tonic-clonic seizures (GTCS) and display high specificity and moderate sensitivity. Metabolic markers such as ammonia and lactate may have diagnostic potential for postictal blood tests. Analyzing blood postictally is important for identifying the cause of the symptomatic seizures due to endocrine, metabolic, toxic or infectious etiologies. Finally, laboratory analyses are used for identifying patients who are at risk for developing rare, threatening complications such as rhabdomyolysis, acute renal failure (ARF) or cardiomyopathy. Presently, no postictal laboratory values can definitively prove or rule out the diagnosis of an epileptic seizure. For seizures with unknown causes, simple blood tests can be a valuable aid for quickly defining the etiology, particularly with certain metabolic and toxic encephalopathies. For this reason, CK, electrolytes, creatinine, liver and renal function tests should be measured on at least one occasion. Further research is needed in order to identify new biomarkers that improve the diagnosis and prognosis of seizures and seizure-related complications. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

5. "TEST STAND 13, CONCRETE STRUCTURAL SECTIONS AND DETAILS." Specifications ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

5. "TEST STAND 1-3, CONCRETE STRUCTURAL SECTIONS AND DETAILS." Specifications No. OC12-50-10; Drawing No. 60-09-06; no sheet number within title block. D.O. SERIES 1109/17, Rev. A. Stamped: AS BUILT; NO CHANGES. Date of Revision A: 11/1/50. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-3, Test Area 1-115, northwest end of Saturn Boulevard, Boron, Kern County, CA

9. "TEST STAND; STRUCTURAL; CABLE TUNNEL, PLAN, SECTIONS, DETAILS." Specifications ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

9. "TEST STAND; STRUCTURAL; CABLE TUNNEL, PLAN, SECTIONS, DETAILS." Specifications No. OC1-55-72-(Rev.); Drawing No. 60-09-12; sheet 43 of 148; file no. AF 1320/94, Rev. A. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A Terminal Room, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

International Seed Testing Association List of stabilized plant names, edition 6

USDA-ARS?s Scientific Manuscript database

Seed-testing laboratories determine the quality of seed lots in national and international seed commerce. Those services most commonly requested include purity analysis, noxious-weed seed detection, and viability tests. Rigorous procedures for performing various tests on specific crops have been est...

An investigation into the effectiveness of problem-based learning in a physical chemistry laboratory course

NASA Astrophysics Data System (ADS)

Gürses, Ahmet; Açıkyıldız, Metin; Doğar, Çetin; Sözbilir, Mustafa

2007-04-01

The aim of this study was to investigate the effectiveness of a problem-based learning (PBL) approach in a physical chemistry laboratory course. The parameters investigated were students’ attitudes towards a chemistry laboratory course, scientific process skills of students and their academic achievement. The design of the study was one group pre-test post-test. Four experiments, covering the topics adsorption, viscosity, surface tension and conductivity were performed using a PBL approach in the fall semester of the 2003/04 academic year at Kazim Karabekir Education Faculty of Atatürk University. Each experiment was done over a three week period. A total of 40 students, 18 male and 22 female, participated in the study. Students took the Physical Chemistry Laboratory Concept Test (PCLCT), Attitudes towards Chemistry Laboratory (ATCL) questionnaire and Science Process Skills Test (SPST) as pre and post-tests. In addition, the effectiveness of the PBL approach was also determined through four different scales; Scales Specific to Students’ Views of PBL. A statistically significant difference between the students’ academic achievement and scientific process skills at p

Research on air sprays and unique foam application methods. Phase II report. Laboratory investigation of foam systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1982-06-01

The objective of this study is to assess the effectiveness of air sprays and foam systems for dust control on longwall double-drum shearer faces. Laboratory testing has been conducted using foam systems and promising results have been obtained. Upon Bureau approval, underground testing will be scheduled to assess the effectiveness of foam systems under actual operating conditions. Laboratory testing of air sprays is being conducted at present. This report presents the results of the laboratory testing of foam systems. Specifically, the results obtained on the evaluation of selected foaming agents are presented, the feasibility investigation of flushing foam through themore » shearer-drum are demonstrated, and conceptual layout of the foam system on the shearer is discussed. The laboratory investigation of the selected foaming agents reveal that the Onyx Microfoam, Onyx Maprosyl and DeTer Microfoam foaming agents have higher expansion ratios compared to the others tested. Flushing foam through the shearer drum is entirely feasible and could be a viable technique for dust suppression on longwall faces.« less

How is the high vaginal swab used to investigate vaginal discharge in primary care and how do GPs' expectations of the test match the tests performed by their microbiology services?

PubMed

Noble, H; Estcourt, C; Ison, C; Goold, P; Tite, L; Carter, Y H

2004-06-01

To describe the management of vaginal discharge in general practice, with particular regard to the use of the high vaginal swab (HVS), and to compare GPs' expectations of this test with the processing and reporting undertaken by different laboratories. A postal questionnaire survey of 2146 GPs in the North Thames area and postal questionnaire study of the 22 laboratories serving the same GPs were carried out. GPs were asked how they would manage a young woman with vaginal discharge and what information they would like on an HVS report. Laboratories were asked how they would process and report on the HVS sample from the same patient. Response rate was 26%. 72% of GPs would take an HVS and 62% would refer on to a genitourinary medicine (GUM) clinic. 45% would offer empirical therapy and 47% of these would treat for candida initially. 75% of GPs routinely request "M,C&S" on HVS samples but 55% only want to be informed about specific pathogens. Routine processing of HVS samples varies widely between laboratories and 86% only report specific pathogens. 78% of GPs would like to be offered a suggested diagnosis on HVS reports, and 74% would like a suggested treatment. 43% of laboratories ever provide a diagnosis, and 14% provide a suggested treatment. GPs frequently manage vaginal discharge and most of them utilise the HVS. GPs' expectations of the test are not well matched to laboratory processing or reporting of the samples.

Fitness testing of tennis players: How valuable is it?

PubMed Central

Fernandez-Fernandez, Jaime; Ulbricht, Alexander; Ferrauti, Alexander

2014-01-01

In tennis, sport-specific technical skills are predominant factors, although a complex profile of physical performance factors is also required. The fitness test batteries assist in examining tennis players’ capabilities for performance at different levels in the laboratory as well as in the field, in the junior or elite level. While laboratory tests can be, and are, used to evaluate basic performance characteristics of athletes in most individual sports, in a more specific approach, field-based methods are better suited to the demands of complex intermittent sports like tennis. A regular test battery performed at different periods of the year allows to obtain an individual's performance profile, as well as the ability to prescribe individual training interventions. Thus, the aim of the present review was to describe and evaluate the different physical tests recommended and used by practitioners, sports scientists and institutions (national tennis federations). PMID:24668375

Performance Tested Method multiple laboratory validation study of ELISA-based assays for the detection of peanuts in food.

PubMed

Park, Douglas L; Coates, Scott; Brewer, Vickery A; Garber, Eric A E; Abouzied, Mohamed; Johnson, Kurt; Ritter, Bruce; McKenzie, Deborah

2005-01-01

Performance Tested Method multiple laboratory validations for the detection of peanut protein in 4 different food matrixes were conducted under the auspices of the AOAC Research Institute. In this blind study, 3 commercially available ELISA test kits were validated: Neogen Veratox for Peanut, R-Biopharm RIDASCREEN FAST Peanut, and Tepnel BioKits for Peanut Assay. The food matrixes used were breakfast cereal, cookies, ice cream, and milk chocolate spiked at 0 and 5 ppm peanut. Analyses of the samples were conducted by laboratories representing industry and international and U.S governmental agencies. All 3 commercial test kits successfully identified spiked and peanut-free samples. The validation study required 60 analyses on test samples at the target level 5 microg peanut/g food and 60 analyses at a peanut-free level, which was designed to ensure that the lower 95% confidence limit for the sensitivity and specificity would not be <90%. The probability that a test sample contains an allergen given a prevalence rate of 5% and a positive test result using a single test kit analysis with 95% sensitivity and 95% specificity, which was demonstrated for these test kits, would be 50%. When 2 test kits are run simultaneously on all samples, the probability becomes 95%. It is therefore recommended that all field samples be analyzed with at least 2 of the validated kits.

Test set readings predict clinical performance to a limited extent: preliminary findings

NASA Astrophysics Data System (ADS)

Soh, BaoLin P.; Lee, Warwick M.; Kench, Peter L.; Reed, Warren M.; McEntee, Mark F.; Brennan, Patrick C.

2013-03-01

Aim: To investigate the level of agreement between test sets and actual clinical reading Background: The performance of screen readers in detecting breast cancer is being assessed in some countries by using mammographic test sets. However, previous studies have provided little evidence that performance assessed by test sets strongly correlate to performance in clinical reading. Methods: Five clinicians from BreastScreen New South Wales participated in this study. Each clinician was asked to read 200 de-identified mammographic examinations gathered from their own case history within the BreastScreen NSW Digital Imaging Library. All test sets were designed with specific proportions of true positive, true negative, false positive and false negative examinations from the previous actual clinical reads of each reader. A prior mammogram examination for comparison (when available) was also provided for each case. Results: Preliminary analyses have shown that there is a moderate level of agreement (Kappa 0.42-0.56, p < 0.001) between laboratory test sets and actual clinical reading. In addition, a mean increase of 38% in sensitivity in the laboratory test sets as compared to their actual clinical readings was demonstrated. Specificity is similar between the laboratory test sets and actual clinical reading. Conclusion: This study demonstrated a moderate level of agreement between actual clinical reading and test set reading, which suggests that test sets have a role in reflecting clinical performance.

42 CFR 493.17 - Test categorization.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Test categorization. 493.17 Section 493.17 Public...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.17 Test categorization. (a) Categorization by criteria. Notices will be published in the Federal Register which list each specific test...

42 CFR 493.17 - Test categorization.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Test categorization. 493.17 Section 493.17 Public...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.17 Test categorization. (a) Categorization by criteria. Notices will be published in the Federal Register which list each specific test...

42 CFR 493.17 - Test categorization.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Test categorization. 493.17 Section 493.17 Public...) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS General Provisions § 493.17 Test categorization. (a) Categorization by criteria. Notices will be published in the Federal Register which list each specific test...

Agreement between allergen-specific IgE assays and ensuing immunotherapy recommendations from four commercial laboratories in the USA

PubMed Central

Plant, Jon D; Neradelik, Moni B; Polissar, Nayak L; Fadok, Valerie A; Scott, Brian A

2014-01-01

Background Canine allergen-specific IgE assays in the USA are not subjected to an independent laboratory reliability monitoring programme. Hypothesis/Objectives The aim of this study was to evaluate the agreement of diagnostic results and treatment recommendations of four serum IgE assays commercially available in the USA. Methods Replicate serum samples from 10 atopic dogs were submitted to each of four laboratories for allergen-specific IgE assays (ACTT®, VARL Liquid Gold, ALLERCEPT® and Greer® Aller-g-complete®). The interlaboratory agreement of standard, regional panels and ensuing treatment recommendations were analysed with the kappa statistic (κ) to account for agreement that might occur merely by chance. Six comparisons of pairs of laboratories and overall agreement among laboratories were analysed for ungrouped allergens (as tested) and also with allergens grouped according to reported cross-reactivity and taxonomy. Results The overall chance-corrected agreement of the positive/negative test results for ungrouped and grouped allergens was slight (κ = 0.14 and 0.13, respectively). Subset analysis of the laboratory pair with the highest level of diagnostic agreement (κ = 0.36) found slight agreement (κ = 0.13) for ungrouped plants and fungi, but substantial agreement (κ = 0.71) for ungrouped mites. The overall agreement of the treatment recommendations was slight (κ = 0.11). Altogether, 85.1% of ungrouped allergen treatment recommendations were unique to one laboratory or another. Conclusions and clinical importance Our study indicated that the choice of IgE assay may have a major influence on the positive/negative results and ensuing treatment recommendations. PMID:24461034

A real-time computer for monitoring a rapid-scanning Fourier spectrometer

NASA Technical Reports Server (NTRS)

Michel, G.

1973-01-01

A real-time Fourier computer has been designed and tested as part of the Lunar and Planetary Laboratory's program of airborne infrared astronomy using Fourier spectroscopy. The value and versatility of this device are demonstrated with specific examples of laboratory and in-flight applications.

Syncope or seizure? The diagnostic value of the EEG and hyperventilation test in transient loss of consciousness.

PubMed Central

Hoefnagels, W A; Padberg, G W; Overweg, J; Roos, R A; van Dijk, J G; Kamphuisen, H A

1991-01-01

In a prospective study of consecutive patients (age 15 or over) with transient loss of consciousness 45 patients had a history of seizure and 74 patients had a history of syncope. All patients had an EEG, ECG, laboratory tests and a hyperventilation test and were followed for an average of 14.5 months. Epileptiform activity in the interictal EEG had a sensitivity of 0.40 and a specificity of 0.95 for the diagnosis of a seizure. Epileptiform activity nearly doubled the probability of a seizure in doubtful cases. If no epileptiform activity was found, this probability remained substantially the same. The hyperventilation test had a sensitivity of 0.57 and a specificity of 0.84 for the diagnosis of syncope. A positive test increased the probability of syncope half as much in doubtful cases. A negative test did not exclude syncope. Laboratory tests were not helpful except for an ECG which was helpful in elderly patients. PMID:1800665

3. "TEST STAND NO. 13, EXCAVATION PLAN & SECTIONS." Specifications ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

3. "TEST STAND NO. 1-3, EXCAVATION PLAN & SECTIONS." Specifications No. ENG 04-353-50-10; Drawing No. 60-0906; no sheet number within title block; D.O. SERIES 1109/10. Stamped: AS BUILT. No revisions or revision dates. Last work date on this drawing "Checked by EAG, 1/31/49." Though this drawing is specific to Test Stand 1-3, it also illustrates the general methods used for excavation design and retaining wall construction at Test Stand 1-5. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-3, Test Area 1-115, northwest end of Saturn Boulevard, Boron, Kern County, CA

College of American Pathologists' laboratory standards for next-generation sequencing clinical tests.

PubMed

Aziz, Nazneen; Zhao, Qin; Bry, Lynn; Driscoll, Denise K; Funke, Birgit; Gibson, Jane S; Grody, Wayne W; Hegde, Madhuri R; Hoeltge, Gerald A; Leonard, Debra G B; Merker, Jason D; Nagarajan, Rakesh; Palicki, Linda A; Robetorye, Ryan S; Schrijver, Iris; Weck, Karen E; Voelkerding, Karl V

2015-04-01

The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL). This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.

Interlaboratory comparability, bias, and precision for four laboratories measuring analytes in wet deposition, October 1983-December 1984

USGS Publications Warehouse

Brooks, Myron H.; Schroder, LeRoy J.; Willoughby, Timothy C.

1987-01-01

Four laboratories involved in the routine analysis of wet-deposition samples participated in an interlaboratory comparison program managed by the U.S. Geological Survey. The four participants were: Illinois State Water Survey central analytical laboratory in Champaign, Illinois; U.S. Geological Survey national water-quality laboratories in Atlanta, Georgia, and Denver, Colorado; and Inland Waters Directorate national water-quality laboratory in Burlington, Ontario, Canada. Analyses of interlaboratory samples performed by the four laboratories from October 1983 through December 1984 were compared.Participating laboratories analyzed three types of interlaboratory samples--natural wet deposition, simulated wet deposition, and deionized water--for pH and specific conductance, and for dissolved calcium, magnesium, sodium, sodium, potassium, chloride, sulfate, nitrate, ammonium, and orthophosphate. Natural wet-deposition samples were aliquots of actual wet-deposition samples. Analyses of these samples by the four laboratories were compared using analysis of variance. Test results indicated that pH, calcium, nitrate, and ammonium results were not directly comparable among the four laboratories. Statistically significant differences between laboratory results probably only were meaningful for analyses of dissolved calcium. Simulated wet-deposition samples with known analyte concentrations were used to test each laboratory for analyte bias. Laboratory analyses of calcium, magnesium, sodium, potassium, chloride, sulfate, and nitrate were not significantly different from the known concentrations of these analytes when tested using analysis of variance. Deionized-water samples were used to test each laboratory for reporting of false positive values. The Illinois State Water Survey Laboratory reported the smallest percentage of false positive values for most analytes. Analyte precision was estimated for each laboratory from results of replicate measurements. In general, the Illinois State Water Survey laboratory achieved the greatest precision, whereas the U.S. Geological Survey laboratories achieved the least precision.

The changing face of clinical laboratories.

PubMed

Plebani, M

1999-07-01

Laboratory medicine has undergone a sea change, and medical laboratories must now adapt to, and meet new, customer-supplier needs springing from shifts in the patterns of disease prevalence, medical practice, and demographics. Managed care and other cost-containment processes have forced those involved in health care to cooperate to develop a full picture of patient care, and this has affected clinical laboratory objectives, the main focus now being on improvement in medical outcomes. More recently, the resource shortages in health care and results of cost/effectiveness analysis have demonstrated that the value of a laboratory test must be ascertained not only on the basis of its chemical or clinical performance characteristics, but also by its impact on patient management, the only true assessment of the quality of testing being quality of patient outcomes. The time is ripe for changing the vision of laboratory medicine, and some of the reasons for this are the availability of results in real-time, the introduction of more specific tests, and the trend to prevent diseases rather than cure them. The information from laboratory tests designed to evaluate biochemical or genetic risk and/or prognostic factors cannot be replaced either by physical examination and/or the assessment of symptoms. Today, the importance of laboratory scientists must be proven in three broad areas: a) guaranteeing the quality of tests, irrespective of where they are performed; b) improving the quality of the service; c) maximizing the impact of laboratory information on patient management.

Serological findings in leprosy. An investigation into the specificity of various serological tests for syphilis.

PubMed

RUGE, H G; FROMM, G; FUHNER, F; GUINTO, R S

1960-01-01

In serological tests for syphilis, leprosy sera often give biologically false positive reactions. These may be due to the presence of non-specific elements-for example, the ubiquitous lipid antibodies-in the leprosy sera; or they may be the result of errors in technique or unfavourable working conditions in the laboratory. This paper presents the results of an investigation in which several hundred sera from lepers were submitted to four of the so-called "standard" serological tests for syphilis (STS), using either cardiolipin or crude lipid antigens; to a complement-fixation test using as antigen a suspension of Reiter treponemes (PR test); and to the Treponema pallidum immobilization (TPI) test. The investigation was carried out in a moderate climate and in technically well-equipped laboratories.It was found that the number of biologically false positive reactions was not as high as had been expected in the light of previous investigations. It was discovered, moreover, that it was the lipid antigens that were mainly responsible for the non-specific reactions, since both the PR and the TPI test showed a far greater specificity than any of the STS. But the TPI test, though highly specific, is also technically very complicated and therefore not suitable for use in regions where technical facilities are lacking. The authors consider that, in such regions, the simpler PR test will give sufficiently accurate results in the serodiagnosis of treponematoses. It must, however, be recognized that even the treponemal tests are not capable of differentiating between syphilis and yaws infections.

Laboratory Capacity for Antimicrobial Susceptibility Surveillance of Neisseria gonorrhoeae-District of Columbia, 2007-2012.

PubMed

Garrett, Tiana A; Davies-Cole, John; Furness, Bruce

2015-08-01

In the District of Columbia (DC), Neisseria gonorrhoeae (gonorrhea) infections accounted for more than 25% of 9321 incident sexually transmitted infections reported in 2011; untreated infections can lead to reproductive complications and a higher risk for HIV transmission. In DC, limited capacity to measure the prevalence of antibiotic-resistant N. gonorrhoeae is available; culture-based antibiotic susceptibility testing (AST) is needed to monitor antimicrobial resistance. We examined the capacity of laboratories that report to the DC Department of Health to perform AST for ongoing surveillance of antibiotic-resistant N. gonorrhoeae and to identify suspected treatment failures. We created a survey about diagnostic methods for gonorrhea testing and identified 33 laboratories that reported gonorrhea results to Department of Health in 2007 to 2012. Laboratories were assessed for use of bacterial culture or nucleic acid amplification testing (NAAT) for gonorrhea testing, prevalence of AST on gonorrhea-positive cultures, and types of antibiotics tested during AST. We estimated the prevalence of laboratory practices on the basis of self-report by staff. Nineteen (58%) laboratories completed the survey, representing 92% of the gonorrhea reporting. Seventeen (89%) of 19 laboratories conducted testing by culture; only 6 (35%) performed AST; 79% performed NAAT. Barriers to AST included longer completion times and limited number of provider requests for AST. Commercial laboratories (32%) were more likely to conduct both culture and NAAT, compared with health care facilities (11%). We report a low prevalence of laboratories performing AST because of multiple barriers. State-specific strategies addressing these barriers are needed to improve detection of antibiotic-resistant gonorrhea stains circulating among the population.

An approach to medical knowledge sharing in a hospital information system using MCLink.

PubMed

Shibuya, Akiko; Inoue, Ryusuke; Nakayama, Masaharu; Kasahara, Shin; Maeda, Yukihiro; Umesato, Yoshimasa; Kondo, Yoshiaki

2013-08-01

Clinicians often need access to electronic information resources that answer questions that occur in daily clinical practice. This information generally comes from publicly available resources. However, clinicians also need knowledge on institution-specific information (e.g., institution-specific guidelines, choice of drug, choice of laboratory test, information on adverse events, and advice from professional colleagues). This information needs to be available in real time. This study characterizes these needs in order to build a prototype hospital information system (HIS) that can help clinicians get timely answers to questions. We previously designed medical knowledge units called Medical Cells (MCs). We developed a portal server of MCs that can create and store medical information such as institution-specific information. We then developed a prototype HIS that embeds MCs as links (MCLink); these links are based on specific terms (e.g., drug, laboratory test, and disease). This prototype HIS presents clinicians with institution-specific information. The HIS clients (e.g., clinicians, nurses, pharmacists, and laboratory technicians) can also create an MCLink in the HIS using the portal server in the hospital. The prototype HIS allowed efficient sharing and use of institution-specific information to clinicians at the point of care. This study included institution-specific information resources and advice from professional colleagues, both of which might have an important role in supporting good clinical decision making.

Development of a Standard Swine Hemorrhage Model for Efficacy Assessment of Topical Hemostatic Agents

DTIC Science & Technology

2011-07-01

Blw:kbourne. MD Background: The diverse infomlation of efficacy of hemostatic pmducts. obtained from different military laboratories using ...model was tested with all or some of these modifications in four experimental conditions (n = 5-6 pigs pc:r condition) using Combat Gauze (CG) as...be suitable lf.>r testing every agent and some modifications may be necessary for specific applications. fu•·thermore, laboratory studies using this

Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine: Part 4: Tissue Tools for Quality Assurance in Immunohistochemistry.

PubMed

Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred; Francis, Glenn D; Fulton, Regan; Gilks, C Blake; Hall, Jacqueline A; Hornick, Jason L; Ibrahim, Merdol; Marchetti, Antonio; Miller, Keith; van Krieken, J Han; Nielsen, Soren; Swanson, Paul E; Taylor, Clive R; Vyberg, Mogens; Zhou, Xiaoge; Torlakovic, Emina E

2017-04-01

The numbers of diagnostic, prognostic, and predictive immunohistochemistry (IHC) tests are increasing; the implementation and validation of new IHC tests, revalidation of existing tests, as well as the on-going need for daily quality assurance monitoring present significant challenges to clinical laboratories. There is a need for proper quality tools, specifically tissue tools that will enable laboratories to successfully carry out these processes. This paper clarifies, through the lens of laboratory tissue tools, how validation, verification, and revalidation of IHC tests can be performed in order to develop and maintain high quality "fit-for-purpose" IHC testing in the era of precision medicine. This is the final part of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

Quicklime specification and test methods

DOT National Transportation Integrated Search

1987-04-01

Samples of pebble quicklime were obtained from each of the six major : lime producers' plants in Texas. These samples were used for laboratory : testing which determined chemical composition of the dry lime, physical : properties of slurries prepared...

Coccidioides complement fixation

MedlinePlus

... antibodies are detected in the blood sample. Normal value ranges may vary slightly among different laboratories. Some labs use different measurements or test different samples. Talk to your health care provider about the meaning of your specific test results.

Stress and Specificity: Reply to Miller (2009)

ERIC Educational Resources Information Center

Denson, Thomas F.; Spanovic, Marija; Miller, Norman

2009-01-01

T. F. Denson, M. Spanovic, and N. Miller (2009) meta-analytically tested the hypotheses that specific appraisals and emotions would predict cortisol and immune responses to laboratory stressors and emotion inductions. Although the cortisol data supported the integrated specificity hypothesis, G. E. Miller (2009) raised questions concerning the…

Amplification of Mycoplasma haemofelis DNA by a PCR for point-of-care use.

PubMed

Hawley, Jennifer; Yaaran, Tal; Maurice, Sarah; Lappin, Michael R

2018-01-01

We compared a qualitative in-clinic (IC)-PCR for the detection of Mycoplasma haemofelis DNA with the results of a commercial qualitative laboratory-based, conventional (c)PCR. In order to determine the specificity of both tests, Bartonella spp. samples were included. Forty-three previously tested blood samples with known PCR results for hemoplasmas and Bartonella spp. were selected. The samples were split between 2 laboratories. At the first laboratory, DNA was purified and run on 2 cPCR assays for the detection of hemoplasmas and Bartonella spp. At the second laboratory, DNA was purified using 2 purification protocols and both run in the IC-PCR assay. The cPCR results confirmed that 18 samples were positive for M. haemofelis, 5 for ' Candidatus M. haemominutum', 8 for Bartonella henselae, 2 for Bartonella clarridgeiae, and 10 were negative for both genera. No mixed infections were observed. The IC-PCR assay for the detection of M. haemofelis had a sensitivity of 94.4% and specificity of 96%, when using the same DNA purification method as the first laboratory. Using the second purification method, the sensitivity of the IC-PCR assay was 77.8% and specificity was 96%. Bartonella species were not detected by the IC-PCR M. haemofelis assay. The IC-PCR assay decreased the amount of time to final result compared to a cPCR assay.

Laboratory errors and patient safety.

PubMed

Miligy, Dawlat A

2015-01-01

Laboratory data are extensively used in medical practice; consequently, laboratory errors have a tremendous impact on patient safety. Therefore, programs designed to identify and reduce laboratory errors, as well as, setting specific strategies are required to minimize these errors and improve patient safety. The purpose of this paper is to identify part of the commonly encountered laboratory errors throughout our practice in laboratory work, their hazards on patient health care and some measures and recommendations to minimize or to eliminate these errors. Recording the encountered laboratory errors during May 2008 and their statistical evaluation (using simple percent distribution) have been done in the department of laboratory of one of the private hospitals in Egypt. Errors have been classified according to the laboratory phases and according to their implication on patient health. Data obtained out of 1,600 testing procedure revealed that the total number of encountered errors is 14 tests (0.87 percent of total testing procedures). Most of the encountered errors lay in the pre- and post-analytic phases of testing cycle (representing 35.7 and 50 percent, respectively, of total errors). While the number of test errors encountered in the analytic phase represented only 14.3 percent of total errors. About 85.7 percent of total errors were of non-significant implication on patients health being detected before test reports have been submitted to the patients. On the other hand, the number of test errors that have been already submitted to patients and reach the physician represented 14.3 percent of total errors. Only 7.1 percent of the errors could have an impact on patient diagnosis. The findings of this study were concomitant with those published from the USA and other countries. This proves that laboratory problems are universal and need general standardization and bench marking measures. Original being the first data published from Arabic countries that evaluated the encountered laboratory errors and launch the great need for universal standardization and bench marking measures to control the laboratory work.

Testing activities at the National Battery Test Laboratory

NASA Astrophysics Data System (ADS)

Hornstra, F.; Deluca, W. H.; Mulcahey, T. P.

The National Battery Test Laboratory (NBTL) is an Argonne National Laboratory facility for testing, evaluating, and studying advanced electric storage batteries. The facility tests batteries developed under Department of Energy programs and from private industry. These include batteries intended for future electric vehicle (EV) propulsion, electric utility load leveling (LL), and solar energy storage. Since becoming operational, the NBTL has evaluated well over 1400 cells (generally in the form of three- to six-cell modules, but up to 140-cell batteries) of various technologies. Performance characterization assessments are conducted under a series of charge/discharge cycles with constant current, constant power, peak power, and computer simulated dynamic load profile conditions. Flexible charging algorithms are provided to accommodate the specific needs of each battery under test. Special studies are conducted to explore and optimize charge procedures, to investigate the impact of unique load demands on battery performance, and to analyze the thermal management requirements of battery systems.

Interlaboratory studies with the Chinese hamster V79 cell metabolic cooperation assay to detect tumor-promoting agents

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bohrman, J.S.; Burg, J.R.; Elmore, E.

1988-01-01

Three laboratories participated in an interlaboratory study to evaluate the usefulness of the Chinese hamster V79 cell metabolic cooperation assay to predict the tumor-promoting activity of selected chemical. Twenty-three chemicals of different chemical structures (phorbol esters, barbiturates, phenols, artificial sweeteners, alkanes, and peroxides) were chosen for testing based on in vivo promotion activities, as reported in the literature. Assay protocols and materials were standardized, and the chemicals were coded to facilitate unbiased evaluation. A chemical was tested only once in each laboratory, with one of the three laboratories testing only 15 out of 23 chemicals. Dunnett's test was used formore » statistical analysis. Chemicals were scored as positive (at least two concentration levels statistically different than control), equivocal (only one concentration statistically different), or negative. For 15 chemicals tested in all three laboratories, there was complete agreement among the laboratories for nine chemicals. For the 23 chemicals tested in only two laboratories, there was agreement on 16 chemicals. With the exception of the peroxides and alkanes, the metabolic cooperation data were in general agreement with in vivo data. However, an overall evaluation of the V79 cell system for predicting in vivo promotion activity was difficult because of the organ specificity of certain chemicals and/or the limited number of adequately tested nonpromoting chemicals.« less

External Quality Assessment for the Detection of Measles Virus by Reverse Transcription-PCR Using Armored RNA

PubMed Central

Jia, Tingting; Zhang, Lei; Wang, Guojing; Zhang, Rui; Zhang, Kuo; Lin, Guigao; Xie, Jiehong; Wang, Lunan; Li, Jinming

2015-01-01

In recent years, nucleic acid tests for detection of measles virus RNA have been widely applied in laboratories belonging to the measles surveillance system of China. An external quality assessment program was established by the National Center for Clinical Laboratories to evaluate the performance of nucleic acid tests for measles virus. The external quality assessment panel, which consisted of 10 specimens, was prepared using armored RNAs, complex of noninfectious MS2 bacteriophage coat proteins encapsulated RNA of measles virus, as measles virus surrogate controls. Conserved sequences amplified from a circulating measles virus strain or from a vaccine strain were encapsulated into these armored RNAs. Forty-one participating laboratories from 15 provinces, municipalities, or autonomous regions that currently conduct molecular detection of measles virus enrolled in the external quality assessment program, including 40 measles surveillance system laboratories and one diagnostic reagent manufacturer. Forty laboratories used commercial reverse transcription-quantitative PCR kits, with only one laboratory applying a conventional PCR method developed in-house. The results indicated that most of the participants (38/41, 92.7%) were able to accurately detect the panel with 100% sensitivity and 100% specificity. Although a wide range of commercially available kits for nucleic acid extraction and reverse transcription polymerase chain reaction were used by the participants, only two false-negative results and one false-positive result were generated; these were generated by three separate laboratories. Both false-negative results were obtained with tests performed on specimens with the lowest concentration (1.2 × 104 genomic equivalents/mL). In addition, all 18 participants from Beijing achieved 100% sensitivity and 100% specificity. Overall, we conclude that the majority of the laboratories evaluated have reliable diagnostic capacities for the detection of measles virus. PMID:26244795

External Quality Assessment for the Detection of Measles Virus by Reverse Transcription-PCR Using Armored RNA.

PubMed

Zhang, Dong; Sun, Yu; Jia, Tingting; Zhang, Lei; Wang, Guojing; Zhang, Rui; Zhang, Kuo; Lin, Guigao; Xie, Jiehong; Wang, Lunan; Li, Jinming

2015-01-01

In recent years, nucleic acid tests for detection of measles virus RNA have been widely applied in laboratories belonging to the measles surveillance system of China. An external quality assessment program was established by the National Center for Clinical Laboratories to evaluate the performance of nucleic acid tests for measles virus. The external quality assessment panel, which consisted of 10 specimens, was prepared using armored RNAs, complex of noninfectious MS2 bacteriophage coat proteins encapsulated RNA of measles virus, as measles virus surrogate controls. Conserved sequences amplified from a circulating measles virus strain or from a vaccine strain were encapsulated into these armored RNAs. Forty-one participating laboratories from 15 provinces, municipalities, or autonomous regions that currently conduct molecular detection of measles virus enrolled in the external quality assessment program, including 40 measles surveillance system laboratories and one diagnostic reagent manufacturer. Forty laboratories used commercial reverse transcription-quantitative PCR kits, with only one laboratory applying a conventional PCR method developed in-house. The results indicated that most of the participants (38/41, 92.7%) were able to accurately detect the panel with 100% sensitivity and 100% specificity. Although a wide range of commercially available kits for nucleic acid extraction and reverse transcription polymerase chain reaction were used by the participants, only two false-negative results and one false-positive result were generated; these were generated by three separate laboratories. Both false-negative results were obtained with tests performed on specimens with the lowest concentration (1.2 × 104 genomic equivalents/mL). In addition, all 18 participants from Beijing achieved 100% sensitivity and 100% specificity. Overall, we conclude that the majority of the laboratories evaluated have reliable diagnostic capacities for the detection of measles virus.

Clinical laboratory accreditation in India.

PubMed

Handoo, Anil; Sood, Swaroop Krishan

2012-06-01

Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

Quality assurance and quality improvement in U.S. clinical molecular genetic laboratories.

PubMed

Chen, Bin; Richards, C Sue; Wilson, Jean Amos; Lyon, Elaine

2011-04-01

A robust quality-assurance program is essential for laboratories that perform molecular genetic testing to maintain high-quality testing and be able to address challenges associated with performance or delivery of testing services as the use of molecular genetic tests continues to expand in clinical and public health practice. This unit discusses quality-assurance and quality-improvement considerations that are critical for molecular genetic testing performed for heritable diseases and conditions. Specific discussion is provided on applying regulatory standards and best practices in establishing/verifying test performance, ensuring quality of the total testing process, monitoring and maintaining personnel competency, and continuing quality improvement. The unit provides a practical reference for laboratory professionals to use in recognizing and addressing essential quality-assurance issues in human molecular genetic testing. It should also provide useful information for genetics researchers, trainees, and fellows in human genetics training programs, as well as others who are interested in quality assurance and quality improvement for molecular genetic testing. 2011 by John Wiley & Sons, Inc.

National Risk Management Research Laboratory (NRMRL) Microbial Research

EPA Science Inventory

Experimental design: Three host-specific PCR assays were tested against fecal and water samples. Host-specificity assays were performed against targeted and nontargeted fecal sources. Detection limits were performed against diluted fecal and water DNA extracts. Groundwater an...

Crashworthiness simulation of composite automotive structures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Botkin, M E; Johnson, N L; Simunovic, S

1998-06-01

In 1990 the Automotive Composites Consortium (ACC) began the investigation of crash worthiness simulation methods for composite materials. A contract was given to Livermore Software Technology Corporation (LSTC) to implement a new damage model in LS-DYNA3D TM specifically for composite structures. This model is in LS-DYNA3D TM and is in use by the ACC partners. In 1994 USCAR, a partnership of American auto companies, entered into a partnership called SCAAP (Super Computing Automotive Applications Partnership) for the express purpose of working with the National Labs on computational oriented research. A CRADA (Cooperative Research and Development Agreement) was signed with Lawrencemore » Livermore National Laboratory, Oak Ridge National Laboratory, Sandia National Laboratory, Argonne National Laboratory, and Los Alamos National Laboratory to work in three distinctly different technical areas, one of which was composites material modeling for crash worthiness. Each Laboratory was assigned a specific modeling task. The ACC was responsible for the technical direction of the composites project and provided all test data for code verification. All new models were to be implemented in DYNA3D and periodically distributed to all partners for testing. Several new models have been developed and implemented. Excellent agreement has been shown between tube crush simulation and experiments.« less

Justification of parameters and selection of equipment for laboratory researches of a rammer's operating element dynamics in a soil foundation of a tank for oil and oil products storage

NASA Astrophysics Data System (ADS)

Gruzin, A. V.; Gruzin, V. V.; Shalay, V. V.

2017-08-01

The development of technology for a directional soil compaction of tank foundations for oil and oil products storage is a relevant problem which solution will enable simultaneously provide required operational characteristics of a soil foundation and reduce time and material costs to prepare the foundation. The impact dynamics of rammers' operating elements on the soil foundation is planned to specify in the course of laboratory studies. A specialized technique is developed to justify the parameters and select the equipment for laboratory researches. The usage of this technique enabled us to calculate dimensions of the models, of a test bench and specifications of the recording equipment, and a lighting system. The necessary equipment for laboratory studies was selected. Preliminary laboratory tests were carried out. The estimate of accuracy for planned laboratory studies was given.

Validation of "laboratory-supported" criteria for functional (psychogenic) tremor.

PubMed

Schwingenschuh, Petra; Saifee, Tabish A; Katschnig-Winter, Petra; Macerollo, Antonella; Koegl-Wallner, Mariella; Culea, Valeriu; Ghadery, Christine; Hofer, Edith; Pendl, Tamara; Seiler, Stephan; Werner, Ulrike; Franthal, Sebastian; Maurits, Natasha M; Tijssen, Marina A; Schmidt, Reinhold; Rothwell, John C; Bhatia, Kailash P; Edwards, Mark J

2016-04-01

In a small group of patients, we have previously shown that a combination of electrophysiological tests was able to distinguish functional (psychogenic) tremor and organic tremor with excellent sensitivity and specificity. This study aims to validate an electrophysiological test battery as a tool to diagnose patients with functional tremor with a "laboratory-supported" level of certainty. For this prospective data collection study, we recruited 38 new patients with functional tremor (mean age 37.9 ± 24.5 years; mean disease duration 5.9 ± 9.0 years) and 73 new patients with organic tremor (mean age 55.4 ± 25.4 years; mean disease duration 15.8 ± 17.7 years). Tremor was recorded at rest, posture (with and without loading), action, while performing tapping tasks (1, 3, and 5 Hz), and while performing ballistic movements with the less-affected hand. Electrophysiological tests were performed by raters blinded to the clinical diagnosis. We calculated a sum score for all performed tests (maximum of 10 points) and used a previously suggested cut-off score of 3 points for a diagnosis of laboratory-supported functional tremor. We demonstrated good interrater reliability and test-retest reliability. Patients with functional tremor had a higher average score on the test battery when compared with patients with organic tremor (3.6 ± 1.4 points vs 1.0 ± 0.8 points; P < .001), and the predefined cut-off score for laboratory-supported functional tremor yielded a test sensitivity of 89.5% and a specificity of 95.9%. We now propose this test battery as the basis of laboratory-supported criteria for the diagnosis of functional tremor, and we encourage its use in clinical and research practice. © 2016 International Parkinson and Movement Disorder Society.

Concordance in diagnostic testing for respiratory pathogens of bighorn sheep

USGS Publications Warehouse

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.

An electronic thesaurus of Evidence Based Laboratory Medicine hematological and biochemical diagnostic tests.

PubMed

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.

Laboratory testing for cytomegalovirus among pregnant women in the United States: a retrospective study using administrative claims data

PubMed Central

2012-01-01

Background Routine cytomegalovirus (CMV) screening during pregnancy is not recommended in the United States and the extent to which it is performed is unknown. Using a medical claims database, we computed rates of CMV-specific testing among pregnant women. Methods We used medical claims from the 2009 Truven Health MarketScan® Commercial databases. We computed CMV-specific testing rates using CPT codes. Results We identified 77,773 pregnant women, of whom 1,668 (2%) had a claim for CMV-specific testing. CMV-specific testing was significantly associated with older age, Northeast or urban residence, and a diagnostic code for mononucleosis. We identified 44 women with a diagnostic code for mononucleosis, of whom 14% had CMV-specific testing. Conclusions Few pregnant women had CMV-specific testing, suggesting that screening for CMV infection during pregnancy is not commonly performed. In the absence of national surveillance for CMV infections during pregnancy, healthcare claims are a potential source for monitoring practices of CMV-specific testing. PMID:23198949

From customer satisfaction survey to corrective actions in laboratory services in a university hospital.

PubMed

Oja, Paula I; Kouri, Timo T; Pakarinen, Arto J

2006-12-01

To find out the satisfaction of clinical units with laboratory services in a university hospital, to point out the most important problems and defects in services, to carry out corrective actions, and thereafter to identify the possible changes in satisfaction. and Senior physicians and nurses-in-charge of the clinical units at Oulu University Hospital, Finland. Customer satisfaction survey using a questionnaire was carried out in 2001, indicating the essential aspects of laboratory services. Customer-specific problems were clarified, corrective actions were performed, and the survey was repeated in 2004. In 2001, the highest dissatisfaction rates were recorded for computerized test requesting and reporting, turnaround times of tests, and the schedule of phlebotomy rounds. The old laboratory information system was not amenable to major improvements, and it was renewed in 2004-05. Several clinical units perceived turnaround times to be long, because the tests were ordered as routine despite emergency needs. Instructions about stat requesting were given to these units. However, no changes were evident in the satisfaction level in the 2004 survey. Following negotiations with the clinics, phlebotomy rounds were re-scheduled. This resulted in a distinct increase in satisfaction in 2004. Satisfaction survey is a screening tool that identifies topics of dissatisfaction. Without further clarifications, it is not possible to find out the specific problems of customers and to undertake targeted corrective actions. Customer-specific corrections are rarely seen as improvements in overall satisfaction rates.

Assessment of algorithms to identify patients with thrombophilia following venous thromboembolism.

PubMed

Delate, Thomas; Hsiao, Wendy; Kim, Benjamin; Witt, Daniel M; Meyer, Melissa R; Go, Alan S; Fang, Margaret C

2016-01-01

Routine testing for thrombophilia following venous thromboembolism (VTE) is controversial. The use of large datasets to study the clinical impact of thrombophilia testing on patterns of care and patient outcomes may enable more efficient analysis of this practice in a wide range of settings. We set out to examine how accurately algorithms using International Classification of Diseases 9th Revision (ICD-9) codes and/or pharmacy data reflect laboratory-confirmed thrombophilia diagnoses. A random sample of adult Kaiser Permanente Colorado patients diagnosed with unprovoked VTE between 1/2004 and 12/2010 underwent medical record abstraction of thrombophilia test results. Algorithms using "ICD-9" (positive if a thrombophilia ICD-9 code was present), "Extended anticoagulation (AC)" (positive if AC therapy duration was >6 months), and "ICD-9 & Extended AC" (positive for both) criteria to identify possible thrombophilia cases were tested. Using positive thrombophilia laboratory results as the gold standard, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value of each algorithm were calculated, along with 95% confidence intervals (CIs). In our cohort of 636 patients, sensitivities were low (<50%) for each algorithm. "ICD-9" yielded the highest PPV (41.5%, 95% CI 26.3-57.9%) and a high specificity (95.9%, 95% CI 94.0-97.4%). "Extended AC" had the highest sensitivity but lowest specificity, and "ICD-9 & Extended AC" had the highest specificity but lowest sensitivity. ICD-9 codes for thrombophilia are highly specific for laboratory-confirmed cases, but all algorithms had low sensitivities. Further development of methods to identify thrombophilia patients in large datasets is warranted. Copyright © 2015 Elsevier Ltd. All rights reserved.

Laboratory performance of sweat conductivity for the screening of cystic fibrosis.

PubMed

Greaves, Ronda F; Jolly, Lisa; Massie, John; Scott, Sue; Wiley, Veronica C; Metz, Michael P; Mackay, Richard J

2018-03-28

There are several complementary English-language guidelines for the performance of the sweat chloride test. These guidelines also incorporate information for the collection of conductivity samples. However, recommendations for the measurement and reporting of sweat conductivity are less clear than for sweat chloride. The aim of the study was to develop an understanding of the testing and reporting practices of sweat conductivity in Australasian laboratories. A survey specifically directed at conductivity testing was sent to the 12 laboratories registered with the Royal College of Pathologists of Australasia Quality Assurance Programs. Nine (75%) laboratories participated in the survey, seven of whom used Wescor Macroduct® for collecting sweat and the Wescor SWEAT·CHEK™ for conductivity testing, and the remaining two used the Wescor Nanoduct®. There was considerable variation in frequency and staffing for this test. Likewise, criteria about which patients it was inappropriate to test, definitions of adequate collection sweat rate, cutoffs and actions recommended on the basis of the result showed variations between laboratories. Variations in sweat conductivity testing and reporting reflect many of the same issues that were revealed in sweat chloride test audits and have the potential to lead to uncertainty about the result and the proper action in response to the result. We recommend that sweat testing guidelines should include clearer statements about the use of sweat conductivity.

