Sample records for reference standard test

  1. Rabies vaccine standards: comparison of the 5th and 6th WHO international reference standards to the USDA veterinary reference standard.

    PubMed

    Hermann, J; Fry, A; Reising, M; Patterson, P; Siev, D; Gatewood, D

    2012-11-06

    Ensuring rabies vaccines are potent and effective is paramount in preventing transmission of this deadly disease and safeguarding public health. Efficacy of human and veterinary vaccines is ensured by evaluating relative potency estimates of the vaccine compared to a rabies reference standard using the National Institutes of Health (NIH) test. Reference vaccines are based on the International Standard for Rabies Vaccine provided by the World Health Organization (WHO). A comparison study was conducted to determine the relative potency of the 5th WHO, 6th WHO, and United States Department of Agriculture's (USDA) 08-14 reference standards using the NIH test. Results from the study demonstrate that the 6th WHO reference standard is approximately twice as potent as the 5th WHO reference when reconstituted to contain 1 IU per ml. Based on these results, the Center for Veterinary Biologics (CVB) doubled the reconstitution volume of USDA veterinary reference 08-14 from 13 ml to 26 ml, for an initial use dilution of 0.7 IU per ml for use by veterinary biologics manufacturers in the NIH test. This study emphasizes the importance of reference standard calibration for use in the National Institutes of Health test. Published by Elsevier Ltd.

  2. In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.

    PubMed

    Brown, K; Stokes, W

    2012-01-01

    This paper proposes a program under which the use of animals for requalification of in vitro potency tests could be eliminated. Standard References (USDA/CVB nomenclature) would be developed, characterized, stored and monitored by selected reference laboratories worldwide. These laboratories would employ scientists skilled in protein and glycoprotein chemistry and equipped with state-of-the-art instruments for required analyses. After Standard References are established, the reference laboratories would provide them to the animal health industry as "gold standards". Companies would then establish and validate a correlation between the Standard Reference and the company Master Reference (USDA/CVB nomenclature) using an internal in vitro assay. After this correlation is established, the company could use the Standard References for qualifying, monitoring and requalifying company Master References without the use of animals. Such a program would eliminate the need for animals for requalification of Master References and the need for each company to develop and validate a battery of Master Reference Monitoring assays. It would also provide advantages in terms of reduced costs and reduced time for requalification testing. As such it would provide a strong incentive for companies to develop and use in vitro assays for potency testing.

  3. Predictive Accuracy of Sweep Frequency Impedance Technology in Identifying Conductive Conditions in Newborns.

    PubMed

    Aithal, Venkatesh; Kei, Joseph; Driscoll, Carlie; Murakoshi, Michio; Wada, Hiroshi

    2018-02-01

    Diagnosing conductive conditions in newborns is challenging for both audiologists and otolaryngologists. Although high-frequency tympanometry (HFT), acoustic stapedial reflex tests, and wideband absorbance measures are useful diagnostic tools, there is performance measure variability in their detection of middle ear conditions. Additional diagnostic sensitivity and specificity measures gained through new technology such as sweep frequency impedance (SFI) measures may assist in the diagnosis of middle ear dysfunction in newborns. The purpose of this study was to determine the test performance of SFI to predict the status of the outer and middle ear in newborns against commonly used reference standards. Automated auditory brainstem response (AABR), HFT (1000 Hz), transient evoked otoacoustic emission (TEOAE), distortion product otoacoustic emission (DPOAE), and SFI tests were administered to the study sample. A total of 188 neonates (98 males and 90 females) with a mean gestational age of 39.4 weeks were included in the sample. Mean age at the time of testing was 44.4 hr. Diagnostic accuracy of SFI was assessed in terms of its ability to identify conductive conditions in neonates when compared with nine different reference standards (including four single tests [AABR, HFT, TEOAE, and DPOAE] and five test batteries [HFT + DPOAE, HFT + TEOAE, DPOAE + TEOAE, DPOAE + AABR, and TEOAE + AABR]), using receiver operating characteristic (ROC) analysis and traditional test performance measures such as sensitivity and specificity. The test performance of SFI against the test battery reference standard of HFT + DPOAE and single reference standard of HFT was high with an area under the ROC curve (AROC) of 0.87 and 0.82, respectively. Although the HFT + DPOAE test battery reference standard performed better than the HFT reference standard in predicting middle ear conductive conditions in neonates, the difference in AROC was not significant. Further analysis revealed that the highest sensitivity and specificity for SFI (86% and 88%, respectively) was obtained when compared with the reference standard of HFT + DPOAE. Among the four single reference standards, SFI had the highest sensitivity and specificity (76% and 88%, respectively) when compared against the HFT reference standard. The high test performance of SFI against the HFT and HFT + DPOAE reference standards indicates that the SFI measure has appropriate diagnostic accuracy in detection of conductive conditions in newborns. Hence, the SFI test could be used as adjunct tool to identify conductive conditions in universal newborn hearing screening programs, and can also be used in diagnostic follow-up assessments. American Academy of Audiology

  4. Bias in estimating accuracy of a binary screening test with differential disease verification

    PubMed Central

    Brinton, John T.; Ringham, Brandy M.; Glueck, Deborah H.

    2011-01-01

    SUMMARY Sensitivity, specificity, positive and negative predictive value are typically used to quantify the accuracy of a binary screening test. In some studies it may not be ethical or feasible to obtain definitive disease ascertainment for all subjects using a gold standard test. When a gold standard test cannot be used an imperfect reference test that is less than 100% sensitive and specific may be used instead. In breast cancer screening, for example, follow-up for cancer diagnosis is used as an imperfect reference test for women where it is not possible to obtain gold standard results. This incomplete ascertainment of true disease, or differential disease verification, can result in biased estimates of accuracy. In this paper, we derive the apparent accuracy values for studies subject to differential verification. We determine how the bias is affected by the accuracy of the imperfect reference test, the percent who receive the imperfect reference standard test not receiving the gold standard, the prevalence of the disease, and the correlation between the results for the screening test and the imperfect reference test. It is shown that designs with differential disease verification can yield biased estimates of accuracy. Estimates of sensitivity in cancer screening trials may be substantially biased. However, careful design decisions, including selection of the imperfect reference test, can help to minimize bias. A hypothetical breast cancer screening study is used to illustrate the problem. PMID:21495059

  5. 40 CFR 160.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

  6. 40 CFR 160.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

  7. 40 CFR 160.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

  8. 40 CFR 160.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

  9. 40 CFR 160.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... concomitantly according to written standard operating procedures, which provide for periodic analysis of each...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.105 Test...

  10. 40 CFR 792.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

  11. 40 CFR 792.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

  12. 40 CFR 792.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

  13. 40 CFR 792.105 - Test, control, and reference substance characterization.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... or concomitantly according to written standard operating procedures, which provide for periodic...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

  14. 1 CFR 21.21 - General requirements: References.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 1 General Provisions 1 2010-01-01 2010-01-01 false General requirements: References. 21.21 Section... to test methods or consensus standards produced by a Federal agency that have replaced or preempted private or voluntary test methods or consensus standards in a subject matter area. (5) The reference is to...

  15. Standard reference material for Her2 testing: report of a National Institute of Standards and Technology-sponsored Consensus Workshop.

    PubMed

    Hammond, M Elizabeth H; Barker, Peter; Taube, Sheila; Gutman, Steven

    2003-06-01

    A workshop was sponsored by the National Institute of Standards and Technology, the Cancer Diagnosis Program of the National Cancer Institute, the Food and Drug Administration, and the College of American Pathologists to address the need for a reference material for Her2 gene protein testing. It was agreed that such a standard was desirable and necessary to ensure the reliability of Her2 testing to qualify patients for trastuzumab therapy. Two standards consisting of well characterized cell lines will be produced, 1 that will be a National Institute of Standards and Technology-certifiable standard, and 1 that will be a commercially developed standard for use in all Her2 testing. It was also agreed that all Her2 testing must be performed on samples fixed only in 10% buffered formalin, as specified in the Food and Drug Administration-approved testing methods. Participants agreed to plan strategies to educate pathologists, clinicians, and laboratories about the need and use of such a standard. A National Committee for Clinical Laboratory Standards guideline for the use of the standard reference material will be created to facilitate this process.

  16. From plastic to gold: a unified classification scheme for reference standards in medical image processing

    NASA Astrophysics Data System (ADS)

    Lehmann, Thomas M.

    2002-05-01

    Reliable evaluation of medical image processing is of major importance for routine applications. Nonetheless, evaluation is often omitted or methodically defective when novel approaches or algorithms are introduced. Adopted from medical diagnosis, we define the following criteria to classify reference standards: 1. Reliance, if the generation or capturing of test images for evaluation follows an exactly determined and reproducible protocol. 2. Equivalence, if the image material or relationships considered within an algorithmic reference standard equal real-life data with respect to structure, noise, or other parameters of importance. 3. Independence, if any reference standard relies on a different procedure than that to be evaluated, or on other images or image modalities than that used routinely. This criterion bans the simultaneous use of one image for both, training and test phase. 4. Relevance, if the algorithm to be evaluated is self-reproducible. If random parameters or optimization strategies are applied, reliability of the algorithm must be shown before the reference standard is applied for evaluation. 5. Significance, if the number of reference standard images that are used for evaluation is sufficient large to enable statistically founded analysis. We demand that a true gold standard must satisfy the Criteria 1 to 3. Any standard only satisfying two criteria, i.e., Criterion 1 and Criterion 2 or Criterion 1 and Criterion 3, is referred to as silver standard. Other standards are termed to be from plastic. Before exhaustive evaluation based on gold or silver standards is performed, its relevance must be shown (Criterion 4) and sufficient tests must be carried out to found statistical analysis (Criterion 5). In this paper, examples are given for each class of reference standards.

  17. Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study.

    PubMed

    Phinney, Karen W; Sempos, Christopher T; Tai, Susan S-C; Camara, Johanna E; Wise, Stephen A; Eckfeldt, John H; Hoofnagle, Andrew N; Carter, Graham D; Jones, Julia; Myers, Gary L; Durazo-Arvizu, Ramon; Miller, W Greg; Bachmann, Lorin M; Young, Ian S; Pettit, Juanita; Caldwell, Grahame; Liu, Andrew; Brooks, Stephen P J; Sarafin, Kurtis; Thamm, Michael; Mensink, Gert B M; Busch, Markus; Rabenberg, Martina; Cashman, Kevin D; Kiely, Mairead; Galvin, Karen; Zhang, Joy Y; Kinsella, Michael; Oh, Kyungwon; Lee, Sun-Wha; Jung, Chae L; Cox, Lorna; Goldberg, Gail; Guberg, Kate; Meadows, Sarah; Prentice, Ann; Tian, Lu; Brannon, Patsy M; Lucas, Robyn M; Crump, Peter M; Cavalier, Etienne; Merkel, Joyce; Betz, Joseph M

    2017-09-01

    The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials were analyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of American Pathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing to choose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

  18. Spatial Standard Observer

    NASA Technical Reports Server (NTRS)

    Watson, Andrw B. (Inventor)

    2010-01-01

    The present invention relates to devices and methods for the measurement and/or for the specification of the perceptual intensity of a visual image. or the perceptual distance between a pair of images. Grayscale test and reference images are processed to produce test and reference luminance images. A luminance filter function is convolved with the reference luminance image to produce a local mean luminance reference image . Test and reference contrast images are produced from the local mean luminance reference image and the test and reference luminance images respectively, followed by application of a contrast sensitivity filter. The resulting images are combined according to mathematical prescriptions to produce a Just Noticeable Difference, JND value, indicative of a Spatial Standard Observer. SSO. Some embodiments include masking functions. window functions. special treatment for images lying on or near border and pre-processing of test images.