Specifics of Chemical Toxilogical Analyses in the Russian Federation for the Purpose of Identification of Narcotics in Biological Matters

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coates, Cameron W; Eisele, Gerhard R

2011-01-01

The Russian Federation (RF) is committed to implementing a comprehensive drug testing program under its Personnel Reliability Program (PRP) for military personnel involved in handling sensitive nuclear materials. This commitment leads to a number of mandatory requirements for the laboratory conducting the confirmation testing to ensure the legitimacy and integrity of the testing process. These requirements are established by the RF Duma to ensure that individuals conducting these tests have adequate training, certifications, and experience to conduct narcotic confirmation tests. This paper describes the facility requirements and personnel qualifications needed for conducting comprehensive drug abuse confirmation testing. Details regarding themore » personnel training and laboratory experience in the theory and practice of analytical forensic toxicology of drugs of abuse will be presented, as well as the facility requirements for the laboratory conducting such tests. Chain-of-custody, from sample receipt through completion of testing, reporting of results, and continuing until final disposition of specimens will be addressed.« less

Prostate-specific antigen velocity is not better than total prostate-specific antigen in predicting prostate biopsy diagnosis.

PubMed

Gorday, William; Sadrzadeh, Hossein; de Koning, Lawrence; Naugler, Christopher T

2015-12-01

1.) Identify whether prostate-specific antigen velocity improves the ability to predict prostate biopsy diagnosis. 2.) Test whether there is an increase in the predictive capability of models when Gleason 7 prostate cancers are separated into a 3+4 and a 4+3 group. Calgary Laboratory Services' Clinical Laboratory Information System was searched for prostate biopsies reported between January 1, 2009 and December 31, 2013. Total prostate-specific antigen tests were recorded for each patient from January 1, 2007 to the most recent test before their recorded prostate biopsy. The data set was divided into the following three groups for comparison; benign, all prostate cancer and Gleason 7-10. The Gleason grade 7-10 group was further divided into 4+3 and 3+4 Gleason 7 prostate cancers. Prostate-specific antigen velocity was calculated using four different methods found in the literature. Receiver operator curves were used to assess operational characteristics of the tests. 4622 men between the ages of 40-89 with a prostate biopsy were included for analysis. Combining prostate-specific antigen velocity with total prostate-specific antigen (AUC=0.570-0.712) resulted in small non-statistically significant changes to the area under the curve compared to the area under the curve of total prostate-specific antigen alone (AUC=0.572-0.699). There were marked increases in the area under curves when 3+4 and 4+3 Gleason 7 cancers were separated. Prostate-specific antigen velocity does not add predictive value for prostate biopsy diagnosis. The clinical significance of the prostate specific antigen test can be improved by separating Gleason 7 prostate cancers into a 3+4 and 4+3 group. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Avian toxicologic diagnosis

USGS Publications Warehouse

Sigurdson, C.J.; Franson, J.C.; Fudge, A.M.

2000-01-01

This chapter describes the sources and pathophysiology of some potential poisons that affect birds and summarizes useful laboratory tests. The diagnosis of poisoning in birds, as in mammals, requires a complete and accurate history, careful observation of clinical signs, and a thorough necropsy evaluation. Appropriate sample handling and analysis, based on consultation with the diagnostic toxicologist, are critical (Table 19--1). Veterinary toxicology laboratories are becoming increasingly specialized, with only certain laboratories capable of analyzing for drug residues or anticoagulants, for example. Although a local laboratory may not be able to fulfill a specific test request, they may recommend an alternative laboratory or may be willing to forward the sample. As a general rule in suspect poisoning cases, large tissue samples of liver, kidney, brain, and subcutaneous fat and of crop, proventriculus, and ventriculus contents should be collected at necropsy and frozen. Appropriate samples should be submitted frozen, with the remainder held in the freezer for possible later testing. A second set of tissues should be placed in 10% formalin for histopathologic examination.

Virtual laboratory learning media development to improve science literacy skills of mechanical engineering students on basic physics concept of material measurement

NASA Astrophysics Data System (ADS)

Jannati, E. D.; Setiawan, A.; Siahaan, P.; Rochman, C.

2018-05-01

This study aims to determine the description of virtual laboratory learning media development to improve science literacy skills of Mechanical Engineering students on the concept of basic Physics. Quasi experimental method was employed in this research. The participants of this research were first semester students of mechanical engineering in Majalengka University. The research instrument was readability test of instructional media. The results of virtual laboratory learning media readability test show that the average score is 78.5%. It indicates that virtual laboratory learning media development are feasible to be used in improving science literacy skill of Mechanical Engineering students in Majalengka University, specifically on basic Physics concepts of material measurement.

Association between laboratory capacities and world-cup performance in Nordic combined

PubMed Central

Fudel, Ronny; Kocbach, Jan; Moen, Frode; Ettema, Gertjan; Sandbakk, Øyvind

2017-01-01

Background Nordic combined (NC) is an Olympic winter-sport performed as a ski jumping (SJ) event followed by a cross-country (XC) pursuit race employing the skating style. Purpose To elucidate the associations between sport-specific laboratory capacities and SJ, XC skiing, and overall NC performance in a world-cup NC event. Methods Twelve international world-cup NC athletes from 8 nations performed laboratory testing one day prior to participating in a world-cup NC event. Squat jumps and SJ imitations (IMIT) were performed on a three-dimensional force plate, whereas XC skiing-specific physiological characteristics were obtained from roller ski skating tests on a treadmill and an all-out double poling (DP) test. Finally, body composition was measured. Laboratory capacities were correlated against performance in SJ, 10-km XC skiing, and overall NC in the world-cup event. Multiple regression analysis was used to determine the best suited laboratory variables for predicting performance. Results Vertical IMIT velocity together with body-mass provided the best prediction for SJ performance (r2 = 0.70, p<0.01), while body-mass-normalized V˙O2peak and DP power provided the best prediction for XC performance (r2 = 0.68, p<0.05). Body-mass-normalized V˙O2peak was the only significant correlate with overall NC performance (r2 = 0.43, p<0.05) in this competition. Conclusion Overall, the concurrent development of V˙O2peak, upper-body power, and SJ-specific vertical jump capacity while minimizing body-mass within the BMI limit set by FIS should be considered in the seasonal training of NC athletes. PMID:28662163

Reproducibility of risk figures in 2nd-trimester maternal serum screening for down syndrome: comparison of 2 laboratories.

PubMed

Benn, Peter A; Makowski, Gregory S; Egan, James F X; Wright, Dave

2006-11-01

Analytical error affects 2nd-trimester maternal serum screening for Down syndrome risk estimation. We analyzed the between-laboratory reproducibility of risk estimates from 2 laboratories. Laboratory 1 used Bayer ACS180 immunoassays for alpha-fetoprotein (AFP) and human chorionic gonadotropin (hCG), Diagnostic Systems Laboratories (DSL) RIA for unconjugated estriol (uE3), and DSL enzyme immunoassay for inhibin-A (INH-A). Laboratory 2 used Beckman immunoassays for AFP, hCG, and uE3, and DSL enzyme immunoassay for INH-A. Analyte medians were separately established for each laboratory. We used the same computational algorithm for all risk calculations, and we used Monte Carlo methods for computer modeling. For 462 samples tested, risk figures from the 2 laboratories differed >2-fold for 44.7%, >5-fold for 7.1%, and >10-fold for 1.7%. Between-laboratory differences in analytes were greatest for uE3 and INH-A. The screen-positive rates were 9.3% for laboratory 1 and 11.5% for laboratory 2, with a significant difference in the patients identified as screen-positive vs screen-negative (McNemar test, P<0.001). Computer modeling confirmed the large between-laboratory risk differences. Differences in performance of assays and laboratory procedures can have a large effect on patient-specific risks. Screening laboratories should minimize test imprecision and ensure that each assay performs in a manner similar to that assumed in the risk computational algorithm.

Accuracy of dengue clinical diagnosis with and without NS1 antigen rapid test: Comparison between human and Bayesian network model decision.

PubMed

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.

Quality indicators and specifications for strategic and support processes in laboratory medicine.

PubMed

Ricós, Carmen; Biosca, Carme; Ibarz, Mercè; Minchinela, Joana; Llopis, Maantonia; Perich, Carmen; Alsina, Jesus; Alvarez, Virtudes; Doménech, Vicenta; Pastor, Rosa Ma; Sansalvador, Mireia; Isern, Gloria Trujillo; Navarro, Conrad Vilanova

2008-01-01

This work is the second part of a study regarding indicators and quality specifications for the non-analytical processes in laboratory medicine. Five primary care and five hospital laboratories agreed on the indicators for two strategic processes (quality planning and project development) and various support processes (client relationships, instrument and infrastructure maintenance, safety and risk prevention, purchases and storage, personnel training). In the majority of cases, the median values recorded over 1 year is considered to be the state-of-the-art in our setting and proposed as the quality specification for the indicators stated. Values have been stratified according to primary care and hospital laboratory for referred tests and group of personnel for training. In some cases, the specifications have been set equal to zero events, such as serious incidents in the infrastructure maintenance process and number of work accidents in the safety and risk prevention process. In light of this study, an effort is needed to optimize decisions regarding corrective actions and to move from a subjective individual criterion to systematic and comparative management. This preliminary study provides a comprehensive vision of a subject that could motivate further research and advances in the quality of laboratory services.

Agreement between allergen-specific IgE assays and ensuing immunotherapy recommendations from four commercial laboratories in the USA.

PubMed

Plant, Jon D; Neradelik, Moni B; Polissar, Nayak L; Fadok, Valerie A; Scott, Brian A

2014-02-01

Canine allergen-specific IgE assays in the USA are not subjected to an independent laboratory reliability monitoring programme. The aim of this study was to evaluate the agreement of diagnostic results and treatment recommendations of four serum IgE assays commercially available in the USA. Replicate serum samples from 10 atopic dogs were submitted to each of four laboratories for allergen-specific IgE assays (ACTT(®) , VARL Liquid Gold, ALLERCEPT(®) and Greer(®) Aller-g-complete(®) ). The interlaboratory agreement of standard, regional panels and ensuing treatment recommendations were analysed with the kappa statistic (κ) to account for agreement that might occur merely by chance. Six comparisons of pairs of laboratories and overall agreement among laboratories were analysed for ungrouped allergens (as tested) and also with allergens grouped according to reported cross-reactivity and taxonomy. The overall chance-corrected agreement of the positive/negative test results for ungrouped and grouped allergens was slight (κ = 0.14 and 0.13, respectively). Subset analysis of the laboratory pair with the highest level of diagnostic agreement (κ = 0.36) found slight agreement (κ = 0.13) for ungrouped plants and fungi, but substantial agreement (κ = 0.71) for ungrouped mites. The overall agreement of the treatment recommendations was slight (κ = 0.11). Altogether, 85.1% of ungrouped allergen treatment recommendations were unique to one laboratory or another. Our study indicated that the choice of IgE assay may have a major influence on the positive/negative results and ensuing treatment recommendations. © 2014 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and the ACVD.

Laboratory Evaluation of the Alere q Point-of-Care System for Early Infant HIV Diagnosis.

PubMed

Hsiao, Nei-yuan; Dunning, Lorna; Kroon, Max; Myer, Landon

2016-01-01

Early infant diagnosis (EID) and prompt linkage to care are critical to minimise the high morbidity and mortality associated with infant HIV infection. Attrition in the "EID cascade" is common; however, point-of-care (POC) EID assays with same-day result could facilitate prompt linkage of HIV-infected infant to treatment. Despite a number of POC EID assays in development, few have been independently evaluated and data on new technologies are urgently needed to inform policy. We compared Alere q 1/2 Detect POC system laboratory test characteristics with the local standard of care (SOC), Roche CAP/CTM HIV-1 qualitative PCR in an independent laboratory-based evaluation in Cape Town, South Africa. Routinely EID samples collected between November 2013 and September 2014 were each tested by both SOC and POC systems. Repeat testing was done to troubleshoot any discrepancy between POC and SOC results. Overall, 1098 children with a median age of 47 days (IQR, 42-117) were included. Birth PCR (age <7 days) comprised of 8% (n = 92) tests while 56% (n = 620) of children tested as part of routine EID (ages 6-14 weeks). In the overall direct comparison, Alere q Detect achieved sensitivity of 95.5% (95% CI, 91.7-97.9%) and a specificity of 99.8% (95% CI, 99.1-100%). Following repeat testing of discordant samples and exclusion of any inconclusive results, the POC assay sensitivity and specificity were 96.9% (95% CI 93.4-98.9%) and 100% (lower 95% CI 98%) respectively. Among birth PCR tests the POC assay had slightly lower sensitivity (93.3% vs 96.5% in routine EID) and higher assay error rate (10% vs 5% in samples of older children, p = 0.04). Our results indicate this POC assay performs well for EID in the laboratory. The high specificity and thus high positive predictive value would suggest a positive POC result may be adequate for immediate infant ART initiation. While POC testing for EID may have particular utility for birth testing at delivery facilities, the lower sensitivity and error rate requires further attention, as does field implementation of POC EID technologies in other clinical care settings.

UHPC for Blast and Ballistic Protection, Explosion Testing and Composition Optimization

NASA Astrophysics Data System (ADS)

Bibora, P.; Drdlová, M.; Prachař, V.; Sviták, O.

2017-10-01

The realization of high performance concrete resistant to detonation is the aim and expected outcome of the presented project, which is oriented to development of construction materials for larger objects as protective walls and bunkers. Use of high-strength concrete (HSC / HPC - “high strength / performance concrete”) and high-fiber reinforced concrete (UHPC / UHPFC -“Ultra High Performance Fiber Reinforced Concrete”) seems to be optimal for this purpose of research. The paper describes the research phase of the project, in which we focused on the selection of specific raw materials and chemical additives, including determining the most suitable type and amount of distributed fiber reinforcement. Composition of UHPC was optimized during laboratory manufacture of test specimens to obtain the best desired physical- mechanical properties of developed high performance concretes. In connection with laboratory testing, explosion field tests of UHPC specimens were performed and explosion resistance of laboratory produced UHPC testing boards was investigated.

Sensor Acquisition for Water Utilities: A Survey and Technology List

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alai, M; Glascoe, L; Love, A

2005-03-07

The early detection of the deliberate biological and chemical contamination of water distribution systems is a necessary capability for securing the nation's water supply. Current and emerging early-detection technology capabilities and shortcomings need to be identified and assessed to provide government agencies and water utilities with an improved methodology for assessing the value of installing these technologies. The Department of Homeland Security (DHS) has tasked a multi-laboratory team to evaluate current and future needs to protect the nation's water distribution infrastructure by supporting an objective evaluation of current and new technologies. The primary deliverables from this Operational Technology Demonstration (OTD)more » are the following: (1) establishment of an advisory board for review and approval of testing protocols, technology acquisition processes and recommendations for technology test and evaluation in laboratory and field settings; (2) development of a technology acquisition process; (3) creation of laboratory and field testing and evaluation capability; and (4) testing of candidate technologies for insertion into a water early warning system. The initial phase of this study involves the development of two separate but complementary strategies to be reviewed by the advisory board: (1) a technology acquisition strategy, and (2) a technology evaluation strategy. Lawrence Livermore National Laboratory and Sandia National Laboratories are tasked with the first strategy, while Los Alamos, Pacific Northwest, and Oak Ridge National Laboratories are tasked with the second strategy. The first goal of the acquisition strategy is the development of a technology survey process that includes a review of previous sensor surveys and current test programs and then the development of a method to solicit and select existing and emerging sensor technologies for evaluation and testing. In this paper we discuss a survey of previous efforts by governmental agencies and private companies with the aim of facilitating a water sensor technology acquisition procedure. We provide a survey of previous sensor studies with regard to the use of Early Warning Systems (EWS) including earlier surveys, testing programs, and response studies. In the project we extend this earlier work by developing a list of important sensor specifications that are then used to help assemble a sensor selection criteria. A list of sensor technologies with their specifications is appended to this document. This list will assist the second goal of the project which is a recommendation of candidate technologies for laboratory and field testing.« less

Laboratory study of test methods for polymer modified asphalt in hot mix pavement.

DOT National Transportation Integrated Search

1989-11-01

Increasing use of asphalt binders modified with elastomeric or plastic modifiers makes the specification of binders a difficult task. Ideally, a generic specification would allow various suppliers and additives to compete based on expected performanc...

Developments in laboratory diagnostics for isocyanate asthma

PubMed Central

Wisnewski, Adam V.

2011-01-01

Purpose of review Isocyanates, reactive chemicals used to generate polyurethane, are a leading cause of occupational asthma worldwide. Workplace exposure is the best-recognized risk factor for disease development, but is challenging to monitor. Clinical diagnosis and differentiation of isocyanates as the cause of asthma can be difficult. The gold-standard test, specific inhalation challenge, is technically and economically demanding, and is thus only available in a few specialized centers in the world. With the increasing use of isocyanates, efficient laboratory tests for isocyanate asthma and exposure are urgently needed. Recent findings The review focuses on literature published in 2005 and 2006. Over 150 articles, identified by searching PubMed using keywords ‘diphenylmethane’, ‘toluene’ or ‘hexamethylene diisocyanate’, were screened for relevance to isocyanate asthma diagnostics. New advances in understanding isocyanate asthma pathogenesis are described, which help improve conventional radioallergosorbent and enzyme-linked immunosorbent assay approaches for measuring isocyanate-specific IgE and IgG. Newer immunoassays, based on cellular responses and discovery science readouts are also in development. Summary Contemporary laboratory tests that measure isocyanate-specific human IgE and IgG are of utility in diagnosing a subset of workers with isocyanate asthma, and may serve as a biomarker of exposure in a larger proportion of occupationally exposed workers. PMID:17351466

Harmonization in laboratory medicine: Requests, samples, measurements and reports.

PubMed

Plebani, Mario

2016-01-01

In laboratory medicine, the terms "standardization" and "harmonization" are frequently used interchangeably as the final goal is the same: the equivalence of measurement results among different routine measurement procedures over time and space according to defined analytical and clinical quality specifications. However, the terms define two distinct, albeit closely linked, concepts based on traceability principles. The word "standardization" is used when results for a measurement are equivalent and traceable to the International System of Units (SI) through a high-order primary reference material and/or a reference measurement procedure (RMP). "Harmonization" is generally used when results are equivalent, but neither a high-order primary reference material nor a reference measurement procedure is available. Harmonization is a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of accurate and actionable laboratory information. Patients, clinicians and other healthcare professionals assume that clinical laboratory tests performed by different laboratories at different times on the same sample and specimen can be compared, and that results can be reliably and consistently interpreted. Unfortunately, this is not necessarily the case, because many laboratory test results are still highly variable and poorly standardized and harmonized. Although the initial focus was mainly on harmonizing and standardizing analytical processes and methods, the scope of harmonization now also includes all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits as well as tests and test profiles, requests and criteria for interpretation. Several projects and initiatives aiming to improve standardization and harmonization in the testing process are now underway. Laboratory professionals should therefore step up their efforts to provide interchangeable and comparable laboratory information in order to ultimately assure better diagnosis and treatment in patient care.

[Validation of a questionnaire to evaluate patient safety in clinical laboratories].

PubMed

Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

2012-01-01

The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

Development of a multiplex serological assay reveals a worldwide distribution of murine astrovirus infections in laboratory mice.

PubMed

Schmidt, Katja; Butt, Julia; Mauter, Petra; Vogel, Klaus; Erles-Kemna, Andrea; Pawlita, Michael; Nicklas, Werner

2017-01-01

Laboratory mice play a tremendous role in biomedical research in studies on immunology, infection, cancer and therapy. In the course of standardization of mice used in animal experiments, health monitoring constitutes an important instrument towards microbiological standardization. Infections with murine astroviruses (MuAstV) were only recently discovered and are, therefore, still relatively unknown in laboratory animal science. In rodent health monitoring viral infections within a population are commonly assessed in terms of specific antibodies by serological testing, as active infection and excretion of virus is often temporary and can easily be missed. So far only ongoing infections with astroviruses can be detected by PCR. The objective of this work was the development of a sensitive and specific MuAstV multiplex serological assay with a high-throughput capability to be used in routine testing of laboratory mice. Four different MuAstV proteins were recombinantly expressed and used as antigens. The best reacting antigen, the capsid spike protein VP27, was selected and tested with a panel of 400 sera of mice from units with a known MuAstV status. Assay sensitivity and specificity resulted in 98.5% and 100%, respectively, compared to RT-PCR results. Eventually this assay was used to test 5529 serum samples in total, during routine diagnostics at the German Cancer Research Center (DKFZ) in Heidelberg between 2015 and 2017. High sero-prevalence rates of up to 98% were detected in units with open cages indicating that the virus is highly infectious and circulates within these populations virtually infecting all animals regardless of the mouse strain. In addition, data collected from 312 mice purchased from commercial breeders and from 661 mice from 58 research institutes in 15 countries worldwide allowed the conclusion that MuAstV is widespread in contemporary laboratory mouse populations.

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

Evaluation of FASTPlaqueTB to diagnose smear-negative tuberculosis in a peripheral clinic in Kenya.

PubMed

Bonnet, M; Gagnidze, L; Varaine, F; Ramsay, A; Githui, W; Guerin, P J

2009-09-01

To evaluate the performance and feasibility of FASTPlaqueTB in smear-negative tuberculosis (TB) suspects in a peripheral clinic after laboratory upgrading. Patients with cough > or=2 weeks, two sputum smear-negative results, no response to 1 week of amoxicillin and abnormal chest X-ray were defined as smear-negative suspects. One sputum sample was collected, decontaminated and divided into two: half was tested with FASTPlaqueTB in the clinic laboratory and the other half was cultured on Löwenstein-Jensen medium in the Kenyan Medical Research Institute. Test sensitivity and specificity were evaluated in all patients and in human immunodeficiency virus (HIV) infected patients. Feasibility was assessed by the contamination rate and the resources required to upgrade the laboratory. Of 208 patients included in the study, 56.2% were HIV-infected. Of 203 FASTPlaqueTB tests, 95 (46.8%) were contaminated, which interfered with result interpretation and led to the interruption of the study. Sensitivity and specificity were respectively 31.2% (95%CI 12.1-58.5) and 94.9% (95%CI 86.8-98.4) in all patients and 33.3% (95%CI 9.9-65.1) and 93.9% (95%CI 83.1-98.7) in HIV-infected patients. Upgrading the laboratory cost euro 20,000. FASTPlaqueTB did not perform satisfactorily in this setting. If contamination can be reduced, in addition to laboratory upgrading, its introduction in peripheral clinics would require further assessment in smear-negative and HIV co-infected patients and test adaptation for friendlier use.

The WHO/PEPFAR collaboration to prepare an operations manual for HIV prevention, care, and treatment at primary health centers in high-prevalence, resource-constrained settings: defining laboratory services.

PubMed

Spira, Thomas; Lindegren, Mary Lou; Ferris, Robert; Habiyambere, Vincent; Ellerbrock, Tedd

2009-06-01

The expansion of HIV/AIDS care and treatment in resource-constrained countries, especially in sub-Saharan Africa, has generally developed in a top-down manner. Further expansion will involve primary health centers where human and other resources are limited. This article describes the World Health Organization/President's Emergency Plan for AIDS Relief collaboration formed to help scale up HIV services in primary health centers in high-prevalence, resource-constrained settings. It reviews the contents of the Operations Manual developed, with emphasis on the Laboratory Services chapter, which discusses essential laboratory services, both at the center and the district hospital level, laboratory safety, laboratory testing, specimen transport, how to set up a laboratory, human resources, equipment maintenance, training materials, and references. The chapter provides specific information on essential tests and generic job aids for them. It also includes annexes containing a list of laboratory supplies for the health center and sample forms.

National continuous surveys on internal quality control for HbA1c in 306 clinical laboratories of China from 2012 to 2016: Continual improvement.

PubMed

Li, Tingting; Wang, Wei; Zhao, Haijian; He, Falin; Zhong, Kun; Yuan, Shuai; Wang, Zhiguo

2017-09-01

This study aimed to evaluate whether the quality performance of clinical laboratories in China has been greatly improved and whether Internal Quality Control (IQC) practice of HbA1c has also been changed since National Center for Clinical Laboratories (NCCL) of China organized laboratories to report IQC data for HbA1c in 2012. Internal Quality Control information of 306 External Quality Assessment (EQA) participant laboratories which kept reporting IQC data in February from 2012 to 2016 were collected by Web-based EQA system. Then percentages of laboratories meeting four different imprecision specifications for current coefficient of variations (CVs) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements. The current CVs of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CVs all showed the increasing tendency year by year. As for analytical system, 52.1% (159/306) laboratories changed their systems with the change in principle of assay. And many laboratories began to use cation exchange high-performance liquid chromatography (CE-HPLC) instead of Immunoturbidimetry, because CE-HPLC owed a lower intra-laboratory CVs. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements. The imprecision performance of HbA1c tests has been improved in these 5 years with the change in IQC practice, but it is still disappointing in China. Therefore, laboratories should actively find existing problems and take action to promote performance of HbA1c measurements. © 2016 Wiley Periodicals, Inc.

Benefits and Limitations of Prenatal Screening for Prader-Willi Syndrome

PubMed Central

Butler, Merlin G.

2016-01-01

This review the status of genetic laboratory testing in Prader-Willi syndrome (PWS) due to different genetic subtypes, most often a paternally derived 15q11-q13 deletion, with benefits and limitations related to prenatal screening. Medical literature was searched for prenatal screening and genetic laboratory testing methods in use or under development and discussed in relationship to PWS. Genetic testing includes six established laboratory diagnostic approaches for PWS with direct application to prenatal screening. Ultrasonographic, obstetric and cytogenetic reports were summarized in relationship to the cause of Prader-Willi syndrome and identification of specific genetic subtypes including maternal disomy 15. Advances in genetic technology were described for diagnosing PWS specifically DNA methylation and high-resolution chromosomal SNP microarrays as current tools for genetic screening and incorporating next generation DNA sequencing for noninvasive prenatal testing (NIPT) using cell-free fetal DNA. Positive experiences are reported with NIPT for detection of numerical chromosomal problems (aneuploidies) but not for structural problems (microdeletions). These reports will be discussed along with future directions for genetic screening of PWS. In summary, this review describes and discusses the status of established and ongoing genetic testing options for PWS applicable in prenatal screening including NIPT and future directions for early diagnosis in Prader-Willi syndrome. PMID:27537837

Benefits and limitations of prenatal screening for Prader-Willi syndrome.

PubMed

Butler, Merlin G

2017-01-01

This review summarizes the status of genetic laboratory testing in Prader-Willi syndrome (PWS) with different genetic subtypes, most often a paternally derived 15q11-q13 deletion and discusses benefits and limitations related to prenatal screening. Medical literature was searched for prenatal screening and genetic laboratory testing methods in use or under development and discussed in relationship to PWS. Genetic testing includes six established laboratory diagnostic approaches for PWS with direct application to prenatal screening. Ultrasonographic, obstetric and cytogenetic reports were summarized in relationship to the cause of PWS and identification of specific genetic subtypes including maternal disomy 15. Advances in genetic technology were described for diagnosing PWS specifically DNA methylation and high-resolution chromosomal SNP microarrays as current tools for genetic screening and incorporating next generation DNA sequencing for noninvasive prenatal testing (NIPT) using cell-free fetal DNA. Positive experiences are reported with NIPT for detection of numerical chromosomal problems (aneuploidies) but not for structural problems (microdeletions). These reports will be discussed along with future directions for genetic screening of PWS. In summary, this review describes and discusses the status of established and ongoing genetic testing options for PWS applicable in prenatal screening including NIPT and future directions for early diagnosis in PWS. © 2016 John Wiley & Sons, Ltd. © 2016 John Wiley & Sons, Ltd.

Flue gas desulfurization chemistry studies: limestone grindability. Volume 2. Grindability testing. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Richmann, D.L.; Luke, K.W.; Terry, J.C.

1984-07-01

The results of a study to determine the relative grindability of US limestones and to relate grindability to petrographic properties are presented in this report. A laboratory ball mill test was developed to provide a quick and simple measure of grindability. These values were then used to explore possible correlations between grindability and the chemical and physical properties of the limestones. Chemical analyses and thin section petrographic analyses were used to characterize the limestone samples. The results of the laboratory ball mill test were compared to the results of an industrial grinding test, the Bond Work Index, for six samplesmore » which covered the grindability range. The two tests compared well with a correlation coefficient greater than 0.9. While the laboratory test is not sufficient to provide ball mill design specifications, it can be used as a screening and quality control test. The grinding results, expressed as a grindability index, ranged in values from 2 to 15. This represents a seven-fold range in the relative difficulties to grind for the limestones tested. From the petrographic analysis results, a strong correlation was found between the grindability and the fraction of macrocrystalline (> 5 ..mu..m) carbonate minerals present in the limestone. However, based on the high degree of variability characteristic of most limestone deposits, petrographic information should, in general, only be used to qualitatively predict the grindability of a specific limestone. An actual grinding test is recommended for a quantitative evaluation.« less

Diagnostic Approach to Acute Diarrheal Illness in a Military Population on Training Exercises in Thailand, a Region of Campylobacter Hyperendemicity▿

PubMed Central

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

Fast preparation of a long chimeric armored RNA as controls for external quality assessment for molecular detection of Zika virus.

PubMed

Lin, Guigao; Zhang, Kuo; Zhang, Dong; Han, Yanxi; Xie, Jiehong; Li, Jinming

2017-03-01

The emergence of Zika virus demands accurate laboratory diagnostics. Nucleic acid testing is currently the definitive method for diagnosis of Zika infection. In 2016, an external quality assurance (EQA) for assessing the quality of molecular testing of Zika virus was carried out in China. A single armored RNA encapsulating a 4942-nucleotides (nt) long specific RNA sequence of Zika virus was prepared and used as positive samples. A pre-tested EQA panel, consisting of 4 negative and 6 positive samples with different concentrations of armored RNA, was distributed to 38 laboratories that perform molecular detection of Zika virus. A total of 39 data sets (1 laboratory used two test kits in parallel), produced by using commercial (n=38) or laboratory developed (n=1) quantitative reverse-transcriptase PCR (qRT-PCR) kits, were received. Of these, 35 (89.7%) had correct results for all 10 samples, and 4 (10.3%) reported at least 1 error (11 in total). The testing errors were all false-negatives, highlighting the need of improvements in detecting sensitivity. The EQA reveals that the majority of participating laboratories are proficient in molecular testing of Zika virus. Copyright © 2017 Elsevier B.V. All rights reserved.

Rapid, whole blood diagnostic test for detecting anti-hantavirus antibody in rats.

PubMed

Amada, Takako; Yoshimatsu, Kumiko; Yasuda, Shumpei P; Shimizu, Kenta; Koma, Takaaki; Hayashimoto, Nobuhito; Gamage, Chandika D; Nishio, Sanae; Takakura, Akira; Arikawa, Jiro

2013-10-01

Hantavirus is a causative agent of rodent-borne viral zoonoses, hemorrhagic fever with renal syndrome (HFRS) and hantavirus pulmonary syndrome. Seoul virus (SEOV) is a causative agent of urban and laboratory rat-associated HFRS worldwide. Surveillance of rodents has been done mainly by serological detection of hantavirus-specific antibodies by enzyme linked immunosorbent assay (ELISA) and immunofluorescent antibody assay (IFA). An immunochromatographic (ICG) test was developed with the N-terminal 103 amino acids of nucleocapsid protein of Hantaan virus expressed by Escherichia coli as an antigen to detect IgG antibody specific to hantavirus in sera from Rattus sp. animals. Antibody-detecting sensitivity of the ICG test was the same as that of ELISA and about 100-times higher than that of IFA. Overall sensitivities and specificities of the ICG test in comparison to ELISA and IFA for sera from 192 urban rats and 123 laboratory rats were 99.3% and 100%, respectively. Diluted whole blood samples without separation could be used for the ICG test. The ICG test enabled detection of antibodies to SEOV, Hantaan, Dobrava/Belgrade, and Thailand viruses, which are causative agents of HFRS throughout Eurasia. The ICG test is a rapid, simple and safe method for diagnosis of SEOV infection in rats. Copyright © 2013 Elsevier B.V. All rights reserved.

Additional Progress in the Development and Application of a Direct, Rapid Immunohistochemical Test for Rabies Diagnosis.

PubMed

Rupprecht, Charles E; Xiang, Zhiquan; Servat, Alexandre; Franka, Richard; Kirby, Jordona; Ertl, Hildegund C J

2018-06-20

Laboratory-based surveillance is fundamental to effective rabies prevention and control. The direct fluorescent antibody (AB) test (FAT) is the gold standard for rabies diagnosis. Recently, additional tests besides the FAT have been developed, such as the direct rapid immunohistochemical test (DRIT). In this study, our objective was to further refine technical aspects of the DRIT using a combination of two monoclonal ABs (MABs), 502 and 802, conduct additional testing among rabies reference laboratories using a diversity of animal species and rabies virus (RV) variants and compare the potential utility of the DRIT for end users via proficiency testing (PT) against the FAT. Considering the ideal molar ratios of biotin to AB in formulation of the DRIT conjugate, 3.9 was found to be superior to 7.4, for detection of RV antigens in the brain of a naturally infected raccoon. Optimization of the DRIT conjugate may also be dependent upon the apparent choice of specific viral antigens for testing, as a gray fox RV variant reacted less strongly than a raccoon RV variant in determining the working dilution of the MAB cocktail. Using the same MABs and protocol, the DRIT was compared to the FAT using more than 800 samples of mammalian brains, representative of more than 25 taxa, including in excess of 250 animal rabies cases from Europe and North America. Sensitivity was determined at 98% (96⁻100%, 95% CI) and specificity was calculated at 95% (92⁻96%, 95% CI). In a comparison among end users, PT of laboratory personnel resulted in values of 77⁻100% sensitivity and 86-100% specificity. Based upon these and previously reported results, the DRIT appears to be a suitable alternative to the FAT for use in lyssavirus diagnosis.

The economic impact of poor sample quality in clinical chemistry laboratories: results from a global survey.

PubMed

Erdal, Erik P; Mitra, Debanjali; Khangulov, Victor S; Church, Stephen; Plokhoy, Elizabeth

2017-03-01

Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.

Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories.

PubMed

DiFrancesco, Robin; Rosenkranz, Susan L; Taylor, Charlene R; Pande, Poonam G; Siminski, Suzanne M; Jenny, Richard W; Morse, Gene D

2013-10-01

Among National Institutes of Health HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals. Drug assay data are, in turn, entered into study-specific data sets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis, and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semiannual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1) assess the precision and accuracy of concentrations reported by individual CPLs and (2) determine factors associated with round-specific and long-term assay accuracy, precision, and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21) drug concentration results reported for clinical trial samples by multiple CPLs). Using the Clinical Laboratory Improvement Act acceptance of meeting criteria for ≥2/3 consecutive rounds, all 10 laboratories that participated in 3 or more rounds per analyte maintained Clinical Laboratory Improvement Act proficiency. Significant associations were present between magnitude of error and CPL (Kruskal-Wallis P < 0.001) and antiretroviral (Kruskal-Wallis P < 0.001).

Clinical utility of routine laboratory testing to identify possible secondary causes in older men with osteoporosis: the Osteoporotic Fractures in Men (MrOS) Study

PubMed Central

Fink, Howard A.; Litwack-Harrison, Stephanie; Taylor, Brent C.; Bauer, Douglas C.; Orwoll, Eric S.; Lee, Christine G.; Barrett-Connor, Elizabeth; Schousboe, John T.; Kado, Deborah M.; Garimella, Pranav S.; Ensrud, Kristine E.

2016-01-01

Purpose To evaluate the utility of recommended laboratory testing to identify secondary causes in older men with osteoporosis, we examined prevalence of laboratory abnormalities in older men with and without osteoporosis. Methods 1572 men aged ≥65 years in the Osteoporotic Fractures in Men study completed bone mineral density (BMD) testing and a battery of laboratory measures, including serum calcium, phosphorus, alkaline phosphatase, parathyroid hormone (PTH), thyroid-stimulating hormone (TSH), 25-OH vitamin D, total testosterone, spot urine calcium/creatinine ratio, spot urine albumin-creatinine ratio, creatinine-derived estimate glomerular filtration rate, 24-hour urine calcium, and 24-hour urine free cortisol. Using cross-sectional analyses, we calculated prevalence ratios (PR) and 95% confidence intervals (CI) for the association of any and specific laboratory abnormalities with osteoporosis, and the number of men with osteoporosis needed to test to identify one additional laboratory abnormality compared to testing men without osteoporosis. Results Approximately 60% of men had ≥1 laboratory abnormality in both men with and without osteoporosis. Among individual tests, only vitamin D insufficiency (PR, 1.13; 95% CI, 1.05–1.22) and high alkaline phosphatase (PR, 3.05; 95% CI, 1.52–6.11) were more likely in men with osteoporosis. Hypercortisolism and hyperthyroidism were uncommon and not significantly more frequent in men with osteoporosis. No osteoporotic men had hypercalciuria. Conclusions Though most of these older men had ≥1 laboratory abnormality, few routinely recommended individual tests were more common in men with osteoporosis than in those without osteoporosis. Possibly excepting vitamin D and alkaline phosphatase, benefit of routine laboratory testing to identify possible secondary causes in older osteoporotic men appears low. Results may not be generalizable to younger men or to older men in whom history and exam findings raise clinical suspicion for a secondary cause of osteoporosis. PMID:26458388

32 CFR 199.18 - Uniform HMO Benefit.

Code of Federal Regulations, 2012 CFR

2012-07-01

... schedule, including frequency or age specifications for: (i) Laboratory and x-ray tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Pap smears; (iii) Eye exams; (iv) Immunizations; (v) Periodic health promotion and disease prevention exams; (vi) Blood...

32 CFR 199.18 - Uniform HMO Benefit.

Code of Federal Regulations, 2011 CFR

2011-07-01

... schedule, including frequency or age specifications for: (i) Laboratory and x-ray tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Pap smears; (iii) Eye exams; (iv) Immunizations; (v) Periodic health promotion and disease prevention exams; (vi) Blood...

32 CFR 199.18 - Uniform HMO Benefit.

Code of Federal Regulations, 2013 CFR

2013-07-01

... schedule, including frequency or age specifications for: (i) Laboratory and x-ray tests, including blood lead, rubella, cholesterol, fecal occult blood testing, and mammography; (ii) Pap smears; (iii) Eye exams; (iv) Immunizations; (v) Periodic health promotion and disease prevention exams; (vi) Blood...

Chromium - blood test

MedlinePlus

Serum chromium level normally is less than or equal to 1.4 micrograms/milliliter (µg/mL) or 26924.80 nanomoles/L (nmol/L). Normal value ranges may vary slightly among different laboratories. Talk to your provider about the meaning of your specific test result.

Comparison of clinical characteristics and laboratory findings of malaria, dengue, and enteric fever in returning travelers: 8-year experience at a referral center in Tokyo, Japan.

PubMed

Kutsuna, Satoshi; Hayakawa, Kayoko; Kato, Yasuyuki; Fujiya, Yoshihiro; Mawatari, Momoko; Takeshita, Nozomi; Kanagawa, Shuzo; Ohmagari, Norio

2015-07-01

Without specific symptoms, diagnosis of febrile illness in returning travelers is challenging. Dengue, malaria, and enteric fever are common causes of fever in returning travelers and timely and appropriate treatment is important. However, differentiation is difficult without specific diagnostic tests. A retrospective study was conducted at the National Centre for Global Health and Medicine (NCGM) from April 2005 to March 2013. Febrile travelers returning from overseas who were diagnosed with dengue, malaria, or enteric fever were included in this study. Clinical characteristics and laboratory findings were compared for each diagnosis. During the study period, 86 malaria, 85 dengue, and 31 enteric fever cases were identified. The mean age of the study cohort was 33.1 ± 12 years and 134 (66.3%) study participants were male. Asia was the most common area visited by returning travelers with fevers (89% of dengue, 18.6% of malaria, and 100% of enteric fever cases), followed by Africa (1.2% of dengue and 70.9% of malaria cases). Clinical characteristics and laboratory findings were significantly different among each group with each diagnosis. Decision tree models revealed that returning from Africa and CRP levels < 10 mg/L were factors specific for diagnosis of malaria and dengue fever, respectively. Clinical manifestations, simple laboratory test results, and regions of travel are helpful to distinguish between dengue, malaria, and enteric fever in febrile returning travelers with non-specific symptoms.

Validity of diagnoses, procedures, and laboratory data in Japanese administrative data.

PubMed

Yamana, Hayato; Moriwaki, Mutsuko; Horiguchi, Hiromasa; Kodan, Mariko; Fushimi, Kiyohide; Yasunaga, Hideo

2017-10-01

Validation of recorded data is a prerequisite for studies that utilize administrative databases. The present study evaluated the validity of diagnoses and procedure records in the Japanese Diagnosis Procedure Combination (DPC) data, along with laboratory test results in the newly-introduced Standardized Structured Medical Record Information Exchange (SS-MIX) data. Between November 2015 and February 2016, we conducted chart reviews of 315 patients hospitalized between April 2014 and March 2015 in four middle-sized acute-care hospitals in Shizuoka, Kochi, Fukuoka, and Saga Prefectures and used them as reference standards. The sensitivity and specificity of DPC data in identifying 16 diseases and 10 common procedures were identified. The accuracy of SS-MIX data for 13 laboratory test results was also examined. The specificity of diagnoses in the DPC data exceeded 96%, while the sensitivity was below 50% for seven diseases and variable across diseases. When limited to primary diagnoses, the sensitivity and specificity were 78.9% and 93.2%, respectively. The sensitivity of procedure records exceeded 90% for six procedures, and the specificity exceeded 90% for nine procedures. Agreement between the SS-MIX data and the chart reviews was above 95% for all 13 items. The validity of diagnoses and procedure records in the DPC data and laboratory results in the SS-MIX data was high in general, supporting their use in future studies. Copyright © 2017 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

Laboratory evaluation on the sensitivity and specificity of a novel and rapid detection method for malaria diagnosis based on magneto-optical technology (MOT).

PubMed

Mens, Petra F; Matelon, Raphael J; Nour, Bakri Y M; Newman, Dave M; Schallig, Henk D F H

2010-07-19

This study describes the laboratory evaluation of a novel diagnostic platform for malaria. The Magneto Optical Test (MOT) is based on the bio-physical detection of haemozoin in clinical samples. Having an assay time of around one minute, it offers the potential of high throughput screening. Blood samples of confirmed malaria patients from different regions of Africa, patients with other diseases and healthy non-endemic controls were used in the present study. The samples were analysed with two reference tests, i.e. an histidine rich protein-2 based rapid diagnostic test (RDT) and a conventional Pan-Plasmodium PCR, and the MOT as index test. Data were entered in 2 x 2 tables and analysed for sensitivity and specificity. The agreement between microscopy, RDT and PCR and the MOT assay was determined by calculating Kappa values with a 95% confidence interval. The observed sensitivity/specificity of the MOT test in comparison with clinical description, RDT or PCR ranged from 77.2 - 78.8% (sensitivity) and from 72.5 - 74.6% (specificity). In general, the agreement between MOT and the other assays is around 0.5 indicating a moderate agreement between the reference and the index test. However, when RDT and PCR are compared to each other, an almost perfect agreement can be observed (k = 0.97) with a sensitivity and specificity of >95%. Although MOT sensitivity and specificity are currently not yet at a competing level compared to other diagnostic test, such as PCR and RDTs, it has a potential to rapidly screen patients for malaria in endemic as well as non-endemic countries.

Operating environmental laboratories--an overview of analysis equipment procurement and management.

PubMed

Pandya, G H; Shinde, V M; Kanade, G S; Kondawar, V K

2003-10-01

Management of equipment in an environmental laboratory requires planning involving assessment of the workload on a particular equipment, establishment of criteria and specification for the purchase of equipment, creation of infrastructure for installation and testing of the equipment, optimization of analysis conditions, development of preventive maintenance procedures and establishment of in-house repair facilities. The paper reports the results of such an analysis carried for operating environmental laboratories associated with R& D work, serving as an Govt. laboratory or attached to an Industry for analysing industrial emissions.

Proceedings of the drug testing laboratory managers symposium, 28 January--1 February 1974. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Noe, E.R.; Romanchick, W.A.; Ainsworth, C.A. III

1975-06-01

This report deals with broad concepts of managing mass screening programs for drugs of abuse; e.g., morphine, barbiturate, amphetamine, cocaine, and methaqualone. The interactions of the screening process and of the rehabilitation program were covered. Psychotherapy and group therapy are both utilized in rehabilitation programs. The semiautomated radioimmunoassay (RIA) screening procedures are both sensitive and specific at nanogram quantities. Future evaluations of a wafer disk transferral system and of a latex test for morphine are presented. The unique quality control system employed by military drug abuse testing laboratories is discussed. (Author) (GRA)

Rapid detection of methicillin resistance in coagulase-negative staphylococci by a penicillin-binding protein 2a-specific latex agglutination test.

PubMed

Horstkotte, M A; Knobloch, J K; Rohde, H; Mack, D

2001-10-01

The detection of PBP 2a by the MRSA-Screen latex agglutination test with 201 clinical coagulase-negative staphylococci had an initial sensitivity of 98% and a high degree of specificity for Staphylococcus epidermidis strains compared to PCR for mecA. Determination of oxacillin MICs evaluated according to the new breakpoint (0.5 microg/ml) of the National Committee for Clinical Laboratory Standards exhibited an extremely low specificity for this population.

Evaluation of the Xpert MTB/RIF assay for diagnosis of tuberculosis and rifampin resistance in county-level laboratories in Hunan province, China.

PubMed

Hu, Peilei; Bai, Liqiong; Liu, Fengping; Ou, Xichao; Zhang, Zhiying; Yi, Songlin; Chen, Zhongnan; Gong, Daofang; Liu, Binbin; Guo, Jingwei; Tan, Yunhong

2014-01-01

The Xpert MTB/RIF showed high sensitivity and specificity in previous studies carried out in different epidemiological and geographical settings and patient populations in high-burden tuberculosis (TB) countries. However, there were little data obtained by validation or demonstration study of the assay in China. In this study, the performance of Xpert MTB/RIF was investigated in two county-level laboratories in Hunan Province, China. Consecutive patients with suspected pulmonary tuberculosis (PTB) and suspicion for multidrug-resistant tuberculosis (MDR-TB) were enrolled. For each patient suspected to have PTB, three sputum specimens (one spot sputum, one night sputum, and one morning sputum) were collected and each sputum was tested with smear microscopy, Löwenstein-Jensen (LJ) culture, and Xpert MTB/RIF test. For comparison across subgroups and testing methods, 95% confidence intervals were calculated. All analyses were done with SPSS 16.0, and P < 0.05 was regarded as significant. For case detection, the sensitivity of Xpert MTB/RIF was 100% for smear- and culture-positive TB and 88.6% for smear-negative and culture-positive TB; the overall sensitivity was 94.5% for all culture-positive patients. The specificity was 99.8%. The sensitivity of Xpert MTB/RIF assay was 22.0% in clinical TB patients and the specificity reached 100.0% in the group of patients who are infected with nontuberculous mycobacteria. For the detection of rifampin resistance, the sensitivity of MTB/RIF RIF-resistance detection was 92.9%, and the specificity was 98.7%. Of the 26 Xpert MTB/RIF-positive and RIF-resistant patients confirmed by LJ proportion tests, 20 (76.9%) patients were infected by MDR-TB. The Xpert MTB/RIF assay is a highly sensitive and specific method for diagnosis of TB and RIF resistance, which will enable it to have the potential to be used in county-level laboratories and lead to the reduction of the infectious pool and improvements in TB control in China. Further evaluations in county-level laboratories for implementing the assay are still required.

Use of amplified Mycobacterium tuberculosis direct test in respiratory samples from HIV-infected patients in Brazil.

PubMed

Barreto, Leonardo Bruno Paz Ferreira; Lourenço, Maria Cristina da Silva; Rolla, Valéria Cavalcanti; Veloso, Valdiléia Gonçalves; Huf, Gisele

2014-01-01

To compare the accuracy of the amplified Mycobacterium tuberculosis direct (AMTD) test with reference methods for the laboratory diagnosis of tuberculosis in HIV-infected patients. This was a study of diagnostic accuracy comparing AMTD test results with those obtained by culture on Löwenstein-Jensen (LJ) medium and by the BACTEC Mycobacteria Growth Indicator Tube 960 (BACTEC MGIT 960) system in respiratory samples analyzed at the Bioassay and Bacteriology Laboratory of the Oswaldo Cruz Foundation Evandro Chagas Clinical Research Institute in the city of Rio de Janeiro, Brazil. We analyzed respiratory samples collected from 118 patients, of whom 88 (74.4%) were male. The mean age was 36.6 ± 10.6 years. Using the AMTD test, the BACTEC MGIT 960 system, and LJ culture, we identified M. tuberculosis complex in 31.0%, 29.7%, and 27.1% of the samples, respectively. In comparison with LJ culture, the AMTD test had a sensitivity, specificity, positive predictive value, and negative predictive value of 87.5%, 89.4%, 75.7%, and 95.0%, respectively, for LJ culture, whereas, in comparison with the BACTEC MGIT 960 system, it showed values of 88.6%, 92.4%, 83.8%, and 94.8%, respectively. The AMTD test showed good sensitivity and specificity in the population studied, enabling the laboratory detection of M. tuberculosis complex in paucibacillary respiratory specimens.

Recent Improvements to the Acoustical Testing Laboratory at the NASA Glenn Research Center

NASA Technical Reports Server (NTRS)

Podboy, Devin M.; Mirecki, Julius H.; Walker, Bruce E.; Sutliff, Daniel L.

2014-01-01

The Acoustical Testing Laboratory (ATL) consists of a 27- by 23- by 20-ft (height) convertible hemi/anechoic chamber and separate sound-attenuating test support enclosure. Absorptive fiberglass wedges in the test chamber provide an anechoic environment down to 100 Hz. A spring-isolated floor system affords vibration isolation above 3 Hz. These specifications, along with very low design background levels, enable the acquisition of accurate and repeatable acoustical measurements on test articles that produce very low sound pressures. Removable floor wedges allow the test chamber to operate in either a hemi-anechoic or anechoic configuration, depending on the size of the test article and the specific test being conducted. The test support enclosure functions as a control room during normal operations. Recently improvements were accomplished in support of continued usage of the ATL by NASA programs including an analysis of the ultra-sonic characteristics. A 3-D traverse system inside the chamber was utilized for acquiring acoustic data for these tests. The traverse system drives a linear array of 13, 1/4 in.-microphones spaced 3 in. apart (36 in. span). An updated data acquisition system was also incorporated into the facility.

Recent Improvements to the Acoustical Testing Laboratory at the NASA Glenn Research Center

NASA Technical Reports Server (NTRS)

Podboy, Devin M.; Mirecki, Julius H.; Walker, Bruce E.; Sutliff, Daniel L.

2014-01-01

The Acoustical Testing Laboratory (ATL) consists of a 27 by 23 by 20 ft (height) convertible hemi/anechoic chamber and separate sound-attenuating test support enclosure. Absorptive fiberglass wedges in the test chamber provide an anechoic environment down to 100 Hz. A spring-isolated floor system affords vibration isolation above 3 Hz. These specifications, along with very low design background levels, enable the acquisition of accurate and repeatable acoustical measurements on test articles that produce very low sound pressures. Removable floor wedges allow the test chamber to operate in either a hemi-anechoic or anechoic configuration, depending on the size of the test article and the specific test being conducted. The test support enclosure functions as a control room during normal operations. Recently improvements were accomplished in support of continued usage of the ATL by NASA programs including an analysis of the ultra-sonic characteristics. A 3 dimensional traverse system inside the chamber was utilized for acquiring acoustic data for these tests. The traverse system drives a linear array of 13, 1/4"-microphones spaced 3" apart (36" span). An updated data acquisition system was also incorporated into the facility.

Could accreditation bodies facilitate the implementation of medical guidelines in laboratories?

PubMed

Aakre, Kristin M; Oosterhuis, Wytze P; Misra, Shivani; Langlois, Michel R; Joseph, Watine; Twomey, Patrick J; Barth, Julian H

2017-05-01

Several studies have shown that recommendations related to how laboratory testing should be performed and results interpreted are limited in medical guidelines and that the uptake and implementation of the recommendations that are available need improvement. The EFLM/UEMS Working Group on Guidelines conducted a survey amongst the national societies for clinical chemistry in Europe regarding development of laboratory-related guidelines. The results showed that most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a formal procedure for accepting such guidelines and few countries have guideline committees. Based on this, the EFLM/UEMS Working Group on Guidelines conclude that there is still room for improvement regarding these processes in Europe and raise the question if the accreditation bodies could be a facilitator for an improvement.

New Assessment Process in an Introductory Undergraduate Physics Laboratory: An Exploration on Collaborative Learning

ERIC Educational Resources Information Center

Leung, Anthony C. K.; Hashemi Pour, Banafsheh; Reynolds, Dan; Jerzak, Stanislaw

2017-01-01

A new team learning assessment process was designed and tested in a first-year university physics laboratory class. The assessment process was designed to provide a strong incentive for students to cooperate and feel responsible for each other's learning and fostering a sense of collaboration rather than competition. Specifically, the new…

Demonstration and Certification of Amphibian Ecological Risk Assessment Protocol

DTIC Science & Technology

2009-04-01

evidence that these species are relatively long-lived (~ 20 years), adding to the ethical concerns from harvesting these species for site-specific...hazards (for example Salmonella, Vibrio ssp.). All laboratory-specific health and safety considerations should be followed. (see Test Method E 1706

Verification of performance specifications for a US Food and Drug Administration-approved molecular microbiology test: Clostridium difficile cytotoxin B using the Becton, Dickinson and Company GeneOhm Cdiff assay.

PubMed

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.

Challenges of measles and rubella laboratory diagnostic in the era of elimination.

PubMed

Hübschen, J M; Bork, S M; Brown, K E; Mankertz, A; Santibanez, S; Ben Mamou, M; Mulders, M N; Muller, C P

2017-08-01

The Member States of the WHO European Region adopted the goal of measles and rubella elimination more than 10 years ago, but so far only 21 of 53 countries have reached this target. Laboratory investigation of suspected cases is essential to support disease elimination efforts. Therefore, WHO maintains a network of accredited laboratories providing high-quality testing. Laboratory investigation heavily relies on specific IgM serology and increasingly on virus detection by reverse transcription (RT)-PCR, but other methods such as IgG avidity testing and genetic characterization of virus strains have gained in importance. In elimination settings, often few samples from suspected cases are available for testing, but testing proficiency must be maintained. The predictive value of an IgM-positive result decreases and other rash-fever disease aetiologies become more important. In addition, cases with a rash after measles/rubella vaccination or with mild disease after waning of vaccine-induced antibodies are seen more often. Thus, it is necessary to perform comprehensive and potentially time-consuming and costly investigations of every suspected case using quality-controlled laboratory methods. At the same time rapid feedback to public health officers is required for timely interventions. The introduction of new laboratory methods for comprehensive case investigations requires training of staff under the supervision of WHO-accredited reference laboratories and the definition of appropriate test algorithms. Clinical, laboratory, and epidemiological data are essential for final case classification and investigation of chains of transmission in the endgame of measles and rubella elimination. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Updating the immunology curriculum in clinical laboratory science.

PubMed

Stevens, C D

2000-01-01

To determine essential content areas of immunology/serology courses at the clinical laboratory technician (CLT) and clinical laboratory scientist (CLS) levels. A questionnaire was designed which listed all major topics in immunology and serology. Participants were asked to place a check beside each topic covered. For an additional list of serological and immunological laboratory testing, participants were asked to indicate if each test was performed in either the didactic or clinical setting, or not performed at all. A national survey of 593 NAACLS approved CLT and CLS programs was conducted by mail under the auspices of ASCLS. Responses were obtained from 158 programs. Respondents from all across the United States included 60 CLT programs, 48 hospital-based CLS programs, 45 university-based CLS programs, and 5 university-based combined CLT and CLS programs. The survey was designed to enumerate major topics included in immunology and serology courses by a majority of participants at two distinct educational levels, CLT and CLS. Laboratory testing routinely performed in student laboratories as well as in the clinical setting was also determined for these two levels of practitioners. Certain key topics were common to most immunology and serology courses. There were some notable differences in the depth of courses at the CLT and CLS levels. Laboratory testing associated with these courses also differed at the two levels. Testing requiring more detailed interpretation, such as antinuclear antibody patterns (ANAs), was mainly performed by CLS students only. There are certain key topics as well as specific laboratory tests that should be included in immunology/serology courses at each of the two different educational levels to best prepare students for the workplace. Educators can use this information as a guide to plan a curriculum for such courses.

An alternative perspective on how laboratory medicine can contribute to solve the health care crisis: a model to save costs by acquiring excellence in diagnostic systems.

PubMed

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.

Reliability of the MODS assay decentralisation process in three health regions in Peru

PubMed Central

Mendoza, A.; Castillo, E.; Gamarra, N.; Huamán, T.; Perea, M.; Monroi, Y.; Salazar, R.; Coronel, J.; Acurio, M.; Obregón, G.; Roper, M.; Bonilla, C.; Asencios, L.; Moore, D. A. J.

2011-01-01

OBJECTIVE To deliver rapid isoniazid (INH) and rifampicin (RMP) drug susceptibility testing (DST) close to the patient, we designed a decentralisation process for the microscopic observation drug susceptibility (MODS) assay in Peru and evaluated its reliability. METHODS After 2 weeks of training, laboratory staff processed ≥120 consecutive sputum samples each in three regional laboratories. Samples were processed in parallel with MODS testing at an expert laboratory. Blinded paired results were independently analysed by the Instituto Nacional de Salud (INS) according to predetermined criteria: concordance for culture, DST against INH and RMP and diagnosis of multidrug-resistant t uberculosis (MDR-TB) ≥ 95%, McNemar's P > 0.05, kappa index (κ) ≥ 0.75 and contamination 1–4%. Sensitivity and specificity for MDR-TB were calculated. RESULTS The accreditation process for Callao (126 samples, 79.4% smear-positive), Lima Sur (n = 130, 84%) and Arequipa (n = 126, 80%) took respectively 94, 97 and 173 days. Pre-determined criteria in all regional laboratories were above expected values. The sensitivity and specificity for detecting MDR-TB in regional laboratories were >95%, except for sensitivity in Lima Sur, which was 91.7%. Contamination was 1.0–2.3%. Mean delay to positive MODS results was 9.9–12.9 days. CONCLUSION Technology transfer of MODS was reliable, effective and fast, enabling the INS to accredit regional laboratories swiftly. PMID:21219684

Laboratory screening markers in gastroenterology--state of the art.

PubMed

Kocna, Petr; Vanickova, Zdislava; Zima, Tomas

2013-06-01

Screening tests for gastrointestinal diseases acceptable for population with a high sensitivity and high specificity can now be offered by clinical laboratories. This paper summarizes major recent advances in this area of laboratory medicine. Relevant articles published within the last 5 years in the NLM (National Library of Medicine) PubMed - Medline database covering the three gastrointestinal diseases - colorectal cancer, coeliac disease, and atrophic gastritis were included for this overview. In Europe, colorectal cancer (CRCA) is the second most frequent malignant disease. Quantitative immunochemical analysis of the stool for haemoglobin provides the best screening test to date, with both sensitivity and specificity approaching 95%. Even though coeliac disease (CD) affects approximately 1% of the general population, it remains largely unrecognised. Recommended methods for screening currently involve the detection of IgA and IgG antibodies against tissue transglutaminase and deamidated gliadin peptide. Evaluations of screening are now discussed for other diseases of the gastrointestinal tract - such as chronic atrophic gastritis (CAG), and inflammatory bowel disease (IBD). Detection of infection by Helicobacter pylori and stomach-specific plasmatic biomarkers, especially pepsinogen I/II ratio, could help with the prevention of gastric carcinomas. The use of faecal calprotectin as a screening test could substantially reduce the number of invasive methods necessary for the diagnostic work-up of patients with IBD. Screening tests for CRCA and CD have been used worldwide for many years. Screening strategies for gastrointestinal diseases are suggested in the text, based on recent basic science, clinical papers as well as our own experience.

Practical challenges related to point of care testing.

PubMed

Shaw, Julie L V

2016-04-01

Point of care testing (POCT) refers to laboratory testing that occurs near to the patient, often at the patient bedside. POCT can be advantageous in situations requiring rapid turnaround time of test results for clinical decision making. There are many challenges associated with POCT, mainly related to quality assurance. POCT is performed by clinical staff rather than laboratory trained individuals which can lead to errors resulting from a lack of understanding of the importance of quality control and quality assurance practices. POCT is usually more expensive than testing performed in the central laboratory and requires a significant amount of support from the laboratory to ensure the quality testing and meet accreditation requirements. Here, specific challenges related to POCT compliance with accreditation standards are discussed along with strategies that can be used to overcome these challenges. These areas include: documentation of POCT orders, charting of POCT results as well as training and certification of individuals performing POCT. Factors to consider when implementing connectivity between POCT instruments and the electronic medical record are also discussed in detail and include: uni-directional versus bidirectional communication, linking patient demographic information with POCT software, the importance of positive patient identification and considering where to chart POCT results in the electronic medical record.

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

Practical diagnostic testing for human immunodeficiency virus.

PubMed Central

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

14. "SITE WORK, CIVIL, SITE PLAN." Test Area 1120. Specifications ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

14. "SITE WORK, CIVIL, SITE PLAN." Test Area 1-120. Specifications No. OC2-55-72; Drawing No. 60-09-12; sheet 7 of 148; file no. 1320/58, Rev. C. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338 Rev. C, Date: 16 April 1957. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Leuhman Ridge near Highways 58 & 395, Boron, Kern County, CA

3. "LAUNCH SILOS; AREA PAVING AND GRADING PLAN." Specifications No. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

3. "LAUNCH SILOS; AREA PAVING AND GRADING PLAN." Specifications No. ENG-04-353-59-73; Drawing No. 5841C-11; D.O. SERIES AW-1525/17; Stamped: RECORD DRAWING AS CONSTRUCTED. Below stamp: Contract No. 6601, Date 18 Sep 59. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Missile Silo Type, Test Area 1-100, northeast end of Test Area 1-100 Road, Boron, Kern County, CA

4. "LAUNCH SILOS, EQUIPMENT ROOMS SECTIONS AND DETAILS." Specifications ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

4. "LAUNCH SILOS, EQUIPMENT ROOMS - SECTIONS AND DETAILS." Specifications No. ENG-04-353-59-73; Drawing No. 5841S-5; D.O. SERIES AW-1525/28; Stamped: RECORD DRAWING AS CONSTRUCTED. Below Stamp: Contract No. 6601, Date 18 Sep 59. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Missile Silo Type, Test Area 1-100, northeast end of Test Area 1-100 Road, Boron, Kern County, CA

5. "LAUNCH SILOS; EQUIP. ROOM; SECTIONS AND DETAILS." Specifications No. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

5. "LAUNCH SILOS; EQUIP. ROOM; SECTIONS AND DETAILS." Specifications No. ENG-04-353-59-73; Drawing No. 5841S-6; D.O. SERIES AW-1525/29; Stamped: RECORD DRAWING AS CONSTRUCTED. Below stamp: Contract No. 6601, Date 18 Sep 59. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Missile Silo Type, Test Area 1-100, northeast end of Test Area 1-100 Road, Boron, Kern County, CA

10. "ARCHITECTURAL, SECTIONS AND DETAILS." Specifications No. ENG043535572; Drawing No. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

10. "ARCHITECTURAL, SECTIONS AND DETAILS." Specifications No. ENG-04-353-55-72; Drawing No. 60-09-12; sheet 23 of 148; file no. 1320/74. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A Terminal Room, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

Alchemy: A Web 2.0 Real-time Quality Assurance Platform for Human Immunodeficiency Virus, Hepatitis C Virus, and BK Virus Quantitation Assays.

PubMed

Agosto-Arroyo, Emmanuel; Coshatt, Gina M; Winokur, Thomas S; Harada, Shuko; Park, Seung L

2017-01-01

The molecular diagnostics laboratory faces the challenge of improving test turnaround time (TAT). Low and consistent TATs are of great clinical and regulatory importance, especially for molecular virology tests. Laboratory information systems (LISs) contain all the data elements necessary to do accurate quality assurance (QA) reporting of TAT and other measures, but these reports are in most cases still performed manually: a time-consuming and error-prone task. The aim of this study was to develop a web-based real-time QA platform that would automate QA reporting in the molecular diagnostics laboratory at our institution, and minimize the time expended in preparing these reports. Using a standard Linux, Nginx, MariaDB, PHP stack virtual machine running atop a Dell Precision 5810, we designed and built a web-based QA platform, code-named Alchemy. Data files pulled periodically from the LIS in comma-separated value format were used to autogenerate QA reports for the human immunodeficiency virus (HIV) quantitation, hepatitis C virus (HCV) quantitation, and BK virus (BKV) quantitation. Alchemy allowed the user to select a specific timeframe to be analyzed and calculated key QA statistics in real-time, including the average TAT in days, tests falling outside the expected TAT ranges, and test result ranges. Before implementing Alchemy, reporting QA for the HIV, HCV, and BKV quantitation assays took 45-60 min of personnel time per test every month. With Alchemy, that time has decreased to 15 min total per month. Alchemy allowed the user to select specific periods of time and analyzed the TAT data in-depth without the need of extensive manual calculations. Alchemy has significantly decreased the time and the human error associated with QA report generation in our molecular diagnostics laboratory. Other tests will be added to this web-based platform in future updates. This effort shows the utility of informatician-supervised resident/fellow programming projects as learning opportunities and workflow improvements in the molecular laboratory.

Using iron studies to predict HFE mutations in New Zealand: implications for laboratory testing.

PubMed

O'Toole, Rebecca; Romeril, Kenneth; Bromhead, Collette

2017-04-01

The diagnosis of hereditary haemochromatosis (HH) is not straightforward because symptoms are often absent or non-specific. Biochemical markers of iron-overloading may be affected by other conditions. To measure the correlation between iron studies and HFE genotype to inform evidence-based recommendations for laboratory testing in New Zealand. Results from 2388 patients genotyped for C282Y, H63D and S65C in Wellington, New Zealand from 2007 to 2013 were compared with their biochemical phenotype as quantified by serum ferritin (SF), transferrin saturation (TS), serum iron (SI) and serum transferrin (ST). The predictive power of these markers was evaluated by receiver operator characteristic (ROC) curve analysis, and if a statistically significant association for a variable was seen, sensitivity, specificity and predictive values were calculated. Test ordering patterns showed that 62% of HFE genotyping tests were ordered because of an elevated SF alone and only 11% of these had a C-reactive protein test to rule out an acute phase reaction. The association between SF and significant HFE genotypes SF was low. However, TS values ≥45% predicted HH mutations with the highest sensitivity and specificity. A SF of >1000 µg/L was found in one at-risk patient (C282Y homozygote) who had a TS <45%. Our analysis highlights the need for clear guidelines for investigation of hyperferritinaemia and HH in New Zealand. Using our findings, we developed an evidence-based laboratory testing algorithm based on a TS ≥45%, a SF ≥1000 µg/L and/or a family history of HH which identified all C282Y homozygotes in this study. © 2016 Royal Australasian College of Physicians.

B-type natriuretic peptide and its clinical utility in patients with heart failure.

PubMed

Wu, A H

2001-10-01

The implementation of entirely new clinical laboratory tests such as BNP assays is much more difficult today than it ever has been in the past. Medicare and Medicaid have been operating for many years on fixed reimbursements based on Diagnosis Related Groups (DRGs). Many third-party payers now have capitated contracts, i.e., a fixed reimbursement per member per month, regardless of the number of tests ordered and performed. Laboratories are now cost centers and not sources of revenue, thus the limited amount of income from fee-for-service reimbursements may not sufficient to cover the expenses for performing all testing. Therefore, in order to justify BNP testing, laboratory directors and hospital administrators must be able to demonstrate that implementation of BNP testing results in a savings for the hospital as a whole, even if the laboratory has a negative cost balance. If BNP testing can lead to a reduction or elimination of other tests, or if it improves the efficiency and accuracy of CHF diagnosis so that the number of inappropriate admissions is reduced, the test may be justified. Table 2 lists some specific areas where BNP might impact the other clinical areas. Outcome studies should be performed to determine if any of these changes in clinical practices can be justified.

Laboratory diagnosis of Ebola virus disease and corresponding biosafety considerations in the China Ebola Treatment Center.

PubMed

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.

National survey on turnaround time of clinical biochemistry tests in 738 laboratories in China.

PubMed

Zhang, Xiaoyan; Fei, Yang; Wang, Wei; Zhao, Haijian; Wang, Minqi; Chen, Bingquan; Zhou, Jie; Wang, Zhiguo

2018-02-01

This survey was initiated to estimate the current status of turnaround time (TAT) monitoring of clinical biochemistry in China, provide baseline data for establishment of quality specifications and analyze the impact factors of TAT. 738 laboratories were included. Questionnaires involved general information and data of related indicators of TAT during 1 week were provided to participating laboratories. Nine quality indicators were covered, which were medians, 90th and outlier rates of pre-examination, examination, and post-examination TAT. The 25th percentile, median, and 75th percentile of TATs were calculated as optimum, desirable, and minimum quality specifications. Percentages and sigma values were used to describe the outlier rates. Mann-Whitney and Kruskal-Wallis tests were used to identify the potential impacts of TAT. Response rate of this survey was 46.44%. More than 50% of the laboratories indicated they had set up target TATs in three time intervals and monitored TATs generally. The post-examination TAT of most laboratories was 0min, while the pre-examination and examination TAT varied. Sigma values of outlier rates for 45%~60% of laboratories were above 4, while 15%~20% of labs whose sigma values were below 3. Group comparisons suggested nurse or mechanical pipeline transportation, link laboratory information system with hospital information system, and using computer reporting instead of printing report were related to shorter TATs. Despite of the remarkable progresses of TATs in China, there was also room to improve. Laboratories should strengthen the construction of information systems, identify reasons for TAT delay to improve the service quality continuously. © 2017 Wiley Periodicals, Inc.

Molecular Methods and Platforms for Infectious Diseases Testing

PubMed Central

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

Wildlife specimen collection, preservation, and shipment

USGS Publications Warehouse

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.

Organism support for life sciences spacelab experiments

NASA Technical Reports Server (NTRS)

Drake, G. L.; Heppner, D. B.

1976-01-01

This paper presents an overview of the U.S. life sciences laboratory concepts envisioned for the Shuttle/Spacelab era. The basic development approach is to provide a general laboratory facility supplemented by specific experiment hardware as required. The laboratory concepts range from small carry-on laboratories to fully dedicated laboratories in the Spacelab pressurized module. The laboratories will encompass a broad spectrum of research in biology and biomedicine requiring a variety of research organisms. The environmental control and life support of these organisms is a very important aspect of the success of the space research missions. Engineering prototype organism habitats have been designed and fabricated to be compatible with the Spacelab environment and the experiment requirements. These first-generation habitat designs and their subsystems have supported plants, cells/tissues, invertebrates, and small vertebrates in limited evaluation tests. Special handling and transport equipment required for the ground movement of the experiment organisms at the launch/landing site have been built and tested using these initial habitat prototypes.

Study of occupational stress among railway engine pilots

PubMed Central

Kumar, Devesh; Singh, Jai Vir; Kharwar, Poonam S.

2011-01-01

Background: Traffic volume and speed is going to be increased in Indian Railways successively, leading to higher stress in staff connected with train operations. The jobs of railway engine pilots come under the category of high-strain jobs, necessitating a need to conduct multicentric study to unfold the factors associated with occupational stress and organizational strategies. Materials and Methods: Present study covered 185 railway engine pilots and office clerks working in various railway zones by incidental method. Occupational Stress Index (OSI) test developed by Srivastva and Singh, questionnaire of specific stressors constructed by authors and laboratory test battery for psychological screening of high-speed train pilots were used as tools. Results: Means of OSI and all the 12 occupational stressors of railway engine pilots were found significantly higher to that of office clerks. Means of OSI and occupational stressors of goods train pilots were significantly higher in comparison to high-speed train pilots and passenger train pilots. Study revealed positive correlation of speed perception and complex reaction time tests and negative correlation of other constituent tests of laboratory test battery to OSI test. Highest subgroup of stressor observedwas role overload followed by role conflict. Conclusions: These findings provide a prima facie evidence of higher occupational stress among railway engine pilots because of identified specific stressors prevalent in their job and explore the possible intervention strategies for its reduction. Significant correlation is noticed between OSI and laboratory test results, indicating its relevant utility in preliminary psychological screening. PMID:21808497

An Ibero-American inter-laboratory trial to evaluate serological tests for the detection of anti-Neospora caninum antibodies in cattle.

PubMed

Campero, Lucía M; Moreno-Gonzalo, Javier; Venturini, María C; Moré, Gastón; Dellarupe, Andrea; Rambeaud, Magdalena; Echaide, Ignacio E; Valentini, Beatriz; Campero, Carlos M; Moore, Dadín P; Cano, Dora B; Fort, Marcelo; Mota, Rinaldo A; Serrano-Martínez, Marcos E; Cruz-Vázquez, Carlos; Ortega-Mora, Luis M; Álvarez-García, Gema

2018-01-01

We carried out an inter-laboratory trial to compare the serological tests commonly used for the detection of specific Neospora caninum antibodies in cattle in Ibero-American countries. A total of eight laboratories participated from the following countries: Argentina (n = 4), Brazil (n = 1), Peru (n = 1), Mexico (n = 1), and Spain (n = 1). A blind panel of well-characterized cattle sera (n = 143) and sera representative of the target population (n = 351) was tested by seven in-house indirect fluorescent antibody tests (IFATs 1-7) and three enzyme-linked immunosorbent assays (ELISAs 1-3; two in-house and one commercial). Diagnostic performance of the serological tests was calculated and compared according to the following criteria: (1) the "Pre-test information," which uses previous epidemiological and serological data; (2) the "Majority of tests," which classifies a serum as positive or negative according to the results obtained by most tests evaluated. Unexpectedly, six tests showed either sensitivity (Se) or specificity (Sp) values lower than 90%. In contrast, the best tests in terms of Se, Sp, and area under the ROC curve (AUC) values were IFAT 1 and optimized ELISA 1 and ELISA 2. We evaluated a high number of IFATs, which are the most widely used tests in Ibero-America. The significant discordances observed among the tests regardless of the criteria employed hinder control programs and urge the use of a common test or with similar performances to either the optimized IFAT 1 and ELISAs 1 and 2.

42 CFR 493.15 - Laboratories performing waived tests.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and... rate—non-automated; (6) Hemoglobin—copper sulfate—non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin...

42 CFR 493.15 - Laboratories performing waived tests.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and... rate—non-automated; (6) Hemoglobin—copper sulfate—non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin...

Direct detection and characterization of foot-and-mouth disease virus in East Africa using a field-ready real-time PCR platform.

PubMed

Howson, E L A; Armson, B; Lyons, N A; Chepkwony, E; Kasanga, C J; Kandusi, S; Ndusilo, N; Yamazaki, W; Gizaw, D; Cleaveland, S; Lembo, T; Rauh, R; Nelson, W M; Wood, B A; Mioulet, V; King, D P; Fowler, V L

2018-02-01

Effective control and monitoring of foot-and-mouth disease (FMD) relies upon rapid and accurate disease confirmation. Currently, clinical samples are usually tested in reference laboratories using standardized assays recommended by The World Organisation for Animal Health (OIE). However, the requirements for prompt and serotype-specific diagnosis during FMD outbreaks, and the need to establish robust laboratory testing capacity in FMD-endemic countries have motivated the development of simple diagnostic platforms to support local decision-making. Using a portable thermocycler, the T-COR™ 8, this study describes the laboratory and field evaluation of a commercially available, lyophilized pan-serotype-specific real-time RT-PCR (rRT-PCR) assay and a newly available FMD virus (FMDV) typing assay (East Africa-specific for serotypes: O, A, Southern African Territories [SAT] 1 and 2). Analytical sensitivity, diagnostic sensitivity and specificity of the pan-serotype-specific lyophilized assay were comparable to that of an OIE-recommended laboratory-based rRT-PCR (determined using a panel of 57 FMDV-positive samples and six non-FMDV vesicular disease samples for differential diagnosis). The FMDV-typing assay was able to correctly identify the serotype of 33/36 FMDV-positive samples (no cross-reactivity between serotypes was evident). Furthermore, the assays were able to accurately detect and type FMDV RNA in multiple sample types, including epithelial tissue suspensions, serum, oesophageal-pharyngeal (OP) fluid and oral swabs, both with and without the use of nucleic acid extraction. When deployed in laboratory and field settings in Tanzania, Kenya and Ethiopia, both assays reliably detected and serotyped FMDV RNA in samples (n = 144) collected from pre-clinical, clinical and clinically recovered cattle. These data support the use of field-ready rRT-PCR platforms in endemic settings for simple, highly sensitive and rapid detection and/or characterization of FMDV. © 2017 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.

Human Papillomavirus (HPV) Genotyping: Automation and Application in Routine Laboratory Testing

PubMed Central

Torres, M; Fraile, L; Echevarria, JM; Hernandez Novoa, B; Ortiz, M

2012-01-01

A large number of assays designed for genotyping human papillomaviruses (HPV) have been developed in the last years. They perform within a wide range of analytical sensitivity and specificity values for the different viral types, and are used either for diagnosis, epidemiological studies, evaluation of vaccines and implementing and monitoring of vaccination programs. Methods for specific genotyping of HPV-16 and HPV-18 are also useful for the prevention of cervical cancer in screening programs. Some commercial tests are, in addition, fully or partially automated. Automation of HPV genotyping presents advantages such as the simplicity of the testing procedure for the operator, the ability to process a large number of samples in a short time, and the reduction of human errors from manual operations, allowing a better quality assurance and a reduction of cost. The present review collects information about the current HPV genotyping tests, with special attention to practical aspects influencing their use in clinical laboratories. PMID:23248734

Thermocouple Calibration and Accuracy in a Materials Testing Laboratory

NASA Technical Reports Server (NTRS)

Lerch, B. A.; Nathal, M. V.; Keller, D. J.

2002-01-01

A consolidation of information has been provided that can be used to define procedures for enhancing and maintaining accuracy in temperature measurements in materials testing laboratories. These studies were restricted to type R and K thermocouples (TCs) tested in air. Thermocouple accuracies, as influenced by calibration methods, thermocouple stability, and manufacturer's tolerances were all quantified in terms of statistical confidence intervals. By calibrating specific TCs the benefits in accuracy can be as great as 6 C or 5X better compared to relying on manufacturer's tolerances. The results emphasize strict reliance on the defined testing protocol and on the need to establish recalibration frequencies in order to maintain these levels of accuracy.

[Application of a continual improvement approach to selecting diagnostic markers for acute pancreatitis in an emergency department].

PubMed

Salinas, María; Flores, Emilio; López-Garrigós, Maite; Díaz, Elena; Esteban, Patricia; Leiva-Salinas, Carlos

2017-01-01

To apply a continual improvement model to develop an algorithm for ordering laboratory tests to diagnose acute pancreatitis in a hospital emergency department. Quasi-experimental study using the continual improvement model (plan, do, check, adjust cycles) in 2 consecutive phases in emergency patients: amylase and lipase results were used to diagnose acute pancreatitis in the first phase; in the second, only lipase level was first determined; amylase testing was then ordered only if the lipase level fell within a certain range. We collected demographic data, number amylase and lipase tests ordered and the findings, final diagnosis, and the results of a questionnaire to evaluate satisfaction with emergency care. The first phase included 517 patients, of whom 20 had acute pancreatitis. For amylase testing sensitivity was 0.70; specificity, 0.85; positive predictive value (PPV), 17; and negative predictive value (NPV), 0.31. For lipase testing these values were sensitivity, 0.85; specificity, 0.96; PPV, 21, and NPV, 0.16. When both tests were done, sensitivity was 0.85; specificity 0.99; PPV, 85; and NPV, 0.15. The second phase included data for 4815 patients, 118 of whom had acute pancreatitis. The measures of diagnostic yield for the new algorithm were sensitivity, 0.92; specificity, 0.98; PPV, 46; and NPV, 0.08]. This study demonstrates a process for developing a protocol to guide laboratory testing in acute pancreatitis in the hospital emergency department. The proposed sequence of testing for pancreatic enzyme levels can be effective for diagnosing acute pancreatitis in patients with abdominal pain.

Biomarkers in prostate cancer: what’s new?

PubMed Central

Sartori, David A.; Chan, Daniel W.

2014-01-01

Purpose of review This review is intended to provide an overview of the current state of biomarkers for prostate cancer (PCa), with a focus on biomarkers approved by the US Food and Drug Administration (FDA) as well as biomarkers available from Clinical Laboratory Improvement Amendment (CLIA)-certified clinical laboratories within the last 1–2 years. Recent findings During the past 2 years, two biomarkers have been approved by the US FDA. These include proPSA as part of the Prostate Health Index (phi) by Beckman Coulter, Inc and PCA3 as Progensa by Gen Probe, Inc. With the advances in genomic and proteomic technologies, several new CLIA-based laboratory-developed tests have become available. Examples are Oncotype DX from Genomics Health, Inc, and Prolaris from Myriad Genetics, Inc. In most cases, these new tests are based on a combination of multiple genomic or proteomic biomarkers. Summary Several new tests, as discussed in this review, have become available during the last 2 years. Although the intended use of most of these tests is to distinguish PCa from benign prostatic conditions with better sensitivity and specificity than prostate-specific antigen, studies have shown that some of them may also be useful in the differentiation of aggressive from nonaggressive forms of PCa. PMID:24626128

Multicentre evaluation of a direct agglutination test prototype kit (DAT-LPC) for diagnosis of visceral leishmaniasis.

PubMed

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.

Impact of Exposure to Pressure of 50 MPa on the Specific Surface Area of Clay

NASA Astrophysics Data System (ADS)

Koszela-Marek, Ewa

2017-12-01

The paper presents results of laboratory tests conducted to determine the impact of pressure of 50 MPa on specific surface area of clay. These tests were carried out in an original, high-pressure test stand. The specific surface area of clay extracted directly from an open pit mine was compared with the specific surface area of the same clay subjected to the pressure of 50 MPa in a high-pressure chamber. The study found that the specific surface area of the clay subjected to the pressure of 50 MPa increased distinctly by over 35 %. The increase in specific surface can be a result of changes in the microstructure of clay particles and microstructural alteration in the soil skeleton, caused by the pressure.

Effect of Population Heterogenization on the Reproducibility of Mouse Behavior: A Multi-Laboratory Study

PubMed Central

Richter, S. Helene; Garner, Joseph P.; Zipser, Benjamin; Lewejohann, Lars; Sachser, Norbert; Touma, Chadi; Schindler, Britta; Chourbaji, Sabine; Brandwein, Christiane; Gass, Peter; van Stipdonk, Niek; van der Harst, Johanneke; Spruijt, Berry; Võikar, Vootele; Wolfer, David P.; Würbel, Hanno

2011-01-01

In animal experiments, animals, husbandry and test procedures are traditionally standardized to maximize test sensitivity and minimize animal use, assuming that this will also guarantee reproducibility. However, by reducing within-experiment variation, standardization may limit inference to the specific experimental conditions. Indeed, we have recently shown in mice that standardization may generate spurious results in behavioral tests, accounting for poor reproducibility, and that this can be avoided by population heterogenization through systematic variation of experimental conditions. Here, we examined whether a simple form of heterogenization effectively improves reproducibility of test results in a multi-laboratory situation. Each of six laboratories independently ordered 64 female mice of two inbred strains (C57BL/6NCrl, DBA/2NCrl) and examined them for strain differences in five commonly used behavioral tests under two different experimental designs. In the standardized design, experimental conditions were standardized as much as possible in each laboratory, while they were systematically varied with respect to the animals' test age and cage enrichment in the heterogenized design. Although heterogenization tended to improve reproducibility by increasing within-experiment variation relative to between-experiment variation, the effect was too weak to account for the large variation between laboratories. However, our findings confirm the potential of systematic heterogenization for improving reproducibility of animal experiments and highlight the need for effective and practicable heterogenization strategies. PMID:21305027

A Laboratory-Based Evaluation of Four Rapid Point-of-Care Tests for Syphilis

PubMed Central

Causer, Louise M.; Kaldor, John M.; Fairley, Christopher K.; Donovan, Basil; Karapanagiotidis, Theo; Leslie, David E.; Robertson, Peter W.; McNulty, Anna M.; Anderson, David; Wand, Handan; Conway, Damian P.; Denham, Ian; Ryan, Claire; Guy, Rebecca J.

2014-01-01

Background Syphilis point-of-care tests may reduce morbidity and ongoing transmission by increasing the proportion of people rapidly treated. Syphilis stage and co-infection with HIV may influence test performance. We evaluated four commercially available syphilis point-of-care devices in a head-to-head comparison using sera from laboratories in Australia. Methods Point-of-care tests were evaluated using sera stored at Sydney and Melbourne laboratories. Sensitivity and specificity were calculated by standard methods, comparing point-of-care results to treponemal immunoassay (IA) reference test results. Additional analyses by clinical syphilis stage, HIV status, and non-treponemal antibody titre were performed. Non-overlapping 95% confidence intervals (CI) were considered statistically significant differences in estimates. Results In total 1203 specimens were tested (736 IA-reactive, 467 IA-nonreactive). Point-of-care test sensitivities were: Determine 97.3%(95%CI:95.8–98.3), Onsite 92.5%(90.3–94.3), DPP 89.8%(87.3–91.9) and Bioline 87.8%(85.1–90.0). Specificities were: Determine 96.4%(94.1–97.8), Onsite 92.5%(90.3–94.3), DPP 98.3%(96.5–99.2), and Bioline 98.5%(96.8–99.3). Sensitivity of the Determine test was 100% for primary and 100% for secondary syphilis. The three other tests had reduced sensitivity among primary (80.4–90.2%) compared to secondary syphilis (94.3–98.6%). No significant differences in sensitivity were observed by HIV status. Test sensitivities were significantly higher among high-RPR titre (RPR≥8) (range: 94.6–99.5%) than RPR non-reactive infections (range: 76.3–92.9%). Conclusions The Determine test had the highest sensitivity overall. All tests were most sensitive among high-RPR titre infections. Point-of-care tests have a role in syphilis control programs however in developed countries with established laboratory infrastructures, the lower sensitivities of some tests observed in primary syphilis suggest these would need to be supplemented with additional tests among populations where syphilis incidence is high to avoid missing early syphilis cases. PMID:24618681

Population screening for coeliac disease in primary care by district nurses using a rapid antibody test: diagnostic accuracy and feasibility study

PubMed Central

2007-01-01

Objective To evaluate the feasibility and diagnostic accuracy of screening for coeliac disease by rapid detection of IgA antibodies to tissue transglutaminase performed in primary care. Design District nurses screened 6 year old children using rapid antibody testing of finger prick blood. They also collected capillary blood samples for laboratory determination of IgA and IgG antibodies to endomysium and IgA antibodies to tissue transglutaminase. Children with positive rapid test results were directly sent for biopsy of the small intestine. Setting Primary care in Jász-Nagykun-Szolnok county, Hungary. Participants 2690 children (77% of 6 year olds living in the county) and 120 nurses. Main outcome measures Positivity for antibodies to endomysium or transglutaminase in the laboratory and coeliac disease confirmed at biopsy. Results 37 children (1.4%, 95% confidence interval 0.9% to 1.8%) had biopsy confirmed coeliac disease. Only five of these children had been diagnosed clinically before screening. Rapid testing had a 78.1% sensitivity (70.0% to 89.3%) and 100% specificity (88.4% to 100%) for a final diagnosis of coeliac disease by biopsy. Sensitivity was 65.1% (50.2% to 77.6%) and specificity was 100% (99.8% to 100%) compared with combined results of IgA and IgG laboratory tests. Trained laboratory workers detected 30 of the 31 newly diagnosed IgA competent patients with the rapid test kit used blindly. Median time to biopsy after a positive rapid test result was significantly shorter (20 days, range 4-148) than after a positive laboratory result (142 days, 70-256; P<0.001). Children with coeliac disease detected at screening were smaller and had worse health status than their peers but they improved on a gluten-free diet. Conclusions A simple rapid antibody test enabled primary care nurses to detect patients with coeliac disease in the community who were not picked up in clinical care. Extra training is needed to improve sensitivity. PMID:18063612

A multivariate assessment of the effect of the laboratory homework component of a microcomputer-based laboratory for a college freshman physics course

NASA Astrophysics Data System (ADS)

Ramlo, Susan E.