  19. Spatial Standard Observer

    NASA Technical Reports Server (NTRS)

    Watson, Andrew B. (Inventor)

    2012-01-01

    The present invention relates to devices and methods for the measurement and/or for the specification of the perceptual intensity of a visual image, or the perceptual distance between a pair of images. Grayscale test and reference images are processed to produce test and reference luminance images. A luminance filter function is convolved with the reference luminance image to produce a local mean luminance reference image. Test and reference contrast images are produced from the local mean luminance reference image and the test and reference luminance images respectively, followed by application of a contrast sensitivity filter. The resulting images are combined according to mathematical prescriptions to produce a Just Noticeable Difference, JND value, indicative of a Spatial Standard Observer, SSO. Some embodiments include masking functions, window functions, special treatment for images lying on or near borders and pre-processing of test images.

  20. A Framework for Establishing Standard Reference Scale of Texture by Multivariate Statistical Analysis Based on Instrumental Measurement and Sensory Evaluation.

    PubMed

    Zhi, Ruicong; Zhao, Lei; Xie, Nan; Wang, Houyin; Shi, Bolin; Shi, Jingye

    2016-01-13

    A framework of establishing standard reference scale (texture) is proposed by multivariate statistical analysis according to instrumental measurement and sensory evaluation. Multivariate statistical analysis is conducted to rapidly select typical reference samples with characteristics of universality, representativeness, stability, substitutability, and traceability. The reasonableness of the framework method is verified by establishing standard reference scale of texture attribute (hardness) with Chinese well-known food. More than 100 food products in 16 categories were tested using instrumental measurement (TPA test), and the result was analyzed with clustering analysis, principal component analysis, relative standard deviation, and analysis of variance. As a result, nine kinds of foods were determined to construct the hardness standard reference scale. The results indicate that the regression coefficient between the estimated sensory value and the instrumentally measured value is significant (R(2) = 0.9765), which fits well with Stevens's theory. The research provides reliable a theoretical basis and practical guide for quantitative standard reference scale establishment on food texture characteristics.

  1. 40 CFR 92.5 - Reference materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...: (1) ASTM material. The following table sets forth material from the American Society for Testing and...., Philadelphia, PA 19103. The table follows: Document number and name 40 CFR part 92 reference ASTM D 86-95, Standard Test Method for Distillation of Petroleum Products § 92.113 ASTM D 93-94, Standard Test Methods...

  2. A Meta-Analysis of Typhoid Diagnostic Accuracy Studies: A Recommendation to Adopt a Standardized Composite Reference

    PubMed Central

    Storey, Helen L.; Huang, Ying; Crudder, Chris; Golden, Allison; de los Santos, Tala; Hawkins, Kenneth

    2015-01-01

    Novel typhoid diagnostics currently under development have the potential to improve clinical care, surveillance, and the disease burden estimates that support vaccine introduction. Blood culture is most often used as the reference method to evaluate the accuracy of new typhoid tests; however, it is recognized to be an imperfect gold standard. If no single gold standard test exists, use of a composite reference standard (CRS) can improve estimation of diagnostic accuracy. Numerous studies have used a CRS to evaluate new typhoid diagnostics; however, there is no consensus on an appropriate CRS. In order to evaluate existing tests for use as a reference test or inclusion in a CRS, we performed a systematic review of the typhoid literature to include all index/reference test combinations observed. We described the landscape of comparisons performed, showed results of a meta-analysis on the accuracy of the more common combinations, and evaluated sources of variability based on study quality. This wide-ranging meta-analysis suggests that no single test has sufficiently good performance but some existing diagnostics may be useful as part of a CRS. Additionally, based on findings from the meta-analysis and a constructed numerical example demonstrating the use of CRS, we proposed necessary criteria and potential components of a typhoid CRS to guide future recommendations. Agreement and adoption by all investigators of a standardized CRS is requisite, and would improve comparison of new diagnostics across independent studies, leading to the identification of a better reference test and improved confidence in prevalence estimates. PMID:26566275

  3. 46 CFR 160.174-3 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... by reference in this subpart are: American Society for Testing and Materials (ASTM) 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959. ASTM C 177-85 (1993), Standard Test Method for Steady-State...—160.174-17 ASTM C 518-91, Standard Test Method for Steady-State Heat Flux Measurements and Thermal...

  4. Measurement of susceptibility artifacts with histogram-based reference value on magnetic resonance images according to standard ASTM F2119.

    PubMed

    Heinrich, Andreas; Teichgräber, Ulf K; Güttler, Felix V

    2015-12-01

    The standard ASTM F2119 describes a test method for measuring the size of a susceptibility artifact based on the example of a passive implant. A pixel in an image is considered to be a part of an image artifact if the intensity is changed by at least 30% in the presence of a test object, compared to a reference image in which the test object is absent (reference value). The aim of this paper is to simplify and accelerate the test method using a histogram-based reference value. Four test objects were scanned parallel and perpendicular to the main magnetic field, and the largest susceptibility artifacts were measured using two methods of reference value determination (reference image-based and histogram-based reference value). The results between both methods were compared using the Mann-Whitney U-test. The difference between both reference values was 42.35 ± 23.66. The difference of artifact size was 0.64 ± 0.69 mm. The artifact sizes of both methods did not show significant differences; the p-value of the Mann-Whitney U-test was between 0.710 and 0.521. A standard-conform method for a rapid, objective, and reproducible evaluation of susceptibility artifacts could be implemented. The result of the histogram-based method does not significantly differ from the ASTM-conform method.

  5. Reference Standard Test and the Diagnostic Ability of Spectral Domain Optical Coherence Tomography in Glaucoma.

    PubMed

    Rao, Harsha L; Yadav, Ravi K; Addepalli, Uday K; Begum, Viquar U; Senthil, Sirisha; Choudhari, Nikhil S; Garudadri, Chandra S

    2015-08-01

    To evaluate the relationship between the reference standard used to diagnose glaucoma and the diagnostic ability of spectral domain optical coherence tomograph (SDOCT). In a cross-sectional study, 280 eyes of 175 consecutive subjects, referred to a tertiary eye care center for glaucoma evaluation, underwent optic disc photography, visual field (VF) examination, and SDOCT examination. The cohort was divided into glaucoma and control groups based on 3 reference standards for glaucoma diagnosis: first based on the optic disc classification (179 glaucoma and 101 control eyes), second on VF classification (glaucoma hemifield test outside normal limits and pattern SD with P-value of <5%, 130 glaucoma and 150 control eyes), and third on the presence of both glaucomatous optic disc and glaucomatous VF (125 glaucoma and 155 control eyes). Relationship between the reference standards and the diagnostic parameters of SDOCT were evaluated using areas under the receiver operating characteristic curve, sensitivity, and specificity. Areas under the receiver operating characteristic curve and sensitivities of most of the SDOCT parameters obtained with the 3 reference standards (ranging from 0.74 to 0.88 and 72% to 88%, respectively) were comparable (P>0.05). However, specificities of SDOCT parameters were significantly greater (P<0.05) with optic disc classification as reference standard (74% to 88%) compared with VF classification as reference standard (57% to 74%). Diagnostic parameters of SDOCT that was significantly affected by reference standard was the specificity, which was greater with optic disc classification as the reference standard. This has to be considered when comparing the diagnostic ability of SDOCT across studies.

  6. Standard setting: comparison of two methods.

    PubMed

    George, Sanju; Haque, M Sayeed; Oyebode, Femi

    2006-09-14

    The outcome of assessments is determined by the standard-setting method used. There is a wide range of standard-setting methods and the two used most extensively in undergraduate medical education in the UK are the norm-reference and the criterion-reference methods. The aims of the study were to compare these two standard-setting methods for a multiple-choice question examination and to estimate the test-retest and inter-rater reliability of the modified Angoff method. The norm-reference method of standard-setting (mean minus 1 SD) was applied to the 'raw' scores of 78 4th-year medical students on a multiple-choice examination (MCQ). Two panels of raters also set the standard using the modified Angoff method for the same multiple-choice question paper on two occasions (6 months apart). We compared the pass/fail rates derived from the norm reference and the Angoff methods and also assessed the test-retest and inter-rater reliability of the modified Angoff method. The pass rate with the norm-reference method was 85% (66/78) and that by the Angoff method was 100% (78 out of 78). The percentage agreement between Angoff method and norm-reference was 78% (95% CI 69% - 87%). The modified Angoff method had an inter-rater reliability of 0.81-0.82 and a test-retest reliability of 0.59-0.74. There were significant differences in the outcomes of these two standard-setting methods, as shown by the difference in the proportion of candidates that passed and failed the assessment. The modified Angoff method was found to have good inter-rater reliability and moderate test-retest reliability.

  7. 40 CFR 160.107 - Test, control, and reference substance handling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Test, control, and reference substance handling. 160.107 Section 160.107 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.107 Test...

  8. The role of standards in the development and implementation of clinical laboratory tests: a domestic and global perspective.

    PubMed

    Michaud, Ginette Y

    2005-01-01

    In the field of clinical laboratory medicine, standardization is aimed at increasing the trueness and reliability of measured values. Standardization relies on the use of written standards, reference measurement procedures and reference materials. These are important tools for the design and validation of new tests, and for establishing the metrological traceability of diagnostic assays. Their use supports the translation of research technologies into new diagnostic assays and leads to more rapid advances in science and medicine, as well as improvements in the quality of patient care. The various standardization tools are described, as are the procedures by which written standards, reference procedures and reference materials are developed. Recent efforts to develop standards for use in the field of molecular diagnostics are discussed. The recognition of standardization tools by the FDA and other regulatory authorities is noted as evidence of their important role in ensuring the safety and performance of in vitro diagnostic devices.

  9. 21 CFR 660.25 - Potency tests without reference preparations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

  10. 21 CFR 660.25 - Potency tests without reference preparations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

  11. 21 CFR 660.25 - Potency tests without reference preparations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

  12. 21 CFR 660.25 - Potency tests without reference preparations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

  13. 21 CFR 660.25 - Potency tests without reference preparations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

  14. Testing and Standards: A Brief Encyclopedia.

    ERIC Educational Resources Information Center

    Wilde, Sandra

    This reference guide contains clear and concise explanations of concepts related to educational testing and standards. The book may be read straight through as a primer on educational assessment or may be used as a reference for particular topics. The sections are: (1) Accountability (Consumers, Taxpayers, and Citizens); (2) Authenticity in…

  15. A NEW APPROACH FOR CULTURING LEMNA MINOR (DUCKWEED) AND STANDARDIZED METHOD FOR USING ATRAZINE AS A REFERENCE TOXICANT

    EPA Science Inventory

    Lemna minor (Duckweed) is commonly used in aquatic toxicity investigations. Methods for culturing and testing with reference toxicants, such as atrazine, are somewhat variable among researchers. Our goal was to develop standardized methods of culturing and testing for use with L....