Microcomputer-based laboratories (MBLs) have been defined as software that uses an electronic probe to collect information about a physical system and then converts that information into graphical systems in real-time. Realtime Physics Laboratories (RTP) are an example of laboratories that combine the use of MBLs with collaboration and guided-inquiry. RTP Mechanics Laboratories include both laboratory activities and laboratory homework for the first semester of college freshman physics courses. Prior research has investigated the effectiveness of the RTP laboratories as a package (laboratory activities with laboratory homework). In this study, an experimental-treatment had students complete both the RTP laboratory activity and the associated laboratory homework during the same laboratory period. Observations of this treatment indicated that students primarily consulted the laboratory instructor and referred to their completed laboratory activity while completing the homework in their collaborative groups. In the control-treatment, students completed the laboratory homework outside the laboratory period. Measures of force and motion conceptual understanding included the Force and Motion Conceptual Understanding (FMCE), a 47 multiple-choice question test. Analyses of the FMCE indicated that it is both a reliable and a valid measure of force and motion conceptual understanding. A distinct, five-factor structure for the FMCE post-test answers reflected specific concepts related to force and motion. However, the three FMCE pretest factors were less distinct. Analysis of the experimental-treatment, compared to a control-treatment, included multiple regression analysis with covariates of age, prior physics-classroom experience, and the three FMCE pretest factors. Criterion variables included each of the five post-test factors, the total laboratory homework score, and a group of seven exam questions. The results were all positive, in favor of the experimental-treatment. However, the results were significant only with the criterions of the FMCE post-test factor "Concepts Regarding Newton's First and Second Laws" and the laboratory homework score. The interaction between the treatments and prior physics-classroom experience was not significant. Implications of the qualitative and quantitative findings are discussed.

[Comparability study of analytical results between a group of clinical laboratories].

PubMed

Alsius-Serra, A; Ballbé-Anglada, M; López-Yeste, M L; Buxeda-Figuerola, M; Guillén-Campuzano, E; Juan-Pereira, L; Colomé-Mallolas, C; Caballé-Martín, I

2015-01-01

To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Results of external quality-assurance program for the National Atmospheric Deposition Program and National Trends Network during 1985

USGS Publications Warehouse

Brooks, M.H.; Schroder, L.J.; Willoughby, T.C.

1988-01-01

External quality assurance monitoring of the National Atmospheric Deposition Program (NADP) and National Trends Network (NTN) was performed by the U.S. Geological Survey during 1985. The monitoring consisted of three primary programs: (1) an intersite comparison program designed to assess the precision and accuracy of onsite pH and specific conductance measurements made by NADP and NTN site operators; (2) a blind audit sample program designed to assess the effect of routine field handling on the precision and bias of NADP and NTN wet deposition data; and (3) an interlaboratory comparison program designed to compare analytical data from the laboratory processing NADP and NTN samples with data produced by other laboratories routinely analyzing wet deposition samples and to provide estimates of individual laboratory precision. An average of 94% of the site operators participated in the four voluntary intersite comparisons during 1985. A larger percentage of participating site operators met the accuracy goal for specific conductance measurements (average, 87%) than for pH measurements (average, 67%). Overall precision was dependent on the actual specific conductance of the test solution and independent of the pH of the test solution. Data for the blind audit sample program indicated slight positive biases resulting from routine field handling for all analytes except specific conductance. These biases were not large enough to be significant for most data users. Data for the blind audit sample program also indicated that decreases in hydrogen ion concentration were accompanied by decreases in specific conductance. Precision estimates derived from the blind audit sample program indicate that the major source of uncertainty in wet deposition data is the routine field handling that each wet deposition sample receives. Results of the interlaboratory comparison program were similar to results of previous years ' evaluations, indicating that the participating laboratories produced comparable data when they analyzed identical wet deposition samples, and that the laboratory processing NADP and NTN samples achieved the best analyte precision of the participating laboratories. (Author 's abstract)

Use of a hand-held meter for detecting subclinical ketosis in dairy cows.

PubMed

Voyvoda, Huseyin; Erdogan, Hasan

2010-12-01

The Optium Xceed is a new hand-held meter for determining blood β-hydroxybutyrate (BHBA) and glucose in human medicine. The objective of this study was to compare BHBA and glucose results obtained using the hand-held meter with those results made with a laboratory method and to evaluate its usefulness as a cowside test in the diagnosis of subclinical ketosis (SCK) in dairy cows. Seventy-eight blood samples from clinically healthy Holstein cows between 5 and 60 days post-calving were analysed. BHBA and glucose values were significantly higher with the hand-held meter versus laboratory methods. Correlation coefficients (r) for BHBA and glucose with the Optium Xceed versus laboratory methods were 0.97 and 0.63, respectively. Based on Bland-Altman plot and Passing-Bablok regression, agreement between two methods was good for BHBA but the agreement for glucose was only fair. When SCK was defined as plasma BHBA levels ≥ 1200 μmol/L, the sensitivity and specificity of the hand-held meter ketone testing in determining SCK were 85% and 94%, respectively. Raising the threshold of the laboratory method to ≥ 1400 μmol/L, the sensitivity and specificity incremented to 0.90 and 0.98, respectively. In conclusion, the blood ketone-monitoring device can be used as a rapid and reliable diagnostic test to detect SCK under field conditions. Copyright © 2010 Elsevier Ltd. All rights reserved.

[The requirements of standard and conditions of interchangeability of medical articles].

PubMed

Men'shikov, V V; Lukicheva, T I

2013-11-01

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

NREL and SDG&E Collaboration to Support SDG&E Grid and Storage Efforts: Cooperative Research and Development Final Report, CRADA Number CRD-14-562

DOE Office of Scientific and Technical Information (OSTI.GOV)

Baggu, Murali

2017-01-01

This project will enable effective utilization of high penetration of photovoltaics (PV) in islanded microgrids, increasing overall system efficiency, decreased fuel costs and resiliency of the overall system to help meet the SunShot goals of enhancing system integration methods to increase penetration of PV. National Renewable Energy Laboratory (NREL) will collaborate with San Diego Gas & Electric (SDG&E) to provide research and testing support to address their needs in energy storage sizing and placement, Integrated Test Facility (ITF) development, Real Time Digital Simulator (RTDS) Modeling and simulation support at ITF, Visualization and Virtual connection to Energy Systems Integration Facility (ESIF),more » and microgrid simulation and testing areas. Specifically in this project a real microgrid scenario with high penetration of PV (existing in SDG&E territory) is tested in the ESIF laboratory. Multiple control cases for firming PV using storage in a microgrid scenario will be investigated and tested in the laboratory setup.« less

[Efficacy of a rapid test to diagnose Plasmodium vivax in symptomatic patients of Chiapas, Mexico].

PubMed

González-Cerón, Lilia; Rodríguez, Mario H; Betanzos, Angel F; Abadía, Acatl

2005-01-01

To evaluate, under laboratory conditions, the sensitivity and specificity of a rapid diagnostic test (OptiMAL), based on immunoreactive strips, to detect Plasmodium vivax infection in febrile patients in Southern Chiapas, Mexico. The presence of parasites in blood samples of 893 patients was investigated by Giemsa-stained thick blood smear microscopic examination (gold standard). A blood drop from the same sample was smeared on immunoreactive strips to investigate the presence of the parasite pLDH. Discordant results were resolved by PCR amplification of the parasite's 18S SSU rRNA, to discard infection. OptiMAL had an overall sensitivity of 93.3% and its specificity was 99.5%. Its positive and negative predictive values were 96.5% and 98.9%, respectively. Signal intensity in OptiMAL strips correlated well with the parasitemia density in the blood samples (r = 0.601, p = 0.0001). This rapid test had acceptable sensitivity and specificity to detect P. vivax under laboratory conditions and could be useful for malaria diagnosis in field operations in Mexico.

A Next-Generation Sequencing Primer—How Does It Work and What Can It Do?

PubMed Central

Alekseyev, Yuriy O.; Fazeli, Roghayeh; Yang, Shi; Basran, Raveen; Miller, Nancy S.

2018-01-01

Next-generation sequencing refers to a high-throughput technology that determines the nucleic acid sequences and identifies variants in a sample. The technology has been introduced into clinical laboratory testing and produces test results for precision medicine. Since next-generation sequencing is relatively new, graduate students, medical students, pathology residents, and other physicians may benefit from a primer to provide a foundation about basic next-generation sequencing methods and applications, as well as specific examples where it has had diagnostic and prognostic utility. Next-generation sequencing technology grew out of advances in multiple fields to produce a sophisticated laboratory test with tremendous potential. Next-generation sequencing may be used in the clinical setting to look for specific genetic alterations in patients with cancer, diagnose inherited conditions such as cystic fibrosis, and detect and profile microbial organisms. This primer will review DNA sequencing technology, the commercialization of next-generation sequencing, and clinical uses of next-generation sequencing. Specific applications where next-generation sequencing has demonstrated utility in oncology are provided. PMID:29761157

Corrosion of radioactive waste tanks containing washed sludge and precipitates

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bickford, D.F.; Congdon, J.W.; Oblath, S.B.

1988-05-01

At the US Department of Energy (DOE) Savannah River Plant, the corrosion of carbon steel storage tanks containing alkaline, high-level radioactive waste is controlled by specification of limits on waste composition and temperature. Laboratory tests, conducted to determine minimum corrosion inhibitor levels, indicated pitting of carbon steel near the waterline for proposed storage conditions. In situ electrochemical measurements of full-scale radioactive process demonstrations were conducted to assess the validity of laboratory tests. The in situ results are compared to those of laboratory tests, with particular regard given to simulated solution composition. Transition metal hydroxide sludge contains strong passivating species formore » carbon steel. Washed precipitate contains organic species that lower solution pH and tend to reduce passivating films, requiring higher inhibitor concentrations than the 0.01 M nitrite required for reactor fuel reprocessing wastes.« less

Test Results of a 200 W Class Hall Thruster

NASA Technical Reports Server (NTRS)

Jacobson, David; Jankovsky, Robert S.

1999-01-01

The performance of a 200 W class Hall thruster was evaluated. Performance measurements were taken at power levels between 90 W and 250 W. At the nominal 200 W design point, the measured thrust was 11.3 mN. and the specific impulse was 1170 s excluding cathode flow in the calculation. A laboratory model 3 mm diameter hollow cathode was used for all testing. The engine was operated on laboratory power supplies in addition to a breadboard power processing unit fabricated from commercially available DC to DC converters.

The suitability of matrix assisted laser desorption/ionization time of flight mass spectrometry in a laboratory developed test using cystic fibrosis carrier screening as a model.

PubMed

Farkas, Daniel H; Miltgen, Nicholas E; Stoerker, Jay; van den Boom, Dirk; Highsmith, W Edward; Cagasan, Lesley; McCullough, Ron; Mueller, Reinhold; Tang, Lin; Tynan, John; Tate, Courtney; Bombard, Allan

2010-09-01

We designed a laboratory developed test (LDT) by using an open platform for mutation/polymorphism detection. Using a 108-member (mutation plus variant) cystic fibrosis carrier screening panel as a model, we completed the last phase of LDT validation by using matrix-assisted laser desorption/ionization time of flight mass spectrometry. Panel customization was accomplished via specific amplification primer and extension probe design. Amplified genomic DNA was subjected to allele specific, single base extension endpoint analysis by mass spectrometry for inspection of the cystic fibrosis transmembrane regulator gene (NM_000492.3). The panel of mutations and variants was tested against 386 blinded samples supplied by "authority" laboratories highly experienced in cystic fibrosis transmembrane regulator genotyping; >98% concordance was observed. All discrepant and discordant results were resolved satisfactorily. Taken together, these results describe the concluding portion of the LDT validation process and the use of mass spectrometry to detect a large number of complex reactions within a single run as well as its suitability as a platform appropriate for interrogation of scores to hundreds of targets.

7. "LAUNCH SILOS; SECTIONS, DETAILS." Specifications No. ENG043535973; Drawing No. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

7. "LAUNCH SILOS; SECTIONS, DETAILS." Specifications No. ENG-04-353-59-73; Drawing No. 5841-S-4; D.O. SERIES AW1525/26 Rev. A.; Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract No. 6601, Rev. A., Date 11 Sep 59. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Missile Silo Type, Test Area 1-100, northeast end of Test Area 1-100 Road, Boron, Kern County, CA

6. "LAUNCH SILOS, PLAN AND DETAILS." Specifications No. OC15973; Drawing ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

6. "LAUNCH SILOS, PLAN AND DETAILS." Specifications No. OC1-59-73; Drawing No. 5841 S-3; D.O. SERIES AW-1525/25 Rev. A.; Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract No. 6601, Rev. A., Date 11 Sep 59. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Missile Silo Type, Test Area 1-100, northeast end of Test Area 1-100 Road, Boron, Kern County, CA

7. "CONTROL BUILDING; FLOOR PLAN, ELEVATIONS AND DETAILS." Specifications No. ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

7. "CONTROL BUILDING; FLOOR PLAN, ELEVATIONS AND DETAILS." Specifications No. OC1-59-53; Drawing No. 5841-A-1; D.O. SERIES AW1525/2 Rev. B. Stamped: RECORD DRAWING AS CONSTRUCTED. Below stamp: Contract No. 5619, Rev. B. Date: 7-8-59. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Firing Control Building, Test Area 1-100, northeast end of Test Area 1-100 Road, Boron, Kern County, CA

Validation of Metagenomic Next-Generation Sequencing Tests for Universal Pathogen Detection.

PubMed

Schlaberg, Robert; Chiu, Charles Y; Miller, Steve; Procop, Gary W; Weinstock, George

2017-06-01

- Metagenomic sequencing can be used for detection of any pathogens using unbiased, shotgun next-generation sequencing (NGS), without the need for sequence-specific amplification. Proof-of-concept has been demonstrated in infectious disease outbreaks of unknown causes and in patients with suspected infections but negative results for conventional tests. Metagenomic NGS tests hold great promise to improve infectious disease diagnostics, especially in immunocompromised and critically ill patients. - To discuss challenges and provide example solutions for validating metagenomic pathogen detection tests in clinical laboratories. A summary of current regulatory requirements, largely based on prior guidance for NGS testing in constitutional genetics and oncology, is provided. - Examples from 2 separate validation studies are provided for steps from assay design, and validation of wet bench and bioinformatics protocols, to quality control and assurance. - Although laboratory and data analysis workflows are still complex, metagenomic NGS tests for infectious diseases are increasingly being validated in clinical laboratories. Many parallels exist to NGS tests in other fields. Nevertheless, specimen preparation, rapidly evolving data analysis algorithms, and incomplete reference sequence databases are idiosyncratic to the field of microbiology and often overlooked.

The concordance of serial ANA tests in an Australian tertiary hospital pathology laboratory.

PubMed

Lee, Adrian Y S; Hudspeth, Andrew R; Adelstein, Stephen

2016-10-01

The antinuclear antibody (ANA) tests are some of the more frequently requested tests for the diagnosis of autoimmunity. Although they are used primarily as diagnostic blood tests, multiple requests on the same patient continue to be encountered in the laboratory. This retrospective analysis of serial ANA testing at one pathology laboratory in Australia is the first study that examines the statistical concordance and possible implications of this on clinical practice. High-titred ANA have quite good repeatability for titre and pattern, and low-titred ANA, which can be non-specific, have poor repeatability. Staining patterns are, in general, almost random in nature on serial tests when compared to the first-obtained ANA pattern for each patient. This study confirms that there is little benefit in serial ANA testing, and only if there is a clear change in the patient's clinical picture would repeat of an initial low-titred ANA be useful. The findings reinforce the need for pathology stewardship to minimise costs, wasted resources and unnecessary referrals. Copyright © 2016 Royal College of Pathologists of Australasia. All rights reserved.

Improving lab compaction specifications for flexible bases within the Texas DOT.

DOT National Transportation Integrated Search

2009-04-01

In Test Methods Tex-113-E and Tex-114-E, the Texas Department of Transportation (TxDOT) employs an impact hammer method of sample compaction for laboratory preparation of road base and subgrade materials for testing. In this third and final report do...

42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Establishment and verification of..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS... of test results for the test system. (vi) Reference intervals (normal values). (vii) Any other...

7 CFR 91.19 - General requirements of suitable samples.

Code of Federal Regulations, 2011 CFR

2011-01-01

... the analyses requested. (b) Each sample must be identified with the following information: (1) Product... other information which is required by the specific program under which analysis or test is performed. ... LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Samples § 91.19 General requirements of suitable...

7 CFR 91.19 - General requirements of suitable samples.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the analyses requested. (b) Each sample must be identified with the following information: (1) Product... other information which is required by the specific program under which analysis or test is performed. ... LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Samples § 91.19 General requirements of suitable...

7 CFR 91.19 - General requirements of suitable samples.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the analyses requested. (b) Each sample must be identified with the following information: (1) Product... other information which is required by the specific program under which analysis or test is performed. ... LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Samples § 91.19 General requirements of suitable...

7 CFR 91.19 - General requirements of suitable samples.

Code of Federal Regulations, 2010 CFR

2010-01-01

... the analyses requested. (b) Each sample must be identified with the following information: (1) Product... other information which is required by the specific program under which analysis or test is performed. ... LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Samples § 91.19 General requirements of suitable...

7 CFR 91.19 - General requirements of suitable samples.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the analyses requested. (b) Each sample must be identified with the following information: (1) Product... other information which is required by the specific program under which analysis or test is performed. ... LABORATORY TESTING PROGRAMS SERVICES AND GENERAL INFORMATION Samples § 91.19 General requirements of suitable...

Comparison of clinical characteristics and laboratory findings of malaria, dengue, and enteric fever in returning travelers: 8-year experience at a referral center in Tokyo, Japan.

PubMed

Kutsuna, Satoshi; Hayakawa, Kayoko; Kato, Yasuyuki; Fujiya, Yoshihiro; Mawatari, Momoko; Takeshita, Nozomi; Kanagawa, Shuzo; Ohmagari, Norio

2015-04-01

Without specific symptoms, diagnosis of febrile illness in returning travelers is challenging. Dengue, malaria, and enteric fever are common causes of fever in returning travelers and timely and appropriate treatment is important. However, differentiation is difficult without specific diagnostic tests. A retrospective study was conducted at the National Centre for Global Health and Medicine (NCGM) from April 2005 to March 2013. Febrile travelers returning from overseas who were diagnosed with dengue, malaria, or enteric fever were included in this study. Clinical characteristics and laboratory findings were compared for each diagnosis. During the study period, 86 malaria, 85 dengue, and 31 enteric fever cases were identified. The mean age of the study cohort was 33.1 ± 12 years and 134 (66.3%) study participants were male. Asia was the most common area visited by returning travelers with fevers (89% of dengue, 18.6% of malaria, and 100% of enteric fever cases), followed by Africa (1.2% of dengue and 70.9% of malaria cases). Clinical characteristics and laboratory findings were significantly different among each group with each diagnosis. Decision tree models revealed that returning from Africa and CRP levels <10 mg/L were factors specific for diagnosis of malaria and dengue fever, respectively. Clinical manifestations, simple laboratory test results, and regions of travel are helpful to distinguish between dengue, malaria, and enteric fever in febrile returning travelers with non-specific symptoms. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Maintaining Life-saving Testing for Patients With Infectious Diseases: Infectious Diseases Society of America, American Society for Microbiology, and Pan American Society for Clinical Virology Recommendations on the Regulation of Laboratory-developed Tests.

PubMed

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.

Multicenter Clinical Evaluation of the Novel Alere i Strep A Isothermal Nucleic Acid Amplification Test.

PubMed

Cohen, Daniel M; Russo, Michael E; Jaggi, Preeti; Kline, Jennifer; Gluckman, William; Parekh, Amisha

2015-07-01

Rapid detection of group A beta-hemolytic streptococcus (GAS) is used routinely to help diagnose and treat pharyngitis. However, available rapid antigen detection tests for GAS have relatively low sensitivity, and backup testing is recommended in children. Newer assays are more sensitive yet require excessive time for practical point-of-care use as well as laboratory personnel. The Alere i strep A test is an isothermal nucleic acid amplification test designed to offer highly sensitive results at the point of care within 8 min when performed by nonlaboratory personnel. The performance of the Alere i strep A test was evaluated in a multicenter prospective trial in a Clinical Laboratory Improvement Amendments (CLIA)-waived setting in comparison to bacterial culture in 481 children and adults. Compared to culture, the Aleri i strep A test had 96.0% sensitivity and 94.6% specificity. Discrepant results were adjudicated by PCR and found the Alere i strep A test to have 98.7% sensitivity and 98.5% specificity. Overall, the Alere i strep A test could provide a one-step, rapid, point-of-care testing method for GAS pharyngitis and obviate backup testing on negative results. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Evaluation of the World Health Organization global measles and rubella quality assurance program, 2001-2008.

PubMed

Stambos, Vicki; Leydon, Jennie; Riddell, Michaela; Clothier, Hazel; Catton, Mike; Featherstone, David; Kelly, Heath

2011-07-01

During 2001-2008, the Victorian Infectious Diseases Reference Laboratory (VIDRL) prepared and provided a measles and rubella proficiency test panel for distribution to the World Health Organization (WHO) measles and rubella network laboratories as part of their annual laboratory accreditation assessment. Panel test results were forwarded to VIDRL, and results from 8 consecutive years were analyzed. We assessed the type of assays used and results achieved on the basis of the positive and negative interpretation of submitted results, by year and WHO region, for measles and rubella. Over time, there has been a noticeable increase in laboratory and WHO regional participation. For all panels, the proportion of laboratories in all WHO regions using the WHO-validated Dade Behring assay for measles and rubella-specific IgM antibodies ranged from 35% to 100% and 59% to 100%, respectively. For all regions and years, the proportion of laboratories obtaining a pass score ranged from 87% to 100% for measles and 93% to 100% for rubella. During 2001-2008, a large proportion of laboratories worldwide achieved and maintained a pass score for both measles and rubella. Measles and rubella proficiency testing is regarded as a major achievement for the WHO measles and rubella laboratory program. © The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.

Clinico-laboratory aspects of anti-nuclear and anti-native DNA antibody tests.

PubMed

Webb, J

1978-01-01

Available techniques for detection of anti-nuclear antibodies are here briefly reviewed. The relatively insensitive LE cell test has been largely supplanted by the indirect immunofluorescent ANA test which should be reported in terms of titre and pattern. Specific measurement of nDNA antibodies is now a regular technique in SLE diagnosis and management.

SITE-SPECIFIC VALIDATION OF A CHRONIC TOXICITY TEST WITH THE AMPHIPOD HYALELLA AZTECA : AN INTEGRATED STUDY OF HEAVY METAL CONTAMINATED SEDIMENTS IN PEAK CREEK, VIRGINIA

EPA Science Inventory

We will measure the correspondence of endpoints from chronic toxicity tests with the amphipod, Hyalella azteca, to a series of in situ macrobenthic community endpoints, starting with those endpoints most similar to those monitored in the laboratory test, then expanding to include...

Strength, Endurance, Throwing Velocity and in-Water Jump Performance of Elite German Water Polo Players

PubMed Central

Zinner, Christoph; Sperlich, Billy; Krueger, Malte; Focke, Tim; Reed, Jennifer; Mester, Joachim

2015-01-01

The purpose of this study was threefold: 1) to assess the eggbeater kick and throwing performance using a number of water polo specific tests, 2) to explore the relation between the eggbeater kick and throwing performance, and 3) to investigate the relation between the eggbeater kick in the water and strength tests performed in a controlled laboratory setting in elite water polo players. Fifteen male water polo players of the German National Team completed dynamic and isometric strength tests for muscle groups (adductor, abductor, abdominal, pectoralis) frequently used during water polo. After these laboratory strength tests, six water polo specific in-water tests were conducted. The eggbeater kick assessed leg endurance and agility, maximal throwing velocity and jump height. A 400 m test and a sprint test examined aerobic and anaerobic performance. The strongest correlation was found between jump height and arm length (p < 0.001, r = 0.89). The laboratory diagnostics of important muscles showed positive correlations with the results of the in-water tests (p < 0.05, r = 0.52–0.70). Muscular strength of the adductor, abdominal and pectoralis muscles was positively related to in-water endurance agility as assessed by the eggbeater kick (p < 0.05; r = 0.53–0.66). Findings from the current study emphasize the need to assess indices of water polo performance both in and out of the water as well as the relation among these parameters to best assess the complex profile of water polo players. PMID:25964818

Enzyme immunoassays for IgG and IgM antibodies to Toxoplasma gondii based on enhanced chemiluminescence.

PubMed Central

Crouch, C F

1995-01-01

AIMS--To evaluate the clinical performance of enzyme immunoassays for IgG and IgM antibodies to Toxoplasma gondii based on enhanced chemiluminescence. METHODS--Classification of routine clinical samples from the originating laboratories was compared with that obtained using the chemiluminescence based assays. Resolution of discordant results was achieved by testing in alternative enzyme immunoassays (IgM) or by an independent laboratory using the dye test (IgG). RESULTS--Compared with resolved data, the IgM assay was found to be highly specific (100%) with a cut off selected to give optimal performance with respect to both the early detection of specific IgM and the detection of persistent levels of specific IgM (sensitivity 98%). Compared with resolved data, the IgG assay was shown to have a sensitivity and a specificity of 99.4%. CONCLUSIONS--The Amerlite Toxo IgM assay possesses high levels of sensitivity and specificity. Assay interference due to rheumatoid factor like substances is not a problem. The Amerlite Toxo IgG assay possesses good sensitivity and specificity, but is less sensitive for the detection of seroconversion than methods detecting both IgG and IgM. PMID:7560174

Validation of a Rapid Rabies Diagnostic Tool for Field Surveillance in Developing Countries

PubMed Central

Léchenne, Monique; Naïssengar, Kemdongarti; Lepelletier, Anthony; Alfaroukh, Idriss Oumar; Bourhy, Hervé; Zinsstag, Jakob; Dacheux, Laurent

2016-01-01

Background One root cause of the neglect of rabies is the lack of adequate diagnostic tests in the context of low income countries. A rapid, performance friendly and low cost method to detect rabies virus (RABV) in brain samples will contribute positively to surveillance and consequently to accurate data reporting, which is presently missing in the majority of rabies endemic countries. Methodology/Principal findings We evaluated a rapid immunodiagnostic test (RIDT) in comparison with the standard fluorescent antibody test (FAT) and confirmed the detection of the viral RNA by real time reverse transcription polymerase chain reaction (RT-qPCR). Our analysis is a multicentre approach to validate the performance of the RIDT in both a field laboratory (N’Djamena, Chad) and an international reference laboratory (Institut Pasteur, Paris, France). In the field laboratory, 48 samples from dogs were tested and in the reference laboratory setting, a total of 73 samples was tested, representing a wide diversity of RABV in terms of animal species tested (13 different species), geographical origin of isolates with special emphasis on Africa, and different phylogenetic clades. Under reference laboratory conditions, specificity was 93.3% and sensitivity was 95.3% compared to the gold standard FAT test. Under field laboratory conditions, the RIDT yielded a higher reliability than the FAT test particularly on fresh and decomposed samples. Viral RNA was later extracted directly from the test filter paper and further used successfully for sequencing and genotyping. Conclusion/Significance The RIDT shows excellent performance qualities both in regard to user friendliness and reliability of the result. In addition, the test cassettes can be used as a vehicle to ship viral RNA to reference laboratories for further laboratory confirmation of the diagnosis and for epidemiological investigations using nucleotide sequencing. The potential for satisfactory use in remote locations is therefore very high to improve the global knowledge of rabies epidemiology. However, we suggest some changes to the protocol, as well as careful further validation, before promotion and wider use. PMID:27706156

Determination of Soil Moisture Content using Laboratory Experimental and Field Electrical Resistivity Values

NASA Astrophysics Data System (ADS)

Hazreek, Z. A. M.; Rosli, S.; Fauziah, A.; Wijeyesekera, D. C.; Ashraf, M. I. M.; Faizal, T. B. M.; Kamarudin, A. F.; Rais, Y.; Dan, M. F. Md; Azhar, A. T. S.; Hafiz, Z. M.

2018-04-01

The efficiency of civil engineering structure require comprehensive geotechnical data obtained from site investigation. In the past, conventional site investigation was heavily related to drilling techniques thus suffer from several limitations such as time consuming, expensive and limited data collection. Consequently, this study presents determination of soil moisture content using laboratory experimental and field electrical resistivity values (ERV). Field and laboratory electrical resistivity (ER) test were performed using ABEM SAS4000 and Nilsson400 soil resistance meter. Soil sample used for resistivity test was tested for characterization test specifically on particle size distribution and moisture content test according to BS1377 (1990). Field ER data was processed using RES2DINV software while laboratory ER data was analyzed using SPSS and Excel software. Correlation of ERV and moisture content shows some medium relationship due to its r = 0.506. Moreover, coefficient of determination, R2 analyzed has demonstrate that the statistical correlation obtain was very good due to its R2 value of 0.9382. In order to determine soil moisture content based on statistical correlation (w = 110.68ρ-0.347), correction factor, C was established through laboratory and field ERV given as 19.27. Finally, this study has shown that soil basic geotechnical properties with particular reference to water content was applicably determined using integration of laboratory and field ERV data analysis thus able to compliment conventional approach due to its economic, fast and wider data coverage.

46 CFR 162.028-5 - Independent laboratories: Listing.

Code of Federal Regulations, 2014 CFR

2014-10-01

... MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Extinguishers, Fire, Portable, Marine Type... or tests of portable fire extinguishers: (a) For dry chemical, CO2, water and foam type portable fire...

46 CFR 162.028-5 - Independent laboratories: Listing.

Code of Federal Regulations, 2011 CFR

2011-10-01

... MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Extinguishers, Fire, Portable, Marine Type... or tests of portable fire extinguishers: (a) For dry chemical, CO2, water and foam type portable fire...

46 CFR 162.028-5 - Independent laboratories: Listing.

Code of Federal Regulations, 2013 CFR

2013-10-01

... MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Extinguishers, Fire, Portable, Marine Type... or tests of portable fire extinguishers: (a) For dry chemical, CO2, water and foam type portable fire...

46 CFR 162.028-5 - Independent laboratories: Listing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Extinguishers, Fire, Portable, Marine Type... or tests of portable fire extinguishers: (a) For dry chemical, CO2, water and foam type portable fire...

46 CFR 162.028-5 - Independent laboratories: Listing.

Code of Federal Regulations, 2012 CFR

2012-10-01

... MATERIALS: SPECIFICATIONS AND APPROVAL ENGINEERING EQUIPMENT Extinguishers, Fire, Portable, Marine Type... or tests of portable fire extinguishers: (a) For dry chemical, CO2, water and foam type portable fire...

Comparison of the Performance of Skin Prick, ImmunoCAP, and ISAC Tests in the Diagnosis of Patients with Allergy.

PubMed

Griffiths, Rebecca L M; El-Shanawany, Tariq; Jolles, Stephen R A; Selwood, Clive; Heaps, Adrian G; Carne, Emily M; Williams, Paul E

2017-01-01

Allergy is diagnosed from typical symptoms, and tests are performed to incriminate the suspected precipitant. Skin prick tests (SPTs) are commonly performed, inexpensive, and give immediate results. Laboratory tests (ImmunoCAP) for serum allergen-specific IgE antibodies are usually performed more selectively. The immuno-solid phase allergen chip (ISAC) enables testing for specific IgE against multiple allergen components in a multiplex assay. We retrospectively analysed clinic letters, case notes, and laboratory results of 118 patients attending the National Adult Allergy Service at the University Hospital of Wales who presented diagnostic difficulty, to evaluate which testing strategy (SPT, ImmunoCAP, or ISAC) was the most appropriate to use to confirm the diagnosis in these complex patients, evaluated in a "real-life" clinical service setting. In patients with nut allergy, the detection rates of SPTs (56%) and ISAC (65%) were lower than those of ImmunoCAP (71%). ISAC had a higher detection rate (88%) than ImmunoCAP (69%) or SPT (33%) in the diagnosis of oral allergy syndrome. ImmunoCAP test results identified all 9 patients with anaphylaxis due to wheat allergy (100%), whereas ISAC was positive in only 6 of these 9 (67%). In this difficult diagnostic group, the ImmunoCAP test should be the preferred single test for possible allergy to nuts, wheat, other specific foods, and anaphylaxis of any cause. In these conditions, SPT and ISAC tests give comparable results. The most useful single test for oral allergy syndrome is ISAC, and SPT should be the preferred test for latex allergy. © 2017 S. Karger AG, Basel.

Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group "Laboratory Error and Patient Safety" and EFLM Task and Finish Group "Performance specifications for the extra-analytical phases".

PubMed

Sciacovelli, Laura; Panteghini, Mauro; Lippi, Giuseppe; Sumarac, Zorica; Cadamuro, Janne; Galoro, César Alex De Olivera; Pino Castro, Isabel Garcia Del; Shcolnik, Wilson; Plebani, Mario

2017-08-28

The improving quality of laboratory testing requires a deep understanding of the many vulnerable steps involved in the total examination process (TEP), along with the identification of a hierarchy of risks and challenges that need to be addressed. From this perspective, the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is focusing its activity on implementation of an efficient tool for obtaining meaningful information on the risk of errors developing throughout the TEP, and for establishing reliable information about error frequencies and their distribution. More recently, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has created the Task and Finish Group "Performance specifications for the extra-analytical phases" (TFG-PSEP) for defining performance specifications for extra-analytical phases. Both the IFCC and EFLM groups are working to provide laboratories with a system to evaluate their performances and recognize the critical aspects where improvement actions are needed. A Consensus Conference was organized in Padova, Italy, in 2016 in order to bring together all the experts and interested parties to achieve a consensus for effective harmonization of quality indicators (QIs). A general agreement was achieved and the main outcomes have been the release of a new version of model of quality indicators (MQI), the approval of a criterion for establishing performance specifications and the definition of the type of information that should be provided within the report to the clinical laboratories participating to the QIs project.

Performance criteria and quality indicators for the post-analytical phase.

PubMed

Sciacovelli, Laura; Aita, Ada; Padoan, Andrea; Pelloso, Michela; Antonelli, Giorgia; Piva, Elisa; Chiozza, Maria Laura; Plebani, Mario

2016-07-01

Quality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase. This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory. Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.

Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by High-Performance Liquid Chromatography with FMOC-Su Derivatization: Collaborative Study

PubMed Central

Zhou, Joseph Ziqi; Waszkuc, Ted; Mohammed, Felicia

2008-01-01

A collaborative study was conducted for determination of glucosamine in raw materials and dietary supplements containing glucosamine sulfate and/or glucosamine hydrochloride by high-performance liquid Chromatography (HPLC) with N-(9-fluorenyl-methoxycarbonyloxy) succinimide (FMOC-Su) derivatization. Thirteen blind materials, one pair of which were duplicates, were tested by 12 collaborating laboratories. The test samples consisted of various commercial products, including tablets, capsules, drink mix, and liquids as well as raw materials, blanks, and those for spike recovery analyses. The tests with blank products and products spiked with glucosamine showed good specificity of the method. The average recoveries at spike levels of 100 and 150% of the declared amount were 99.0% with a relative standard deviation (RSD) of 2.1%, and 101% with an RSD of 2.3%, respectively. The test results between laboratories on each commercial product were reproducible with RSD values of no more than 4.0%, and the results were repeatable in the same laboratory with an average RSD of 0.7%. HorRat values ranged from 0.5 to 1.7 on both tests of spike recovery and reproducibility between laboratories on commercial products. The average determination coefficient of the calibration curves from the laboratories was 0.9995 with an RSD of 0.03%. All of the 12 collaborating laboratories succeeded in the study and none of their reported test results were outliers, partly indicating the robustness of the method. It is recommended that the method be accepted by AOAC INTERNATIONAL as Official First Action. PMID:16152919

Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

PubMed

Wiegers, Ann L

2003-07-01

Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.

Verification of examination procedures in clinical laboratory for imprecision, trueness and diagnostic accuracy according to ISO 15189:2012: a pragmatic approach.

PubMed

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.

Use of experimental ecosystems in regulatory decision making

NASA Astrophysics Data System (ADS)

La Point, Thomas W.; Perry, James A.

1989-09-01

Tiered testing for the effects of chemicals on aquatic ecosystems has begun to include tests at the ecosystem level as a component in pesticide regristration. Because such tests are expensive, regulators and industry need to know what additional information they can gain from such tests relative to the costs of the simpler single-species toxicity bioassays. Requirements for ecosystem-level testing have developed because resource managers have not fully understood the implications of potential damage to resources without having evaluations of the predicted impacts under field conditions. We review approaches taken in the use of experimental ecosystems, discuss benefits and limitations of small- and large-scale ecosystem tests, and point to correlative approaches between laboratory and field toxicity testing. Laboratory experimental ecosystems (microcosms) have been successfully used to measure contaminant bioavailability, to determine routes of uptake in moderately complex aquatic systems, and to isolate factors modifying contaminant uptake into the biota. Such factors cannot be as readily studied in outdoor experimental ecosystems because direct cause-and-effect relations are often confounded and difficult to isolate. However, laboratory tests can be designed to quantify the relations among three variables: known concentrations of Stressors; specific sublethal behavioral, biochemical, and physiological effects displayed by organisms; and responses that have been observed in ecosystem-level analyses. For regulatory purposes, the specificity of test results determines how widely they can be applied. Ecotoxicological research should be directed at attempts to identify instances where single-species testing would be the appropriate level of analysis for identifying critical ecological endpoints and for clarifying relationships between ecosystem structure and function, and where it would be inadequate for a given level of analysis.

Use of experimental ecosystems in regulatory decision making

USGS Publications Warehouse

La Point, Thomas W.; Perry, James A.

1989-01-01

Tiered testing for the effects of chemicals on aquatic ecosystems has begun to include tests at the ecosystem level as a component in pesticide regristration. Because such tests are expensive, regulators and industry need to know what additional information they can gain from such tests relative to the costs of the simpler single-species toxicity bioassays. Requirements for ecosystem-level testing have developed because resource managers have not fully understood the implications of potential damage to resources without having evaluations of the predicted impacts under field conditions. We review approaches taken in the use of experimental ecosystems, discuss benefits and limitations of small- and large-scale ecosystem tests, and point to correlative approaches between laboratory and field toxicity testing.Laboratory experimental ecosystems (microcosms) have been successfully used to measure contaminant bioavailability, to determine routes of uptake in moderately complex aquatic systems, and to isolate factors modifying contaminant uptake into the biota. Such factors cannot be as readily studied in outdoor experimental ecosystems because direct cause-and-effect relations are often confounded and difficult to isolate. However, laboratory tests can be designed to quantify the relations among three variables: known concentrations of Stressors; specific sublethal behavioral, biochemical, and physiological effects displayed by organisms; and responses that have been observed in ecosystem-level analyses. For regulatory purposes, the specificity of test results determines how widely they can be applied. Ecotoxicological research should be directed at attempts to identify instances where single-species testing would be the appropriate level of analysis for identifying critical ecological endpoints and for clarifying relationships between ecosystem structure and function, and where it would be inadequate for a given level of analysis.

How do rehomed laboratory beagles behave in everyday situations? Results from an observational test and a survey of new owners

PubMed Central

Nick, Ophelia; Bauer, Alexander; Küchenhoff, Helmut; Erhard, Michael H.

2017-01-01

When laboratory dogs are rehomed into private households, they experience an extreme change in their life situation. They leave their familiar, limited environment in the research facility and encounter a multitude of animate and inanimate stimuli in their new home. Although literature reports have described the experiences with rehoming as being mostly positive, scientific observations of the dogs in everyday situations have not been done. Hence, we conducted an observational test with 74 laboratory beagles 6 weeks after adoption in their new homes. This test included standardized tasks and elements; the dogs were observed during specific interactions with their new owners and during a walk. Furthermore, the owners of these 74 and of 71 additional dogs participated in standardized phone interviews 1 and 12 weeks after adoption, during which they answered questions about the dogs’ behavior in everyday situations. In the observational test, the dogs behaved mostly friendly towards humans and dogs, were tolerant during manipulations by the owner and were relaxed during the walk, even in traffic. Eighty percent (of n = 71) of the dogs walked well behaved on the leash without pulling. According to the interviews, the majority of the dogs showed desired, friendly and relaxed behavior, and the survey results reflected the bonding between dog and owner. The analysis of a possible influence of various factors (age, sex, origin, etc.) using mixed regression models confirmed the results from two previous behavior tests and interviews. Specifically, dogs that had been bred in the research facility scored significantly better than dogs that the research facility had purchased from commercial laboratory dog breeders (p = 0.0113). The results of this study demonstrate a successful adaptation of the rehomed beagles to their new life situation. PMID:28742824

Severe congenital toxoplasmosis in the United States: clinical and serologic findings in untreated infants.

PubMed

Olariu, Tudor Rares; Remington, Jack S; McLeod, Rima; Alam, Ambereen; Montoya, Jose G

2011-12-01

Congenital toxoplasmosis can cause significant neurologic manifestations and other untoward sequelae. The Palo Alto Medical Foundation Toxoplasma Serology Laboratory database was searched for data on infants 0 to 180 days old, in whom congenital toxoplasmosis had been confirmed and who had been tested for Toxoplasma gondii-specific immunoglobulin G (IgG), IgM, and IgA antibodies, between 1991 and 2005. Their clinical findings were confirmed at the National Collaborative Chicago-based Congenital Toxoplasmosis Study center. We reviewed available clinical data and laboratory profiles of 164 infants with congenital toxoplasmosis whose mothers had not been treated for the parasite during gestation. One or more severe clinical manifestations of congenital toxoplasmosis were reported in 84% of the infants and included eye disease (92.2%), brain calcifications (79.6%), and hydrocephalus (67.7%). In 61.6% of the infants, eye disease, brain calcifications, and hydrocephalus were present concurrently. T. gondii-specific IgM, IgA, and IgE antibodies were demonstrable in 86.6%, 77.4%, and 40.2% of the infants, respectively. Testing for IgM and IgA antibodies increased the sensitivity of making the diagnosis of congenital toxoplasmosis to 93% compared with testing for IgM or IgA individually. IgM and IgA antibodies were still present in 43.9% of infants diagnosed between 1 and 6 months of life. Our study reveals that severe clinical signs of congenital toxoplasmosis including hydrocephalus, eye disease, or intracranial calcifications occurred in 85% infants whose sera were referred to our reference Toxoplasma Serology Laboratory during a period of 15 years. Laboratory tests, including serologic and polymerase chain reaction tests, were critical for diagnosis in the infants. Our results contrast remarkably with those of European investigators who rarely observe severe clinical signs in infants with congenital toxoplasmosis.

21 CFR 864.4020 - Analyte specific reagents.

Code of Federal Regulations, 2010 CFR

2010-04-01

... practitioners, e.g., forensic, academic, research, and other nonclinical laboratories. (b) Classification. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these... blood products (e.g., tests for hepatitis or tests for identifying blood groups). (c) Date of 510(k), or...

Lymph node culture

MedlinePlus

A normal result means there was no growth of microorganisms on the lab dish. Normal value ranges may vary slightly among different laboratories. Talk to your doctor about the meaning of your specific test results.

External quality assessment studies for laboratory performance of molecular and serological diagnosis of Chikungunya virus infection.

PubMed

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.

Discordance of Self-report and Laboratory Measures of HIV Viral Load Among Young Men Who Have Sex with Men and Transgender Women in Chicago: Implications for Epidemiology, Care, and Prevention.

PubMed

Mustanski, Brian; Ryan, Daniel T; Remble, Thomas A; D'Aquila, Richard T; Newcomb, Michael E; Morgan, Ethan

2018-04-10

Suppressing HIV viral load through daily antiretroviral therapy (ART) substantially reduces the risk of HIV transmission, however, the potential population impact of treatment as prevention (TasP) is mitigated due to challenges with sustained care engagement and ART adherence. For an undetectable viral load (VL) to inform decision making about transmission risk, individuals must be able to accurately classify their VL as detectable or undetectable. Participants were 205 HIV-infected young men who have sex with men (YMSM) and transgender women (TGW) from a large cohort study in the Chicago area. Analyses examined correspondence among self-reported undetectable VL, study-specific VL, and most recent medical record VL. Among HIV-positive YMSM/TGW, 54% had an undetectable VL (< 200 copies/mL) via study-specific laboratory testing. Concordance between self-report and medical record VL values was 80% and between self-report and study-specific laboratory testing was 73%; 34% of participants with a detectable study-specific VL self-reported an undetectable VL at last medical visit, and another 28% reported not knowing their VL status. Periods of lapsed viral suppression between medical visits may represent a particular risk for the TasP strategy among YMSM/TGW. Strategies for frequent viral load monitoring, that are not burdensome to patients, may be necessary to optimize TasP.

Commercial Molecular Tests for Fungal Diagnosis from a Practical Point of View.

PubMed

Lackner, Michaela; Lass-Flörl, Cornelia

2017-01-01

The increasing interest in molecular diagnostics is a result of tremendously improved knowledge on fungal infections in the past 20 years and the rapid development of new methods, in particular polymerase chain reaction. High expectations have been placed on molecular diagnostics, and the number of laboratories now using the relevant technology is rapidly increasing-resulting in an obvious need for standardization and definition of laboratory organization. In the past 10 years, multiple new molecular tools were marketed for the detection of DNA, antibodies, cell wall components, or other antigens. In contrast to classical culture methods, molecular methods do not detect a viable organisms, but only molecules which indicate its presence; this can be nucleic acids, cell components (antigens), or antibodies (Fig. 1). In this chapter, an overview is provided on commercially available detection tools, their strength and how to use them. A main focus is laid on providing tips and tricks that make daily life easier. We try to focus and mention methodical details which are not highlighted in the manufacturer's instructions of these test kits, but are based on our personal experience in the laboratory. Important to keep in mind is that molecular tools cannot replace culture, microscopy, or a critical view on patients' clinical history, signs, and symptoms, but provide a valuable add on tool. Diagnosis should not be based solely on a molecular test, but molecular tools might deliver an important piece of information that helps matching the diagnostic puzzle to a diagnosis, in particular as few tests are in vitro diagnostic tests (IVD) or only part of the whole test carries the IVD certificate (e.g., DNA extraction is often not included). Please be aware that the authors do not claim to provide a complete overview on all commercially available diagnostic assays being currently marketed for fungal detection, as those are subject to constant change. A main focus is put on commonly used panfungal assays and pathogen-specific assays, including Aspergillus-specific, Candida-specific, Cryptococcus specific, Histoplasma-specific, and Pneumocystis-specific assays. Assays are categorized according to their underlying principle in either antigen-detecting or antibody-detecting or DNA-detecting (Fig. 1). Other non-DNA-detecting nucleic acid methods such as FISH and PNA FISH are not summarized in this chapter and an overview on test performance, common false positives, and the clinical evaluation of commercial tests in studies is provided already in a previous book series by Javier Yugueros Marcos and David H. Pincus (Marcos and Pincus, Methods Mol Biol 968:25-54, 2013).

Evaluation of ID-PaGIA syphilis antibody test.

PubMed

Naaber, Paul; Makoid, Ene; Aus, Anneli; Loivukene, Krista; Poder, Airi

2009-01-01

Laboratory diagnosis of syphilis is usually accomplished by serology. There are currently a large number of different commercial treponemal tests available that vary in format, sensitivity and specificity. To evaluate the ID-PaGIA Syphilis Antibody Test as an alternative to other specific treponemal tests for primary screening or confirmation of diagnosis. Serum samples from healthy adults (n = 100) were used for detection of specificity of ID-PaGIA. To evaluate sensitivity of ID-PaGIA serum samples (n = 101) from patients with confirmed or suspected syphilis were tested for syphilis antibodies with FTA-Abs IgM, ID-PaGIA, ELISA IgM and TPHA tests. No false-positive results were found with ID-PaGIA. Sensitivity of various treponemal tests was the following: FTA-Abs IgM: 95.5%, ID-PaGIA and ELISA IgM: 94%, and TPHA 75%. The positive and negative predictive values of ID-PaGIA were 100 and 89.5%, respectively. Compared with other treponemal tests ID-PaGIA has excellent sensitivity and specificity.

12. "OBSERVATION POSTS, STRUCTURAL PLANS AND DETAILS." Specifications No. OC25572; ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

12. "OBSERVATION POSTS, STRUCTURAL PLANS AND DETAILS." Specifications No. OC2-55-72; Drawing No. 60-09-12; sheet 89 of 148; file no. 1321/40, Rev. A. Very faint stamp above note reads: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Observation Bunkers for Test Stand 1-A, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

HIT or miss? A comprehensive contemporary investigation of laboratory tests for heparin induced thrombocytopenia.

PubMed

Favaloro, Emmanuel J; McCaughan, Georgia; Mohammed, Soma; Lau, Kun Kan Edwin; Gemmell, Rosalie; Cavanaugh, Lauren; Donikian, Dea; Kondo, Mayuko; Brighton, Timothy; Pasalic, Leonardo

2018-04-17

Heparin induced thrombocytopenia (HIT) is a rare but potentially fatal complication of heparin therapy, which in a proportion of patients causes platelet activation and thrombosis. Initial clinical assessment of the likelihood of HIT is facilitated by laboratory testing to confirm or exclude HIT. This prospective investigation was performed over an 18-month period, and has involved testing of over 300 test samples from over 100 consecutive patients. Clinical assessment by 4T score was supplemented by laboratory tests that comprised both immunological [lateral flow ('STiC'), chemiluminescence (AcuStar; HIT-IgG (PF4-H) ), ELISA (Asserachrom HPIA IgG)] and functional assays [SRA, platelet aggregation using whole blood ('Multiplate') and platelet rich plasma ('LTA')]. We observed both false positive and false negative test findings with most assays. Overall, the whole blood aggregation method provided a reasonable alternative to SRA for identifying functional HIT. STiC, AcuStar and ELISA procedures were fairly comparable in terms of screening for HIT, although STiC and AcuStar both yielded false negatives, albeit also resulting in fewer false positives than ELISA. The 4T score had less utility in our patient cohort than we were expecting, although there was an association with the likelihood of HIT. Nevertheless, we accept that our observations are based on limited test numbers. In conclusion, no single approach (clinical or laboratory) was associated with optimal sensitivity or specificity of HIT exclusion or identification, and thus, a combination of clinical evaluation and laboratory testing will best ensure the accuracy of diagnosis. Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.

Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008-2010.

PubMed

Dimech, Wayne; Lim, Megan S C; Van Gemert, Caroline; Guy, Rebecca; Boyle, Douglas; Donovan, Basil; Hellard, Margaret

2014-06-12

Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data highlight much lower levels of testing in young people aged 20 years or less; in particular female patients aged less than 16 years, despite being the group with the highest positivity rate. Strategies are needed to increase the uptake of testing in this high-risk group.

Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008–2010

PubMed Central

2014-01-01

Background Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. Methods The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. Results From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). Conclusions The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data highlight much lower levels of testing in young people aged 20 years or less; in particular female patients aged less than 16 years, despite being the group with the highest positivity rate. Strategies are needed to increase the uptake of testing in this high-risk group. PMID:24920016

Determining the hydraulic properties of saturated, low-permeability geological materials in the laboratory: Advances in theory and practice

USGS Publications Warehouse

Zhang, M.; Takahashi, M.; Morin, R.H.; Endo, H.; Esaki, T.; ,

2002-01-01

The accurate hydraulic characterization of low-permeability subsurface environments has important practical significance. In order to examine this issue from the perspective of laboratory-based approaches, we review some recent advancements in the theoretical analyses of three different laboratory techniques specifically applied to low-permeability geologic materials: constant-head, constant flow-rate and transient-pulse permeability tests. Some potential strategies for effectively decreasing the time required to confidently estimate the permeability of these materials are presented. In addition, a new and versatile laboratory system is introduced that can implement any of these three test methods while simultaneously subjecting a specimen to high confining pressures and pore pressures, thereby simulating in situ conditions at great depths. The capabilities and advantages of this innovative system are demonstrated using experimental data derived from Shirahama sandstone and Inada granite, two rock types widely encountered in Japan.

A reassessment of ground water flow conditions and specific yield at Borden and Cape Cod

USGS Publications Warehouse

Grimestad, Garry

2002-01-01

Recent widely accepted findings respecting the origin and nature of specific yield in unconfined aquifers rely heavily on water level changes observed during two pumping tests, one conducted at Borden, Ontario, Canada, and the other at Cape Cod, Massachusetts. The drawdown patterns observed during those tests have been taken as proof that unconfined specific yield estimates obtained from long-duration pumping tests should approach the laboratory-estimated effective porosity of representative aquifer formation samples. However, both of the original test reports included direct or referential descriptions of potential supplemental sources of pumped water that would have introduced intractable complications and errors into straightforward interpretations of the drawdown observations if actually present. Searches for evidence of previously neglected sources were performed by screening the original drawdown observations from both locations for signs of diagnostic skewing that should be present only if some of the extracted water was derived from sources other than main aquifer storage. The data screening was performed using error-guided computer assisted fitting techniques, capable of accurately sensing and simulating the effects of a wide range of non-traditional and external sources. The drawdown curves from both tests proved to be inconsistent with traditional single-source pumped aquifer models but consistent with site-specific alternatives that included significant contributions of water from external sources. The corrected pumping responses shared several important features. Unsaturated drainage appears to have ceased effectively at both locations within the first day of pumping, and estimates of specific yield stabilized at levels considerably smaller than the corresponding laboratory-measured or probable effective porosity. Separate sequential analyses of progressively later field observations gave stable and nearly constant specific yield estimates for each location, with no evidence from either test that more prolonged pumping would have induced substantially greater levels of unconfined specific yield.

From the sea to the laboratory: Characterization of microplastic as prerequisite for the assessment of ecotoxicological impact.

PubMed

Potthoff, Annegret; Oelschlägel, Kathrin; Schmitt-Jansen, Mechthild; Rummel, Christoph Daniel; Kühnel, Dana

2017-05-01

The presence of microplastic (MP) in the aquatic environment is recognized as a global-scale pollution issue. Secondary MP particles result from an ongoing fragmentation process governed by various biotic and abiotic factors. For a reliable risk assessment of these MP particles, knowledge about interactions with biota is needed. However, extensive testing with standard organisms under reproducible laboratory conditions with well-characterized MP suspensions is not available yet. As MP in the environment represents a mixture of particles differing in properties (e.g., size, color, polymer type, surface characteristics), it is likely that only specific particle fractions pose a threat towards organisms. In order to assign hazardous effects to specific particle properties, these characteristics need to be analyzed. As shown by the testing of particles (e.g. nanoparticles), characteristics other than chemical properties are important for the emergence of toxicity in organisms, and parameters such as surface area or size distribution need consideration. Therefore, the use of "well-defined" particles for ecotoxicological testing (i.e., standard particles) facilitates the establishment of causal links between physical-chemical properties of MP particles and toxic effects in organisms. However, the benefits of well-defined particles under laboratory conditions are offset by the disadvantage of the unknown comparability with MP in the environment. Therefore, weathering effects caused by biological, chemical, physical or mechanical processes have to be considered. To date, the characterization of the progression of MP weathering based on powder and suspension characterization methods is in its infancy. The aim of this commentary is to illustrate the prerequisites for testing MP in the laboratory from 3 perspectives: (i) knowledge of particle properties; (ii) behavior of MP in test setups involving ecotoxicological test organisms; and (iii) accordingly, test conditions that may need adjustment. Only under those prerequisites will reliable hazard assessment of MP be feasible. Integr Environ Assess Manag 2017;13:500-504. © 2017 SETAC. © 2017 SETAC.

Comparison of a New and Rapid Method: Brucella Coombs Gel Test With Other Diagnostic Tests.

PubMed

Kalem, Fatma; Ergün, Ayşe Gül; Durmaz, Süleyman; Doğan, Metin; Ertuğrul, Ömür; Gündem, Seval

2016-09-01

The aim of this study was to detect reliability of Brucella Coombs gel test (BCGT) by comparing with with ELISA (IgG + IgM), Standard agglutination test, and Brucella immunocapture agglutination methods in serological diagnosis of brucellosis. Brucella Coombs gel test (BCGT), Brucella ELISA (IgG + IgM), Standard agglutination test, and Brucella immunocapture agglutination tests of 78 patients with presumptive diagnosis of brucellosis which were sent to Microbiology Laboratory of Konya Numune Hospital from various regions of Konya were studied. Of 78 patients with ELISA IgG and IgM, STA, BICA and BCGT; 26, 21, 10, 12 and 12 were positive. When compared with BICA, the sensitivity and specifity of BCGT were 100% and 100%, respectively. According to results BCGT can be used as a diagnostic test in routine laboratories after more comprehensive studies in control groups and patients. © 2016 Wiley Periodicals, Inc.

Electrochemical probing of high-level radioactive waste tanks containing washed sludge and precipitates

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bickford, D.F.; Congdon, J.W.; Oblath, S.B.

1987-01-01

At the U.S. Department of Energy's Savannah River Plant, corrosion of carbon steel storage tanks containing alkaline, high-level radioactive waste is controlled by specification of limits on waste composition and temperature. Processes for the preparation of waste for final disposal will result in waste with low corrosion inhibitor concentrations and, in some cases, high aromatic organic concentrations, neither of which are characteristic of previous operations. Laboratory tests, conducted to determine minimum corrosion inhibitor levels indicated pitting of carbon steel near the waterline for proposed storage conditions. In situ electrochemical measurements of full-scale radioactive process demonstrations have been conducted to assessmore » the validity of laboratory tests. Probes included pH, Eh (potential relative to a standard hydrogen electrode), tank potential, and alloy coupons. In situ results are compared to those of the laboratory tests, with particular regard given to simulated solution composition.« less

Conservatism implications of shock test tailoring for multiple design environments

NASA Technical Reports Server (NTRS)

Baca, Thomas J.; Bell, R. Glenn; Robbins, Susan A.

1987-01-01

A method for analyzing shock conservation in test specifications that have been tailored to qualify a structure for multiple design environments is discussed. Shock test conservation is qualified for shock response spectra, shock intensity spectra and ranked peak acceleration data in terms of an Index of Conservation (IOC) and an Overtest Factor (OTF). The multi-environment conservation analysis addresses the issue of both absolute and average conservation. The method is demonstrated in a case where four laboratory tests have been specified to qualify a component which must survive seven different field environments. Final judgment of the tailored test specification is shown to require an understanding of the predominant failure modes of the test item.

Field testing Diorhabda elongata (Coleoptera:Chrysomelidae) from Crete, Greece to assess potential impact to non-target native California plants in the genus Frankenia

USDA-ARS?s Scientific Manuscript database

When laboratory host specificity tests on weed biological control agents produce ambiguous results or are suspected of producing false positives, field cage or open field tests can be utilized in an attempt to determine the true ecological host range of the agent. The leaf beetle Diorhabda elongata ...

[Development of molecular detection of food-borne pathogenic bacteria using miniaturized microfluidic devices].

PubMed

Iván, Kristóf; Maráz, Anna

2015-12-20

Detection and identification of food-borne pathogenic bacteria are key points for the assurance of microbiological food safety. Traditional culture-based methods are more and more replaced by or supplemented with nucleic acid based molecular techniques, targeting specific (preferably virulence) genes in the genomes. Internationally validated DNA amplification - most frequently real-time polymerase chain reaction - methods are applied by the food microbiological testing laboratories for routine analysis, which will result not only in shortening the time for results but they also improve the performance characteristics (e.g. sensitivity, specificity) of the methods. Beside numerous advantages of the polymerase chain reaction based techniques for routine microbiological analysis certain drawbacks have to be mentioned, such as the high cost of the equipment and reagents, as well as the risk of contamination of the laboratory environment by the polymerase chain reaction amplicons, which require construction of an isolated laboratory system. Lab-on-a-chip systems can integrate most of these laboratory processes within a miniaturized device that delivers the same specificity and reliability as the standard protocols. The benefits of miniaturized devices are: simple - often automated - use, small overall size, portability, sterility due to single use possibility. These miniaturized rapid diagnostic tests are being researched and developed at the best research centers around the globe implementing various sample preparation and molecular DNA amplification methods on-chip. In parallel, the aim of the authors' research is to develop microfluidic Lab-on-a-chip devices for the detection and identification of food-borne pathogenic bacteria.

Rapid C-reactive protein and white cell tests decrease cost and shorten emergency visits.

PubMed

Kokko, Eeva; Korppi, Matti; Helminen, Merja; Hutri-Kähönen, Nina

2014-10-01

Elevated white blood cells (WBC) in blood and C-reactive protein (CRP) in serum are often used as non-specific markers for bacterial etiology of infection in children. The aim of the present study was to evaluate how rapid WBC and CRP testing influences patient flow and cost in the pediatric emergency room (ER). This study was a retrospective chart review. In all, 166 children who were treated during 3 months in the ER of a children's hospital, and in whom rapid tests for WBC and CRP were done, were included. The association between rapid testing and length of ER stay was evaluated, and the cost of rapid tests was compared with the corresponding cost if done in the hospital laboratory. Median ER stay was 147.5 min, if no examinations other than rapid CRP and WBC tests were done and if no emergency treatment was given, compared with 201.5 min for laboratory tests or emergency treatment given (P < 0.001). The respective figures were 142.5 min and 179.5 min in those 96 children discharged home (P = 0.003). The cost of rapid testing was only 41.5% of the corresponding laboratory cost. The simultaneous rapid testing of CRP and WBC in children with presumable infection decreased cost and shortened the length of ER stay, if no other examinations or emergency treatment were needed. The cost of rapid testing was less than half of the corresponding cost in laboratory. © 2014 Japan Pediatric Society.

AFNOR validation of Premi Test, a microbiological-based screening tube-test for the detection of antimicrobial residues in animal muscle tissue.

PubMed

Gaudin, Valerie; Juhel-Gaugain, Murielle; Morétain, Jean-Pierre; Sanders, Pascal

2008-12-01

Premi Test contains viable spores of a strain of Bacillus stearothermophilus which is sensitive to antimicrobial residues, such as beta-lactams, tetracyclines, macrolides and sulphonamides. The growth of the strain is inhibited by the presence of antimicrobial residues in muscle tissue samples. Premi Test was validated according to AFNOR rules (French Association for Normalisation). The AFNOR validation was based on the comparison of reference methods (French Official method, i.e. four plate test (FPT) and the STAR protocol (five plate test)) with the alternative method (Premi Test). A preliminary study was conducted in an expert laboratory (Community Reference Laboratory, CRL) on both spiked and incurred samples (field samples). Several method performance criteria (sensitivity, specificity, relative accuracy) were estimated and are discussed, in addition to detection capabilities. Adequate agreement was found between the alternative method and the reference methods. However, Premi Test was more sensitive to beta-lactams and sulphonamides than the FPT. Subsequently, a collaborative study with 11 laboratories was organised by the CRL. Blank and spiked meat juice samples were sent to participants. The expert laboratory (CRL) statistically analysed the results. It was concluded that Premi Test could be used for the routine determination of antimicrobial residues in muscle of different animal origin with acceptable analytical performance. The detection capabilities of Premi Test for beta-lactams (amoxicillin, ceftiofur), one macrolide (tylosin) and tetracycline were at the level of the respective maximum residue limits (MRL) in muscle samples or even lower.

Point-of-care syndrome-based, rapid diagnosis of infections on commercial ships.

PubMed

Bouricha, Mehdi; Samad, Marc Abdul; Levy, Pierre-Yves; Raoult, Didier; Drancourt, Michel

2014-01-01

Suspicion of contagious disease on commercial ships tends to be poorly managed, as there is little capacity to confirm a case on board except for malaria. Here we implemented a point-of-care (POC) laboratory on one container ship and one cruise ship for the rapid syndrome-based diagnosis of infectious diseases on board. In 2012 we implemented a POC laboratory on board a freight ship and on board a cruise ship. The POC laboratory ran a total of six different color-coded, syndrome-based kits incorporating 10 different commercially available immunochromatographic tests. The POC tests were taught within 1-hour as part of training to staff without any previous knowledge in microbiology. Compared with terrestrial POCs, specific constraints included the necessity to secure POC devices into the motile ship, to use robust devices, to overcome difficulties in communicating with the core laboratory, and to overcome limited intimacy of patients. However, a total of 36 POC tests were easily performed and yielded contributive negative results. This first experiment indicates that it is possible to run POC laboratories by nonexpert staff after providing rapid teaching course on board commercial ships. Generalization of on-board POC laboratories is expected to help in improving the medical management of staff and passengers. © 2013 International Society of Travel Medicine.

A simple screening test for the detection of metallo-β-lactamase-producing Pseudomonas aeruginosa and Acinetobacter in a tertiary care hospital.

PubMed

Wan Nor Amilah, W A W; Noor Izani, N J; Ng, W K; Ashraful Haq, J

2012-12-01

Clinical utilization of carbapenems remains under threat with the emergence of acquired carbapenemase-producing bacteria, particularly metallo-β-lactamases (MBL). Rapid detection of MBL-producing Gram-negative bacilli is essential to prevent their widespread dissemination. However, no standardized detection method is available for routine laboratory use. The purpose of the study was to evaluate a chelating-agent based double disk synergic test and disk potentiation test for MBL-producing strain detection and to determine the isolation rate of MBL-producing Pseudomonas aeruginosa and Acinetobacter from clinical samples in our tertiary teaching hospital. A total of 22 and 66 imipenem-resistant P. aeruginosa and Acinetobacter isolates respectively were tested with ceftazidime (CAZ) disk by modified double disk synergic test and disk potentiation test using ethylenediaminetetraacetic acid (EDTA) and 2-mercaptopropionic acid (as chelating agents) to detect MBL production. The tests were compared with EDTA-phenanthroline-imipenem (EPI) microdilution MIC test as gold standard. MBL positive strains were detected in 17 (77.3%) P. aeruginosa and 2 (3.5%) Acinetobacter isolates. The disk potentiation test with 2-mercaptopropionic acid (2-MPA) dilution of 1:12 provided the most acceptable sensitivities and specificities (88.2% sensitivity and 100% specificity in P. aeruginosa; 100% sensitivity and specificity in Acinetobacter) compared to other screening methods used in this study. This study provided useful information on the local prevalence of MBL-producing P. aeruginosa and Acinetobacter in our hospital. Disc potentiation test with CAZ/2-MPA disc appears to be reliable and convenient MBL detection method in the routine clinical laboratory.

Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

PubMed

Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

2014-07-01

The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

Optimizing the design of a reproduction toxicity test with the pond snail Lymnaea stagnalis.

PubMed

Charles, Sandrine; Ducrot, Virginie; Azam, Didier; Benstead, Rachel; Brettschneider, Denise; De Schamphelaere, Karel; Filipe Goncalves, Sandra; Green, John W; Holbech, Henrik; Hutchinson, Thomas H; Faber, Daniel; Laranjeiro, Filipe; Matthiessen, Peter; Norrgren, Leif; Oehlmann, Jörg; Reategui-Zirena, Evelyn; Seeland-Fremer, Anne; Teigeler, Matthias; Thome, Jean-Pierre; Tobor Kaplon, Marysia; Weltje, Lennart; Lagadic, Laurent

2016-11-01

This paper presents the results from two ring-tests addressing the feasibility, robustness and reproducibility of a reproduction toxicity test with the freshwater gastropod Lymnaea stagnalis (RENILYS strain). Sixteen laboratories (from inexperienced to expert laboratories in mollusc testing) from nine countries participated in these ring-tests. Survival and reproduction were evaluated in L. stagnalis exposed to cadmium, tributyltin, prochloraz and trenbolone according to an OECD draft Test Guideline. In total, 49 datasets were analysed to assess the practicability of the proposed experimental protocol, and to estimate the between-laboratory reproducibility of toxicity endpoint values. The statistical analysis of count data (number of clutches or eggs per individual-day) leading to ECx estimation was specifically developed and automated through a free web-interface. Based on a complementary statistical analysis, the optimal test duration was established and the most sensitive and cost-effective reproduction toxicity endpoint was identified, to be used as the core endpoint. This validation process and the resulting optimized protocol were used to consolidate the OECD Test Guideline for the evaluation of reproductive effects of chemicals in L. stagnalis. Copyright © 2016 Elsevier Inc. All rights reserved.

The impact of commercial rapid respiratory virus diagnostic tests on patient outcomes and health system utilization.

PubMed

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.

Technical standards and guidelines: prenatal screening for Down syndrome that includes first-trimester biochemistry and/or ultrasound measurements.

PubMed

Palomaki, Glenn E; Lee, Jo Ellen S; Canick, Jacob A; McDowell, Geraldine A; Donnenfeld, Alan E

2009-09-01

This statement is intended to augment the current general ACMG Standards and Guidelines for Clinical Genetics Laboratories and to address guidelines specific to first-trimester screening for Down syndrome. The aim is to provide the laboratory the necessary information to ensure accurate and reliable Down syndrome screening results given a screening protocol (e.g., combined first trimester and integrated testing). Information about various test combinations and their expected performance are provided, but other issues such as availability of reagents, patient interest in early test results, access to open neural tube defect screening, and availability of chorionic villus sampling are all contextual factors in deciding which screening protocol(s) will be selected by individual health care providers. Individual laboratories are responsible for meeting the quality assurance standards described by the Clinical Laboratory Improvement Act, the College of American Pathologists, and other regulatory agencies, with respect to appropriate sample documentation, assay validation, general proficiency, and quality control measures. These guidelines address first-trimester screening that includes ultrasound measurement and interpretation of nuchal translucency thickness and protocols that combine markers from both the first and second trimesters. Laboratories can use their professional judgment to make modification or additions.

Ice pack heat sink subsystem - phase 1, volume 2

NASA Technical Reports Server (NTRS)

Roebelen, G. J., Jr.

1973-01-01

The design, development, and test of a functional laboratory model ice pack heat sink subsystem are discussed. Operating instructions to include mechanical and electrical schematics, maintenance instructions, and equipment specifications are presented.

Tuberculous otitis media: a significant diagnostic challenge.

PubMed

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.

Enhancing case definitions for surveillance of human monkeypox in the Democratic Republic of Congo.

PubMed

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.

Laboratory tests for identification or exclusion of heparin induced thrombocytopenia: HIT or miss?

PubMed

Favaloro, Emmanuel J

2018-02-01

Heparin induced thrombocytopenia (HIT) is a potentially fatal condition that arises subsequent to formation of antibodies against complexes containing heparin, usually platelet-factor 4-heparin ("anti-PF4-heparin"). Assessment for HIT involves both clinical evaluation and, if indicated, laboratory testing for confirmation or exclusion, typically using an initial immunological assay ("screening"), and only if positive, a secondary functional assay for confirmation. Many different immunological and functional assays have been developed. The most common contemporary immunological assays comprise enzyme-linked immunosorbent assay [ELISA], chemiluminescence, lateral flow, and particle gel techniques. The most common functional assays measure platelet aggregation or platelet activation events (e.g., serotonin release assay; heparin-induced platelet activation (HIPA); flow cytometry). All assays have some sensitivity and specificity to HIT antibodies, but differ in terms of relative sensitivity and specificity for pathological HIT, as well as false negative and false positive error rate. This brief article overviews the different available laboratory methods, as well as providing a suggested approach to diagnosis or exclusion of HIT. © 2017 Wiley Periodicals, Inc.

The Shock and Vibration Bulletin. Part 3. Acoustic and Vibration Testing, Impact and Blast

DTIC Science & Technology

1976-08-01

Research Institute, San Antonio, Texas DESIGN OF A BLAST LOAD GENERATOR FOR OVERPRESSURE TESTING .................................. 261I P. Lieberman...Mathews and B. W. Duggin, Sandia Laboratories, Albuquerque, New Mexico ESTIMATION OF SHIP SHOCK PARAMETERS FOR CONSISTENT DESIGN AND TEST SPECIFICATION G. C...Seattle, Washington COMPONENT TESTING OF LIQUID SHOCK ISOLATORS AND ELASTOMERS IN SUPPORT OF RECENT SHOCK ISOLATION SYSTEM DESIGNS AJ.IP. Ashley, Boeing

An international inter-laboratory ring trial to evaluate a real-time PCR assay for the detection of bovine herpesvirus 1 in extended bovine semen.

PubMed

Wang, Jianning; O'Keefe, Joseph; Orr, Della; Loth, Leo; Banks, Malcolm; Wakeley, Philip; West, Donna; Card, Roderick; Ibata, Georgina; Van Maanen, Kees; Thoren, Peter; Isaksson, Mats; Kerkhofs, Pierre

2008-01-01

Six laboratories participated in a ring trial to evaluate the reliability of a real-time PCR assay for the detection of bovine herpesvirus 1 (BoHV-1) from extended bovine semen. Sets of coded samples were prepared and distributed to each of the laboratories. The sample panel contained semen from naturally and artificially infected bulls, serial dilutions of positive semen with negative semen, semen from uninfected seronegative bulls, negative semen spiked with virus, as well as serial dilutions of reference virus. The samples were tested using a previously validated real-time PCR assay for the detection of BoHV-1 in each participating laboratory. The PCR tests were conducted with four different real-time PCR amplification platforms, including RotorGene 3000, Stratagene MX 3000/4000, ABI 7900, and Roche LightCycler 2.0. Virus isolation using one set of samples was performed in one laboratory. The results of the laboratories were compared with one another, and with those of virus isolation. It was found that the sensitivity and specificity of the real-time PCR test was greater than those of virus isolation (82.7% versus 53.6% and 93.6% versus 84.6%, respectively). A high level of agreement on PCR testing results between the laboratories was achieved (kappa value 0.59-0.95). The results of this study indicate that the real-time PCR assay is suitable for the detection of BoHV-1 in extended semen, and would be a good substitute for the slow and laborious virus isolation, for the screening testing at artificial insemination centres and for international trade.

Acoustical Testing Laboratory Developed to Support the Low-Noise Design of Microgravity Space Flight Hardware

NASA Technical Reports Server (NTRS)

Cooper, Beth A.

2001-01-01

The NASA John H. Glenn Research Center at Lewis Field has designed and constructed an Acoustical Testing Laboratory to support the low-noise design of microgravity space flight hardware. This new laboratory will provide acoustic emissions testing and noise control services for a variety of customers, particularly for microgravity space flight hardware that must meet International Space Station limits on noise emissions. These limits have been imposed by the space station to support hearing conservation, speech communication, and safety goals as well as to prevent noise-induced vibrations that could impact microgravity research data. The Acoustical Testing Laboratory consists of a 23 by 27 by 20 ft (height) convertible hemi/anechoic chamber and separate sound-attenuating test support enclosure. Absorptive 34-in. fiberglass wedges in the test chamber provide an anechoic environment down to 100 Hz. A spring-isolated floor system affords vibration isolation above 3 Hz. These criteria, along with very low design background levels, will enable the acquisition of accurate and repeatable acoustical measurements on test articles, up to a full space station rack in size, that produce very little noise. Removable floor wedges will allow the test chamber to operate in either a hemi/anechoic or anechoic configuration, depending on the size of the test article and the specific test being conducted. The test support enclosure functions as a control room during normal operations but, alternatively, may be used as a noise-control enclosure for test articles that require the operation of noise-generating test support equipment.

Design, development and fabrication of a Solar Experiment Alignment Sensor (SEAS)

NASA Technical Reports Server (NTRS)

Bancroft, J. R.; Fain, M. Z.; Johnson, D. F.

1971-01-01

The design, development and testing of a laboratory SEAS (Solar Experiment Alignment Sensor) system are presented. The system is capable of overcoming traditional alignment and calibration problems to permit pointing anywhere on the solar disc to an accuracy of five arc seconds. The concept, development and laboratory testing phases of the program are discussed, and particular attention has been given to specific problems associated with selection of materials, and components. The conclusions summarize performance capability and discuss areas for further study including the effects of solar limb darkening and effects of annual variations in the apparent solar diameter.

[Comparative research into sensitivity and specificity of immune-enzyme analysis with chemiluminescence and colorimetric detection for detecting antigens and antibodies to avian influenza viruses and newcastle disease].

PubMed

Vitkova, O N; Kapustina, T P; Mikhailova, V V; Safonov, G A; Vlasova, N N; Belousova, R V

2015-01-01

The goal of this work was to demonstrate the results of the development of the enzyme-linked immunosorbent tests with chemiluminescence detection and colorimetric detection of specific viral antigens and antibodies for identifying the avian influenza and the Newcastle disease viruses: high sensitivity and specificity of the immuno- chemiluminescence assay, which are 10-50 times higher than those of the ELISA colorimetric method. The high effectiveness of the results and the automation of the process of laboratory testing (using a luminometer) allow these methods to be recommended for including in primary screening tests for these infectious diseases.

Laboratory testing in primary care: A systematic review of health IT impacts.

PubMed

Maillet, Éric; Paré, Guy; Currie, Leanne M; Raymond, Louis; Ortiz de Guinea, Ana; Trudel, Marie-Claude; Marsan, Josianne

2018-08-01

Laboratory testing in primary care is a fundamental process that supports patient management and care. Any breakdown in the process may alter clinical information gathering and decision-making activities and can lead to medical errors and potential adverse outcomes for patients. Various information technologies are being used in primary care with the goal to support the process, maximize patient benefits and reduce medical errors. However, the overall impact of health information technologies on laboratory testing processes has not been evaluated. To synthesize the positive and negative impacts resulting from the use of health information technology in each phase of the laboratory 'total testing process' in primary care. We conducted a systematic review. Databases including Medline, PubMed, CINAHL, Web of Science and Google Scholar were searched. Studies eligible for inclusion reported empirical data on: 1) the use of a specific IT system, 2) the impacts of the systems to support the laboratory testing process, and were conducted in 3) primary care settings (including ambulatory care and primary care offices). Our final sample consisted of 22 empirical studies which were mapped to a framework that outlines the phases of the laboratory total testing process, focusing on phases where medical errors may occur. Health information technology systems support several phases of the laboratory testing process, from ordering the test to following-up with patients. This is a growing field of research with most studies focusing on the use of information technology during the final phases of the laboratory total testing process. The findings were largely positive. Positive impacts included easier access to test results by primary care providers, reduced turnaround times, and increased prescribed tests based on best practice guidelines. Negative impacts were reported in several studies: paper-based processes employed in parallel to the electronic process increased the potential for medical errors due to clinicians' cognitive overload; systems deemed not reliable or user-friendly hampered clinicians' performance; and organizational issues arose when results tracking relied on the prescribers' memory. The potential of health information technology lies not only in the exchange of health information, but also in knowledge sharing among clinicians. This review has underscored the important role played by cognitive factors, which are critical in the clinician's decision-making, the selection of the most appropriate tests, correct interpretation of the results and efficient interventions. By providing the right information, at the right time to the right clinician, many IT solutions adequately support the laboratory testing process and help primary care clinicians make better decisions. However, several technological and organizational barriers require more attention to fully support the highly fragmented and error-prone process of laboratory testing. Copyright © 2018 Elsevier B.V. All rights reserved.

Sport-Specific Assessment of the Effectiveness of Neuromuscular Training in Young Athletes

PubMed Central

Zemková, Erika; Hamar, Dušan

2018-01-01

Neuromuscular training in young athletes improves performance and decreases the risk of injuries during sports activities. These effects are primarily ascribed to the enhancement of muscle strength and power but also balance, speed and agility. However, most studies have failed to demonstrate significant improvement in these abilities. This is probably due to the fact that traditional tests do not reflect training methods (e.g., plyometric training vs. isometric or isokinetic strength testing, dynamic balance training vs. static balance testing). The protocols utilized in laboratories only partially fulfill the current needs for testing under sport-specific conditions. Moreover, laboratory testing usually requires skilled staff and a well equipped and costly infrastructure. Nevertheless, experience demonstrates that high-technology and expensive testing is not the only way to proceed. A number of physical fitness field tests are available today. However, the low reliability and limited number of parameters retrieved from simple equipment used also limit their application in competitive sports. Thus, there is a need to develop and validate a functional assessment platform based on portable computerized systems. Variables obtained should be directly linked to specific features of particular sports and capture their complexity. This is essential for revealing weak and strong components of athlete performance and design of individually-tailored exercise programs. Therefore, identifying the drawbacks associated with the assessment of athlete performance under sport-specific conditions would provide a basis for the formation of an innovative approach to their long-term systematic testing. This study aims (i) to review the testing methods used for the evaluation of the effect of neuromuscular training on sport-specific performance in young athletes, (ii) to introduce stages within the Sport Longlife Diagnostic Model, and (iii) to propose future research in this topic. Analysis of the literature identified gaps in the current standard testing methods in terms of their low sensitivity in discriminating between athletes of varied ages and performance levels, insufficent tailoring to athlete performance level and individual needs, a lack of specificity to the requirements of particular sports and also in revealing the effect of training. In order to partly fill in these gaps, the Sport Longlife Diagnostic Model was proposed. PMID:29695970

Sport-Specific Assessment of the Effectiveness of Neuromuscular Training in Young Athletes.

PubMed

Zemková, Erika; Hamar, Dušan

2018-01-01

Neuromuscular training in young athletes improves performance and decreases the risk of injuries during sports activities. These effects are primarily ascribed to the enhancement of muscle strength and power but also balance, speed and agility. However, most studies have failed to demonstrate significant improvement in these abilities. This is probably due to the fact that traditional tests do not reflect training methods (e.g., plyometric training vs. isometric or isokinetic strength testing, dynamic balance training vs. static balance testing). The protocols utilized in laboratories only partially fulfill the current needs for testing under sport-specific conditions. Moreover, laboratory testing usually requires skilled staff and a well equipped and costly infrastructure. Nevertheless, experience demonstrates that high-technology and expensive testing is not the only way to proceed. A number of physical fitness field tests are available today. However, the low reliability and limited number of parameters retrieved from simple equipment used also limit their application in competitive sports. Thus, there is a need to develop and validate a functional assessment platform based on portable computerized systems. Variables obtained should be directly linked to specific features of particular sports and capture their complexity. This is essential for revealing weak and strong components of athlete performance and design of individually-tailored exercise programs. Therefore, identifying the drawbacks associated with the assessment of athlete performance under sport-specific conditions would provide a basis for the formation of an innovative approach to their long-term systematic testing. This study aims (i) to review the testing methods used for the evaluation of the effect of neuromuscular training on sport-specific performance in young athletes, (ii) to introduce stages within the Sport Longlife Diagnostic Model, and (iii) to propose future research in this topic. Analysis of the literature identified gaps in the current standard testing methods in terms of their low sensitivity in discriminating between athletes of varied ages and performance levels, insufficent tailoring to athlete performance level and individual needs, a lack of specificity to the requirements of particular sports and also in revealing the effect of training. In order to partly fill in these gaps, the Sport Longlife Diagnostic Model was proposed.

Evolutionary Design of a Phased Array Antenna Element

NASA Technical Reports Server (NTRS)

Globus, Al; Linden, Derek; Lohn, Jason

2006-01-01

We present an evolved S-band phased array antenna element design that meets the requirements of NASA's TDRS-C communications satellite scheduled for launch early next decade. The original specification called for two types of elements, one for receive only and one for transmit/receive. We were able to evolve a single element design that meets both specifications thereby simplifying the antenna and reducing testing and integration costs. The highest performance antenna found using a genetic algorithm and stochastic hill-climbing has been fabricated and tested. Laboratory results are largely consistent with simulation. Researchers have been investigating evolutionary antenna design and optimization since the early 1990s, and the field has grown in recent years its computer speed has increased and electromagnetic simulators have improved. Many antenna types have been investigated, including wire antennas, antenna arrays and quadrifilar helical antennas. In particular, our laboratory evolved a wire antenna design for NASA's Space Technology 5 (ST5) spacecraft. This antenna has been fabricated, tested, and is scheduled for launch on the three spacecraft in 2006.

Evaluation of platelet adhesion and activation on polymers: Round-robin study to assess inter-center variability.

PubMed

Braune, S; Sperling, C; Maitz, M F; Steinseifer, U; Clauser, J; Hiebl, B; Krajewski, S; Wendel, H P; Jung, F

2017-10-01

The regulatory agencies provide recommendations rather than protocols or standard operation procedures for the hemocompatibility evaluation of novel materials e.g. for cardiovascular applications. Thus, there is a lack of specifications with regard to test setups and procedures. As a consequence, laboratories worldwide perform in vitro assays under substantially different test conditions, so that inter-laboratory and inter-study comparisons are impossible. Here, we report about a prospective, randomized and double-blind multicenter trial which demonstrates that standardization of in vitro test protocols allows a reproducible assessment of platelet adhesion and activation from fresh human platelet rich plasma as possible indicators of the thrombogenicity of cardiovascular implants. Standardization of the reported static in vitro setup resulted in a laboratory independent scoring of the following materials: poly(dimethyl siloxane) (PDMS), poly(ethylene terephthalate) (PET) and poly(tetrafluoro ethylene) (PTFE). The results of this in vitro study provide evidence that inter-laboratory and inter-study comparisons can be achieved for the evaluation of the adhesion and activation of platelets on blood-contacting biomaterials by stringent standardization of test protocols. Copyright © 2017 Elsevier B.V. All rights reserved.

Occupational asthma due to turpentine in art painter--case report.

PubMed

Dudek, Wojciech; Wittczak, Tomasz; Swierczyńska-Machura, Dominika; Walusiak-Skorupa, Jolanta; Pałczyński, Cezary

2009-01-01

Turpentine is a fluid obtained by distillation of wood resins containing mixture of terpens. It can act as an irritant and sensitiser. Most common health problem among workers exposed to turpentine is contact dermatitis. Little is know about turpentine to cause type I hypersensitivity reaction. We present a case of a 27-year old art painter using turpentine as a thinner for oil-based paints. She developed asthmatic reactions after 5 years of working with turpentine. A number of clinical procedures were performed, including clinical examination, routine laboratory tests, total serum IgE, skin prick tests to common aeroallergens, metal salts, oil-based paints and balsamic turpentine, resting spirometry test, histamine challenge, and a single-blind, placebo-controlled specific inhalation challenge with balsamic turpentine. Clinical findings and laboratory test results were normal but a significant bronchial hyperreactivity was found. During the specific challenge, dyspnoea and decreased forced expiratory volume (FEV1) were observed in late phase of asthmatic reaction. An increased proportion of eosinophils in induced sputum could also be noted 24 h after the challenge. Positive clinical response to the specific challenge as well as the morphological changes found in induced sputum served as the basis for diagnosing occupational asthma. To our knowledge, this is the first well-documented case of turpentine-induced occupational asthma.

Cardiac markers: from enzymes to proteins, diagnosis to prognosis, laboratory to bedside.

PubMed

Wu, A H

1999-01-01

For many years, serologic markers have been used to assist cardiologists in the diagnosis and management of patients with cardiovascular diseases. The use of laboratory markers has evolved and kept pace with the field of cardiology itself. The early markers involved testing for total enzyme activity such as aspartate aminotransferase, lactate dehydrogenase and creatine kinase. Shortly thereafter, the World Health Organization included serial enzyme markers as part of the triad for diagnosis of acute myocardial infarction (AMI). It was soon recognized that isoenzymes such as for CK-MB and LD-1 provided more specific organ specificity. The need for reporting rapid results led to the development of totally automated isoenzyme assays, which have evolved from immunoinhibition (INH) techniques to mass assays. The current emphasis for cardiac markers is use of protein markers such as cardiac troponin T (cTnT) and I (cTnI). These markers are more sensitive and specific than isoenzyme markers and enable risk stratification for non-AMI patients with unstable angina: patients with high troponin have a higher risk for AMI and cardiac death within the immediate future (4 to 6 weeks). Prospective management of cardiac patients requires more rapid testing and reporting of results. Point-of-care testing platforms on whole blood are now available for emergency testing at bedside.

Opportunities for Improved Serodiagnosis of Human Tuberculosis, Bovine Tuberculosis, and Paratuberculosis

PubMed Central

Wadhwa, Ashutosh; Hickling, Graham J.; Eda, Shigetoshi

2012-01-01

Mycobacterial infections—tuberculosis (TB), bovine tuberculosis (bTB), and Johne's disease (JD)—are major infectious diseases of both human and animals. Methods presently in use for diagnosis of mycobacterial infections include bacterial culture, nucleic acid amplification, tuberculin skin test, interferon-γ assay, and serology. Serological tests have several advantages over other methods, including short turn-around time, relatively simple procedures, and low cost. However, current serodiagnostic methods for TB, bTB and JD exhibit low sensitivity and/or specificity. Recent studies that have aimed to develop improved serodiagnostic tests have mostly focused on identifying useful species-specific protein antigens. A review of recent attempts to improve diagnostic test performance indicates that the use of multiple antigens can improve the accuracy of serodiagnosis of these mycobacterial diseases. Mycobacteria also produce a variety of species-specific nonprotein molecules; however, only a few such molecules (e.g., cord factor and lipoarabinomannan) have so far been evaluated for their effectiveness as diagnostic antigens. For TB and bTB, there has been recent progress in developing laboratory-free diagnostic methods. New technologies such as microfluidics and “Lab-on-Chip” are examples of promising new technologies that can underpin development of laboratory-free diagnostic devices for these mycobacterial infections. PMID:22720192

Design and Laboratory Evaluation of Future Elongation and Diameter Measurements at the Advanced Test Reactor

DOE Office of Scientific and Technical Information (OSTI.GOV)

K. L. Davis; D. L. Knudson; J. L. Rempe

New materials are being considered for fuel, cladding, and structures in next generation and existing nuclear reactors. Such materials can undergo significant dimensional and physical changes during high temperature irradiations. In order to accurately predict these changes, real-time data must be obtained under prototypic irradiation conditions for model development and validation. To provide such data, researchers at the Idaho National Laboratory (INL) High Temperature Test Laboratory (HTTL) are developing several instrumented test rigs to obtain data real-time from specimens irradiated in well-controlled pressurized water reactor (PWR) coolant conditions in the Advanced Test Reactor (ATR). This paper reports the status ofmore » INL efforts to develop and evaluate prototype test rigs that rely on Linear Variable Differential Transformers (LVDTs) in laboratory settings. Although similar LVDT-based test rigs have been deployed in lower flux Materials Testing Reactors (MTRs), this effort is unique because it relies on robust LVDTs that can withstand higher temperatures and higher fluxes than often found in other MTR irradiations. Specifically, the test rigs are designed for detecting changes in length and diameter of specimens irradiated in ATR PWR loops. Once implemented, these test rigs will provide ATR users with unique capabilities that are sorely needed to obtain measurements such as elongation caused by thermal expansion and/or creep loading and diameter changes associated with fuel and cladding swelling, pellet-clad interaction, and crud buildup.« less

A new multiplex real-time PCR test for HSV1/2 and syphilis: an evaluation of its impact in the laboratory and clinical setting.