  16. Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

    PubMed Central

    Laslett, Mark; McDonald, Barry; Tropp, Hans; Aprill, Charles N; Öberg, Birgitta

    2005-01-01

    Background The tissue origin of low back pain (LBP) or referred lower extremity symptoms (LES) may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC) statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216) with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement (PCC) was estimated at 13%. "Exact" agreement between clinical and reference standard diagnoses was 32% and "clinical agreement" 51%. For six pathoanatomic categories (disc, facet joint, sacroiliac joint, hip joint, nerve root and spinal stenosis), PCC was 33% with actual agreement 56%. There was no overlap of 95% confidence intervals on any comparison. Diagnostic agreement on the six most common patho-anatomic categories produced a kappa of 0.31. Conclusion Clinical diagnoses agree with reference standards diagnoses more often than chance. Using available reference standards, most patients can have a tissue source of pain identified. PMID:15943873

  17. 40 CFR 792.107 - Test, control, and reference substance handling.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Test, control, and reference substance handling. 792.107 Section 792.107 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference...

  18. Agreement between gastrointestinal panel testing and standard microbiology methods for detecting pathogens in suspected infectious gastroenteritis: Test evaluation and meta-analysis in the absence of a reference standard.

    PubMed

    Freeman, Karoline; Tsertsvadze, Alexander; Taylor-Phillips, Sian; McCarthy, Noel; Mistry, Hema; Manuel, Rohini; Mason, James

    2017-01-01

    Multiplex gastrointestinal pathogen panel (GPP) tests simultaneously identify bacterial, viral and parasitic pathogens from the stool samples of patients with suspected infectious gastroenteritis presenting in hospital or the community. We undertook a systematic review to compare the accuracy of GPP tests with standard microbiology techniques. Searches in Medline, Embase, Web of Science and the Cochrane library were undertaken from inception to January 2016. Eligible studies compared GPP tests with standard microbiology techniques in patients with suspected gastroenteritis. Quality assessment of included studies used tailored QUADAS-2. In the absence of a reference standard we analysed test performance taking GPP tests and standard microbiology techniques in turn as the benchmark test, using random effects meta-analysis of proportions. No study provided an adequate reference standard with which to compare the test accuracy of GPP and conventional tests. Ten studies informed a meta-analysis of positive and negative agreement. Positive agreement across all pathogens was 0.93 (95% CI 0.90 to 0.96) when conventional methods were the benchmark and 0.68 (95% CI: 0.58 to 0.77) when GPP provided the benchmark. Negative agreement was high in both instances due to the high proportion of negative cases. GPP testing produced a greater number of pathogen-positive findings than conventional testing. It is unclear whether these additional 'positives' are clinically important. GPP testing has the potential to simplify testing and accelerate reporting when compared to conventional microbiology methods. However the impact of GPP testing upon the management, treatment and outcome of patients is poorly understood and further studies are needed to evaluate the health economic impact of GPP testing compared with standard methods. The review protocol is registered with PROSPERO as CRD42016033320.

  19. Comparison of three commercially available fit-test methods.

    PubMed

    Janssen, Larry L; Luinenburg, D Michael; Mullins, Haskell E; Nelson, Thomas J

    2002-01-01

    American National Standards Institute (ANSI) standard Z88.10, Respirator Fit Testing Methods, includes criteria to evaluate new fit-tests. The standard allows generated aerosol, particle counting, or controlled negative pressure quantitative fit-tests to be used as the reference method to determine acceptability of a new test. This study examined (1) comparability of three Occupational Safety and Health Administration-accepted fit-test methods, all of which were validated using generated aerosol as the reference method; and (2) the effect of the reference method on the apparent performance of a fit-test method under evaluation. Sequential fit-tests were performed using the controlled negative pressure and particle counting quantitative fit-tests and the bitter aerosol qualitative fit-test. Of 75 fit-tests conducted with each method, the controlled negative pressure method identified 24 failures; bitter aerosol identified 22 failures; and the particle counting method identified 15 failures. The sensitivity of each method, that is, agreement with the reference method in identifying unacceptable fits, was calculated using each of the other two methods as the reference. None of the test methods met the ANSI sensitivity criterion of 0.95 or greater when compared with either of the other two methods. These results demonstrate that (1) the apparent performance of any fit-test depends on the reference method used, and (2) the fit-tests evaluated use different criteria to identify inadequately fitting respirators. Although "acceptable fit" cannot be defined in absolute terms at this time, the ability of existing fit-test methods to reject poor fits can be inferred from workplace protection factor studies.

  20. Towards a Framework for Developing Semantic Relatedness Reference Standards

    PubMed Central

    Pakhomov, Serguei V.S.; Pedersen, Ted; McInnes, Bridget; Melton, Genevieve B.; Ruggieri, Alexander; Chute, Christopher G.

    2010-01-01

    Our objective is to develop a framework for creating reference standards for functional testing of computerized measures of semantic relatedness. Currently, research on computerized approaches to semantic relatedness between biomedical concepts relies on reference standards created for specific purposes using a variety of methods for their analysis. In most cases, these reference standards are not publicly available and the published information provided in manuscripts that evaluate computerized semantic relatedness measurement approaches is not sufficient to reproduce the results. Our proposed framework is based on the experiences of medical informatics and computational linguistics communities and addresses practical and theoretical issues with creating reference standards for semantic relatedness. We demonstrate the use of the framework on a pilot set of 101 medical term pairs rated for semantic relatedness by 13 medical coding experts. While the reliability of this particular reference standard is in the “moderate” range; we show that using clustering and factor analyses offers a data-driven approach to finding systematic differences among raters and identifying groups of potential outliers. We test two ontology-based measures of relatedness and provide both the reference standard containing individual ratings and the R program used to analyze the ratings as open-source. Currently, these resources are intended to be used to reproduce and compare results of studies involving computerized measures of semantic relatedness. Our framework may be extended to the development of reference standards in other research areas in medical informatics including automatic classification, information retrieval from medical records and vocabulary/ontology development. PMID:21044697

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

    Roach, Dennis Patrick; Rackow, Kirk A.

    The FAA's Airworthiness Assurance NDI Validation Center, in conjunction with the Commercial Aircraft Composite Repair Committee, developed a set of composite reference standards to be used in NDT equipment calibration for accomplishment of damage assessment and post-repair inspection of all commercial aircraft composites. In this program, a series of NDI tests on a matrix of composite aircraft structures and prototype reference standards were completed in order to minimize the number of standards needed to carry out composite inspections on aircraft. Two tasks, related to composite laminates and non-metallic composite honeycomb configurations, were addressed. A suite of 64 honeycomb panels, representingmore » the bounding conditions of honeycomb construction on aircraft, was inspected using a wide array of NDI techniques. An analysis of the resulting data determined the variables that play a key role in setting up NDT equipment. This has resulted in a set of minimum honeycomb NDI reference standards that include these key variables. A sequence of subsequent tests determined that this minimum honeycomb reference standard set is able to fully support inspections over the full range of honeycomb construction scenarios found on commercial aircraft. In the solid composite laminate arena, G11 Phenolic was identified as a good generic solid laminate reference standard material. Testing determined matches in key velocity and acoustic impedance properties, as well as, low attenuation relative to carbon laminates. Furthermore, comparisons of resonance testing response curves from the G11 Phenolic NDI reference standard was very similar to the resonance response curves measured on the existing carbon and fiberglass laminates. NDI data shows that this material should work for both pulse-echo (velocity-based) and resonance (acoustic impedance-based) inspections.« less

  2. 46 CFR 160.151-5 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... reference in this subpart and the sections affected are as follows: American Society for Testing and... of Standards and Technology (formerly National Bureau of Standards) c/o National Technical...

  3. 46 CFR 160.151-5 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... reference in this subpart and the sections affected are as follows: American Society for Testing and... of Standards and Technology (formerly National Bureau of Standards) c/o National Technical...

  4. Some possible reference materials for fire toxicity tests

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Solis, A. N.

    1977-01-01

    Suitable reference materials need to be selected in order to standardize any test method. The evaluation of cotton, polyethylene, polyether sulfone, polycarbonate, polystyrene, and polyurethane flexible and rigid foams as possible reference materials for the University of San Francisco/NASA toxicity screening test method is discussed.

  5. 40 CFR 94.5 - Reference materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .../code_of_federal_regulations/ibr_locations.html. (a) ASTM material. Table 1 of § 94.5 lists material... of § 94.5—ASTM Materials Document No. and name Part 94 reference ASTM D 86-01, Standard Test Method for Distillation of Petroleum Products at Atmospheric Pressure 94.108 ASTM D 93-02, Standard Test...

  6. 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...

  7. SEDIMENT TOXICITY ASSESSMENT: COMPARISON OF STANDARD AND NEW TESTING DESIGNS

    EPA Science Inventory

    Standard methods of sediment toxicity testing are fairly well accepted; however, as with all else, evolution of these methods is inevitable. We compared a standard ASTM 10-day amphipod toxicity testing method with smaller, 48- and 96-h test methods using very toxic and reference ...

  8. Analysis of household refrigerators for different testing standards

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

    Bansal, P.K.; McGill, I.

    This study highlights the salient differences among various testing standards for household refrigerator-freezers and proposes a methodology for predicting the performance of a single evaporator-based vapor-compression refrigeration system (either refrigerator or freezer) from one test standard (where the test data are available-the reference case) to another (the alternative case). The standards studied during this investigation include the Australian-New Zealand Standard (ANZS), the International Standard (ISO), the American National Standard (ANSI), the Japanese Industrial Standard (JIS), and the Chinese National Standard (CNS). A simple analysis in conjunction with the BICYCLE model (Bansal and Rice 1993) is used to calculate the energymore » consumption of two refrigerator cabinets from the reference case to the alternative cases. The proposed analysis includes the effect of door openings (as required by the JIS) as well as defrost heaters. The analytical results are found to agree reasonably well with the experimental observations for translating energy consumption information from one standard to another.« less

  9. Field Demonstration and Validation of a New Device for Measuring Water and Solute Fluxes at CFB Borden

    DTIC Science & Technology

    2006-11-01

    All Quality Control Reference Materials are acquired only from authorized vendors or sources commonly used by U.S. EPA Regional Laboratories...Institue of Standards and Testing (NITS) Standard Reference Materials (SRM) or to the U.S. EPA Reference Standards. Working Standards The commercial...contaminants from clothing or equipment by blowing, shaking or any other means that may disperse material into the air is prohibited. 7.1.3. All disposable

  10. Towards a framework for developing semantic relatedness reference standards.

    PubMed

    Pakhomov, Serguei V S; Pedersen, Ted; McInnes, Bridget; Melton, Genevieve B; Ruggieri, Alexander; Chute, Christopher G

    2011-04-01

    Our objective is to develop a framework for creating reference standards for functional testing of computerized measures of semantic relatedness. Currently, research on computerized approaches to semantic relatedness between biomedical concepts relies on reference standards created for specific purposes using a variety of methods for their analysis. In most cases, these reference standards are not publicly available and the published information provided in manuscripts that evaluate computerized semantic relatedness measurement approaches is not sufficient to reproduce the results. Our proposed framework is based on the experiences of medical informatics and computational linguistics communities and addresses practical and theoretical issues with creating reference standards for semantic relatedness. We demonstrate the use of the framework on a pilot set of 101 medical term pairs rated for semantic relatedness by 13 medical coding experts. While the reliability of this particular reference standard is in the "moderate" range; we show that using clustering and factor analyses offers a data-driven approach to finding systematic differences among raters and identifying groups of potential outliers. We test two ontology-based measures of relatedness and provide both the reference standard containing individual ratings and the R program used to analyze the ratings as open-source. Currently, these resources are intended to be used to reproduce and compare results of studies involving computerized measures of semantic relatedness. Our framework may be extended to the development of reference standards in other research areas in medical informatics including automatic classification, information retrieval from medical records and vocabulary/ontology development. Copyright © 2010 Elsevier Inc. All rights reserved.

  11. 40 CFR 75.6 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., phone: 610-832-9585, http://www.astm.org/DIGITAL_LIBRARY/index.shtml. (1) ASTM D129-00, Standard Test... Information Reference Unit of the U.S. EPA, 401 M St., SW., Washington, DC and at the Library (MD-35), U.S... D4052-96 (Reapproved 2002), Standard Test Method for Density and Relative Density of Liquids by Digital...

  12. 40 CFR 75.6 - Incorporation by reference.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., phone: 610-832-9585, http://www.astm.org/DIGITAL_LIBRARY/index.shtml. (1) ASTM D129-00, Standard Test... Information Reference Unit of the U.S. EPA, 401 M St., SW., Washington, DC and at the Library (MD-35), U.S... D4052-96 (Reapproved 2002), Standard Test Method for Density and Relative Density of Liquids by Digital...

  13. 40 CFR 75.6 - Incorporation by reference.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., phone: 610-832-9585, http://www.astm.org/DIGITAL_LIBRARY/index.shtml. (1) ASTM D129-00, Standard Test... Information Reference Unit of the U.S. EPA, 401 M St., SW., Washington, DC and at the Library (MD-35), U.S... D4052-96 (Reapproved 2002), Standard Test Method for Density and Relative Density of Liquids by Digital...

  14. 40 CFR 75.6 - Incorporation by reference.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., phone: 610-832-9585, http://www.astm.org/DIGITAL_LIBRARY/index.shtml. (1) ASTM D129-00, Standard Test... Information Reference Unit of the U.S. EPA, 401 M St., SW., Washington, DC and at the Library (MD-35), U.S... D4052-96 (Reapproved 2002), Standard Test Method for Density and Relative Density of Liquids by Digital...

  15. Clinical accuracy of point-of-care urine culture in general practice.

    PubMed

    Holm, Anne; Cordoba, Gloria; Sørensen, Tina Møller; Jessen, Lisbeth Rem; Frimodt-Møller, Niels; Siersma, Volkert; Bjerrum, Lars

    2017-06-01

    To assess the clinical accuracy (sensitivity (SEN), specificity (SPE), positive predictive value and negative predictive value) of two point-of-care (POC) urine culture tests for the identification of urinary tract infection (UTI) in general practice. Prospective diagnostic accuracy study comparing two index tests (Flexicult™ SSI-Urinary Kit or ID Flexicult™) with a reference standard (urine culture performed in the microbiological department). General practice in the Copenhagen area patients. Adult female patients consulting their general practitioner with suspected uncomplicated, symptomatic UTI. (1) Overall accuracy of POC urine culture in general practice. (2) Individual accuracy of each of the two POC tests in this study. (3) Accuracy of POC urine culture in general practice with enterococci excluded, since enterococci are known to multiply in boric acid used for transportation for the reference standard. (4) Accuracy based on expert reading of photographs of POC urine cultures performed in general practice. Standard culture performed in the microbiological department was used as reference standard for all four measures. Twenty general practices recruited 341 patients with suspected uncomplicated UTI. The overall agreement between index test and reference was 0.76 (CI: 0.71-0.80), SEN 0.88 (CI: 0.83-0.92) and SPE 0.55 (CI: 0.46-0.64). The two POC tests produced similar results individually. Overall agreement with enterococci excluded was 0.82 (0.77-0.86) and agreement between expert readings of photographs and reference results was 0.81 (CI: 0.76-0.85). POC culture used in general practice has high SEN but low SPE. Low SPE could be due to both misinterpretation in general practice and an imperfect reference standard. Registration number: ClinicalTrials.gov NCT02323087.

  16. 40 CFR 1066.605 - Mass-based and molar-based exhaust emission calculations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... the test interval, corrected to standard temperature and pressure. m PMfil = mass of particulate... = stabilized, ht = hot transient), corrected to standard reference conditions. m PMfil = mass of particulate... stabilized), corrected to standard reference conditions. m PMfil = mass of particulate matter emissions on...

  17. 78 FR 13243 - Updates to Standards Incorporated by Reference; Reapproved ASTM Standards; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... Characteristics of Plastic Film 2009)[egr]1. and Sheeting. Standard Specification for F682-82a F682-82a 46 56.01-2... (Reapproved Standard Test Method for Determining Gas 2009)[egr]1. Permeability Characteristics of Plastic Film..., Fire prevention, Hazardous substances, Incorporation by reference, Oil pollution, Reporting and...

  18. Standard method of test for grindability of coal by the Hardgrove-machine method

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

    Not Available

    1975-01-01

    A procedure is described for sampling coal, grinding in a Hardgrove grinding machine, and passing through standard sieves to determine the degree of pulverization of coals. The grindability index of the coal tested is calculated from a calibration chart prepared by plotting weight of material passing a No. 200 sieve versus the Hardgrove Grindability Index for the standard reference samples. The Hardgrove machine is shown schematically. The method for preparing and determining grindability indexes of standard reference samples is given in the appendix. (BLM)

  19. [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.

  20. Quantitative Assessment of Commutability for Clinical Viral Load Testing Using a Digital PCR-Based Reference Standard

    PubMed Central

    Tang, L.; Sun, Y.; Buelow, D.; Gu, Z.; Caliendo, A. M.; Pounds, S.

    2016-01-01

    Given recent advances in the development of quantitative standards, particularly WHO international standards, efforts to better understand the commutability of reference materials have been made. Existing approaches in evaluating commutability include prediction intervals and correspondence analysis; however, the results obtained from existing approaches may be ambiguous. We have developed a “deviation-from-ideal” (DFI) approach to evaluate commutability of standards and applied it to the assessment of Epstein-Bar virus (EBV) load testing in four quantitative PCR assays, treating digital PCR as a reference assay. We then discuss advantages and limitations of the DFI approach as well as experimental design to best evaluate the commutability of an assay in practice. PMID:27076654

  1. 40 CFR 89.6 - Reference materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... set forth the material that has been incorporated by reference in this part. (1) ASTM material. The... 19428-2959. Document number and name 40 CFR part 89 reference ASTM D86-97: “Standard Test Method for Distillation of Petroleum Products at Atmospheric Pressure” Appendix A to Subpart D. ASTM D93-97: “Standard...

  2. 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.

  3. Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

    PubMed

    Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

    2016-03-26

    Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine.

  4. Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population

    PubMed Central

    Flegar-Meštrić, Zlata; Perkov, Sonja; Radeljak, Andrea

    2016-01-01

    Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients’ care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety. Through the standardization and harmonization processes of analytical methods the ability to create unique reference intervals is achieved. Such reference intervals could be applied globally in all laboratories using methods traceable to the same reference measuring system and analysing the biological samples from the populations with similar socio-demographic and ethnic characteristics. In this review we outlined the results of the harmonization processes in Croatia in the field of population based reference intervals for clinically relevant blood and serum constituents which are in accordance with ongoing activity for worldwide standardization and harmonization based on traceability in laboratory medicine. PMID:27019800

  5. Effect of Harm Anchors in Visual Displays of Test Results on Patient Perceptions of Urgency About Near-Normal Values: Experimental Study.

    PubMed

    Zikmund-Fisher, Brian J; Scherer, Aaron M; Witteman, Holly O; Solomon, Jacob B; Exe, Nicole L; Fagerlin, Angela

    2018-03-26

    Patient-facing displays of laboratory test results typically provide patients with one reference point (the "standard range"). To test the effect of including an additional harm anchor reference point in visual displays of laboratory test results, which indicates how far outside of the standard range values would need to be in order to suggest substantial patient risk. Using a demographically diverse, online sample, we compared the reactions of 1618 adults in the United States who viewed visual line displays that included both standard range and harm anchor reference points ("Many doctors are not concerned until here") to displays that included either (1) only a standard range, (2) standard range plus evaluative categories (eg, "borderline high"), or (3) a color gradient showing degree of deviation from the standard range. Providing the harm anchor reference point significantly reduced perceived urgency of close-to-normal alanine aminotransferase and creatinine results (P values <.001) but not generally for platelet count results. Notably, display type did not significantly alter perceptions of more extreme results in potentially harmful ranges. Harm anchors also substantially reduced the number of participants who wanted to contact their doctor urgently or go to the hospital about these test results. Presenting patients with evaluative cues regarding when test results become clinically concerning can reduce the perceived urgency of out-of-range results that do not require immediate clinical action. ©Brian J Zikmund-Fisher, Aaron M Scherer, Holly O Witteman, Jacob B Solomon, Nicole L Exe, Angela Fagerlin. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 26.03.2018.

  6. 40 CFR 98.7 - What standardized methods are incorporated by reference into this part?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ....astm.org. (1) ASTM C25-06 Standard Test Method for Chemical Analysis of Limestone, Quicklime, and....194(c), and § 98.334(b). (2) ASTM C114-09 Standard Test Methods for Chemical Analysis of Hydraulic... approved for § 98.6. (4) ASTM D240-02 (Reapproved 2007) Standard Test Method for Heat of Combustion of...

  7. 40 CFR 98.7 - What standardized methods are incorporated by reference into this part?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ....astm.org. (1) ASTM C25-06 Standard Test Method for Chemical Analysis of Limestone, Quicklime, and....194(c), and § 98.334(b). (2) ASTM C114-09 Standard Test Methods for Chemical Analysis of Hydraulic... approved for § 98.6. (4) ASTM D240-02 (Reapproved 2007) Standard Test Method for Heat of Combustion of...

  8. Evaluation of ability of reference toxicity tests to identify stress in laboratory populations of the amphipod Hyalella azteca

    USGS Publications Warehouse

    McNulty, E.W.; Dwyer, F.J.; Ellersieck, Mark R.; Greer, E.I.; Ingersoll, C.G.; Rabeni, C.F.