PubMed

Scott, Laura Jane; Gunson, Rory N; Carman, William F; Winter, Andrew J

2010-12-01

To develop, evaluate and implement a new multiplex real-time PCR test for the detection of herpes simplex virus (HSV)1, HSV2 and syphilis in a single sample using a single test. A multiplex real-time PCR test detecting HSV1, HSV2 and Treponema pallidum was designed, validated and evaluated for a period of 6 months on patients attending the Sandyford Initiative (a series of genitourinary medicine clinics in and around Glasgow). A total of 692 samples were tested, and T pallidum PCR positives were confirmed by a second PCR at the Scottish Reference Laboratory (SBSTIRL). All PCR results were aligned with dark ground microscopy findings and serological results where available and compared. The laboratory validation of the multiplex assay showed the test to be sensitive, specific and robust. Of the 692 samples, 139 were positive for HSV1, 136 for HSV2, 15 for syphilis, one for both syphilis and HSV1, and 401 were negative; the reference laboratory confirmed all T pallidum PCR-positive samples. The PCR test was more sensitive than both dark ground microscopy and serological testing for the diagnosis of primary syphilis. The introduction of this new test has led to a better turnaround time for the diagnosis of genital ulcer disease, better detection of primary syphilis infection, and the detection of unexpected cases of syphilis where the aetiological agent suspected was HSV.

Laboratory Diagnosis of Zika Virus Infection.

PubMed

Landry, Marie Louise; St George, Kirsten

2017-01-01

-The rapid and accurate diagnosis of Zika virus infection is an international priority. -To review current recommendations, methods, limitations, and priorities for Zika virus testing. -Sources include published literature, public health recommendations, laboratory procedures, and testing experience. -Until recently, the laboratory diagnosis of Zika infection was confined to public health or research laboratories that prepared their own reagents, and test capacity has been limited. Furthermore, Zika cross-reacts serologically with other flaviviruses, such as dengue, West Nile, and yellow fever. Current or past infection, or even vaccination with another flavivirus, will often cause false-positive or uninterpretable Zika serology results. Detection of viral RNA during acute infection using nucleic acid amplification tests provides more specific results, and a number of commercial nucleic acid amplification tests have received emergency use authorization. In addition to serum, testing of whole blood and urine is recommended because of the higher vial loads and longer duration of shedding. However, nucleic acid amplification testing has limited utility because many patients are asymptomatic or present for testing after the brief period of Zika shedding has passed. Thus, the greatest need and most difficult challenge is development of accurate antibody tests for the diagnosis of recent Zika infection. Research is urgently needed to identify Zika virus epitopes that do not cross-react with other flavivirus antigens. New information is emerging at a rapid pace and, with ongoing public-private and international collaborations and government support, it is hoped that rapid progress will be made in developing robust and widely applicable diagnostic tools.

External Quality Assessment for Zika Virus Molecular Diagnostic Testing, Brazil.

PubMed

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.

Alchemy: A Web 2.0 Real-time Quality Assurance Platform for Human Immunodeficiency Virus, Hepatitis C Virus, and BK Virus Quantitation Assays

PubMed Central

Agosto-Arroyo, Emmanuel; Coshatt, Gina M.; Winokur, Thomas S.; Harada, Shuko; Park, Seung L.

2017-01-01

Background: The molecular diagnostics laboratory faces the challenge of improving test turnaround time (TAT). Low and consistent TATs are of great clinical and regulatory importance, especially for molecular virology tests. Laboratory information systems (LISs) contain all the data elements necessary to do accurate quality assurance (QA) reporting of TAT and other measures, but these reports are in most cases still performed manually: a time-consuming and error-prone task. The aim of this study was to develop a web-based real-time QA platform that would automate QA reporting in the molecular diagnostics laboratory at our institution, and minimize the time expended in preparing these reports. Methods: Using a standard Linux, Nginx, MariaDB, PHP stack virtual machine running atop a Dell Precision 5810, we designed and built a web-based QA platform, code-named Alchemy. Data files pulled periodically from the LIS in comma-separated value format were used to autogenerate QA reports for the human immunodeficiency virus (HIV) quantitation, hepatitis C virus (HCV) quantitation, and BK virus (BKV) quantitation. Alchemy allowed the user to select a specific timeframe to be analyzed and calculated key QA statistics in real-time, including the average TAT in days, tests falling outside the expected TAT ranges, and test result ranges. Results: Before implementing Alchemy, reporting QA for the HIV, HCV, and BKV quantitation assays took 45–60 min of personnel time per test every month. With Alchemy, that time has decreased to 15 min total per month. Alchemy allowed the user to select specific periods of time and analyzed the TAT data in-depth without the need of extensive manual calculations. Conclusions: Alchemy has significantly decreased the time and the human error associated with QA report generation in our molecular diagnostics laboratory. Other tests will be added to this web-based platform in future updates. This effort shows the utility of informatician-supervised resident/fellow programming projects as learning opportunities and workflow improvements in the molecular laboratory. PMID:28480121

[Equipping the bacteriological laboratories of a tuberculosis service as the most important element of assurance of the quality and safety of their work].

PubMed

Sevast'ianova, E V; Martynova, L P; Barilo, V N; Golyshevskaia, V I; Shul'gina, M V

2009-01-01

By taking into account the present requirements for the equipping of the laboratories, the authors have drawn up the minimum standard list of equipment, as well as a list of additional equipment for the specialized bacteriological laboratory of a tuberculosis-controlling institution, which performs microbiological studies for the diagnosis and control of chemotherapy for tuberculosis. The specifications and characteristics of the baric types of equipment used to fit out the laboratories under the present conditions are described. Equipping the laboratories in accordance with the draw-up lists is shown to ensure a qualitative, effective, and safe work. Recommendations on how to supply the laboratories with equipment, to make the optimal choice, and to use consumables for tests are given.

Acoustic Characteristics of Various Treatment Panel Designs Specific to HSCT Mixer-Ejector Application

NASA Technical Reports Server (NTRS)

Salikuddin, M.; Kinzie, K.; Vu, D. D.; Langenbrunner, L. E.; Szczepkowski, G. T.

2006-01-01

The development process of liner design methodology is described in several reports. The results of the initial effort of concept development, screening, laboratory testing of various liner concepts, and preliminary correlation (generic data) are presented in a report Acoustic Characteristics of Various Treatment Panel Designs for HSCT Ejector Liner Acoustic Technology Development Program. The second phase of laboratory test results of more practical concepts and their data correlations are presented in this report (product specific). In particular, this report contains normal incidence impedance measurements of several liner types in both a static rig and in a high temperature flow duct rig. The flow duct rig allows for temperatures up to 400 F with a grazing flow up to Mach 0.8. Measurements of impedance, DC flow resistance, and in the flow rig cases, impact of the liner on boundary layer profiles are documented. In addition to liner rig tests, a limited number of tests were made on liners installed in a mixer-Ejector nozzle to confirm the performance of the liner prediction in an installed configuration.

A rigorous approach to facilitate and guarantee the correctness of the genetic testing management in human genome information systems.

PubMed

Araújo, Luciano V; Malkowski, Simon; Braghetto, Kelly R; Passos-Bueno, Maria R; Zatz, Mayana; Pu, Calton; Ferreira, João E

2011-12-22

Recent medical and biological technology advances have stimulated the development of new testing systems that have been providing huge, varied amounts of molecular and clinical data. Growing data volumes pose significant challenges for information processing systems in research centers. Additionally, the routines of genomics laboratory are typically characterized by high parallelism in testing and constant procedure changes. This paper describes a formal approach to address this challenge through the implementation of a genetic testing management system applied to human genome laboratory. We introduced the Human Genome Research Center Information System (CEGH) in Brazil, a system that is able to support constant changes in human genome testing and can provide patients updated results based on the most recent and validated genetic knowledge. Our approach uses a common repository for process planning to ensure reusability, specification, instantiation, monitoring, and execution of processes, which are defined using a relational database and rigorous control flow specifications based on process algebra (ACP). The main difference between our approach and related works is that we were able to join two important aspects: 1) process scalability achieved through relational database implementation, and 2) correctness of processes using process algebra. Furthermore, the software allows end users to define genetic testing without requiring any knowledge about business process notation or process algebra. This paper presents the CEGH information system that is a Laboratory Information Management System (LIMS) based on a formal framework to support genetic testing management for Mendelian disorder studies. We have proved the feasibility and showed usability benefits of a rigorous approach that is able to specify, validate, and perform genetic testing using easy end user interfaces.

A rigorous approach to facilitate and guarantee the correctness of the genetic testing management in human genome information systems

PubMed Central

2011-01-01

Background Recent medical and biological technology advances have stimulated the development of new testing systems that have been providing huge, varied amounts of molecular and clinical data. Growing data volumes pose significant challenges for information processing systems in research centers. Additionally, the routines of genomics laboratory are typically characterized by high parallelism in testing and constant procedure changes. Results This paper describes a formal approach to address this challenge through the implementation of a genetic testing management system applied to human genome laboratory. We introduced the Human Genome Research Center Information System (CEGH) in Brazil, a system that is able to support constant changes in human genome testing and can provide patients updated results based on the most recent and validated genetic knowledge. Our approach uses a common repository for process planning to ensure reusability, specification, instantiation, monitoring, and execution of processes, which are defined using a relational database and rigorous control flow specifications based on process algebra (ACP). The main difference between our approach and related works is that we were able to join two important aspects: 1) process scalability achieved through relational database implementation, and 2) correctness of processes using process algebra. Furthermore, the software allows end users to define genetic testing without requiring any knowledge about business process notation or process algebra. Conclusions This paper presents the CEGH information system that is a Laboratory Information Management System (LIMS) based on a formal framework to support genetic testing management for Mendelian disorder studies. We have proved the feasibility and showed usability benefits of a rigorous approach that is able to specify, validate, and perform genetic testing using easy end user interfaces. PMID:22369688

Proficiency testing of Hb A1c: a 4-year experience in Taiwan and the Asian Pacific region.

PubMed

Shiesh, Shu-Chu; Wiedmeyer, Hsiao-Mei; Kao, Jau-Tsuen; Vasikaran, Samuel D; Lopez, Joseph B

2009-10-01

The correlation between hemoglobin A(1c) (Hb A(1c)) and risk for complications in diabetic patients heightens the need to measure Hb A(1c) with accuracy. We evaluated the current performance for measuring Hb A(1c) in the Asian and Pacific region by examining data submitted by laboratories participating in the Taiwan proficiency-testing program. Five fresh-pooled blood samples were sent to participating laboratories twice each year. The results were evaluated against target values assigned by the National Glycohemoglobin Standardization Program network laboratories; a passing criterion of +/-7% of the target value was used. Measurement uncertainty at Hb A(1c) concentrations of 7.0% and 8.0% were determined. A total of 276 laboratories from 11 countries took part in the Hb A(1c) survey. At the Hb A(1c) concentrations tested method-specific interlaboratory imprecision (CVs) were 1.1%-13.9% in 2005, 1.3%-10.1% in 2006, 1.2%-8.2% in 2007, and 1.1%-6.1% in 2008. Differences between target values and median values from the commonly used methods ranged from -0.24% to 0.22% Hb A(1c) in 2008. In 2005 83% of laboratories passed the survey, and in 2008 93% passed. At 7.0% Hb A(1c), measurement uncertainty was on average 0.49% Hb A(1c). The use of accuracy-based proficiency testing with stringent quality criteria has improved the performance of Hb A(1c) testing in the Asian and Pacific laboratories during the 4 years of assessment.

Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 81 Institutions.

PubMed

McCall, Shannon J; Souers, Rhona J; Blond, Barbara; Massie, Larry

2016-10-01

-Assessment of customer satisfaction is a vital component of the laboratory quality improvement program. -To survey the level of physician satisfaction with hospital clinical laboratory services. -Participating institutions provided demographic information and survey results of physician satisfaction, with specific features of clinical laboratory services individually rated on a scale of 5 (excellent) to 1 (poor). -Eighty-one institutions submitted 2425 surveys. The median overall satisfaction score was 4.2 (10th percentile, 3.6; 90th percentile, 4.6). Of the 16 surveyed areas receiving the highest percentage of excellent/good ratings (combined scores of 4 and 5), quality of results was highest along with test menu adequacy, staff courtesy, and overall satisfaction. Of the 4 categories receiving the lowest percentage values of excellent/good ratings, 3 were related to turnaround time for inpatient "STAT" (tests performed immediately), outpatient STAT, and esoteric tests. The fourth was a new category presented in this survey: ease of electronic order entry. Here, 11.4% (241 of 2121) of physicians assigned below-average (2) or poor (1) scores. The 5 categories deemed most important to physicians included quality of results, turnaround times for inpatient STAT, routine, and outpatient STAT tests, and clinical report format. Overall satisfaction as measured by physician willingness to recommend their laboratory to another physician remains high at 94.5% (2160 of 2286 respondents). -There is a continued trend of high physician satisfaction and loyalty with clinical laboratory services. Physician dissatisfaction with ease of electronic order entry represents a new challenge. Test turnaround times are persistent areas of dissatisfaction, representing areas for improvement.

Internal quality control practice of thyroid disease related tests and imprecision analysis in China.

PubMed

Hu, Li-Tao; Wang, Zhi-Guo

2014-01-01

Internal quality control (IQC) has a long and well-established role in clinical laboratories and the quality of laboratories has achieved great improvement in China. However, the practice of IQC varies significantly between institutions and many problems still exists. Consequently, the Chinese National Center for Clinical Laboratories has been undertaking monthly nation-wide surveys of current IQC practice of tests since 2010 to monitor laboratory quality. Thyroid disease related tests were chosen for this research. Different numbers of laboratories in China participating national external quality assessment (EQA) schemes of Total Thyroxine (TT4), Total Triiodothyronine (TT3), Free Thyroxine (FT4) and Free Triiodothyronine (FT3) tests, and Thyroid Stimulating Hormone (TSH) measurements, were required to report the IQC information though the national external quality assessment (EQA) network platform. Survey data showed significant variability in all aspects of IQC practice. More than half of the laboratories are using a single concentration level of IQC material and up to 28.6% of the laboratories only use 1(2s) or 1(3s) to monitor IQC results for FT3, TT3, FT4, TT4, and TSH. The medians of the average time intervals of two control tests for FT3, TT3, FT4, TT4, and TSH are 33.6, 35.4, 33.6, 35.4, and 33.6 hours, respectively, more or less 1.4 days. When quality specifications based on biological variation are applied to imprecision evaluation, only 46.3%, 52.1%, 31.3%, 12.8%, and 5.86% laboratories meet the minimum performance for FT3, TT3, FT4, and TT4, 24.5%, 23.6%, 12.8%, and 5.86% of the all meet the desirable performance, and 4.4%, 3.9%, 2.5% and 3.0% of the all meet the optimal performance. While it shows a higher percentage of acceptable laboratories (98.1%, 87.9% and 39.0% meeting the minimum, desirable and optimal performance, respectively) for TSH. Not-well-designed IQC practices may affect the effectiveness of laboratory IQC and, thus, the adequacy of a laboratory to monitor system performance. Consequently, IQC practice should be designed according to performance of measure method and instrument. Both clinical laboratories and the government should make efforts to improve quality of clinical testing to ensure the patients' safety.

Differential Sensitivity Between a Virtual Reality Balance Module and Clinically Used Concussion Balance Modalities.

PubMed

Teel, Elizabeth F; Gay, Michael R; Arnett, Peter A; Slobounov, Semyon M

2016-03-01

Balance assessments are part of the recommended clinical concussion evaluation, along with computerized neuropsychological testing and self-reported symptoms checklists. New technology has allowed for the creation of virtual reality (VR) balance assessments to be used in concussion care, but there is little information on the sensitivity and specificity of these evaluations. The purpose of this study is to establish the sensitivity and specificity of a VR balance module for detecting lingering balance deficits clinical concussion care. Retrospective case-control study. Institutional research laboratory. Normal controls (n = 94) and concussed participants (n = 27). All participants completed a VR balance assessment paradigm. Concussed participants were diagnosed by a Certified Athletic Trainer or physician (with 48 hours postinjury) and tested in the laboratory between 7 and 10 days postinjury. Receiver operating characteristic curves were performed to establish the VR module's sensitivity and specificity for detecting lingering balance deficits. Final balance score. For the VR balance module, a cutoff score of 8.25 was established to maximize sensitivity at 85.7% and specificity at 87.8%. The VR balance module has high sensitivity and specificity for detecting subacute balance deficits after concussive injury. The VR balance has a high subacute sensitivity and specificity as a stand-alone balance assessment tool and may detect ongoing balance deficits not readily detectable by the Balance Error Scoring System or Sensory Organization Test. Virtual reality balance modules may be a beneficial addition to the current clinical concussion diagnostic battery.

Competency assessment of microbiology medical laboratory technologists in Ontario, Canada.

PubMed

Desjardins, Marc; Fleming, Christine Ann

2014-08-01

Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program--Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

Competency Assessment of Microbiology Medical Laboratory Technologists in Ontario, Canada

PubMed Central

Fleming, Christine Ann

2014-01-01

Accreditation in Ontario, Canada, requires that licensed clinical laboratories participate in external quality assessment (also known as proficiency testing) and perform competency evaluation of their staff. To assess the extent of ongoing competency assessment practices, the Quality Management Program—Laboratory Services (QMP-LS) Microbiology Committee surveyed all 112 licensed Ontario microbiology laboratories. The questionnaire consisted of a total of 21 questions that included yes/no, multiple-choice, and short-answer formats. Participants were asked to provide information about existing programs, the frequency of testing, what areas are evaluated, and how results are communicated to the staff. Of the 111 responding laboratories, 6 indicated they did not have a formal evaluation program since they perform only limited bacteriology testing. Of the remaining 105 respondents, 87% perform evaluations at least annually or every 2 years, and 61% include any test or task performed, whereas 16% and 10% focus only on problem areas and high-volume complex tasks, respectively. The most common methods of evaluation were review of external quality assessment (EQA) challenges, direct observation, and worksheet review. With the exception of one participant, all communicate results to staff, and most take remedial action to correct the deficiencies. Although most accredited laboratories have a program to assess the ongoing competency of their staff, the methods used are not standardized or consistently applied, indicating that there is room for improvement. The survey successfully highlighted potential areas for improvement and allowed the QMP-LS Microbiology Committee to provide guidance to Ontario laboratories for establishing or improving existing microbiology-specific competency assessment programs. PMID:24899030

Preanalytical management: serum vacuum tubes validation for routine clinical chemistry.

PubMed

Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

2012-01-01

The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Blood specimens from 100 volunteers in five different serum vacuum tubes (Tube I: VACUETTE, Tube II: LABOR IMPORT, Tube III: S-Monovette, Tube IV: SST and Tube V: SST II) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas 6000 module. The significance of the differences between samples was assessed by paired Student's t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Basically, our validation will permit the laboratory or hospital managers to select the brand's vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices.

Preanalytical management: serum vacuum tubes validation for routine clinical chemistry

PubMed Central

Lima-Oliveira, Gabriel; Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Picheth, Geraldo; Guidi, Gian Cesare

2012-01-01

Introduction The validation process is essential in accredited clinical laboratories. Aim of this study was to validate five kinds of serum vacuum tubes for routine clinical chemistry laboratory testing. Materials and methods: Blood specimens from 100 volunteers in five diff erent serum vacuum tubes (Tube I: VACUETTE®, Tube II: LABOR IMPORT®, Tube III: S-Monovette®, Tube IV: SST® and Tube V: SST II®) were collected by a single, expert phlebotomist. The routine clinical chemistry tests were analyzed on cobas® 6000 module. The significance of the diff erences between samples was assessed by paired Student’s t-test after checking for normality. The level of statistical significance was set at P < 0.005. Finally, the biases from Tube I, Tube II, Tube III, Tube IV and Tube V were compared with the current desirable quality specifications for bias (B), derived from biological variation. Results and conclusions: Basically, our validation will permit the laboratory or hospital managers to select the brand’s vacuum tubes validated according him/her technical or economical reasons, in order to perform the following laboratory tests: glucose, total cholesterol, high density lipoprotein-cholesterol, triglycerides, total protein, albumin, blood urea nitrogen, uric acid, alkaline phosphatise, aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase, creatine kinase, total bilirubin, direct bilirubin, calcium, iron, sodium and potassium. On the contrary special attention will be required if the laboratory already performs creatinine, amylase, phosphate and magnesium determinations and the quality laboratory manager intend to change the serum tubes. We suggest that laboratory management should both standardize the procedures and frequently evaluate the quality of in vitro diagnostic devices. PMID:22838184

[Evaluation of a rapid diagnostic test in the diagnosis of toxoplasmosis in pregnant women in Cotonou (Bénin)].

PubMed

Ogouyèmi-Hounto, A; Agbayahoun-Chokki, F; Sissinto Savi de Tove, Y; Biokou Bankole, B; Adinsi de Souza, V; Assogba, M; Kinde-Gazard, D; Massougbodji, A

2014-05-01

The aim of the study was to evaluate the performance of the ImmunoComb® Toxo IgG and ImmunoComb® Toxo IgMassays (rapid diagnostic test) in the laboratory diagnosis of toxoplasmosis in pregnant women in Cotonou. We interviewed 266 pregnant women, who first answered an epidemiological questionnaire, and collected blood samples for measurement of IgG and IgM anti T. gondii antibodies with the ImmunoComb toxo assays and with the ARCHITECT CIMA method. The sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) were calculated to determine the performance of the rapid test. The seroprevalences of IgG against T. gondii by CIMA technique and rapid test were respectively 48.9% and 48.5%. The prevalence increased with age. Performances for IgG were: sensitivity 97%, specificity 100%, PPV 100%, NPV = 97.10%. For IgM, Sensitivity: 33.3% Specificity: 100%, PPV 100%, NPV = 99.2%. Seroprevalence obtained shows that about half of the study population is not immune against T. gondii and requires regular serological monitoring until delivery. According to these results, and given the needs of toxoplasmosis diagnosis on the field characterized by an important decrease of immunized women, this test may be recommended in the laboratory diagnosis of toxoplasmosis in peripheral levels of the health pyramid.

Toxicity and bioaccumulation of sediment-associated contaminants using freshwater invertebrates: A review of methods and applications

USGS Publications Warehouse

Ingersoll, C.G.; Ankley, G.T.; Benoit, D.A.; Brunson, E.L.; Burton, G.A.; Dwyer, F.J.; Hoke, R.A.; Landrum, P.F.; Norberg-King, T. J.; Winger, P.V.

1995-01-01

This paper reviews recent developments in methods for evaluating the toxicity and bioaccumulation of contaminants associated with freshwater sediments and summarizes example case studies demonstrating the application of these methods. Over the past decade, research has emphasized development of more specific testing procedures for conducting 10-d toxicity tests with the amphipod Hyalella azteca and the midge Chironomus tentans. Toxicity endpoints measured in these tests are survival for H. azteca and survival and growth for C. tentans. Guidance has also been developed for conducting 28-d bioaccumulation tests with the oligochaete Lumbriculus variegatus, including determination of bioaccumulation kinetics for different compound classes. These methods have been applied to a variety of sediments to address issues ranging from site assessments to bioavailability of organic and inorganic contaminants using field-collected and laboratory-spiked samples. Survival and growth of controls routinely meet or exceed test acceptability criteria. Results of laboratory bioaccumulation studies with L. variegatus have been confirmed with comparisons to residues (PCBs, PAHs, DDT) present from synoptically collected field populations of oligochaetes. Additional method development is currently underway to develop chronic toxicity tests and to provide additional data-confirming responses observed in laboratory sediment tests with natural benthic populations.

Current insights into the laboratory diagnosis of HIT.

PubMed

Bakchoul, T; Zöllner, H; Greinacher, A

2014-06-01

Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction and prothrombotic disorder caused by immunization against platelet factor 4 (PF4) after complex formation with heparin or other polyanions. After antibody binding to PF4/heparin complexes, HIT antibodies are capable of intravascular platelet activation by cross-linking Fc gamma receptor IIa (FcγRIIa) on the platelet surface leading to a platelet count decrease and/or thrombosis. In contrast to most other immune-mediated disorders, the currently available laboratory tests for anti-PF4/heparin antibodies show a high sensitivity also for clinically irrelevant antibodies. This makes the diagnosis of HIT challenging and bears the risk to substantially overdiagnose HIT. The strength of the antigen assays for HIT is in ruling out HIT when the test is negative. Functional assays have a higher specificity for clinically relevant antibodies, but they are restricted to specialized laboratories. Currently, a Bayesian approach combining the clinical likelihood estimation for HIT with laboratory tests is the most appropriate approach to diagnose HIT. In this review, we give an overview on currently available diagnostic procedures and discuss their limitations. © 2014 John Wiley & Sons Ltd.

Diagnostic challenges in celiac disease.

PubMed

Kowalski, Karol; Mulak, Agata; Jasińska, Maria; Paradowski, Leszek

2017-07-01

Diagnosis of celiac disease in adults is currently based on serologic tests in combination with histopathological assessment of small intestinal biopsy specimens. High titers of celiac-specific antibodies in immunocompetent patients with villous atrophy in a good quality biopsy sample allow us to state a confident diagnosis. The relief of symptoms and histological improvement after embarking on a gluten free diet further support the initial diagnosis. However, in some cases, these conditions are not fulfilled, which requires a critical evaluation of laboratory and histopathology results and a consideration of other potential causes for the observed pathologies. To avoid diagnostic uncertainty, both biopsy and laboratory testing should be performed on a diet containing gluten. Immune deficiency, cross reaction of antibodies and possibilities of seronegative or latent celiac disease should be considered while evaluating serology results. Uneven distribution and variable intensity of histopathological changes in the small intestine along with multiple disorders presenting a similar specimen image may lead to invalid biopsy results. Additional laboratory testing and careful examination of a patient's history may deliver important data for a differential diagnosis and a more specific biopsy evaluation. Persistence or recurrence of symptoms, despite the ongoing treatment, requires a revision of the initial diagnosis, an evaluation of the gluten free diet and a search for concurrent disorders or complications.

Capacity building and predictors of success for HIV-1 drug resistance testing in the Asia-Pacific region and Africa

PubMed Central

Land, Sally; Zhou, Julian; Cunningham, Philip; Sohn, Annette H; Singtoroj, Thida; Katzenstein, David; Mann, Marita; Sayer, David; Kantor, Rami

2013-01-01

Background The TREAT Asia Quality Assessment Scheme (TAQAS) was developed as a quality assessment programme through expert education and training, for laboratories in the Asia-Pacific and Africa that perform HIV drug-resistance (HIVDR) genotyping. We evaluated the programme performance and factors associated with high-quality HIVDR genotyping. Methods Laboratories used their standard protocols to test panels of human immunodeficiency virus (HIV)-positive plasma samples or electropherograms. Protocols were documented and performance was evaluated according to a newly developed scoring system, agreement with panel-specific consensus sequence, and detection of drug-resistance mutations (DRMs) and mixtures of wild-type and resistant virus (mixtures). High-quality performance was defined as detection of ≥95% DRMs. Results Over 4.5 years, 23 participating laboratories in 13 countries tested 45 samples (30 HIV-1 subtype B; 15 non-B subtypes) in nine panels. Median detection of DRMs was 88–98% in plasma panels and 90–97% in electropherogram panels. Laboratories were supported to amend and improve their test outcomes as appropriate. Three laboratories that detected <80% DRMs in early panels demonstrated subsequent improvement. Sample complexity factors – number of DRMs (p<0.001) and number of DRMs as mixtures (p<0.001); and laboratory performance factors – detection of mixtures (p<0.001) and agreement with consensus sequence (p<0.001), were associated with high performance; sample format (plasma or electropherogram), subtype and genotyping protocol were not. Conclusion High-quality HIVDR genotyping was achieved in the TAQAS collaborative laboratory network. Sample complexity and detection of mixtures were associated with performance quality. Laboratories conducting HIVDR genotyping are encouraged to participate in quality assessment programmes. PMID:23845227

Evaluating laboratory approaches to the identification of lupus anticoagulants: a diagnostic challenge from the RCPA Haematology QAP.

PubMed

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.

Electromagnetic propulsion for spacecraft

NASA Technical Reports Server (NTRS)

Myers, Roger M.

1993-01-01

Three electromagnetic propulsion technologies, solid propellant pulsed plasma thrusters (PPT), magnetoplasmadynamic (MPD) thrusters, and pulsed inductive thrusters (PIT), were developed for application to auxiliary and primary spacecraft propulsion. Both the PPT and MPD thrusters were flown in space, though only PPT's were used on operational satellites. The performance of operational PPT's is quite poor, providing only approximately 8 percent efficiency at approximately 1000 s specific impulse. However, laboratory PPT's yielding 34 percent efficiency at 2000 s specific impulse were extensively tested, and peak performance levels of 53 percent efficiency at 5170 s specific impulse were demonstrated. MPD thrusters were flown as experiments on the Japanese MS-T4 spacecraft and the Space Shuttle and were qualified for a flight in 1994. The flight MPD thrusters were pulsed, with a peak performance of 22 percent efficiency at 2500 s specific impulse using ammonia propellant. Laboratory MPD thrusters were demonstrated with up to 70 percent efficiency and 700 s specific impulse using lithium propellant. While the PIT thruster has never been flown, recent performance measurements using ammonia and hydrazine propellants are extremely encouraging, reaching 50 percent efficiency for specific impulses between 4000 to 8000 s. The fundamental operating principles, performance measurements, and system level design for the three types of electromagnetic thrusters are reviewed, and available data on flight tests are discussed for the PPT and MPD thrusters.

Laboratory and Field Evaluation of a New Rapid Test for Detecting Wuchereria bancrofti Antigen in Human Blood

PubMed Central

Weil, Gary J.; Curtis, Kurt C.; Fakoli, Lawrence; Fischer, Kerstin; Gankpala, Lincoln; Lammie, Patrick J.; Majewski, Andrew C.; Pelletreau, Sonia; Won, Kimberly Y.; Bolay, Fatorma K.; Fischer, Peter U.

2013-01-01

Global Program to Eliminate Lymphatic Filariasis (GPELF) guidelines call for using filarial antigen testing to identify endemic areas that require mass drug administration (MDA) and for post-MDA surveillance. We compared a new filarial antigen test (the Alere Filariasis Test Strip) with the reference BinaxNOW Filariasis card test that has been used by the GPELF for more than 10 years. Laboratory testing of 227 archived serum or plasma samples showed that the two tests had similar high rates of sensitivity and specificity and > 99% agreement. However, the test strip detected 26.5% more people with filarial antigenemia (124/503 versus 98/503) and had better test result stability than the card test in a field study conducted in a filariasis-endemic area in Liberia. Based on its increased sensitivity and other practical advantages, we believe that the test strip represents a major step forward that will be welcomed by the GPELF and the filariasis research community. PMID:23690552

Testing of flat conductor cable to Underwriters Laboratory standards UL719 and UL83

NASA Technical Reports Server (NTRS)

Loggins, R. W.; Herndon, R. H.

1974-01-01

The flat conductor cable (FCC) which was tested consisted of three AWG No. 12 flat copper conductors laminated between two films of polyethylene terephthalate (Mylar) insulation with a self-extinguishing polyester adhesive. Results of the tests conducted on this cable, according to specifications, warrants the use of this FCC for electrical interconnections in a surface nonmetallic protective covering.

HEMISPHERIC CENTER FOR ENVIRONMENTAL TECHNOLOGY

DOE Office of Scientific and Technical Information (OSTI.GOV)

M.A. Ebadian

1999-07-31

FIU-HCET personnel visited the Special Technologies Laboratory (STL) for discussions with the Principal Investigator (PI) of Laser Induced Fluorescence Imaging (LIFI) and for training in LIFI. Mr. Peter Gibbons, Tanks Retrieval Technology Integration Manager, visited FIU-HCET on July 20, 1999. Mr. Gibbons inspected the pipeline unplugging experimental facility at the HCET testing field. The detailed test bed construction, testing plan, and plugging material specifications were discussed.

Successful Performance of Laboratory Investigations with Blood Glucose Meters Employing a Dynamic Electrochemistry-Based Correction Algorithm Is Dependent on Careful Sample Handling.

PubMed

Demircik, Filiz; Klonoff, David; Musholt, Petra B; Ramljak, Sanja; Pfützner, Andreas

2016-10-01

Devices employing electrochemistry-based correction algorithms (EBCAs) are optimized for patient use and require special handling procedures when tested in the laboratory. This study investigated the impact of sample handling on the results of an accuracy and hematocrit interference test performed with BG*Star, iBG*Star; OneTouch Verio Pro and Accu-Chek Aviva versus YSI Stat 2300. Venous heparinized whole blood was manipulated to contain three different blood glucose concentrations (64-74, 147-163, and 313-335 mg/dL) and three different hematocrit levels (30%, 45%, and 60%). Sample preparation was done by either a very EBCA-experienced laboratory testing team (A), a group experienced with other meters but not EBCAs (B), or a team inexperienced with meter testing (C). Team A ensured physiological pO 2 and specific sample handling requirements, whereas teams B and C did not consider pO 2 . Each sample was tested four times with each device. In a separate experiment, a different group similar to group B performed the experiment before (D1) and after (D2) appropriate sample handling training. Mean absolute deviation from YSI was calculated as a metrix for all groups and devices. Mean absolute relative difference was 4.3% with team A (B: 9.2%, C: 5.2%). Team B had much higher readings and team C produced 100% of "sample composition" errors with high hematocrit levels. In a separate experiment, group D showed a result similar to group B before the training and improved significantly when considering the sample handling requirements (D1: 9.4%, D2: 4.5%, P < 0.05). Laboratory performance testing of EBCA devices should only be performed by trained staff considering specific sample handling requirements. The results suggest that healthcare centers should evaluate EBCA-based devices with capillary blood from patients in accordance with the instructions for use to achieve reliable results.

Biomechanical characteristics, patient preference and activity level with different prosthetic feet: a randomized double blind trial with laboratory and community testing.

PubMed

Raschke, Silvia U; Orendurff, Michael S; Mattie, Johanne L; Kenyon, David E A; Jones, O Yvette; Moe, David; Winder, Lorne; Wong, Angie S; Moreno-Hernández, Ana; Highsmith, M Jason; J Sanderson, David; Kobayashi, Toshiki

2015-01-02

Providing appropriate prosthetic feet to those with limb loss is a complex and subjective process influenced by professional judgment and payer guidelines. This study used a small load cell (Europa™) at the base of the socket to measure the sagittal moments during walking with three objective categories of prosthetic feet in eleven individuals with transtibial limb loss with MFCL K2, K3 and K4 functional levels. Forefoot stiffness and hysteresis characteristics defined the three foot categories: Stiff, Intermediate, and Compliant. Prosthetic feet were randomly assigned and blinded from participants and investigators. After laboratory testing, participants completed one week community wear tests followed by a modified prosthetics evaluation questionnaire to determine if a specific category of prosthetic feet was preferred. The Compliant category of prosthetic feet was preferred by the participants (P=0.025) over the Stiff and Intermediate prosthetic feet, and the Compliant and Intermediate feet had 15% lower maximum sagittal moments during walking in the laboratory (P=0.0011) compared to the Stiff feet. The activity level of the participants did not change significantly with any of the wear tests in the community, suggesting that each foot was evaluated over a similar number of steps, but did not inherently increase activity. This is the first randomized double blind study in which prosthetic users have expressed a preference for a specific biomechanical characteristic of prosthetic feet: those with lower peak sagittal moments were preferred, and specifically preferred on slopes, stairs, uneven terrain, and during turns and maneuvering during real world use. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Evaluation of Targeted Next-Generation Sequencing for Detection of Bovine Pathogens in Clinical Samples.

PubMed

Anis, Eman; Hawkins, Ian K; Ilha, Marcia R S; Woldemeskel, Moges W; Saliki, Jeremiah T; Wilkes, Rebecca P

2018-07-01

The laboratory diagnosis of infectious diseases, especially those caused by mixed infections, is challenging. Routinely, it requires submission of multiple samples to separate laboratories. Advances in next-generation sequencing (NGS) have provided the opportunity for development of a comprehensive method to identify infectious agents. This study describes the use of target-specific primers for PCR-mediated amplification with the NGS technology in which pathogen genomic regions of interest are enriched and selectively sequenced from clinical samples. In the study, 198 primers were designed to target 43 common bovine and small-ruminant bacterial, fungal, viral, and parasitic pathogens, and a bioinformatics tool was specifically constructed for the detection of targeted pathogens. The primers were confirmed to detect the intended pathogens by testing reference strains and isolates. The method was then validated using 60 clinical samples (including tissues, feces, and milk) that were also tested with other routine diagnostic techniques. The detection limits of the targeted NGS method were evaluated using 10 representative pathogens that were also tested by quantitative PCR (qPCR), and the NGS method was able to detect the organisms from samples with qPCR threshold cycle ( C T ) values in the 30s. The method was successful for the detection of multiple pathogens in the clinical samples, including some additional pathogens missed by the routine techniques because the specific tests needed for the particular organisms were not performed. The results demonstrate the feasibility of the approach and indicate that it is possible to incorporate NGS as a diagnostic tool in a cost-effective manner into a veterinary diagnostic laboratory. Copyright © 2018 Anis et al.

Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain.

PubMed

Weykamp, Cas; Secchiero, Sandra; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Thomas, Annette; Jassam, Nuthar; Barth, Julian H; Perich, Carmen; Ricós, Carmen; Faria, Ana Paula

2017-02-01

Optimum patient care in relation to laboratory medicine is achieved when results of laboratory tests are equivalent, irrespective of the analytical platform used or the country where the laboratory is located. Standardization and harmonization minimize differences and the success of efforts to achieve this can be monitored with international category 1 external quality assessment (EQA) programs. An EQA project with commutable samples, targeted with reference measurement procedures (RMPs) was organized by EQA institutes in Italy, the Netherlands, Portugal, UK, and Spain. Results of 17 general chemistry analytes were evaluated across countries and across manufacturers according to performance specifications derived from biological variation (BV). For K, uric acid, glucose, cholesterol and high-density density (HDL) cholesterol, the minimum performance specification was met in all countries and by all manufacturers. For Na, Cl, and Ca, the minimum performance specifications were met by none of the countries and manufacturers. For enzymes, the situation was complicated, as standardization of results of enzymes toward RMPs was still not achieved in 20% of the laboratories and questionable in the remaining 80%. The overall performance of the measurement of 17 general chemistry analytes in European medical laboratories met the minimum performance specifications. In this general picture, there were no significant differences per country and no significant differences per manufacturer. There were major differences between the analytes. There were six analytes for which the minimum quality specifications were not met and manufacturers should improve their performance for these analytes. Standardization of results of enzymes requires ongoing efforts.

The LSLE echocardiograph - Commercial hardware aboard Spacelab. [Life Sciences Laboratory Equipment

NASA Technical Reports Server (NTRS)

Schwarz, R.

1983-01-01

The Life Sciences Laboratory Equipment Echocardiograph, a commercial 77020AC Ultrasound Imaging System modified to meet NASA's spacecraft standards, is described. The assembly consists of four models: display and control, scanner, scan converter, and physioamplifiers. Four separate processors communicate over an IEE-488 bus, and the system has more than 6000 individual components on 35 printed circuit cards. Three levels of self test are provided: a short test during power up, a basic test initiated by a front panel switch, and interactive tests for specific routines. Default mode operation further enhances reliability. Modifications of the original system include the replacement of ac power supplies with dc to dc converters, a slide-out keyboard (to prevent accidental operation), Teflon insulated wire, and additional shielding for the ultrasound transducer cable.

Performance of serological tests for syphilis in sexually transmitted diseases clinics in Guangxi Autonomous Region, China: implications for syphilis surveillance and control.

PubMed

Yin, Yue-Ping; Wei, Wan-Hui; Wang, Hong-Chun; Zhu, Bang-Yong; Yu, Yan-Hua; Chen, Xiang-Sheng; Peeling, Rosanna W; Cohen, Myron S

2009-03-01

China is experiencing a growing syphilis epidemic. Individuals are currently screened and cases are confirmed using traditional serological testing methods. A total of 11 558 serum specimens from patients at 14 sexually transmitted diseases (STD) clinics at provincial, prefecture and county levels in Guangxi Autonomous Region were tested at local clinics using the toluidine red unheated serum test (TRUST) and the SD Bioline Syphilis 3.0 Treponema Pallidum (SD-TP) test and then transported to the National STD Reference Laboratory for TRUST and confirmatory Treponema pallidum particle assay (TPPA) testing. In local clinics, 13.2% of specimens were TRUST positive and 12.8% were TRUST and SD-TP positive. At the Reference Laboratory, 15.4% of specimens were TRUST positive and 11.8% were TRUST and TPPA positive. Local clinics showed a significantly higher prevalence of active syphilis compared with results from the Reference Laboratory (12.8 v. 11.8%, chi(2) = 4.59, P = 0.03). The local TRUST tests had consistent results with Reference Laboratory tests qualitatively among 96.2% of the specimens and quantitatively among 95.5% of the specimens. The algorithm of TRUST screening and then SD-TP confirmation among positive TRUST specimens at local STD clinics had 96.6% sensitivity and 99.3% specificity in diagnosing active syphilis compared with the 'gold standard' based on TRUST and TPPA positivity at the Reference Laboratory (positive predictive value 95.1% and negative predictive value 99.5%). The TRUST screening and SD-TP confirmation in combination can be used at local STD clinics for the efficient diagnosis of serologically active syphilis. However, continuing capacity building and quality assurance remain critical in ensuring the quality of syphilis diagnosis at local clinics.

Self-Reported HIV-Positive Status But Subsequent HIV-Negative Test Result Using Rapid Diagnostic Testing Algorithms Among Seven Sub-Saharan African Military Populations

DTIC Science & Technology

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

Assessment of Accuracy of Identification of Pathogenic Yeasts in Microbiology Laboratories in the United Kingdom

PubMed Central

Szekely, Adrien; Palmer, Michael D.; Johnson, Elizabeth M.

2012-01-01

Rapid, accurate identification of yeast isolates from clinical samples has always been important given their innately variable antifungal susceptibility profiles. Recently, this has become paramount with the proposed introduction of species-specific interpretive breakpoints for MICs obtained in yeast antifungal susceptibility tests (M. A. Pfaller, D. Andes, D. J. Diekema, A. Espinel–Ingroff, D. Sheehan, and CLSI Subcommittee for Antifungal Susceptibility Testing, Drug Resist. Updat. 13:180–195, 2010). Here, we present the results of a 12-month evaluation of the accuracy of identifications that accompany yeast isolates submitted to the Mycology Reference Laboratory (United Kingdom) for either confirmation of identity or susceptibility testing. In total, 1,781 yeast isolates were analyzed, and the robustness of prior identifications obtained in microbiology laboratories throughout the United Kingdom was assessed using a combination of culture on chromogenic agar, morphology on cornmeal agar, and molecular identification by pyrosequencing. Over 40% of isolates (755) were submitted without any suggested identification. Of those isolates with a prior identification, 100 (9.7%) were incorrectly identified. Error rates ranged from 5.2% (for organisms submitted for antifungal susceptibility testing) to 18.2% (for organisms requiring confirmation of identity) and varied in a strictly species-specific manner. At least 50% of identification errors would be likely to affect interpretation of MIC data, with a possible impact on patient management. In addition, 2.3% of submitted cultures were found to contain mixtures of at least two yeast species. The vast majority of mixtures had gone undetected in the referring laboratory and would have impacted the interpretation of antifungal susceptibility profiles and patient management. Some of the more common misidentifications are discussed according to the identification method employed, with suggestions for avoiding such misinterpretations. PMID:22649009

Assessment of accuracy of identification of pathogenic yeasts in microbiology laboratories in the United kingdom.