    1999-01-01

    Standard methods for conducting toxicity tests imply that the condition of test organisms can be established using reference toxicity tests. However, only a limited number of studies have evaluated whether reference toxicity tests can actually be used to determine if organisms are in good condition at the start of a test. We evaluated the ability of reference toxicants to identify stress associated with starvation in laboratory populations of the amphipod Hyalella azteca using acute toxicity tests and four reference toxicants: KCl, CdCl2, sodium pentachlorophenate (NaPCP), and carbaryl. Stress associated with severe starvation was observed with exposure of amphipods to carbaryl or NaPCP but not with exposure to KCl or CdCl2 (i.e., lower LC50 with severe starvation). Although the LC50s for NaPCP and carbaryl were statistically different between starved and fed amphipods, this difference may not be biologically significant given the variability expected in acute lethality tests. Stress associated with sieving, heat shock, or cold shock of amphipods before the start of a test was not evident with exposure to carbaryl or KCl as reference toxicants. The chemicals evaluated in this study provided minimal information about the condition of the organisms used to start a toxicity test. Laboratories should periodically perform reference toxicity tests to assess the sensitivity of life stages or strains of test organisms. However, use of other test acceptability criteria required in standard methods such as minimum survival, growth, or reproduction of organisms in the control treatment at the end of a test, provides more useful information about the condition of organisms used to start a test compared to data generated from reference toxicity tests.

  9. Reference Materials and Subject Matter Knowledge Codes for Airman Knowledge Testing

    DOT National Transportation Integrated Search

    2004-06-08

    The listings of reference materials and subject matter knowledge codes have been : prepared by the Federal Aviation Administration (FAA) to establish specific : references for all knowledge standards. The listings contain reference materials : to be ...

  10. International Standards and Reference Materials for Quantitative Molecular Infectious Disease Testing

    PubMed Central

    Madej, Roberta M.; Davis, Jack; Holden, Marcia J.; Kwang, Stan; Labourier, Emmanuel; Schneider, George J.

    2010-01-01

    The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same value across methods and test versions or by using reliable and stable conversions. Universally available standards and reference materials specific to quantitative molecular technologies are critical to this process but are few in number. This review describes recent history in the establishment of international standards for nucleic acid test development, organizations involved in current efforts, and future issues and initiatives. PMID:20075208

  11. 29 CFR Appendix A to Subpart Q of... - References to subpart Q of Part 1926

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... (ASTM C39-86). • Standard Test Method for Making and Curing Concrete Test Specimens in the Field (ASTM C31-85). • Standard Test Method for Penetration Resistance of Hardened Concrete (ASTM C803-82... (ASTM C873-85). • Standard Method for Developing Early Age Compressive Test Values and Projecting Later...

  12. Development of Composite Honeycomb and Solid Laminate Reference Standards to Aid Aircraft Inspections

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

    Dorrell, L.; Roach, D.

    1999-03-04

    The rapidly increasing use of composites on commercial airplanes coupled with the potential for economic savings associated with their use in aircraft structures means that the demand for composite materials technology will continue to increase. Inspecting these composite structures is a critical element in assuring their continued airworthiness. The FAA's Airworthiness Assurance NDI Validation Center, in conjunction with the Commercial Aircraft Composite Repair Committee (CACRC), is developing a set of composite reference standards to be used in NDT equipment calibration for accomplishment of damage assessment and post-repair inspection of all commercial aircraft composites. In this program, a series of NDImore » tests on a matrix of composite aircraft structures and prototype reference standards were completed in order to minimize the number of standards needed to carry out composite inspections on aircraft. Two tasks, related to composite laminates and non-metallic composite honeycomb configurations, were addressed. A suite of 64 honeycomb panels, representing the bounding conditions of honeycomb construction on aircraft, were inspected using a wide array of NDI techniques. An analysis of the resulting data determined the variables that play a key role in setting up NDT equipment. This has resulted in a prototype set of minimum honeycomb reference standards that include these key variables. A sequence of subsequent tests determined that this minimum honeycomb reference standard set is able to fully support inspections over the fill range of honeycomb construction scenarios. Current tasks are aimed at optimizing the methods used to engineer realistic flaws into the specimens. In the solid composite laminate arena, we have identified what appears to be an excellent candidate, G11 Phenolic, as a generic solid laminate reference standard material. Testing to date has determined matches in key velocity and acoustic impedance properties, as well as, low attenuation relative to carbon laminates. Furthermore, comparisons of resonance testing response curves from the G11 Phenolic prototype standard was very similar to the resonance response curves measured on the existing carbon and fiberglass laminates. NDI data shows that this material should work for both pulse-echo (velocity-based) and resonance (acoustic impedance-based) inspections. Additional testing and industry review activities are underway to complete the validation of this material.« less

  13. Field Demonstration and Validation of a New Device for Measuring Water and Solute Fluxes at Naval Base Ventura County (NBVC), Port Hueneme, CA

    DTIC Science & Technology

    2006-07-01

    All Quality Control Reference Materials are acquired only from authorized vendors or sources commonly used by U.S. EPA Regional Laboratories...are traceable to the National Institue of Standards and Testing (NITS) Standard Reference Materials (SRM) or to the U.S. EPA Reference Standards... clothing or equipment by blowing, shaking or any other means that may disperse material into the air is prohibited. 7.1.3. All disposable personal

  14. 40 CFR Appendix Xv to Part 86 - Procedure for Determining an Acceptable Exhaust Regeneration Durability-Data Test Schedule for...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Acceptable Exhaust Regeneration Durability-Data Test Schedule for Diesel Cycle Vehicles Equipped With... Appendix XV to Part 86—Procedure for Determining an Acceptable Exhaust Regeneration Durability-Data Test... = Total number of regeneration emission tests. (Subscript “s” refers to standard test schedule) 5. Refer...

  15. 40 CFR Appendix Xv to Part 86 - Procedure for Determining an Acceptable Exhaust Regeneration Durability-Data Test Schedule for...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Acceptable Exhaust Regeneration Durability-Data Test Schedule for Diesel Cycle Vehicles Equipped With... Appendix XV to Part 86—Procedure for Determining an Acceptable Exhaust Regeneration Durability-Data Test... = Total number of regeneration emission tests. (Subscript “s” refers to standard test schedule) 5. Refer...

  16. 40 CFR Appendix Xv to Part 86 - Procedure for Determining an Acceptable Exhaust Regeneration Durability-Data Test Schedule for...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Acceptable Exhaust Regeneration Durability-Data Test Schedule for Diesel Cycle Vehicles Equipped With... Appendix XV to Part 86—Procedure for Determining an Acceptable Exhaust Regeneration Durability-Data Test... = Total number of regeneration emission tests. (Subscript “s” refers to standard test schedule) 5. Refer...

  17. 10 CFR 431.263 - Materials incorporated by reference.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Society for Testing and Materials (ASTM) Standard F2324-03, “Standard Test Method for Prerinse Spray..., Forrestal Building, Room 1J-018 (Resource Room of the Building Technologies Program), 1000 Independence...

  18. 10 CFR 431.263 - Materials incorporated by reference.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Society for Testing and Materials (ASTM) Standard F2324-03, “Standard Test Method for Prerinse Spray..., Forrestal Building, Room 1J-018 (Resource Room of the Building Technologies Program), 1000 Independence...

  19. 40 CFR 89.6 - Reference materials.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... July 1, 2009), Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (the Calculation of Dynamic Viscosity), IBR approved for appendix A to subpart D. (6) ASTM D613-95, Standard Test...

  20. 40 CFR 89.6 - Reference materials.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... July 1, 2009), Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (the Calculation of Dynamic Viscosity), IBR approved for appendix A to subpart D. (6) ASTM D613-95, Standard Test...

  1. 40 CFR 89.6 - Reference materials.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... July 1, 2009), Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (the Calculation of Dynamic Viscosity), IBR approved for appendix A to subpart D. (6) ASTM D613-95, Standard Test...

  2. Methodological Issues in Antifungal Susceptibility Testing of Malassezia pachydermatis

    PubMed Central

    Peano, Andrea; Pasquetti, Mario; Tizzani, Paolo; Chiavassa, Elisa; Guillot, Jacques; Johnson, Elizabeth

    2017-01-01

    Reference methods for antifungal susceptibility testing of yeasts have been developed by the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antibiotic Susceptibility Testing (EUCAST). These methods are intended to test the main pathogenic yeasts that cause invasive infections, namely Candida spp. and Cryptococcus neoformans, while testing other yeast species introduces several additional problems in standardization not addressed by these reference procedures. As a consequence, a number of procedures have been employed in the literature to test the antifungal susceptibility of Malassezia pachydermatis. This has resulted in conflicting results. The aim of the present study is to review the procedures and the technical parameters (growth media, inoculum preparation, temperature and length of incubation, method of reading) employed for susceptibility testing of M. pachydermatis, and when possible, to propose recommendations for or against their use. Such information may be useful for the future development of a reference assay. PMID:29371554

  3. 40 CFR 761.19 - References.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Products (General Bomb Method) § 761.71(b)(2)(vi) ASTM D 240-87 Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuel by Bomb Calorimeter § 761.71(b)(2)(vi) ASTM D 482-87 Standard Test Method... in New and Used Petroleum Products (Bomb Method) § 761.71(b)(2)(vi) ASTM D 923-86 Standard Test...

  4. 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...

  5. Predicting fertility.

    PubMed

    Maheshwari, Abha; Bhattacharya, Siladitya; Johnson, Neil P

    2008-06-01

    Various predictors of fertility have been described, suggesting that none are ideal. The literature on tests of ovarian reserve is largely limited to women undergoing in vitro fertilization, and is reliant on the use of surrogate markers, such as cycle cancellation and number of oocytes retrieved, as reference standards. Currently available prediction models are far from ideal; most are applicable only to subfertile women seeking assisted reproduction, and lack external validation. Systematic reviews and meta-analyses of predictors of fertility are limited by their heterogeneity in terms of the population sampled, predictors tested and reference standards used. There is an urgent need for consensus in the design of these studies, definition of abnormal tests, and, above all, a need to use robust outcomes such as live birth as the reference standard. There are no reliable predictors of fertility that can guide women as to how long childbearing can be deferred.

  6. 40 CFR 91.6 - Reference materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Appendix A to Subpart D. ASTM D2699-92: Standard Test Method for Knock Characteristics of Motor Fuels by the Research Method Appendix A to Subpart D. ASTM D2700-92: Standard Test Method for Knock...

  7. 40 CFR 91.6 - Reference materials.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Appendix A to Subpart D. ASTM D2699-92: Standard Test Method for Knock Characteristics of Motor Fuels by the Research Method Appendix A to Subpart D. ASTM D2700-92: Standard Test Method for Knock...

  8. 40 CFR 98.7 - What standardized methods are incorporated by reference into this part?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...-B2959, (800) 262-1373, http://www.astm.org. (1) ASTM C25-06 Standard Test Method for Chemical Analysis...), § 98.174(b), § 98.184(b), § 98.194(c), and § 98.334(b). (2) ASTM C114-09 Standard Test Methods for... Dry Cleaning Solvent), IBR approved for § 98.6. (4) ASTM D240-02 (Reapproved 2007) Standard Test...

  9. Practised Intelligence Testing Based on a Modern Test Conceptualization and Its Reference to the Common Intelligence Theories

    ERIC Educational Resources Information Center

    Kubinger, Klaus D.; Litzenberger, Margarete; Mrakotsky, Christine

    2006-01-01

    The question is to what extent intelligence test-batteries prove any kind of empirical reference to common intelligence theories. Of particular interest are conceptualized tests that are of a high psychometric standard--those that fit the Rasch model--and hence are not exposed to fundamental critique. As individualized testing, i.e., a…

  10. Standard wool fabric as a reference material. [for fire toxicity tests

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Cumming, H. J.

    1977-01-01

    Standard wool fabric is investigated as a potential reference material. A screening test method for relative toxicity exposes four albino male rats enclosed in a 4.2 liter hemispherical chamber to pyrolysis effluents produced by pyrolyzing a 1.00 g sample under a variety of test conditions (200-800 C with a 40 C/min heating rate). It is found that for fabrics containing 86-100% wool, animal response remains virtually unchanged, although a 100% wool fabric is preferred as it eliminates local composition differences as a source of variation.

  11. 40 CFR 63.14 - Incorporations by reference.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Testing and Materials (ASTM), 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428... (Reapproved 2010), Standard Test Method for Water in Petroleum Products and Bituminous Materials by...-09 Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter...

  12. Screening and surveillance. OSHA's medical surveillance provisions.

    PubMed

    Papp, E M; Miller, A S

    2000-02-01

    The OSH Act requires OSHA to include provisions for medical examinations of employees in its standards. However, the specific test and examinations criteria are not outlined in the OSH Act. Instead, each standard has specific medical surveillance requirements. These are specific to the adverse health effects triggered by exposure to the hazardous substance. The OSHA uses the term medical surveillance to refer to its employee examination and testing provisions. Most occupational health professionals call this activity employee screening and reserve the term surveillance for aggregate analysis of population data. It is important to remember this distinction when referring to OSHA standards. Many standards are challenged in court resulting in changes to medical surveillance provisions of the standards. Some court decisions support OSHA's language. In either case, the court often sets precedents for future standards.

  13. ITS-90 Thermocouple Database

    National Institute of Standards and Technology Data Gateway

    SRD 60 NIST ITS-90 Thermocouple Database (Web, free access)   Web version of Standard Reference Database 60 and NIST Monograph 175. The database gives temperature -- electromotive force (emf) reference functions and tables for the letter-designated thermocouple types B, E, J, K, N, R, S and T. These reference functions have been adopted as standards by the American Society for Testing and Materials (ASTM) and the International Electrotechnical Commission (IEC).

  14. [Laboratory accreditation and proficiency testing].

    PubMed

    Kuwa, Katsuhiko

    2003-05-01

    ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

  15. Quantitative determination and validation of octreotide acetate using 1 H-NMR spectroscopy with internal standard method.

    PubMed

    Yu, Chen; Zhang, Qian; Xu, Peng-Yao; Bai, Yin; Shen, Wen-Bin; Di, Bin; Su, Meng-Xiang

    2018-01-01

    Quantitative nuclear magnetic resonance (qNMR) is a well-established technique in quantitative analysis. We presented a validated 1 H-qNMR method for assay of octreotide acetate, a kind of cyclic octopeptide. Deuterium oxide was used to remove the undesired exchangeable peaks, which was referred to as proton exchange, in order to make the quantitative signals isolated in the crowded spectrum of the peptide and ensure precise quantitative analysis. Gemcitabine hydrochloride was chosen as the suitable internal standard. Experimental conditions, including relaxation delay time, the numbers of scans, and pulse angle, were optimized first. Then method validation was carried out in terms of selectivity, stability, linearity, precision, and robustness. The assay result was compared with that by means of high performance liquid chromatography, which is provided by Chinese Pharmacopoeia. The statistical F test, Student's t test, and nonparametric test at 95% confidence level indicate that there was no significant difference between these two methods. qNMR is a simple and accurate quantitative tool with no need for specific corresponding reference standards. It has the potential of the quantitative analysis of other peptide drugs and standardization of the corresponding reference standards. Copyright © 2017 John Wiley & Sons, Ltd.

  16. Measuring Thermal Conductivity at LH2 Temperatures

    NASA Technical Reports Server (NTRS)

    Selvidge, Shawn; Watwood, Michael C.

    2004-01-01

    For many years, the National Institute of Standards and Technology (NIST) produced reference materials for materials testing. One such reference material was intended for use with a guarded hot plate apparatus designed to meet the requirements of ASTM C177-97, "Standard Test Method for Steady-State Heat Flux Measurements and Thermal Transmission Properties by Means of the Guarded-Hot-Plate Apparatus." This apparatus can be used to test materials in various gaseous environments from atmospheric pressure to a vacuum. It allows the thermal transmission properties of insulating materials to be measured from just above ambient temperature down to temperatures below liquid hydrogen. However, NIST did not generate data below 77 K temperature for the reference material in question. This paper describes a test method used at NASA's Marshall Space Flight Center (MSFC) to optimize thermal conductivity measurements during the development of thermal protection systems. The test method extends the usability range of this reference material by generating data at temperatures lower than 77 K. Information provided by this test is discussed, as are the capabilities of the MSFC Hydrogen Test Facility, where advanced methods for materials testing are routinely developed and optimized in support of aerospace applications.

  17. National Survey of Adult and Pediatric Reference Intervals in Clinical Laboratories across Canada: A Report of the CSCC Working Group on Reference Interval Harmonization.

    PubMed

    Adeli, Khosrow; Higgins, Victoria; Seccombe, David; Collier, Christine P; Balion, Cynthia M; Cembrowski, George; Venner, Allison A; Shaw, Julie

    2017-11-01

    Reference intervals are widely used decision-making tools in laboratory medicine, serving as health-associated standards to interpret laboratory test results. Numerous studies have shown wide variation in reference intervals, even between laboratories using assays from the same manufacturer. Lack of consistency in either sample measurement or reference intervals across laboratories challenges the expectation of standardized patient care regardless of testing location. Here, we present data from a national survey conducted by the Canadian Society of Clinical Chemists (CSCC) Reference Interval Harmonization (hRI) Working Group that examines variation in laboratory reference sample measurements, as well as pediatric and adult reference intervals currently used in clinical practice across Canada. Data on reference intervals currently used by 37 laboratories were collected through a national survey to examine the variation in reference intervals for seven common laboratory tests. Additionally, 40 clinical laboratories participated in a baseline assessment by measuring six analytes in a reference sample. Of the seven analytes examined, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and creatinine reference intervals were most variable. As expected, reference interval variation was more substantial in the pediatric population and varied between laboratories using the same instrumentation. Reference sample results differed between laboratories, particularly for ALT and free thyroxine (FT4). Reference interval variation was greater than test result variation for the majority of analytes. It is evident that there is a critical lack of harmonization in laboratory reference intervals, particularly for the pediatric population. Furthermore, the observed variation in reference intervals across instruments cannot be explained by the bias between the results obtained on instruments by different manufacturers. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  18. Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)

    PubMed Central

    2010-01-01

    Background The Worldwide Antimalarial Resistance Network (WWARN) is a global collaboration to support the objective that anyone affected by malaria receives effective and safe drug treatment. The Pharmacology module aims to inform optimal anti-malarial drug selection. There is an urgent need to define the drug exposure - effect relationship for most anti-malarial drugs. Few anti-malarials have had their therapeutic blood concentration levels defined. One of the main challenges in assessing safety and efficacy data in relation to drug concentrations is the comparability of data generated from different laboratories. To explain differences in anti-malarial pharmacokinetics in studies with different measurement laboratories it is necessary to confirm the accuracy of the assay methods. This requires the establishment of an external quality assurance process to assure results that can be compared. This paper describes this process. Methods The pharmacology module of WWARN has established a quality assurance/quality control (QA/QC) programme consisting of two separate components: 1. A proficiency testing programme where blank human plasma spiked with certified reference material (CRM) in different concentrations is sent out to participating bioanalytical laboratories. 2. A certified reference standard programme where accurately weighed amounts of certified anti-malarial reference standards, metabolites, and internal standards are sent to participating bioanalytical and in vitro laboratories. Conclusion The proficiency testing programme is designed as a cooperative effort to help participating laboratories assess their ability to carry out drug analysis, resolve any potential problem areas and to improve their results - and, in so doing, to improve the quality of anti-malarial pharmacokinetic data published and shared with WWARN. By utilizing the same source of standards for all laboratories, it is possible to minimize bias arising from poor quality reference standards. By providing anti-malarial drug standards from a central point, it is possible to lower the cost of these standards. PMID:21184684

  19. 40 CFR 63.705 - Performance test methods and procedures to determine initial compliance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... per gram-mole. Pi = Barometric pressure at the time of sample analysis, millimeters mercury absolute. 760 = Reference or standard pressure, millimeters mercury absolute. 293 = Reference or standard...: ER15DE94.005 (i) The value of RSi is zero unless the owner or operator submits the following information to...

  20. 40 CFR 63.705 - Performance test methods and procedures to determine initial compliance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... per gram-mole. Pi = Barometric pressure at the time of sample analysis, millimeters mercury absolute. 760 = Reference or standard pressure, millimeters mercury absolute. 293 = Reference or standard...: ER15DE94.005 (i) The value of RSi is zero unless the owner or operator submits the following information to...

  1. 40 CFR 63.705 - Performance test methods and procedures to determine initial compliance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... per gram-mole. Pi = Barometric pressure at the time of sample analysis, millimeters mercury absolute. 760 = Reference or standard pressure, millimeters mercury absolute. 293 = Reference or standard...: ER15DE94.005 (i) The value of RSi is zero unless the owner or operator submits the following information to...

  2. 40 CFR 63.705 - Performance test methods and procedures to determine initial compliance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... per gram-mole. Pi = Barometric pressure at the time of sample analysis, millimeters mercury absolute. 760 = Reference or standard pressure, millimeters mercury absolute. 293 = Reference or standard...: ER15DE94.005 (i) The value of RSi is zero unless the owner or operator submits the following information to...

  3. 40 CFR 63.705 - Performance test methods and procedures to determine initial compliance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... per gram-mole. Pi = Barometric pressure at the time of sample analysis, millimeters mercury absolute. 760 = Reference or standard pressure, millimeters mercury absolute. 293 = Reference or standard...: ER15DE94.005 (i) The value of RSi is zero unless the owner or operator submits the following information to...

  4. Evaluation of p,p'-DDT as a reference toxicant in bioassays

    USGS Publications Warehouse

    Marking, Leif L.

    1966-01-01

    p,p'-DDT was tested as a reference standard toxicant against 19 species of freshwater fish, including 39 lots from 10 sources. In particular, the rapidity, nonselectivity, and consistency of its toxicity to fish were evaluated in 96-hour static bioassays. The chemical was rapidly and consistently toxic to lake trout, carp, green sunfish, bluegill, and yellow perch. It lacked either rapid or consistent toxicity to rainbow trout, brook trout, goldfish, fathead minnows, and longear sunfish in 96-hour tests. Thus, p,p'-DDT is of limited usefulness as a reference standard toxicant in large bioassays with many species of fish.