PubMed

Borman, Andrew M; Szekely, Adrien; Palmer, Michael D; Johnson, Elizabeth M

2012-08-01

Rapid, accurate identification of yeast isolates from clinical samples has always been important given their innately variable antifungal susceptibility profiles. Recently, this has become paramount with the proposed introduction of species-specific interpretive breakpoints for MICs obtained in yeast antifungal susceptibility tests (M. A. Pfaller, D. Andes, D. J. Diekema, A. Espinel-Ingroff, D. Sheehan, and CLSI Subcommittee for Antifungal Susceptibility Testing, Drug Resist. Updat. 13:180-195, 2010). Here, we present the results of a 12-month evaluation of the accuracy of identifications that accompany yeast isolates submitted to the Mycology Reference Laboratory (United Kingdom) for either confirmation of identity or susceptibility testing. In total, 1,781 yeast isolates were analyzed, and the robustness of prior identifications obtained in microbiology laboratories throughout the United Kingdom was assessed using a combination of culture on chromogenic agar, morphology on cornmeal agar, and molecular identification by pyrosequencing. Over 40% of isolates (755) were submitted without any suggested identification. Of those isolates with a prior identification, 100 (9.7%) were incorrectly identified. Error rates ranged from 5.2% (for organisms submitted for antifungal susceptibility testing) to 18.2% (for organisms requiring confirmation of identity) and varied in a strictly species-specific manner. At least 50% of identification errors would be likely to affect interpretation of MIC data, with a possible impact on patient management. In addition, 2.3% of submitted cultures were found to contain mixtures of at least two yeast species. The vast majority of mixtures had gone undetected in the referring laboratory and would have impacted the interpretation of antifungal susceptibility profiles and patient management. Some of the more common misidentifications are discussed according to the identification method employed, with suggestions for avoiding such misinterpretations.

Can administrative health utilisation data provide an accurate diabetes prevalence estimate for a geographical region?

PubMed

Chan, Wing Cheuk; Papaconstantinou, Dean; Lee, Mildred; Telfer, Kendra; Jo, Emmanuel; Drury, Paul L; Tobias, Martin

2018-05-01

To validate the New Zealand Ministry of Health (MoH) Virtual Diabetes Register (VDR) using longitudinal laboratory results and to develop an improved algorithm for estimating diabetes prevalence at a population level. The assigned diabetes status of individuals based on the 2014 version of the MoH VDR is compared to the diabetes status based on the laboratory results stored in the Auckland regional laboratory result repository (TestSafe) using the New Zealand diabetes diagnostic criteria. The existing VDR algorithm is refined by reviewing the sensitivity and positive predictive value of the each of the VDR algorithm rules individually and as a combination. The diabetes prevalence estimate based on the original 2014 MoH VDR was 17% higher (n = 108,505) than the corresponding TestSafe prevalence estimate (n = 92,707). Compared to the diabetes prevalence based on TestSafe, the original VDR has a sensitivity of 89%, specificity of 96%, positive predictive value of 76% and negative predictive value of 98%. The modified VDR algorithm has improved the positive predictive value by 6.1% and the specificity by 1.4% with modest reductions in sensitivity of 2.2% and negative predictive value of 0.3%. At an aggregated level the overall diabetes prevalence estimated by the modified VDR is 5.7% higher than the corresponding estimate based on TestSafe. The Ministry of Health Virtual Diabetes Register algorithm has been refined to provide a more accurate diabetes prevalence estimate at a population level. The comparison highlights the potential value of a national population long term condition register constructed from both laboratory results and administrative data. Copyright © 2018 Elsevier B.V. All rights reserved.

Quality-assurance results for field pH and specific-conductance measurements, and for laboratory analysis, National Atmospheric Deposition Program and National Trends Network; January 1980-September 1984

USGS Publications Warehouse

Schroder, L.J.; Brooks, M.H.; Malo, B.A.; Willoughby, T.C.

1986-01-01

Five intersite comparison studies for the field determination of pH and specific conductance, using simulated-precipitation samples, were conducted by the U.S.G.S. for the National Atmospheric Deposition Program and National Trends Network. These comparisons were performed to estimate the precision of pH and specific conductance determinations made by sampling-site operators. Simulated-precipitation samples were prepared from nitric acid and deionized water. The estimated standard deviation for site-operator determination of pH was 0.25 for pH values ranging from 3.79 to 4.64; the estimated standard deviation for specific conductance was 4.6 microsiemens/cm at 25 C for specific-conductance values ranging from 10.4 to 59.0 microsiemens/cm at 25 C. Performance-audit samples with known analyte concentrations were prepared by the U.S.G.S.and distributed to the National Atmospheric Deposition Program 's Central Analytical Laboratory. The differences between the National Atmospheric Deposition Program and national Trends Network-reported analyte concentrations and known analyte concentrations were calculated, and the bias and precision were determined. For 1983, concentrations of calcium, magnesium, sodium, and chloride were biased at the 99% confidence limit; concentrations of potassium and sulfate were unbiased at the 99% confidence limit. Four analytical laboratories routinely analyzing precipitation were evaluated in their analysis of identical natural- and simulated precipitation samples. Analyte bias for each laboratory was examined using analysis of variance coupled with Duncan 's multiple-range test on data produced by these laboratories, from the analysis of identical simulated-precipitation samples. Analyte precision for each laboratory has been estimated by calculating a pooled variance for each analyte. Interlaboratory comparability results may be used to normalize natural-precipitation chemistry data obtained from two or more of these laboratories. (Author 's abstract)

Retesting The Validity Of A Specific Field Test For Judo Training

PubMed Central

Santos, Luis; González, Vicente; Iscar, Marta; Brime, Juan I.; Fernández-Río, Javier; Rodríguez, Blanca; Montoliu, Mª Ángeles

2011-01-01

The main goal of this research project was to retest the validity of a specifically designed judo field test (Santos Test) in a different group of judokas. Eight (n=8) national-level male judokas underwent laboratory and field testing. The mean data (mean +/− SD) obtained in the laboratory tests was: HRmax: 200 ± 4.0 beats × min−1, VO2 max: 52.8 ± 7.9 ± ml × kg−1 × min−1, lactate max: 12 ± 2.5 mmol × l−1, HR at the anaerobic threshold: 174.2 ± 9.4 beats × min−1, percentage of maximum heart rate at which the anaerobic threshold appears: 87 ± 3.6 %, lactate threshold: 4.0 ± 0.2 mmol × l−1, and RPE: 17.2 ± 1.0. The mean data obtained in the field test (Santos) was: HRmax: 201.3 ± 4.1 beats × min−1, VO2 max: 55.6 ± 5.8 ml × kg−1 × min−1, lactate max: 15.6 ± 2.8 mmol × l−1, HR at the anaerobic threshold: 173.2 ± 4.3 beats × min−1, percentage of maximum heart rate at which the anaerobic threshold appears: 86 ± 2.5 %, lactate threshold: 4.0 ± 0.2 mmol × l−1, and RPE: 16.7 ± 1.0. There were no significant differences between the data obtained on both tests in any of the parameters, except for maximum lactate concentration. Therefore, the Santos test can be considered a valid tool specific for judo training. PMID:23486994

Specimen origin, type and testing laboratory are linked to longer turnaround times for HIV viral load testing in Malawi

PubMed Central

Chipungu, Geoffrey; Kim, Andrea A.; Sarr, Abdoulaye; Ali, Hammad; Mwenda, Reuben; Nkengasong, John N.; Singer, Daniel

2017-01-01

Background Efforts to reach UNAIDS’ treatment and viral suppression targets have increased demand for viral load (VL) testing and strained existing laboratory networks, affecting turnaround time. Longer VL turnaround times delay both initiation of formal adherence counseling and switches to second-line therapy for persons failing treatment and contribute to poorer health outcomes. Methods We utilized descriptive statistics and logistic regression to analyze VL testing data collected in Malawi between January 2013 and March 2016. The primary outcomes assessed were greater-than-median pretest phase turnaround time (days elapsed from specimen collection to receipt at the laboratory) and greater-than-median test phase turnaround time (days from receipt to testing). Results The median number of days between specimen collection and testing increased 3-fold between 2013 (8 days, interquartile range (IQR) = 6–16) and 2015 (24, IQR = 13–39) (p<0.001). Multivariable analysis indicated that the odds of longer pretest phase turnaround time were significantly higher for specimen collection districts without laboratories capable of conducting viral load tests (adjusted odds ratio (aOR) = 5.16; 95% confidence interval (CI) = 5.04–5.27) as well as for Malawi’s Northern and Southern regions. Longer test phase turnaround time was significantly associated with use of dried blood spots instead of plasma (aOR = 2.30; 95% CI = 2.23–2.37) and for certain testing months and testing laboratories. Conclusion Increased turnaround time for VL testing appeared to be driven in part by categorical factors specific to the phase of turnaround time assessed. Given the implications of longer turnaround time and the global effort to scale up VL testing, addressing these factors via increasing efficiencies, improving quality management systems and generally strengthening the VL spectrum should be considered essential components of controlling the HIV epidemic. PMID:28235013

Evaluation of chemical data from selected sites in the Surface-Water Ambient Monitoring Program (SWAMP) in Florida

USGS Publications Warehouse

Katz, B.G.; Collins, J.J.

1998-01-01

A cooperative study between the Florida Department of Environmental Protection (FDEP) and the U.S. Geological Survey was conducted to assess the integrity of selected water-quality data collected at 150 sites in the FDEP Surface-Water Ambient Monitoring Program (SWAMP) in Florida. The assessment included determining the consistency of the water-quality data collected statewide, including commonality of monitoring procedures and analytes, screening of the gross validity of a chemical analysis, and quality assurance and quality control (QA/QC) procedures. Four tests were used to screen data at selected SWAMP sites to estimate the gross validity of selected chemical data: (1) the ratio of dissolved solids (in milligrams per liter) to specific conductance (in microsiemens per centimeter); (2) the ratio of total cations (in milliequivalents per liter) multiplied by 100 to specific conductance (in microsiemens per centimeter); (3) the ratio of total anions (in milliequivalents per liter) multiplied by 100 to specific conductance (in microsiemens per centimeter); and (4) the ionic charge-balance error. Although the results of the four screening tests indicate that the chemical data generally are quite reliable, the extremely small number of samples (less than 5 percent of the total number of samples) with sufficient chemical information to run the tests may not provide a representative indication of the analytical accuracy of all laboratories in the program. In addition to the four screening tests, unusually low or high values were flagged for field and laboratory pH (less than 4.0 and greater than 9.0) and specific conductance (less than 10 and greater than 10,000 microsiemens per centimeter). The numbers of flagged data were less than 1 percent of the 19,937 water samples with pH values and less than 0.6 percent of the 16,553 water samples with specific conductance values. Thirty-four agencies responded to a detailed questionnaire that was sent to more than 60 agencies involved in the collection and analysis of surface-water-quality data for SWAMP. The purpose of the survey was to evaluate quality assurance methods and consistency of methods statewide. Information was compiled and summarized on monitoring network design, data review and upload procedures, laboratory and field sampling methods, and data practices. Currently, most agencies that responded to the survey follow FDEP-approved QA/QC protocol for sampling and have quality assurance practices for recording and reporting data. Also, most agencies responded that calibration procedures were followed in the laboratory for analysis of data, but no responses were given about the specific procedures. Approximately 50 percent of the respondents indicated that laboratory analysis methods have changed over time. With so many laboratories involved in analyzing samples for SWAMP, it is difficult to compare water quality from one site to another due to different reporting conventions for chemical constituents and different analytical methods over time. Most agencies responded that calibration methods are followed in the field, but no specific details were provided. Grab samples are the most common method of collection. Other data screening procedures are necessary to further evaluate the validity of chemical data collected at SWAMP sites. High variability in the concentration of targeted constituents may signal analytical problems, but more likely changes in concentration are related to hydrologic conditions. This underscores the need for accurate measurements of discharge, lake stage, tidal stage at the time of sampling so that changes in constituent concentrations can be properly evaluated and fluxes (loads) of nutrients or metals, for example, can be calculated and compared over time.

Laboratory hemostasis: from biology to the bench.

PubMed

Lippi, Giuseppe; Favaloro, Emmanuel J

2018-06-27

Physiological hemostasis is an intricate biological system, where procoagulant and anticoagulant forces interplay and preserves blood fluidity when blood vessels are intact, or trigger clot formation to prevent excessive bleeding when blood vessels are injured. The modern model of hemostasis is divided into two principal phases. The first, defined as primary hemostasis, involves the platelet-vessel interplay, whilst the second, defined as secondary hemostasis, mainly involves coagulation factors, damaged cells and platelet surfaces, where the so-called coagulation cascade rapidly develops. The activation and amplification of the coagulation cascade is finely modulated by the activity of several physiological inhibitors. Once bleeding has been efficiently stopped by blood clot formation, dissolution of the thrombus is essential to restore vessel permeability. This process, known as fibrinolysis, also develops through coordinate action of a vast array of proteins and enzymes. An accurate diagnosis of hemostasis disturbance entails a multifaceted approach, encompassing family and personal history of hemostatic disorders, accurate collection of clinical signs and symptoms, integrated with laboratory hemostasis testing. Regarding laboratory testing, a reasonable approach entails classifying hemostasis testing according to cost, complexity and available clinical information. Laboratory workout may hence initiate with some rapid and inexpensive "screening" tests, characterized by high negative predictive value, then followed by second- or third-line analyses, specifically aimed to clarify the nature and severity of bleeding or thrombotic phenotype. This article aims to provide a general overview of the hemostatic process, and to provide some general suggestions to optimally facilitate laboratory hemostasis testing.

Interlaboratory comparison of test results for detection of Lyme disease by 516 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Proficiency Testing Program.

PubMed Central

Bakken, L L; Callister, S M; Wand, P J; Schell, R F

1997-01-01

In 1991, we reported that 55% of laboratories participating in the Wisconsin Proficiency Testing Program could not accurately identify serum samples from Lyme disease patients containing antibody against Borrelia burgdorferi. The purpose of this study was to determine whether the accuracy of Lyme disease test results reported by approximately 500 participants in the Wisconsin State Laboratory of Hygiene/College of American Pathologists Lyme Disease Survey had improved. From 1992 through 1994, 50 serum samples were sent to participants of the survey. Each laboratory received 28 serum samples from individuals with Lyme disease according to the case definition of the Centers for Disease Control and Prevention and 22 serum samples from healthy individuals. Unfortunately, the serodiagnosis of Lyme disease by participants had not improved. The specificity of the Lyme disease assays steadily decreased from approximately 95% to approximately 81% during the 3-year period of the survey. False-positive test results approached 55% with some of the serum samples from healthy donors. A serum sample containing antibody against Treponema pallidum was reported as positive by 70% of the participants. In addition, the sensitivity fluctuated between 93 and 75%, depending upon the conjugate used by the laboratories. These results suggest that stronger criteria must be applied for approving and continuing to approve commercially available kits for the serodiagnosis of Lyme disease. PMID:9041384

Genetic testing in domestic cats

PubMed Central

Lyons, Leslie A.

2012-01-01

Varieties of genetic tests are currently available for the domestic cat that support veterinary health care, breed management, species identification, and forensic investigations. Approximately thirty-five genes contain over fifty mutations that cause feline health problems or alterations in the cat’s appearance. Specific genes, such as sweet and drug receptors, have been knocked-out of Felidae during evolution and can be used along with mtDNA markers for species identification. Both STR and SNP panels differentiate cat race, breed, and individual identity, as well as gender-specific markers to determine sex of an individual. Cat genetic tests are common offerings for commercial laboratories, allowing both the veterinary clinician and the private owner to obtain DNA test results. This article will review the genetic tests for the domestic cat, and their various applications in different fields of science. Highlighted are genetic tests specific to the individual cat, which are a part of the cat’s genome. PMID:22546621

12. "TEST STAND; STRUCTURAL; DEFLECTOR PIT DETAILS, SHEET NO. 1." ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

12. "TEST STAND; STRUCTURAL; DEFLECTOR PIT DETAILS, SHEET NO. 1." Specifications No. ENG-04-353-55-72; Drawing No. 60-09-12; sheet 41 of 148; file no. 1320/92, Rev. A. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A Terminal Room, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

11. "INSTRUMENTATION AND CONTROL SYSTEMS, EQUIPMENT LOCATION, TEST STAND TERMINAL ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

11. "INSTRUMENTATION AND CONTROL SYSTEMS, EQUIPMENT LOCATION, TEST STAND TERMINAL ROOM, PLANS AND SECTION." Specifications No. ENG-04-353-55-72; Drawing No. 60-0912; sheet 106 of 148; file no. 1321/57. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, no change. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A Terminal Room, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

27. "TEST STAND; STRUCTURAL; SIDEWALL, NORTH WALL AND SOUTH WALL ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

27. "TEST STAND; STRUCTURAL; SIDEWALL, NORTH WALL AND SOUTH WALL FRAMING ELEVATIONS." Specifications No. ENG-04353-55-72; Drawing No. 60-09-12; sheet 27 of 148; file no. 1320/78. Stamped: RECORD DRAWING - AS CONSTRUCTED. Below stamp: Contract no. 4338, Rev. B; date: 15 April 1957. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Test Stand 1-A, Test Area 1-120, north end of Jupiter Boulevard, Boron, Kern County, CA

'Nano-immuno test' for the detection of live Mycobacterium avium subspecies paratuberculosis bacilli in the milk samples using magnetic nano-particles and chromogen.

PubMed

Singh, Manju; Singh, Shoor Vir; Gupta, Saurabh; Chaubey, Kundan Kumar; Stephan, Bjorn John; Sohal, Jagdip Singh; Dutta, Manali

2018-04-26

Early rapid detection of Mycobacterium avium subspecies paratuberculosis (MAP) bacilli in milk samples is the major challenge since traditional culture method is time consuming and laboratory dependent. We report a simple, sensitive and specific nano-technology based 'Nano-immuno test' capable of detecting viable MAP bacilli in the milk samples within 10 h. Viable MAP bacilli were captured by MAP specific antibody-conjugated magnetic nano-particles using resazurin dye as chromogen. Test was optimized using true culture positive (10-bovine and 12-goats) and true culture negative (16-bovine and 25-goats) raw milk samples. Domestic livestock species in India are endemically infected with MAP. After successful optimization, sensitivity and specificity of the 'nano-immuno test' in goats with respect to milk culture was 91.7% and 96.0%, respectively. Whereas, it was 90.0% (sensitivity) and 92.6% (specificity) with respect to IS900 PCR. In bovine milk samples, sensitivity and specificity of 'nano-immuno test' with respect to milk culture was 90.0% and 93.7%, respectively. However, with respect to IS900 PCR, the sensitivity and specificity was 88.9% and 94.1%, respectively. Test was validated with field raw milk samples (goats-258 and bovine-138) collected from domestic livestock species to detect live/viable MAP bacilli. Of 138 bovine raw milk samples screened by six diagnostic tests, 81 (58.7%) milk samples were positive for MAP infection in one or more than one diagnostic tests. Of 81 (58.7%) positive bovine raw milk samples, only 24 (17.4%) samples were detected positive for the presence of viable MAP bacilli. Of 258 goats raw milk samples screened by six diagnostic tests, 141 (54.6%) were positive for MAP infection in one or more than one test. Of 141 (54.6%) positive raw milk samples from goats, only 48 (34.0%) were detected positive for live MAP bacilli. Simplicity and efficiency of this novel 'nano-immuno test' makes it suitable for wide-scale screening of milk samples in the field. Standardization, validation and re-usability of functionalized nano-particles and the test was successfully achieved in field samples. Test was highly specific, simple to perform and easy to read by naked eyes and does not require laboratory support in the performance of test. Test has potential to be used as screening test to estimate bio-load of MAP in milk samples at National level.

Scrub typhus in South India: clinical and laboratory manifestations, genetic variability, and outcome.

PubMed

Varghese, George M; Janardhanan, Jeshina; Trowbridge, Paul; Peter, John V; Prakash, John A J; Sathyendra, Sowmya; Thomas, Kurien; David, Thambu S; Kavitha, M L; Abraham, Ooriapadickal C; Mathai, Dilip

2013-11-01

This study sought to document the clinical and laboratory manifestations, genetic variability, and outcomes of scrub typhus, an often severe infection caused by Orientia tsutsugamushi, in South India. Patients admitted to a large teaching hospital with IgM ELISA-confirmed scrub typhus were evaluated. Clinical examination with a thorough search for an eschar, laboratory testing, chest X-ray, and outcome were documented and analyzed. Additionally, a 410-bp region of the 56-kDa type-specific antigen gene of O. tsutsugamushi was sequenced and compared with isolates from other regions of Asia. Most of the 154 patients evaluated presented with fever and non-specific symptoms. An eschar was found in 86 (55%) patients. Mild hepatic involvement was seen in most, with other organ involvement including respiratory, cardiovascular, and renal. Multi-organ dysfunction was noted in 59 (38.3%), and the fatality rate was 7.8%. Hypotension requiring vasoactive agents was found to be an independent predictor of mortality (p<0.001). The phylogeny of 26 samples showed 17 (65%) clustering with the Kato-like group and eight (31%) with the Karp-like group. The presentation of scrub typhus can be variable, often non-specific, but with potentially severe multi-organ dysfunction. Prompt recognition is key to specific treatment and good outcomes. Further study of the circulating strains is essential for the development of a successful vaccine and sensitive point-of-care testing. Copyright © 2013 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Inter-laboratory evaluation of the performance parameters of a Lateral Flow Test device for the detection of Bluetongue virus-specific antibodies.

PubMed

Hanon, Jean-Baptiste; Vandenberge, Valerie; Deruelle, Matthias; De Leeuw, Ilse; De Clercq, Kris; Van Borm, Steven; Koenen, Frank; Liu, Lihong; Hoffmann, Bernd; Batten, Carrie Anne; Zientara, Stéphan; Breard, Emmanuel; Van der Stede, Yves

2016-02-01

Bluetongue (BT) is a viral vector-borne disease affecting domestic and wild ruminants worldwide. In this study, a commercial rapid immuno-chromatographic method or Lateral Flow Test (LFT) device, for the detection of BT virus-specific antibodies in animal serum, was evaluated in an international inter-laboratory proficiency test. The evaluation was done with sera samples of variable background (ruminant species, serotype, field samples, experimental infections, vaccinated animals). The diagnostic sensitivity was 100% (95% C.I. [90.5-100]) and the diagnostic specificity was 95.2% (95% C.I. [76.2-99.9]). The repeatability (accordance) and reproducibility (concordance) were 100% for seropositive samples but were lower for two of the seronegative samples (45% and 89% respectively). The analytical sensitivity, evaluated by testing positive sera at increasing dilutions was better for the BT LFT compared to some commercial ELISAs. Seroconversion of an infected sheep was detected at 4 days post infection. Analytical specificity was impaired by cross-reactions observed with some of the samples seropositive for Epizootic Haemorrhagic Disease Virus (EHDV). The agreement (Cohen's kappa) between the LFT and a commercial BT competitive ELISA was 0.79 (95% CI [0.62-0.95]). Based on these results, it can be concluded that the BT LFT device is a rapid and sensitive first-line serological test that can be used in the field, especially in areas endemic for the disease where there is a lack of diagnostic facilities. Copyright © 2015 Elsevier B.V. All rights reserved.

NEW TECHNOLOGY AND PEC PROCESS - COLUMBUS, GA

EPA Science Inventory

The presentation will discuss Columbus, Georgia’s Biosolids Flow-through Thermophilic Treatment (BFT3) Process. Site-specific equivalency requires proof. Laboratory-scale pathogen testing must exceed Class A performance criteria while simulating full scale as closely as pos...

Anxiety-free Urinalysis.

ERIC Educational Resources Information Center

Schwartz, Marjorie F.

1989-01-01

Discusses simple analysis of urine in the classroom. Describes the materials and procedures for the analysis. Provides a laboratory report giving characteristics of: (1) odor, color, and clarity; (2) specific gravity; (3) sediment; (4) test strips; and (5) albumin and phosphates. (YP)

Fluorescence In Situ Hybridization Probe Validation for Clinical Use.

PubMed

Gu, Jun; Smith, Janice L; Dowling, Patricia K

2017-01-01

In this chapter, we provide a systematic overview of the published guidelines and validation procedures for fluorescence in situ hybridization (FISH) probes for clinical diagnostic use. FISH probes-which are classified as molecular probes or analyte-specific reagents (ASRs)-have been extensively used in vitro for both clinical diagnosis and research. Most commercially available FISH probes in the United States are strictly regulated by the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) the Clinical Laboratory Improvement Amendments (CLIA), and the College of American Pathologists (CAP). Although home-brewed FISH probes-defined as probes made in-house or acquired from a source that does not supply them to other laboratories-are not regulated by these agencies, they too must undergo the same individual validation process prior to clinical use as their commercial counterparts. Validation of a FISH probe involves initial validation and ongoing verification of the test system. Initial validation includes assessment of a probe's technical specifications, establishment of its standard operational procedure (SOP), determination of its clinical sensitivity and specificity, development of its cutoff, baseline, and normal reference ranges, gathering of analytics, confirmation of its applicability to a specific research or clinical setting, testing of samples with or without the abnormalities that the probe is meant to detect, staff training, and report building. Ongoing verification of the test system involves testing additional normal and abnormal samples using the same method employed during the initial validation of the probe.

[The development and implementation of polymerase chain reaction to detect in real-time operation mode yersinia pestis in field material].

PubMed

Afanas'ev, M V; Chipanin, E V; Shestakov, V E; Denisov, A V; Fomina, L A; Ostiak, A S; Balakhonov, S V

2013-03-01

The article presents the results of development and practical implementation of system of polymerase chain reaction testing in real-time operation mode to detect agent of plague infield material. In laboratory conditions the system demonstrated good results and hence it was applied in conditions of field laboratory of epidemiologic team during planned epizootologic examination of Gorno-Altaisk hot spot of plague. The sampling consisted of more than 1400 objects. It was demonstrated that high sensitivity and specificity is immanent to proposed system. The adaptation of the system to the real time amplifier "Smart Cycler" (Cephid, USA) having some specific technical characteristics makes it possible to consider the proposed test-system as an effective sensitive and precise instrument for screening studies in the process of regular epizootologic examinations of hot spots of plague.

Coccidioidomycosis as a Common Cause of Community-acquired Pneumonia

PubMed Central

Valdivia, Lisa; Nix, David; Wright, Mark; Lindberg, Elizabeth; Fagan, Timothy; Lieberman, Donald; Stoffer, T'Prien; Ampel, Neil M.

2006-01-01

The early manifestations of coccidioidomycosis (valley fever) are similar to those of other causes of community-acquired pneumonia (CAP). Without specific etiologic testing, the true frequency of valley fever may be underestimated by public health statistics. Therefore, we conducted a prospective observational study of adults with recent onset of a lower respiratory tract syndrome. Valley fever was serologically confirmed in 16 (29%) of 55 persons (95% confidence interval 16%–44%). Antimicrobial medications were used in 81% of persons with valley fever. Symptomatic differences at the time of enrollment had insufficient predictive value for valley fever to guide clinicians without specific laboratory tests. Thus, valley fever is a common cause of CAP after exposure in a disease-endemic region. If CAP develops in persons who travel or reside in Coccidioides-endemic regions, diagnostic evaluation should routinely include laboratory evaluation for this organism. PMID:16707052

Blood glucose measurement by glucometer in comparison with standard method in diagnosis of neonatal hypoglycemia.

PubMed

Nayeri, Fatemeh; Shariat, Mamak; Mousavi Behbahani, Hamid Modarres; Dehghan, Padideh; Ebrahim, Bita

2014-01-01

Hypoglycemia is considered as a serious risk factor in neonates. In the majority of cases, it occurs with no clinical symptoms. Accordingly, early diagnosis is extremely imperative, which can also lead to less morbidity and mortality. The aim of this study was to assess the importance of screening blood glucose using glucometer (known as a quick and cost-effective diagnostic test) in comparison with laboratory method. A total of 219 neonates at risk of hypoglycemia were included in this study. Blood glucose was measured by glucometer and laboratory. In addition glucose level of capillary blood was measured by glucometer at the same time. Sensitivity and specificity of capillary blood glucose measurement by glucometer were 83.5%, 97.5% respectively (ppv=80%), (npv=98%). Capillary blood glucose measured by glucometer has an acceptable sensitivity and specificity in measurement of neonatal blood glucose. Therefore measurement by glucometer is recommended as a proper diagnostic test.

7 CFR 160.202 - Fees generally for laboratory analysis and testing.

Code of Federal Regulations, 2012 CFR

2012-01-01

... turpentine. (See Note 3). (1) Comprehensive analysis to determine purity, specification compliance, or other... related to quality of utility. (i) Single Sample: (A) Rosin—$14.00. (B) Turpentine—$10.00. (ii) Two or more samples tested at same time: (A) Rosin—per sample—$10.00. (B) Turpentine—per sample—$8.00. Note 3...

7 CFR 160.202 - Fees generally for laboratory analysis and testing.

Code of Federal Regulations, 2011 CFR

2011-01-01

... turpentine. (See Note 3). (1) Comprehensive analysis to determine purity, specification compliance, or other... related to quality of utility. (i) Single Sample: (A) Rosin—$14.00. (B) Turpentine—$10.00. (ii) Two or more samples tested at same time: (A) Rosin—per sample—$10.00. (B) Turpentine—per sample—$8.00. Note 3...

7 CFR 160.202 - Fees generally for laboratory analysis and testing.

Code of Federal Regulations, 2013 CFR

2013-01-01

... turpentine. (See Note 3). (1) Comprehensive analysis to determine purity, specification compliance, or other... related to quality of utility. (i) Single Sample: (A) Rosin—$14.00. (B) Turpentine—$10.00. (ii) Two or more samples tested at same time: (A) Rosin—per sample—$10.00. (B) Turpentine—per sample—$8.00. Note 3...

7 CFR 160.202 - Fees generally for laboratory analysis and testing.

Code of Federal Regulations, 2010 CFR

2010-01-01

... turpentine. (See Note 3). (1) Comprehensive analysis to determine purity, specification compliance, or other... related to quality of utility. (i) Single Sample: (A) Rosin—$14.00. (B) Turpentine—$10.00. (ii) Two or more samples tested at same time: (A) Rosin—per sample—$10.00. (B) Turpentine—per sample—$8.00. Note 3...

7 CFR 160.202 - Fees generally for laboratory analysis and testing.

Code of Federal Regulations, 2014 CFR

2014-01-01

... turpentine. (See Note 3). (1) Comprehensive analysis to determine purity, specification compliance, or other... related to quality of utility. (i) Single Sample: (A) Rosin—$14.00. (B) Turpentine—$10.00. (ii) Two or more samples tested at same time: (A) Rosin—per sample—$10.00. (B) Turpentine—per sample—$8.00. Note 3...

Development of a powered outdoor sealant fatigue test apparatus

Treesearch

Steven Lacher; R. Sam Williams; Corey Halpin; Christopher White

2005-01-01

This chapter describes a new cyclic fatigue test apparatus (CFTA) developed at the USDA Forest Service, Forest Products Laboratory. The new CFTA is computer controlled and powered by electric linear actuators. Computer control allows the CFTA to subject specimens to specific strain/time profiles or replicate input strain data in real time from thermal and/or moisture...

Clinical routine utility of basophil activation testing for diagnosis of hymenoptera-allergic patients with emphasis on individuals with negative venom-specific IgE antibodies.

PubMed

Korošec, Peter; Šilar, Mira; Eržen, Renato; Čelesnik, Nina; Bajrović, Nissera; Zidarn, Mihaela; Košnik, Mitja

2013-01-01

Previous reports suggest the usefulness of basophil activation testing (BAT) in Hymenoptera-allergic patients with negative venom-specific IgE antibodies. We sought to evaluate the diagnostic utility of this testing in a routine clinical laboratory setting. Twenty-one patients with anaphylactic reactions to Hymenoptera sting (median grade III) and negative venom-specific IgE were routinely and prospectively tested with BAT. We were able to diagnose 81% (17 of 21) of patients with BAT and 57% (12 of 21) with intradermal skin testing. Three wasp venom-allergic patients showed IgE positivity to rVes v 5. Four patients (19%) were negative for all tests. In the case of double-positive BAT, the culprit insect correlated with the venom that induced a significantly higher basophil response. BAT allows the identification of severe Hymenoptera-allergic patients with negative specific IgE and skin tests. The routine use of this cellular test should facilitate prescription of venom immunotherapy in complex cases with inconclusive diagnostic results. Copyright © 2013 S. Karger AG, Basel.

Specific Yield--Column drainage and centrifuge moisture content

USGS Publications Warehouse

Johnson, A.I.; Prill, R.C.; Morris, D.A.

1963-01-01

The specific yield of a rock or soil, with respect to water, is the ratio of (1) the volume of water which, after being saturated, it will yield by gravity to (2) its own volume. Specific retention represents the water retained against gravity drainage. The specific yield and retention when added together are equal to the total interconnected porosity of the rock or soil. Because specific retention is more easily determined than specific yield, most methods for obtaining yield first require the determination of specific retention. Recognizing the great need for developing improved methods of determining the specific yield of water-bearing materials, the U.S. Geological Survey and the California Department of Water Resources initiated a cooperative investigation of this subject. The major objectives of this research are (1) to review pertinent literature on specific yield and related subjects, (2) to increase basic knowledge of specific yield and rate of drainage and to determine the most practical methods of obtaining them, (3) to compare and to attempt to correlate the principal laboratory and field methods now commonly used to obtain specific yield, and (4) to obtain improved estimates of specific yield of water-bearing deposits in California. An open-file report, 'Specific yield of porous media, an annotated bibliography,' by A. I. Johnson, D. A. Morris, and R. C. Prill, was released in 1960 in partial fulfillment of the first objective. This report describes the second phase of the specific-yield study by the U.S. Geological Survey Hydrologic Laboratory at Denver, Colo. Laboratory research on column drainage and centrifuge moisture equivalent, two methods for estimating specific retention of porous media, is summarized. In the column-drainage study, a wide variety of materials was packed into plastic columns of 1- to 8-inch diameter, wetted with Denver tap water, and drained under controlled conditions of temperature and humidity. The effects of cleaning the porous media; of different column diameters; of dye and time on drainage; and of different methods of drainage, wetting, and packing were all determined. To insure repeatability of porosity in duplicate columns, a mechanical technique of packing was developed. In the centrifuge moisture-content study, the centrifuge moisture-equivalent (the moisture content retained by a soil that has been first saturated and then subjected to a force equal to 1,000 times the force of gravity for 1 hour) test was first reviewed and evaluated. It was determined that for reproducible moisture-retention results the temperature and humidity should be controlled by use of a controlled-temperature centrifuge. In addition to refining this standard test, the study determined the effect of length of period of centrifuging and of applied tension on the drainage results. The plans for future work require the continuation of the laboratory standardization study qith emphasis on investigation of soil-moisture tension and unsaturated-permeability techniques. A detailed study in the field then will be followed by correlation and evaluation of laboratory and field methods.

A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China.

PubMed

Ou, Xichao; Xia, Hui; Li, Qiang; Pang, Yu; Wang, Shengfen; Zhao, Bing; Song, Yuanyuan; Zhou, Yang; Zheng, Yang; Zhang, Zhijian; Zhang, Zhiying; Li, Junchen; Dong, Haiyan; Chi, Junying; Zhang, Jack; Kam, Kai Man; Huan, Shitong; Jun, Yue; Chin, Daniel P; Zhao, Yanlin

2015-02-01

To evaluate the performance of Xpert MTB/RIF (MTB/RIF) in the county-level tuberculosis (TB) laboratory in China. From April 2011 to January 2012, patients with suspected multidrug-resistant tuberculosis (MDR-TB) and non-MDR-TB were enrolled consecutively from four county-level TB laboratories. The detection of Mycobacterium tuberculosis (MTB) by MTB/RIF was compared to detection by Löwenstein-Jensen culture. The detection of rifampin resistance was compared to detection by conventional drug-susceptibility testing. The impact of multiple specimens on the performance of MTB/RIF was also evaluated. A total of 2142 suspected non-MDR-TB cases and 312 suspected MDR-TB cases were enrolled. For MTB detection in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 94.4% and 90.2%, respectively. The sensitivity in smear-negative patients was 88.8%. For the detection of rifampin resistance in suspected non-MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 97.9%, respectively. For the detection of rifampin resistance in suspected MDR-TB cases, the sensitivity and specificity of MTB/RIF were 87.1% and 91.0%, respectively. Using multiple sputum specimens had no significant influence on the performance of MTB/RIF for MTB detection. The introduction of MTB/RIF could increase the accuracy of detection of MTB and rifampin resistance in peripheral-level TB laboratories in China. One single specimen is adequate for TB diagnosis by MTB/RIF. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Miniature infrared data acquisition and telemetry system

NASA Technical Reports Server (NTRS)

Stokes, J. H.; Ward, S. M.

1985-01-01

The Miniature Infrared Data Acquisition and Telemetry (MIRDAT) Phase 1 study was performed to determine the technical and commercial feasibility of producing a miniaturized electro-optical telemetry system. This system acquires and transmits experimental data from aircraft scale models for realtime monitoring in wind tunnels. During the Phase 1 study, miniature prototype MIRDAT telemetry devices were constructed, successfully tested in the laboratory and delivered to the user for wind tunnel testing. A search was conducted for commercially available components and advanced hybrid techniques to further miniaturize the system during Phase 2 development. A design specification was generated from laboratory testing, user requirements and discussions with component manufacturers. Finally, a preliminary design of the proposed MIRDAT system was documented for Phase 2 development.

Genomic tests for ovarian cancer detection and management.

PubMed

Myers, Evan R; Havrilesky, Laura J; Kulasingam, Shalini L; Sanders, Gillian D; Cline, Kathryn E; Gray, Rebecca N; Berchuck, Andrew; McCrory, Douglas C

2006-10-01

To assess the evidence that the use of genomic tests for ovarian cancer screening, diagnosis, and treatment leads to improved outcomes. PubMed and reference lists of recent reviews. We evaluated tests for: (a) single gene products; (b) genetic variations affecting risk of ovarian cancer; (c) gene expression; and (d) proteomics. For tests covered in recent evidence reports (cancer antigen 125 [CA-125] and breast cancer genes 1 and 2 [BRCA1/2]), we added studies published subsequent to the reports. We sought evidence on: (a) the analytic performance of tests in clinical laboratories; (b) the sensitivity and specificity of tests in different patient populations; (c) the clinical impact of testing in asymptomatic women, women with suspected ovarian cancer, and women with diagnosed ovarian cancer; (d) the harms of genomic testing; and (e) the impact of direct-to-consumer and direct-to-physician advertising on appropriate use of tests. We also constructed a computer simulation model to test the impact of different assumptions about ovarian cancer natural history on the relative effectiveness of different strategies. There are reasonable data on the clinical laboratory performance of most radioimmunoassays, but the majority of the data on other genomic tests comes from research laboratories. Genomic test sensitivity/specificity estimates are limited by small sample sizes, spectrum bias, and unrealistically large prevalences of ovarian cancer; in particular, estimates of positive predictive values derived from most of the studies are substantially higher than would be expected in most screening or diagnostic settings. We found no evidence relevant to the question of the impact of genomic tests on health outcomes in asymptomatic women. Although there is a relatively large literature on the association of test results and various clinical outcomes, the clinical utility of changing management based on these results has not been evaluated. We found no evidence that genomic tests for ovarian cancer have unique harms beyond those common to other tests for genetic susceptibility or other tests used in screening, diagnosis, and management of ovarian cancer. Studies of a direct-to-consumer campaign for BRCA1/2 testing suggest increased utilization, but the effect on "appropriateness" was unclear. Model simulations suggest that annual screening, even with a highly sensitive test, will not reduce ovarian cancer mortality by more than 50 percent; frequent screening has a very low positive predictive value, even with a highly specific test. Although research remains promising, adaptation of genomic tests into clinical practice must await appropriately designed and powered studies in relevant clinical settings.

Alpha-defensin and the Synovasure lateral flow device for the diagnosis of prosthetic joint infection.

PubMed

Marson, B A; Deshmukh, S R; Grindlay, D J C; Scammell, B E

2018-06-01

Aims The aim of this review was to evaluate the available literature and to calculate the pooled sensitivity and specificity for the different alpha-defensin test systems that may be used to diagnose prosthetic joint infection (PJI). Materials and Methods Studies using alpha-defensin or Synovasure (Zimmer Biomet, Warsaw, Indiana) to diagnose PJI were identified from systematic searches of electronic databases. The quality of the studies was evaluated using the Quality Assessment of Studies of Diagnostic Accuracy (QUADAS) tool. Meta-analysis was completed using a bivariate model. Results A total of 11 eligible studies were included. The median QUADAS score was 13 (interquartile range 13 to 13) out of 14. Significant conflicts of interest were identified in five studies. The pooled sensitivity for the laboratory alpha-defensin test was 0.95 (95% confidence interval (CI) 0.91 to 0.98) and the pooled specificity was 0.97 (95% CI 0.95 to 0.98) for four studies with a threshold level of 5.2 mgl -1 The pooled sensitivity for the lateral flow cassette test was 0.85 (95% CI 0.74 to 0.92) and the pooled specificity was 0.90 (95% CI 0.91 to 0.98). There was a statistically significant difference in sensitivity (p = 0.019), but not specificity (p = 0.47). Conclusion Laboratory-based alpha-defensin testing remains a promising tool for diagnosing PJI. The lateral flow cassette has a significantly lower performance and pooled results are comparable to the leucocyte esterase test. Further studies are required before the widespread adoption of the lateral flow cassette alpha-defensin test. Cite this article: Bone Joint J 2018;100-B:703-11.