  5. Alternative mass reference standards for direct analysis in real time mass spectrometry.

    PubMed

    Cody, Robert B; Dane, A John

    2016-05-30

    Mass spectra were acquired with the Direct Analysis in Real Time (DART®) ion source for an amine-terminated polyether used as positive-ion mass reference standards and for several fluorinated materials commonly used as negative-ion reference standards for mass spectrometry. A commercial time-of-flight mass spectrometer equipped with a DART ion source was used for all measurements. Mass reference standards deposited onto the sealed end of a glass melting point tube were suspended in the DART gas stream for analysis. A polyetheramine (Jeffamine® M-600) produced intense peaks corresponding to protonated molecules. Perfluorotributylamine (PFTBA), and perfluorotripentylamine, gave useful reference spectra for different m/z ranges. DART mass spectra of Ultramark 1621® resembled those previously reported for Fast Atom Bombardment (FAB) and Electrospray Ionization (ESI). Fomblin®Y, a fluorinated ether, was the most useful negative-ion reference standard of the materials tested. The material is commercially available, inexpensive, and provides reference peaks covering the m/z range 85 to >3000. Jeffamine-M600 was found to be a convenient alternative to polyethers such as polyethylene glycol (PEG) for DART positive-ion mass calibration. Fomblin Y was suitable for use as a negative-ion reference standard. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  6. 40 CFR 160.47 - Facilities for handling test, control, and reference substances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Facilities for handling test, control, and reference substances. 160.47 Section 160.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Facilities § 160.47 Facilities...

  7. 40 CFR 792.47 - Facilities for handling test, control, and reference substances.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Facilities for handling test, control, and reference substances. 792.47 Section 792.47 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Facilities...

  8. [Preparation and characterization of follwing the national standard anti-Brucella abortus serum, bovine].

    PubMed

    Li, Cui; Guan, Fushi; Dai, Zhihong; Jiang, Hui; Wen, Fang; Lu, Lianshou; Wang, Zaishi

    2011-05-01

    To prepare anti-Brucella abortus serum used for calibrate the agglutination test follwing the national standard, 4 anti-Brucella abortus sera were obtained from 4 cows infected with Brucella abortus naturally. By potency testing, the third serum was selected. Sterility, vaccum degree, residual moisture, uniformity and stability of this standard material were tested and proved to meet the national standard. Referring to the international standard, RBT (Rose-Bengal plate agglutination test), SAT (standard tube agglutination) and CFT (complement fixation test) titers of this standard material were measured to be 1:160 "+" 1:2 400 "++" and 1:800 "++", which are identical with the collaborative assay results. International unit of the standard material is 4 000 IU/mL.

  9. Physical fitness reference standards in European children: the IDEFICS study.

    PubMed

    De Miguel-Etayo, P; Gracia-Marco, L; Ortega, F B; Intemann, T; Foraita, R; Lissner, L; Oja, L; Barba, G; Michels, N; Tornaritis, M; Molnár, D; Pitsiladis, Y; Ahrens, W; Moreno, L A

    2014-09-01

    A low fitness status during childhood and adolescence is associated with important health-related outcomes, such as increased future risk for obesity and cardiovascular diseases, impaired skeletal health, reduced quality of life and poor mental health. Fitness reference values for adolescents from different countries have been published, but there is a scarcity of reference values for pre-pubertal children in Europe, using harmonised measures of fitness in the literature. The IDEFICS study offers a good opportunity to establish normative values of a large set of fitness components from eight European countries using common and well-standardised methods in a large sample of children. Therefore, the aim of this study is to report sex- and age-specific fitness reference standards in European children. Children (10,302) aged 6-10.9 years (50.7% girls) were examined. The test battery included: the flamingo balance test, back-saver sit-and-reach test (flexibility), handgrip strength test, standing long jump test (lower-limb explosive strength) and 40-m sprint test (speed). Moreover, cardiorespiratory fitness was assessed by a 20-m shuttle run test. Percentile curves for the 1st, 3rd, 10th, 25th, 50th, 75th, 90th, 97th and 99th percentiles were calculated using the General Additive Model for Location Scale and Shape (GAMLSS). Our results show that boys performed better than girls in speed, lower- and upper-limb strength and cardiorespiratory fitness, and girls performed better in balance and flexibility. Older children performed better than younger children, except for cardiorespiratory fitness in boys and flexibility in girls. Our results provide for the first time sex- and age-specific physical fitness reference standards in European children aged 6-10.9 years.

  10. Introducing a true internal standard for the Comet assay to minimize intra- and inter-experiment variability in measures of DNA damage and repair

    PubMed Central

    Zainol, Murizal; Stoute, Julia; Almeida, Gabriela M.; Rapp, Alexander; Bowman, Karen J.; Jones, George D. D.

    2009-01-01

    The Comet assay (CA) is a sensitive/simple measure of genotoxicity. However, many features of CA contribute variability. To minimize these, we have introduced internal standard materials consisting of ‘reference’ cells which have their DNA substituted with BrdU. Using a fluorescent anti-BrdU antibody, plus an additional barrier filter, comets derived from these cells could be readily distinguished from the ‘test’-cell comets, present in the same gel. In experiments to evaluate the reference cell comets as external and internal standards, the reference and test cells were present in separate gels on the same slide or mixed together in the same gel, respectively, before their co-exposure to X-irradiation. Using the reference cell comets as internal standards led to substantial reductions in the coefficient of variation (CoV) for intra- and inter-experimental measures of comet formation and DNA damage repair; only minor reductions in CoV were noted when the reference and test cell comets were in separate gels. These studies indicate that differences between individual gels appreciably contribute to CA variation. Further studies using the reference cells as internal standards allowed greater significance to be obtained between groups of replicate samples. Ultimately, we anticipate that development will deliver robust quality assurance materials for CA. PMID:19828597

  11. Structural characterization and antimicrobial activities of transition metal complexes of a hydrazone ligand

    NASA Astrophysics Data System (ADS)

    Bakale, Raghavendra P.; Naik, Ganesh N.; Machakanur, Shrinath S.; Mangannavar, Chandrashekhar V.; Muchchandi, Iranna S.; Gudasi, Kalagouda B.

    2018-02-01

    A hydrazone ligand has been synthesized by the condensation of 2-nitrobenzaldehyde and hydralazine, and its Co(II), Ni(II), Cu(II) and Zn(II) complexes have been reported. Structural characterization of the ligand and its metal complexes has been performed by various spectroscopic [IR, NMR, UV-Vis, Mass], thermal and other physicochemical methods. The structure of the ligand and its Ni(II) complex has been characterized by single crystal X-ray diffraction studies. All the synthesized compounds have been screened for in vitro antimicrobial activity. The antibacterial activity is tested against Gram-positive strains Enterococcus faecalis, Streptococcus mutans and Staphylococcus aureus and Gram-negative strains Escherichia coli, Pseudomonas aeruginosa and Klebsiella pneumoniae using ciprofloxacin as the reference standard. Antifungal activity is tested against Candida albicans, Aspergillus fumigatus and Aspergillus niger using ketoconazole as the reference standard. The minimum inhibitory concentration (MIC) was determined for test compounds as well as for reference standard. Ligand, Cu(II) and Zn(II) complexes have shown excellent activity against Candida albicans.

  12. Expanding Student Assessment.

    ERIC Educational Resources Information Center

    Perrone, Vito, Ed.

    This book supports constructive discussion about assessment and provides concrete directions for change. The 10 chapters outline many of the difficulties associated with current standardized testing. While most educators refer to the new non-standardized test efforts as alternative assessments, this type of assessment is increasingly being called…

  13. A Study of Inference in Standardized Reading Test Items and Its Relationship to Difficulty.

    ERIC Educational Resources Information Center

    Marzano, Robert J.

    To study the relationship between inferences made on standardized reading tests and item difficulty, 50 items on the reading comprehension section of the Metropolitan Achievement Test were analyzed independently in this study by two raters using four general categories of inferences: (1) reference inferences, (2) between proposition inferences,…

  14. 40 CFR 52.742 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... from the American Society for Testing and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103. (1) ASTM D1475-85, Standard Test Method for Density of Paint, Varnish, Lacquer, and Related Products, for § 52.741(a)(4)(i)(B)(3)(i). (2) ASTM D2369-87, Standard Test Method for Volatile Content of...

  15. The Real-Life-Referent as a Standard for News Perspective Bias.

    ERIC Educational Resources Information Center

    Barbatsis, Gretchen S.

    The concept of news perspective bias necessitates the creation of an empirical standard by which to judge that bias. A study defined and tested a real life referent applicable to planned, sustained news events that have identifiable and accessible participants. The study compared the television news coverage of court ordered busing to achieve…

  16. EVALUATION OF ALTERNATIVE REFERENCE TOXICANTS FOR USE IN THE EARTHWORM TOXICITY TEST

    EPA Science Inventory

    The use of the 14-d earthworm toxicity test to aid in the evaluation of the ecological impact of contaminated soils is becoming increasingly widespread. However,the method is in need of further standardization. As part of this continuing process, the choice of reference toxicants...

  17. Limited Aspects of Reality: Frames of Reference in Language Assessment

    ERIC Educational Resources Information Center

    Fulcher, Glenn; Svalberg, Agneta

    2013-01-01

    Language testers operate within two frames of reference: norm-referenced (NRT) and criterion-referenced testing (CRT). The former underpins the world of large-scale standardized testing that prioritizes variability and comparison. The latter supports substantive score meaning in formative and domain specific assessment. Some claim that the…

  18. A Criterion-Referenced Viewpoint on Standards/Cutscores in Language Testing.

    ERIC Educational Resources Information Center

    Davidson, Fred; Lynch, Brian K.

    "Standard" is distinguished from "criterion" as it is used in criterion-referenced testing. The former is argued to refer to the real-world cutpoint at which a decision is made based on a test's result (e.g., exemption from a special training program). The latter is a skill or set of skills to which a test is referenced.…

  19. Bisphenol A polycarbonate as a reference material

    NASA Technical Reports Server (NTRS)

    Hilado, C. J.; Cumming, H. J.; Williams, J. B.

    1977-01-01

    Test methods require reference materials to standardize and maintain quality control. Various materials have been evaluated as possible reference materials, including a sample of bisphenol A polycarbonate without additives. Screening tests for relative toxicity under various experimental conditions were performed using male mice exposed to pyrolysis effluents over a 200-800 C temperature range. It was found that the bisphenol A polycarbonate served as a suitable reference material as it is available in large quantities, and does not significantly change with time.

  20. Establishment of quality assurance procedures for aquatic toxicity testing with the nematode Caenorhabditis elegans

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

    Freeman, M.N.; Marse, T.J.; Williams, P.L.

    1998-12-31

    In this study initial data were generated to develop laboratory control charts for aquatic toxicity testing using the nematode Caenorhabditis elegans. Tests were performed using two reference toxicants: CdCl{sub 2} and CuCl{sub 2}. All tests were performed for 24 h without a food source and of 48 h with a food source in a commonly used nematode aquatic medium. Each test was replicated 6 times with each replicate having 6 wells per concentration with 10 {+-} 1 worms per well. Probit analysis was used to estimate LC{sub 50} values for each test. The data were used to construct a meanmore » ({bar x}) laboratory control chart for each reference toxicant. The coefficient of variation (CV) for three of the four reference toxicant tests was less than 20%, which demonstrates an excellent degree of reproducibility. These CV values are well within suggested standards for determination of organism sensitivity and overall test system credibility. A standardized procedure for performing 24 h and 48 h aquatic toxicity studies with C. elegans is proposed.« less

  1. Historical Evolution of NASA Standard Materials Testing with Hypergolic Propellants and Ammonia (NASA Standard 6001 Test 15)

    NASA Technical Reports Server (NTRS)

    Greene, Benjamin; McClure, Mark B.