Blinded Validation of Breath Biomarkers of Lung Cancer, a Potential Ancillary to Chest CT Screening

PubMed Central

Phillips, Michael; Bauer, Thomas L.; Cataneo, Renee N.; Lebauer, Cassie; Mundada, Mayur; Pass, Harvey I.; Ramakrishna, Naren; Rom, William N.; Vallières, Eric

2015-01-01

Background Breath volatile organic compounds (VOCs) have been reported as biomarkers of lung cancer, but it is not known if biomarkers identified in one group can identify disease in a separate independent cohort. Also, it is not known if combining breath biomarkers with chest CT has the potential to improve the sensitivity and specificity of lung cancer screening. Methods Model-building phase (unblinded): Breath VOCs were analyzed with gas chromatography mass spectrometry in 82 asymptomatic smokers having screening chest CT, 84 symptomatic high-risk subjects with a tissue diagnosis, 100 without a tissue diagnosis, and 35 healthy subjects. Multiple Monte Carlo simulations identified breath VOC mass ions with greater than random diagnostic accuracy for lung cancer, and these were combined in a multivariate predictive algorithm. Model-testing phase (blinded validation): We analyzed breath VOCs in an independent cohort of similar subjects (n = 70, 51, 75 and 19 respectively). The algorithm predicted discriminant function (DF) values in blinded replicate breath VOC samples analyzed independently at two laboratories (A and B). Outcome modeling: We modeled the expected effects of combining breath biomarkers with chest CT on the sensitivity and specificity of lung cancer screening. Results Unblinded model-building phase. The algorithm identified lung cancer with sensitivity 74.0%, specificity 70.7% and C-statistic 0.78. Blinded model-testing phase: The algorithm identified lung cancer at Laboratory A with sensitivity 68.0%, specificity 68.4%, C-statistic 0.71; and at Laboratory B with sensitivity 70.1%, specificity 68.0%, C-statistic 0.70, with linear correlation between replicates (r = 0.88). In a projected outcome model, breath biomarkers increased the sensitivity, specificity, and positive and negative predictive values of chest CT for lung cancer when the tests were combined in series or parallel. Conclusions Breath VOC mass ion biomarkers identified lung cancer in a separate independent cohort, in a blinded replicated study. Combining breath biomarkers with chest CT could potentially improve the sensitivity and specificity of lung cancer screening. Trial Registration ClinicalTrials.gov NCT00639067 PMID:26698306

Extracting laboratory test information from biomedical text

PubMed Central

Kang, Yanna Shen; Kayaalp, Mehmet

2013-01-01

Background: No previous study reported the efficacy of current natural language processing (NLP) methods for extracting laboratory test information from narrative documents. This study investigates the pathology informatics question of how accurately such information can be extracted from text with the current tools and techniques, especially machine learning and symbolic NLP methods. The study data came from a text corpus maintained by the U.S. Food and Drug Administration, containing a rich set of information on laboratory tests and test devices. Methods: The authors developed a symbolic information extraction (SIE) system to extract device and test specific information about four types of laboratory test entities: Specimens, analytes, units of measures and detection limits. They compared the performance of SIE and three prominent machine learning based NLP systems, LingPipe, GATE and BANNER, each implementing a distinct supervised machine learning method, hidden Markov models, support vector machines and conditional random fields, respectively. Results: Machine learning systems recognized laboratory test entities with moderately high recall, but low precision rates. Their recall rates were relatively higher when the number of distinct entity values (e.g., the spectrum of specimens) was very limited or when lexical morphology of the entity was distinctive (as in units of measures), yet SIE outperformed them with statistically significant margins on extracting specimen, analyte and detection limit information in both precision and F-measure. Its high recall performance was statistically significant on analyte information extraction. Conclusions: Despite its shortcomings against machine learning methods, a well-tailored symbolic system may better discern relevancy among a pile of information of the same type and may outperform a machine learning system by tapping into lexically non-local contextual information such as the document structure. PMID:24083058

Effects of Two Physical Training Paradigms on Biological and Cognitive Characteristics of Airmen: Lessons Learned

DTIC Science & Technology

2017-06-07

a 9- week physical training program, tests of physical endurance and strength , body composition analyses, biomarker collections, and cognitive tests...BDNF results to improving training , a new laboratory capability within RHCP was needed, coupled with an initial operational pilot test of that...traditional AF fitness training and that the improvements in cognitive performance would be correlated with changes in BDNF levels. Specifically, the

Evaluation of a Commercial Multiplex PCR for Rapid Detection of Multi Drug Resistant Gram Negative Infections

PubMed Central

Chavada, Ruchir; Maley, Michael

2015-01-01

Introduction: Community and healthcare associated infections caused by multi-drug resistant gram negative organisms (MDR GN) represent a worldwide threat. Nucleic Acid Detection tests are becoming more common for their detection; however they can be expensive requiring specialised equipment and local expertise. This study was done to evaluate the utility of a commercial multiplex tandem (MT) PCR for detection of MDR GN. Methods: The study was done on stored laboratory MDR GN isolates from sterile and non-sterile specimens (n=126, out of stored 567 organisms). Laboratory validation of the MT PCR was done to evaluate sensitivity, specificity and agreement with the current phenotypic methods used in the laboratory. Amplicon sequencing was also done on selected isolates for assessing performance characteristics. Workflow and cost implications of the MT PCR were evaluated. Results: The sensitivity and specificity of the MT PCR were calculated to be 95% and 96.7% respectively. Agreement with the phenotypic methods was 80%. Major lack of agreement was seen in detection of AmpC beta lactamase in enterobacteriaceae and carbapenemase in non-fermenters. Agreement of the MT PCR with another multiplex PCR was found to be 87%. Amplicon sequencing confirmed the genotype detected by MT PCR in 94.2 % of cases tested. Time to result was faster for the MT PCR but cost per test was higher. Conclusion: This study shows that with carefully chosen targets for detection of resistance genes in MDR GN, rapid and efficient identification is possible. MT PCR was sensitive and specific and likely more accurate than phenotypic methods. PMID:26464612

Artificial Neural Network Approach in Laboratory Test Reporting:  Learning Algorithms.

PubMed

Demirci, Ferhat; Akan, Pinar; Kume, Tuncay; Sisman, Ali Riza; Erbayraktar, Zubeyde; Sevinc, Suleyman

2016-08-01

In the field of laboratory medicine, minimizing errors and establishing standardization is only possible by predefined processes. The aim of this study was to build an experimental decision algorithm model open to improvement that would efficiently and rapidly evaluate the results of biochemical tests with critical values by evaluating multiple factors concurrently. The experimental model was built by Weka software (Weka, Waikato, New Zealand) based on the artificial neural network method. Data were received from Dokuz Eylül University Central Laboratory. "Training sets" were developed for our experimental model to teach the evaluation criteria. After training the system, "test sets" developed for different conditions were used to statistically assess the validity of the model. After developing the decision algorithm with three iterations of training, no result was verified that was refused by the laboratory specialist. The sensitivity of the model was 91% and specificity was 100%. The estimated κ score was 0.950. This is the first study based on an artificial neural network to build an experimental assessment and decision algorithm model. By integrating our trained algorithm model into a laboratory information system, it may be possible to reduce employees' workload without compromising patient safety. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

4. "ARCHITECTURAL, FLOOR PLANELEVATIONSSECTIONS, OBSERVATION BUNKERS." Specifications No. ENG (NASA)04353631; ...

Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

4. "ARCHITECTURAL, FLOOR PLAN-ELEVATIONS-SECTIONS, OBSERVATION BUNKERS." Specifications No. ENG (NASA)04-353-63-1; Drawing No. 60-09-34; sheet 325. Ref. No. A-13. D.O. SERIES 1597/87. - Edwards Air Force Base, Air Force Rocket Propulsion Laboratory, Observation Bunker 1-D-3, Test Area 1-125, northwest end of Altair Boulevard, Boron, Kern County, CA

A comparison of traditional physical laboratory and computer-simulated laboratory experiences in relation to engineering undergraduate students' conceptual understandings of a communication systems topic

NASA Astrophysics Data System (ADS)

Javidi, Giti

2005-07-01

This study was designed to investigate an alternative to the use of traditional physical laboratory activities in a communication systems course. Specifically, this study examined whether as an alternative, computer simulation is as effective as physical laboratory activities in teaching college-level electronics engineering education students about the concepts of signal transmission, modulation and demodulation. Eighty undergraduate engineering students participated in the study, which was conducted at a southeastern four-year university. The students were randomly assigned to two groups. The groups were compared on understanding the concepts, remembering the concepts, completion time of the lab experiments and perception toward the laboratory experiments. The physical group's (n = 40) treatment was to conduct laboratory experiments in a physical laboratory. The students in this group used equipment in a controlled electronics laboratory. The Simulation group's (n = 40) treatment was to conduct similar experiments in a PC laboratory. The students in this group used a simulation program in a controlled PC lab. At the completion of the treatment, scores on a validated conceptual test were collected once after the treatment and again three weeks after the treatment. Attitude surveys and qualitative study were administered at the completion of the treatment. The findings revealed significant differences, in favor of the simulation group, between the two groups on both the conceptual post-test and the follow-up test. The findings also revealed significant correlation between simulation groups' attitude toward the simulation program and their post-test scores. Moreover, there was a significant difference between the two groups on their attitude toward their laboratory experience in favor of the simulation group. In addition, there was significant difference between the two groups on their lab completion time in favor of the simulation group. At the same time, the qualitative research has uncovered several issues not explored by the quantitative research. It was concluded that incorporating the recommendations acquired from the qualitative research, especially elements of incorporating hardware experience to avoid lack of hands-on skills, into the laboratory pedagogy should help improve students' experience regardless of the environment in which the laboratory is conducted.

The small-scale treatability study sample exemption

DOE Office of Scientific and Technical Information (OSTI.GOV)

Coalgate, J.

1991-01-01

In 1981, the Environmental Protection Agency (EPA) issued an interim final rule that conditionally exempted waste samples collected solely for the purpose of monitoring or testing to determine their characteristics or composition'' from RCRA Subtitle C hazardous waste regulations. This exemption (40 CFR 261.4(d)) apples to the transportation of samples between the generator and testing laboratory, temporary storage of samples at the laboratory prior to and following testing, and storage at a laboratory for specific purposes such as an enforcement action. However, the exclusion did not include large-scale samples used in treatability studies or other testing at pilot plants ormore » other experimental facilities. As a result of comments received by the EPA subsequent to the issuance of the interim final rule, the EPA reopened the comment period on the interim final rule on September 18, 1987, and specifically requested comments on whether or not the sample exclusion should be expanded to include waste samples used in small-scale treatability studies. Almost all responders commented favorably on such a proposal. As a result, the EPA issued a final rule (53 FR 27290, July 19, 1988) conditionally exempting waste samples used in small-scale treatability studies from full regulation under Subtitle C of RCRA. The question of whether or not to extend the exclusion to larger scale as proposed by the Hazardous Waste Treatment Council was deferred until a later date. This information Brief summarizes the requirements of the small-scale treatability exemption.« less

Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study.

PubMed

Pham, Thu Hang; Peter, Jonathan; Mello, Fernanda C Q; Parraga, Tommy; Lan, Nguyen Thi Ngoc; Nabeta, Pamela; Valli, Eloise; Caceres, Tatiana; Dheda, Keertan; Dorman, Susan E; Hillemann, Doris; Gray, Christen M; Perkins, Mark D

2018-03-01

To evaluate the diagnostic performance of TB-LAMP, a manual molecular tuberculosis (TB) detection method, and provide comparison to the Xpert MTB/RIF assay. In a large multicentre study, two sputum samples were collected from participants with TB symptoms in reference laboratories in Peru, South Africa, Brazil, and Vietnam. Each sample was tested with TB-LAMP. The reference standard consisted of four direct smears, four cultures, and clinical and radiological findings. Individuals negative on conventional tests were followed up after 8 weeks. The Xpert MTB/RIF assay was performed on fresh or frozen samples as a molecular test comparison. A total of 1036 adults with suspected TB were enrolled. Among 375 culture-confirmed TB cases with 750 sputum samples, TB-LAMP detected 75.6% (95% confidence interval (CI) 71.8-79.4%), including 97.9% (95% CI 96.4-99.4%) of smear-positive TB samples and 46.6% (95% CI 40.6-52.7%) of smear-negative TB samples. Specificity in 477 culture-negative participants not treated for TB (954 sputum samples) was 98.7% (95% CI 97.9-99.6%). TB-LAMP test results were indeterminate in 0.3% of cases. TB-LAMP detects nearly all smear-positive and half of smear-negative TB cases and has a high specificity when performed in reference laboratories. Performance was similar to the Xpert MTB/RIF assay. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Clinical Pharmacology Quality Assurance (CPQA) Program: Models for Longitudinal Analysis of Antiretroviral (ARV) Proficiency Testing for International Laboratories

PubMed Central

DiFrancesco, Robin; Rosenkranz, Susan L.; Taylor, Charlene R.; Pande, Poonam G.; Siminski, Suzanne M.; Jenny, Richard W.; Morse, Gene D.

2013-01-01

Among National Institutes of Health (NIH) HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals (ARV). Drug assay data are, in turn, entered into study-specific datasets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semi-annual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance (CPQA) program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1)assess the precision and accuracy of concentrations reported by individual CPLs; (2)determine factors associated with round-specific and long-term assay accuracy, precision and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21)drug concentration results reported for clinical trial samples by multiple CPLs).Using the CLIA acceptance of meeting criteria for ≥2/3 consecutive rounds, all ten laboratories that participated in three or more rounds per analyte maintained CLIA proficiency. Significant associations were present between magnitude of error and CPL (Kruskal Wallis [KW]p<0.001), and ARV (KW p<0.001). PMID:24052065

Serum neuron-specific enolase levels from the same patients differ between laboratories: assessment of a prospective post-cardiac arrest cohort.

PubMed

Mlynash, Michael; Buckwalter, Marion S; Okada, Ami; Caulfield, Anna Finley; Venkatasubramanian, Chitra; Eyngorn, Irina; Verbeek, Marcel M; Wijman, Christine A C

2013-10-01

In comatose post-cardiac arrest patients, a serum neuron-specific enolase (NSE) level of >33 μg/L within 72 h was identified as a reliable marker for poor outcome in a large Dutch study (PROPAC), and this level was subsequently adopted in an American Academy of Neurology practice parameter. Later studies reported that NSE >33 μg/L is not a reliable predictor of poor prognosis. To test whether different clinical laboratories contribute to this variability, we compared NSE levels from the laboratory used in the PROPAC study (DLM-Nijmegen) with those of our hospital's laboratory (ARUP) using paired blood samples. We prospectively enrolled cardiac arrest patients who remained comatose after resuscitation. During the first 3 days, paired blood samples for serum NSE were drawn at a median of 10 min apart. After standard preparation for each lab, one sample was sent to ARUP laboratories and the other to DLM-Nijmegen. Fifty-four paired serum samples from 33 patients were included. Although the serum NSE measurements correlated well between laboratories (R = 0.91), the results from ARUP were approximately 30% lower than those from DLM-Nijmegen. Therapeutic hypothermia did not affect this relationship. Two patients had favorable outcomes after hypothermia despite NSE levels measured by DLM-Nijmegen as >33 μg/L. Absolute serum NSE levels of comatose cardiac arrest patients differ between laboratories. Any specific absolute cut-off levels proposed to prognosticate poor outcome should not be used without detailed data on how neurologic outcomes correspond to a particular laboratory's method, and even then only in conjunction with other prognostic variables.

Development and testing of a rapid diagnostic test for bubonic and pneumonic plague.

PubMed

Chanteau, Suzanne; Rahalison, Lila; Ralafiarisoa, Lalao; Foulon, Jeanine; Ratsitorahina, Mahery; Ratsifasoamanana, Lala; Carniel, Elisabeth; Nato, Farida

2003-01-18

Plague is often fatal without prompt and appropriate treatment. It affects mainly poor and remote populations. Late diagnosis is one of the major causes of human death and spread of the disease, since it limits the effectiveness of control measures. We aimed to develop and assess a rapid diagnostic test (RDT) for plague. We developed a test that used monoclonal antibodies to the F1 antigen of Yersinia pestis. Sensitivity and specificity were assessed with a range of bacterial cultures and clinical samples, and compared with findings from available ELISA and bacteriological tests for plague. Samples from patients thought to have plague were tested with the RDT in the laboratory and by health workers in 26 pilot sites in Madagascar. The RDT detected concentrations of F1 antigen as low as 0.5 ng/mL in up to 15 min, and had a shelf life of 21 days at 60 degrees C. Its sensitivity and specificity were both 100%. RDT detected 41.6% and 31% more positive clinical specimens than did bacteriological methods and ELISA, respectively. The agreement rate between tests done at remote centres and in the laboratory was 89.8%. With the combination of bacteriological methods and F1 ELISA as reference standard, the positive and negative predictive values of the RDT were 90.6% and 86.7%, respectively. Our RDT is a specific, sensitive, and reliable test that can easily be done by health workers at the patient's bedside, for the rapid diagnosis of pneumonic and bubonic plague. This test will be of key importance for the control of plague in endemic countries.

Construction loads experienced by plastic composite ties.

DOT National Transportation Integrated Search

2014-07-01

Damage to plastic composite ties during handling and track installation has been reported by a number of railroads. Results from : a survey conducted to identify specific handling issues were used to develop field and laboratory tests to measure the ...

TROPHIC EFFECT OF LUTEINIZING HORMONE ON THE RAT LEYDIG CELL

EPA Science Inventory

Little is known about the factors controlling Leydig cell growth and differentiation. owever, unique correlations exist between specific testicular compartments and the testosterone-secreting capacity of the testes. elected experimental findings from three common laboratory anima...

Laboratory evaluation of asphalt binder rutting, fracture, and adhesion tests.

DOT National Transportation Integrated Search

2014-04-01

The current performance grading (PG) specification for asphalt binders was developed based on the Strategic Highway : Research Program (SHRP) and is based primarily on the study of unmodified asphalt binders. Over the years, experience has : proven t...

Use of dipstick tests for the rapid diagnosis of malaria in nonimmune travelers.

PubMed

Jelinek, T; Grobusch, M P; Nothdurft, H D

2000-01-01

Swift diagnosis of falciparum malaria in nonendemic areas is frequently complicated by lack of experience on the side of involved laboratory personnel. Diagnostic tools based on the dipstick principle for the detection of plasmodial histidine-rich protein 2 (HRP-2) (ICT Malaria P.f. (R)) and parasite-specific lactate-dehydrogenase (pLDH) (OptiMal(R)), respectively, have become available for the qualitative detection of falciparum malaria. In order to evaluate currently available assays, a series of studies was conducted: sensitivity and specificity were evaluated by investigation of specimens from 231 febrile returnees from endemic areas, cross reactivity in patients with rheumatoid factor (RF) was assessed among 92 patients from a rheumatology unit, and the quality of dipstick self-use by febrile travelers was tested in Kenya. Whereas the test kit based on the detection of HRP-2 performed with a sensitivity of 92.5% and a specificity of 98.3%, the kit for the detection of pLDH showed a sensitivity of 88.5% and a specificity of 99.4%. Cross-reactions with sera positive for rheumatoid factor occurred in 6.6% with the ICT Malaria P.f.(R), and in 3.3% with the OptiMal(R) test. Only ICT Malaria P.f.(R) was tested for quality of self-use among travelers. This dipstick assay was performed successfully by 67 patients (68.4%), but 31 (31.6%) were unable to obtain a result. Dipstick tests have the potential of enhancing speed and accuracy of the diagnosis of falciparum malaria, especially if nonspecialized laboratories are involved. However, microscopical testing remains mandatory in every single patient with the possible diagnosis of malaria. Self-use of dipstick tests for malaria diagnosis by travelers should only be recommended after appropriate instruction and training, including a successful performance of the test procedure.

Customized laboratory information management system for a clinical and research leukemia cytogenetics laboratory.

PubMed

Bakshi, Sonal R; Shukla, Shilin N; Shah, Pankaj M

2009-01-01

We developed a Microsoft Access-based laboratory management system to facilitate database management of leukemia patients referred for cytogenetic tests in regards to karyotyping and fluorescence in situ hybridization (FISH). The database is custom-made for entry of patient data, clinical details, sample details, cytogenetics test results, and data mining for various ongoing research areas. A number of clinical research laboratoryrelated tasks are carried out faster using specific "queries." The tasks include tracking clinical progression of a particular patient for multiple visits, treatment response, morphological and cytogenetics response, survival time, automatic grouping of patient inclusion criteria in a research project, tracking various processing steps of samples, turn-around time, and revenue generated. Since 2005 we have collected of over 5,000 samples. The database is easily updated and is being adapted for various data maintenance and mining needs.

2015 Stewardship Science Academic Programs Annual

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stone, Terri; Mischo, Millicent

The Stockpile Stewardship Academic Programs (SSAP) are essential to maintaining a pipeline of professionals to support the technical capabilities that reside at the National Nuclear Security Administration (NNSA) national laboratories, sites, and plants. Since 1992, the United States has observed the moratorium on nuclear testing while significantly decreasing the nuclear arsenal. To accomplish this without nuclear testing, NNSA and its laboratories developed a science-based Stockpile Stewardship Program to maintain and enhance the experimental and computational tools required to ensure the continued safety, security, and reliability of the stockpile. NNSA launched its academic program portfolio more than a decade ago tomore » engage students skilled in specific technical areas of relevance to stockpile stewardship. The success of this program is reflected by the large number of SSAP students choosing to begin their careers at NNSA national laboratories.« less

Laboratory diagnosis of Chlamydia pneumoniae infections

PubMed Central

Peeling, Rosanna W

1995-01-01

Chlamydia pneumoniae is an important cause of respiratory illness. There is a need for accurate and rapid laboratory diagnostic methods that will lead to improved patient care, appropriate use of antimicrobial therapy and a better understanding of the epidemiology of this emerging pathogen. Culture is highly specific but is technically demanding, expensive, has a long turnaround time and its sensitivity is highly dependent on transport conditions. Antigen detection tests such as enzyme immunoassay and direct fluorescent antibody assay, and molecular detection methods such as the polymerase chain reaction assay, may provide a rapid diagnosis without the requirement for stringent transport conditions. The results of these tests should be interpreted with caution until more thorough evaluation is available. Serology remains the method of choice. The limitations of different serological methods for the laboratory diagnosis of C pneumoniae are discussed. PMID:22514397

State-wide hospital clinical laboratory plan for measuring cholinesterase activity for individuals suspected of exposure to nerve agent chemical weapons.

PubMed

Wu, Alan H B; Smith, Andrew; McComb, Robert; Bowers, George N; Makowski, Gregory S; McKay, Charles A; Vena, Jason; McDonagh, John; Hopfer, Sidney; Sena, Salvatore F; Malkus, Herbert; Forte, Elaine; Kelly, Katherine

2008-02-01

Hospital laboratories currently lack the capacity to provide emergency determination of cholinesterase activity. We have developed a hospital-based 3-tiered system to test plasma for butyrylcholinesterase (BChE) activity and whole blood for red cell acetylcholinesterase (AChE) activity using available technology and personnel. Interagency communications, toxidrome definition, and patient triage will be coordinated by the Connecticut Department of Public Health and the Poison Control Center. Initial BChE data documents good precision between institutions (coefficient of variation < 8%). Laboratory testing of plasma or blood for cholinesterase activity is important in the management of nerve agent exposure and in ruling out disease in those with non-specific symptoms in the setting of a terrorist attack or accidental exposure. Rapid availability of strong hospital-based analytic support in a smoothly functioning network of clinical, public health, and laboratory services will facilitate overall regional response to chemical terrorism or large scale HazMat events.

USAF Development Of Optical Correlation Missile Guidance

NASA Astrophysics Data System (ADS)

Kaehr, Ronald; Spector, Marvin

1980-12-01

In 1965, the Advanced Development Program (ADP)-679A of the Avionics Laboratory initiated development of guidance systems for stand-off tactical missiles. Employing project engineering support from the Aeronautical Systems Division, WPAFB, the Avionics Laboratory funded multiple terminal guidance concepts and related midcourse navigation technology. Optical correlation techniques which utilize prestored reference information for autonomous target acquisition offered the best near-term opportunity for meeting mission goals. From among the systems studied and flight tested, Aimpoint* optical area guidance provided the best and most consistent performance. Funded development by the Air Force ended in 1974 with a MK-84 guided bomb drop test demonstration at White Sands Missile Range and the subsequent transfer of the tactical missile guidance development charter to the Air Force Armament Laboratory, Eglin AFB. A historical review of optical correlation development within the Avionics Laboratory is presented. Evolution of the Aimpoint system is specifically addressed. Finally, a brief discussion of trends in scene matching technology is presented.

Preliminary Report on Oak Ridge National Laboratory Testing of Drake/ACSS/MA2/E3X

DOE Office of Scientific and Technical Information (OSTI.GOV)

Irminger, Philip; King, Daniel J.; Herron, Andrew N.

2016-01-01

A key to industry acceptance of a new technology is extensive validation in field trials. The Powerline Conductor Accelerated Test facility (PCAT) at Oak Ridge National Laboratory (ORNL) is specifically designed to evaluate the performance and reliability of a new conductor technology under real world conditions. The facility is set up to capture large amounts of data during testing. General Cable used the ORNL PCAT facility to validate the performance of TransPowr with E3X Technology a standard overhead conductor with an inorganic high emissivity, low absorptivity surface coating. Extensive testing has demonstrated a significant improvement in conductor performance across amore » wide range of operating temperatures, indicating that E3X Technology can provide a reduction in temperature, a reduction in sag, and an increase in ampacity when applied to the surface of any overhead conductor. This report provides initial results of that testing.« less

Evaluation of Five Antibody Detection Tests for Diagnosis of Bovine Paratuberculosis

PubMed Central

Collins, Michael T.; Wells, Scott J.; Petrini, Kristine R.; Collins, James E.; Schultz, Ronald D.; Whitlock, Robert H.

2005-01-01

Five diagnostic tests based on enzyme-linked immunosorbent assay (ELISA) technology for bovine paratuberculosis were evaluated by using individual serum or milk samples from 359 dairy cattle in seven paratuberculosis-free herds and 2,094 dairy cattle in seven Mycobacterium paratuberculosis-infected dairy herds. Three independent laboratories using three different culture procedures completed fecal cultures for M. paratuberculosis on these cattle and found 417 cows to be shedding M. paratuberculosis in their feces. An animal that was fecal culture positive for M. paratuberculosis by any of the three laboratories was considered a confirmed case of infection. The specificity of three ELISAs (two on serum and one on milk) was ≥99.8%. The specificity of the remaining two ELISAs, both done on serum, was 94.9 and 84.7%. Four of the five ELISAs evaluated produced similar sensitivity in detecting fecal culture-positive cattle (27.8 to 28.9%). Serum ELISA “D” had the lowest specificity (84.7%) and the highest sensitivity (44.5%), but if the cutoff value defining a positive test was changed from 125 to 250% (of the positive control) the sensitivity and specificity, 31.8 and 97.5%, respectively, were comparable to those of the other four assays. If the case definition for M. paratuberculosis infection was based on the culture results of a single laboratory instead of the combined results of three laboratories, ELISA sensitivity estimates were 45.7 to 50.0%. With the exception of ELISA D, assay agreement was high (kappa 0.66 to 0.85) for categorical assay interpretations (positive or negative), but linear regression of quantitative results showed low correlation coefficients (r2 = 0.40 to 0.68) due to the fact that ELISA results for some cows were high in one assay but low in another assay. Likelihood ratio analysis showed a direct relationship between the magnitude of ELISA result and the odds of a cow shedding M. paratuberculosis in its feces. If used judiciously and interpreted quantitatively, these ELISAs are useful tools in support of paratuberculosis control programs in dairy herds. PMID:15939741

Facilities to Support Beamed Energy Launch Testing at the Laser Hardened Materials Evaluation Laboratory (LHMEL)

NASA Astrophysics Data System (ADS)

Lander, Michael L.

2003-05-01

The Laser Hardened Materials Evaluation Laboratory (LHMEL) has been characterizing material responses to laser energy in support of national defense programs and the aerospace industry for the past 26 years. This paper reviews the overall resources available at LHMEL to support fundamental materials testing relating to impulse coupling measurement and to explore beamed energy launch concepts. Located at Wright-Patterson Air Force Base, Ohio, LHMEL is managed by the Air Force Research Laboratory Materials Directorate AFRL/MLPJ and operated by Anteon Corporation. The facility's advanced hardware is centered around carbon dioxide lasers producing output power up to 135kW and neodymium glass lasers producing up to 10 kilojoules of repetitively pulsed output. The specific capabilities of each laser device and related optical systems are discussed. Materials testing capabilities coupled with the laser systems are also described including laser output and test specimen response diagnostics. Environmental simulation capabilities including wind tunnels and large-volume vacuum chambers relevant to beamed energy propulsion are also discussed. This paper concludes with a summary of the procedures and methods by which the facility can be accessed.

Validation of two commercial real-time RT-PCR kits for rapid and specific diagnosis of classical swine fever virus.

PubMed

Le Dimna, M; Vrancken, R; Koenen, F; Bougeard, S; Mesplède, A; Hutet, E; Kuntz-Simon, G; Le Potier, M F

2008-01-01

Two real-time RT-PCR kits, developed by LSI (TaqVet CSF) and ADIAGENE (Adiavet CSF), obtained an agreement to be commercialised in France, subject to conditions, defined by the French Classical Swine Fever (CSF) National Reference Laboratory. The producers were asked to introduce an internal control to check the RNA extraction efficacy. The different criteria assessed were sensitivity, "pestivirus specificity", reproducibility and ease of handling, using 189 different samples. These samples were either CSFV inactivated strains or blood/serum/organs collected from CSFV experimentally infected pigs or naturally infected wild boars. The reproducibility of the assays was confirmed by the analysis of a batch-to-batch panel control that was used for inter-laboratory tests involving nine laboratories. The two kits were also tested for the use in mass diagnostics and the results proved the kits to be suited using pools of blood, serum and tonsils. Moreover, a field evaluation, carried out on spleen samples collected from the CSF surveillance of wild boars in an area known to be infected and from domestic pigs at a slaughterhouse, confirmed the high sensitivity and specificity of the two kits. This step-by-step evaluation procedure confirmed that the two commercial CSF real-time RT-PCR kits have a higher predictive value than the current diagnostic standard, Virus Isolation.

Laboratory-based performance evaluation of PIMA CD4+ T-lymphocyte count point-of-care by lay-counselors in Kenya.

PubMed

Zeh, Clement; Rose, Charles E; Inzaule, Seth; Desai, Mitesh A; Otieno, Fredrick; Humwa, Felix; Akoth, Benta; Omolo, Paul; Chen, Robert T; Kebede, Yenew; Samandari, Taraz

2017-09-01

CD4+ T-lymphocyte count testing at the point-of-care (POC) may improve linkage to care of persons diagnosed with HIV-1 infection, but the accuracy of POC devices when operated by lay-counselors in the era of task-shifting is unknown. We examined the accuracy of Alere's Pima™ POC device on both capillary and venous blood when performed by lay-counselors and laboratory technicians. In Phase I, we compared the perfomance of POC against FACSCalibur™ for 280 venous specimens by laboratory technicians. In Phase II we compared POC performance by lay-counselors versus laboratory technicians using 147 paired capillary and venous specimens, and compared these to FACSCalibur™. Statistical analyses included Bland-Altman analyses, concordance correlation coefficient, sensitivity, and specificity at treatment eligibility thresholds of 200, 350, and 500cells/μl. Phase I: POC sensitivity and specificity were 93.0% and 84.1% at 500cells/μl, respectively. Phase II: Good agreement was observed for venous POC results from both lay-counselors (concordance correlation coefficient (CCC)=0.873, bias -86.4cells/μl) and laboratory technicians (CCC=0.920, bias -65.7cells/μl). Capillary POC had good correlation: lay-counselors (CCC=0.902, bias -71.2cells/μl), laboratory technicians (CCC=0.918, bias -63.0cells/μl). Misclassification at the 500 cells/μl threshold for venous blood was 13.6% and 10.2% for lay-counselors and laboratory technicians and 12.2% for capillary blood in both groups. POC tended to under-classify the CD4 values with increasingly negative bias at higher CD4 values. Pima™ results were comparable to FACSCalibur™ for both venous and capillary specimens when operated by lay-counselors. POC CD4 testing has the potential to improve linkage to HIV care without burdening laboratory technicians in resource-limited settings. Published by Elsevier B.V.

Assessment and management of chemical exposure in the Mohs laboratory.

PubMed

Gunson, Todd H; Smith, Harvey R; Vinciullo, Carl

2011-01-01

The correct handling, storage, and disposal of chemicals used in the processing of tissue for Mohs micrographic surgery are essential. To identify the chemicals involved in the preparation of Mohs frozen sections and assess the associated occupational health risks. To quantify exposure levels of hazardous chemicals and ensure that they are minimized. A risk assessment form was completed for each chemical. Atmospheric sampling was performed at our previous laboratory for formaldehyde and volatile organic compounds. These data were used in the design of our new facility, where testing was repeated. Twenty-five chemicals were identified. Ten were classified as hazardous substances, 10 were flammable, six had specific disposal requirements, four were potential carcinogens, and three were potential teratogens. Formaldehyde readings at our previous laboratory were up to eight times the national exposure standard. Testing at the new laboratory produced levels well below the exposure standards. Chemical exposure within the Mohs laboratory can present a significant occupational hazard. Acutely toxic and potentially carcinogenic formaldehyde was found at high levels in a relatively standard laboratory configuration. A laboratory can be designed with a combination of physical environment and operational protocols that minimizes hazards and creates a safe working environment. © 2010 by the American Society for Dermatologic Surgery, Inc.

A survey of current practices for genomic sequencing test interpretation and reporting processes in US laboratories.

PubMed

O'Daniel, Julianne M; McLaughlin, Heather M; Amendola, Laura M; Bale, Sherri J; Berg, Jonathan S; Bick, David; Bowling, Kevin M; Chao, Elizabeth C; Chung, Wendy K; Conlin, Laura K; Cooper, Gregory M; Das, Soma; Deignan, Joshua L; Dorschner, Michael O; Evans, James P; Ghazani, Arezou A; Goddard, Katrina A; Gornick, Michele; Farwell Hagman, Kelly D; Hambuch, Tina; Hegde, Madhuri; Hindorff, Lucia A; Holm, Ingrid A; Jarvik, Gail P; Knight Johnson, Amy; Mighion, Lindsey; Morra, Massimo; Plon, Sharon E; Punj, Sumit; Richards, C Sue; Santani, Avni; Shirts, Brian H; Spinner, Nancy B; Tang, Sha; Weck, Karen E; Wolf, Susan M; Yang, Yaping; Rehm, Heidi L

2017-05-01

While the diagnostic success of genomic sequencing expands, the complexity of this testing should not be overlooked. Numerous laboratory processes are required to support the identification, interpretation, and reporting of clinically significant variants. This study aimed to examine the workflow and reporting procedures among US laboratories to highlight shared practices and identify areas in need of standardization. Surveys and follow-up interviews were conducted with laboratories offering exome and/or genome sequencing to support a research program or for routine clinical services. The 73-item survey elicited multiple choice and free-text responses that were later clarified with phone interviews. Twenty-one laboratories participated. Practices highly concordant across all groups included consent documentation, multiperson case review, and enabling patient opt-out of incidental or secondary findings analysis. Noted divergence included use of phenotypic data to inform case analysis and interpretation and reporting of case-specific quality metrics and methods. Few laboratory policies detailed procedures for data reanalysis, data sharing, or patient access to data. This study provides an overview of practices and policies of experienced exome and genome sequencing laboratories. The results enable broader consideration of which practices are becoming standard approaches, where divergence remains, and areas of development in best practice guidelines that may be helpful.Genet Med advance online publication 03 Novemeber 2016.

Comprehensive Laboratory Evaluation of a Highly Specific Lateral Flow Assay for the Presumptive Identification of Bacillus anthracis Spores in Suspicious White Powders and Environmental Samples

PubMed Central

Ramage, Jason G.; Prentice, Kristin W.; DePalma, Lindsay; Venkateswaran, Kodumudi S.; Chivukula, Sruti; Chapman, Carol; Bell, Melissa; Datta, Shomik; Singh, Ajay; Hoffmaster, Alex; Sarwar, Jawad; Parameswaran, Nishanth; Joshi, Mrinmayi; Thirunavkkarasu, Nagarajan; Krishnan, Viswanathan; Morse, Stephen; Avila, Julie R.; Sharma, Shashi; Estacio, Peter L.; Stanker, Larry; Hodge, David R.

2016-01-01

We conducted a comprehensive, multiphase laboratory evaluation of the Anthrax BioThreat Alert® test strip, a lateral flow immunoassay (LFA) for the rapid detection of Bacillus anthracis spores. The study, conducted at 2 sites, evaluated this assay for the detection of spores from the Ames and Sterne strains of B. anthracis, as well as those from an additional 22 strains. Phylogenetic near neighbors, environmental background organisms, white powders, and environmental samples were also tested. The Anthrax LFA demonstrated a limit of detection of about 106 spores/mL (ca. 1.5 × 105 spores/assay). In this study, overall sensitivity of the LFA was 99.3%, and the specificity was 98.6%. The results indicated that the specificity, sensitivity, limit of detection, dynamic range, and repeatability of the assay support its use in the field for the purpose of qualitatively evaluating suspicious white powders and environmental samples for the presumptive presence of B. anthracis spores. PMID:27661796

Laboratory Characterization of Cemented Rock Fill for Underhand Cut and Fill Method of Mining

NASA Astrophysics Data System (ADS)

Kumar, Dinesh; Singh, Upendra Kumar; Singh, Gauri Shankar Prasad

2016-10-01

Backfilling with controlled specifications is employed for improved ground support and pillar recovery in underground metalliferous mine workings. This paper reports the results of a laboratory study to characterise various mechanical properties of cemented rock fill (CRF) formulations for different compaction levels and cement content percentage for use in underhand cut and fill method of mining. Laboratory test set ups and procedures have been described for conducting compressive and bending tests of CRF block samples. A three dimensional numerical modelling study has also been carried out to overcome the limitations arising due to non-standard dimension of test blocks used in flexural loading test and the test setup devised for this purpose. Based on these studies, specific relations have been established between the compressive and the flexural properties of the CRF. The flexural strength of the wire mesh reinforced CRF is also correlated with its residual strength and the Young's modulus of elasticity under flexural loading condition. The test results of flexural strength, residual flexural strength and modulus show almost linear relations with cement content in CRF. The compressive strength of the CRF block samples is estimated as seven times the flexural strength whereas the compressive modulus is four times the flexural modulus. It has been found that the strengths of CRF of low compaction and no compaction are 75 and 60 % respectively to that of the medium compaction CRF. The relation between the strength and the unit weight of CRF as obtained in this study is significantly important for design and quality control of CRF during its large scale application in underhand cut and fill stopes.

Laboratory test data on the stability of the STIS MAMAs

NASA Technical Reports Server (NTRS)

Joseph, Charles L.

1997-01-01

STIS has two MAMA detectors systems with distinctly different tube configurations. The first (designated BAND 1) has an opaque CsI photocathode deposited on the microchannel plate (MCP) providing wavelength coverage from 1150A to 1700A. The other MAMA (designated BAND 2) has a semitransparent CS2Te photocathode deposited on the faceplate in close proximity to the input of the MCP. It covers the 1650A to 3100A bandpass and serves as a backup for the short wavelength detector. Laboratory test data indicate that both of these detectors have good sensitivity, have good uniformity and provide stable response, making each capable of collecting data with a signal-to-noise ratio in excess of 100 per Space Telescope Imaging Spectrograph (STIS) optical resolution element. Over a multiyear development effort, a substantial body of laboratory test data (more than 6 GBytes spanning more than 6 years of collection) has accumulated on more than a dozen fabricated tubes. These tests even included a few destructive evaluations to examine the limitations and operating life. In addition, analyses where conducted regarding impact caused by the specified electronic tolerances and expected changes in the Hubble Space Telescope (HST) thermal environment. Perhaps the simplest test of stability is to collect a sequence of images, each with a uniform illumination, and use these individual "flat fields" to remove the pixel-to-pixel sensitivity in the other flat fields. These sequences typically spanned 3-5 weeks of time. The detectors are very stable, allowing the pixel-to-pixel sensitivity to be removed with good precision. The STIS specification for stability is 1% (sufficient for data with a S/N = 100) over a 1 week period and 2% over 30 days. All Engineering Model Units as well as Flight Detectors tested exceeded this specification.

Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

PubMed Central

Schot, Marjolein J C; van Delft, Sanne; Kooijman-Buiting, Antoinette M J; de Wit, Niek J; Hopstaken, Rogier M

2015-01-01

Objective Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice. Setting All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices. Primary and secondary outcome measures Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers. Results The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice. Conclusions The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine use in suspected urinary tract infections in general practice. PMID:25986635

PDC-bit performance under simulated borehole conditions

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anderson, E.E.; Azar, J.J.

1993-09-01

Laboratory drilling tests were used to investigate the effects of pressure on polycrystalline-diamond-compact (PDC) drill-bit performance. Catoosa shale core samples were drilled with PDC and roller-cone bits at up to 1,750-psi confining pressure. All tests were conducted in a controlled environment with a full-scale laboratory drilling system. Test results indicate, that under similar operating conditions, increases in confining pressure reduce PDC-bit performance as much as or more than conventional-rock-bit performance. Specific energy calculations indicate that a combination of rock strength, chip hold-down, and bit balling may have reduced performance. Quantifying the degree to which pressure reduces PDC-bit performance will helpmore » researchers interpret test results and improve bit designs and will help drilling engineers run PDC bits more effectively in the field.« less

Validity and Reliability of Enzyme Immunoassays Using Leishmania major or L. infantum Antigens for the Diagnosis of Canine Visceral Leishmaniasis in Brazil

PubMed Central

de Arruda, Mauro Maciel; Figueiredo, Fabiano Borges; Cardoso, Fernanda Alvarenga; Hiamamoto, Roberto Mitsuyoshi; Brazuna, Júlia Cristina Macksoud; de Oliveira, Maria Regina Fernandes; Noronha, Elza Ferreira; Romero, Gustavo Adolfo Sierra

2013-01-01

Background American visceral leishmaniasis is caused by the protozoan Leishmania infantum. Dogs are the main reservoirs in the domestic transmission cycle. The limited accuracy of diagnostic tests for canine leishmaniasis may contribute to the lack of impact of control measures recommended by the Brazilian Ministry of Health. The objective of this study was to estimate the accuracy of two enzyme-linked immunosorbent assays employing L. major or L. infantum antigens and their reliability between three laboratories of different levels of complexity. Methods A validation study of ELISA techniques using L. major or L. infantum antigens was conducted. Direct visualization of the parasite in hematoxylin/eosin-stained histopathological sections, immunohistochemistry, and isolation of the parasite in culture.were used as gold standard. An animal that was positive in at least one of the tests was defined as infected with L. infantum. Serum samples collected from 1,425 dogs were analyzed. Samples were separated in three aliquots and tested in three different laboratories. Sensitivity, specificity and the area under de ROC curve were calculated and the reliability was evaluated between the participant laboratories. Results The sensitivity was 91.8% and 89.8% for the L. major and L. infantum assays, respectively. The specificity was 83.75% and 82.7% for the L. major and L. infantum assays, respectively. The area under de ROC curve was 0.920 and 0.898 for L. major and L. infantum, respectively. The mean intraclass correlation coefficients between laboratories ranged from 0.890 to 0.948 when L. major was used as antigen, and from 0.818 to 0.879 when L. infantum was used. Interpretation ELISA tests using L. major or L. infantum antigens have similar accuracy and reliability. Our results do not support the substitution of the L. major antigen of the ELISA test currently used for the diagnosis of canine visceral leishmaniasis in Brazil. PMID:23922884

Managing Complexity in the MSL/Curiosity Entry, Descent, and Landing Flight Software and Avionics Verification and Validation Campaign

NASA Technical Reports Server (NTRS)

Stehura, Aaron; Rozek, Matthew

2013-01-01

The complexity of the Mars Science Laboratory (MSL) mission presented the Entry, Descent, and Landing systems engineering team with many challenges in its Verification and Validation (V&V) campaign. This paper describes some of the logistical hurdles related to managing a complex set of requirements, test venues, test objectives, and analysis products in the implementation of a specific portion of the overall V&V program to test the interaction of flight software with the MSL avionics suite. Application-specific solutions to these problems are presented herein, which can be generalized to other space missions and to similar formidable systems engineering problems.

Laboratory aspects of tick-borne diseases: lyme, human granulocytic ehrlichiosis and babesiosis.

PubMed

Aguero-Rosenfeld, Marie E

2003-05-01

Lyme disease, human granulocytic ehrlichiosis (HGE) and babesiosis are emerging infections in the northeastern and midwestern United States, where Ixodes scapularis ticks are prevalent. Lyme disease and babesiosis have also been reported on the West Coast, but less frequently. Lyme disease presents frequently with a skin lesion known as erythema migrans (EM), and diagnostic tests are not necessary if the lesion is classical. Those patients presenting without EM or with atypical skin lesions may need laboratory confirmation. The most frequently used laboratory modality consists of the 2-step serological assays, employing a sensitive ELISA as a first step, followed by IgG and/or IgM immunoblots. Current guidelines for interpretation are those recommended by the CDC. HGE and babesiosis are febrile illnesses with non-specific signs and symptoms. Both infections may present with routine laboratory abnormalities, including leukopenia and/or thrombocytopenia in HGE and anemia in babesiosis. Moderate elevations of liver enzymes may occur in all three tick-borne infections. Specific diagnostic modalities for acute-phase HGE include buffy coat smear examination, culture and PCR. Culture appears to have the greatest sensitivity of the three tests. Babesiosis can be diagnosed by peripheral blood examination for the intraerythrocytic parasites, PCR or serology. Co-infections with these agents exist, but they should be documented by detection of the organisms rather than by serology, since seroprevalence rates are high in endemic areas.

National Survey on Internal Quality Control for HbA(1c) Analytical Instruments in 331 Hospital Laboratories of China.

PubMed

Zeng, Rong; Wang, Wei; Zhao, Haijian; Fei, Yang; Wang, Zhiguo

2015-01-01

The narrow gap of HbA1 value of mass fraction between "normal" (< 6.0%) and "diabetes" (≥ 6.5%) necessitates tight control of inter-assay standardization, assay precision, and trueness. This survey was initiated to obtain knowledge of the current situation of internal quality control (IQC) practice for HbA(1c) in China and find out the most appropriate quality specifications. Data of IQC for HbA(1c) in 331 institutions participating in the national proficiency testing (PT) programs in China were evaluated using four levels of quality specifications, and the percentages of laboratories meeting the quality requirement were calculated to find out the most appropriate quality specifications for control materials of HbA(1c) in China. The IQC data varied vastly among 331 clinical laboratories in China. The measurement of control materials covered a wide range from 4.52% to 12.24% (inter-quartile range) and there were significant differences among the CVs of different methods, including LPLC, CE-HPLC, AC-HPLC, immunoturbidimetry, and others. Among the four main methods, CE-HPLC and AC-HPLC achieved a better precision. As we can see, the performance of laboratories for HbA(1c) has yet to be improved. Clinical laboratories in China should improve their performance with a stricter imprecision criteria.