    2012-01-01

    The NASA Johnson Space Center White Sands Test Facility (WSTF) has performed testing of hazardous and reactive aerospace fluids, including hypergolic propellants, with materials since the 1960s with the Apollo program. Amongst other test activities, Test 15 is a NASA standard test for evaluating the reactivity of materials with selected aerospace fluids, in particular hydrazine, monomethylhydrazine, uns-dimethylhydrazine, Aerozine 50, dinitrogen tetroxide oxidizers, and ammonia. This manuscript provides an overview of the history of Test 15 over a timeline ranging from prior to its development and first implementation as a NASA standard test in 1974 to its current refinement. Precursor documents to NASA standard tests, as they are currently known, are reviewed. A related supplementary test, international standardization, and enhancements to Test 15 are also discussed. Because WSTF was instrumental in the development and implementation of Test 15, WSTF experience and practices are referred to in this manuscript.

  2. Development of a Comprehensive Osteochondral Allograft MRI Scoring System (OCAMRISS) With Histopathologic, Micro–Computed Tomography, and Biomechanical Validation

    PubMed Central

    Pallante-Kichura, Andrea L.; Bae, Won C.; Du, Jiang; Statum, Sheronda; Wolfson, Tanya; Gamst, Anthony C.; Cory, Esther; Amiel, David; Bugbee, William D.; Sah, Robert L.; Chung, Christine B.

    2014-01-01

    Objective: To describe and apply a semiquantitative MRI scoring system for multifeature analysis of cartilage defect repair in the knee by osteochondral allografts and to correlate this scoring system with histopathologic, micro–computed tomography (µCT), and biomechanical reference standards using a goat repair model. Design: Fourteen adult goats had 2 osteochondral allografts implanted into each knee: one in the medial femoral condyle and one in the lateral trochlea. At 12 months, goats were euthanized and MRI was performed. Two blinded radiologists independently rated 9 primary features for each graft, including cartilage signal, fill, edge integration, surface congruity, calcified cartilage integrity, subchondral bone plate congruity, subchondral bone marrow signal, osseous integration, and presence of cystic changes. Four ancillary features of the joint were also evaluated, including opposing cartilage, meniscal tears, synovitis, and fat-pad scarring. Comparison was made with histologic and µCT reference standards as well as biomechanical measures. Interobserver agreement and agreement with reference standards was assessed. Cohen’s κ, Spearman’s correlation, and Kruskal-Wallis tests were used as appropriate. Results: There was substantial agreement (κ > 0.6, P < 0.001) for each MRI feature and with comparison against reference standards, except for cartilage edge integration (κ = 0.6). There was a strong positive correlation between MRI and reference standard scores (ρ = 0.86, P < 0.01). Osteochondral allograft MRI scoring system was sensitive to differences in outcomes between the types of allografts. Conclusions: We have described a comprehensive MRI scoring system for osteochondral allografts and have validated this scoring system with histopathologic and µCT reference standards as well as biomechanical indentation testing. PMID:24489999

  3. Issues and Methods for Standard-Setting.

    ERIC Educational Resources Information Center

    Hambleton, Ronald K.; And Others

    Issues involved in standard setting along with methods for standard setting are reviewed, with specific reference to their relevance for criterion referenced testing. Definitions are given of continuum and state models, and traditional and normative standard setting procedures. Since continuum models are considered more appropriate for criterion…

  4. Part 2: Sensitivity comparisons of the insect Centroptilum triangulifer to Ceriodaphnia dubia and Daphnia magna using standard reference toxicants; NaCl, KCl and CuSO4

    EPA Science Inventory

    Criteria for establishing water quality standards that are protective of all native biota are generally based upon laboratory toxicity tests. These test utilize common model organisms that have established test methods. However, only a small portion of species have established ...

  5. 40 CFR 86.1 - Reference materials.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) ASTM D1945-91, Standard Test Method for Analysis of Natural Gas by Gas Chromatography, IBR approved for §§ 86.113-94, 86.513-94, 86.1213-94, 86.1313-94. (iii) ASTM D2163-91, Standard Test Method for Analysis... §§ 86.113-94, 86.1213-94, 86.1313-94. (iv) ASTM D2986-95a, Reapproved 1999, Standard Practice for...

  6. 40 CFR 86.1 - Reference materials.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) ASTM D1945-91, Standard Test Method for Analysis of Natural Gas by Gas Chromatography, IBR approved for §§ 86.113-94, 86.513-94, 86.1213-94, 86.1313-94. (iii) ASTM D2163-91, Standard Test Method for Analysis... §§ 86.113-94, 86.1213-94, 86.1313-94. (iv) ASTM D2986-95a, Reapproved 1999, Standard Practice for...

  7. 40 CFR 59.412 - Incorporations by reference.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... address: American Society for Testing and Materials (ASTM), 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959. (1) ASTM Method C 1315-95, Standard Specification for Liquid Membrane-Forming Compounds....401, Concrete curing and sealing compound. (2) ASTM Method D 523-89, Standard Test Method for Specular...

  8. Standardized methods and quality control limits for agar and broth microdilution susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum.

    PubMed

    Waites, Ken B; Duffy, Lynn B; Bébéar, Cécile M; Matlow, Anne; Talkington, Deborah F; Kenny, George E; Totten, Patricia A; Bade, Donald J; Zheng, Xiaotian; Davidson, Maureen K; Shortridge, Virginia D; Watts, Jeffrey L; Brown, Steven D

    2012-11-01

    An international multilaboratory collaborative study was conducted to develop standard media and consensus methods for the performance and quality control of antimicrobial susceptibility testing of Mycoplasma pneumoniae, Mycoplasma hominis, and Ureaplasma urealyticum using broth microdilution and agar dilution techniques. A reference strain from the American Type Culture Collection was designated for each species, which was to be used for quality control purposes. Repeat testing of replicate samples of each reference strain by participating laboratories utilizing both methods and different lots of media enabled a 3- to 4-dilution MIC range to be established for drugs in several different classes, including tetracyclines, macrolides, ketolides, lincosamides, and fluoroquinolones. This represents the first multilaboratory collaboration to standardize susceptibility testing methods and to designate quality control parameters to ensure accurate and reliable assay results for mycoplasmas and ureaplasmas that infect humans.

  9. 47 CFR 90.379 - ASTM E2213-03 DSRC Standard (ASTM-DSRC Standard).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false ASTM E2213-03 DSRC Standard (ASTM-DSRC Standard... Communications Service (dsrcs) § 90.379 ASTM E2213-03 DSRC Standard (ASTM-DSRC Standard). Roadside Units... incorporated by reference: American Society for Testing and Materials (ASTM) E2213-03, “Standard Specification...

  10. A Test and Reformulation of Reference Group and Role Correlates of Premarital Sexual Permissiveness Theory

    ERIC Educational Resources Information Center

    Libby, Roger W.; And Others

    1978-01-01

    Propositions concerned with reference group and role correlates of Ira Reiss' premarital sexual permissiveness theory were tested. Reiss' basic propositions are only partially supported. Closeness to mother's sexual standards is considerably more predictive of self-permissiveness than was obvious in Reiss' theory. Closeness to friends' and peers'…

  11. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... distribution, and inflation medium retention test, UL 1517, sections 18 and 19, except: (i) Recreational hybrid... Method Standard 191, or ASTM D 751 (incorporated by reference, see § 160.077-5). (4) Permeability. The permeability of chamber materials must be determined according to ASTM D 1434 (incorporated by reference, see...

  12. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... distribution, and inflation medium retention test, UL 1517, sections 18 and 19, except: (i) Recreational hybrid... Method Standard 191, or ASTM D 751 (incorporated by reference, see § 160.077-5). (4) Permeability. The permeability of chamber materials must be determined according to ASTM D 1434 (incorporated by reference, see...

  13. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... distribution, and inflation medium retention test, UL 1517, sections 18 and 19, except: (i) Recreational hybrid... Method Standard 191, or ASTM D 751 (incorporated by reference, see § 160.077-5). (4) Permeability. The permeability of chamber materials must be determined according to ASTM D 1434 (incorporated by reference, see...

  14. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... distribution, and inflation medium retention test, UL 1517, sections 18 and 19, except: (i) Recreational hybrid... Method Standard 191, or ASTM D 751 (incorporated by reference, see § 160.077-5). (4) Permeability. The permeability of chamber materials must be determined according to ASTM D 1434 (incorporated by reference, see...

  15. 46 CFR 160.077-19 - Approval Testing-Recreational Hybrid PFD's.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... distribution, and inflation medium retention test, UL 1517, sections 18 and 19, except: (i) Recreational hybrid... Method Standard 191, or ASTM D 751 (incorporated by reference, see § 160.077-5). (4) Permeability. The permeability of chamber materials must be determined according to ASTM D 1434 (incorporated by reference, see...

  16. Diagnostic accuracy research in glaucoma is still incompletely reported: An application of Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015.

    PubMed

    Michelessi, Manuele; Lucenteforte, Ersilia; Miele, Alba; Oddone, Francesco; Crescioli, Giada; Fameli, Valeria; Korevaar, Daniël A; Virgili, Gianni

    2017-01-01

    Research has shown a modest adherence of diagnostic test accuracy (DTA) studies in glaucoma to the Standards for Reporting of Diagnostic Accuracy Studies (STARD). We have applied the updated 30-item STARD 2015 checklist to a set of studies included in a Cochrane DTA systematic review of imaging tools for diagnosing manifest glaucoma. Three pairs of reviewers, including one senior reviewer who assessed all studies, independently checked the adherence of each study to STARD 2015. Adherence was analyzed on an individual-item basis. Logistic regression was used to evaluate the effect of publication year and impact factor on adherence. We included 106 DTA studies, published between 2003-2014 in journals with a median impact factor of 2.6. Overall adherence was 54.1% for 3,286 individual rating across 31 items, with a mean of 16.8 (SD: 3.1; range 8-23) items per study. Large variability in adherence to reporting standards was detected across individual STARD 2015 items, ranging from 0 to 100%. Nine items (1: identification as diagnostic accuracy study in title/abstract; 6: eligibility criteria; 10: index test (a) and reference standard (b) definition; 12: cut-off definitions for index test (a) and reference standard (b); 14: estimation of diagnostic accuracy measures; 21a: severity spectrum of diseased; 23: cross-tabulation of the index and reference standard results) were adequately reported in more than 90% of the studies. Conversely, 10 items (3: scientific and clinical background of the index test; 11: rationale for the reference standard; 13b: blinding of index test results; 17: analyses of variability; 18; sample size calculation; 19: study flow diagram; 20: baseline characteristics of participants; 28: registration number and registry; 29: availability of study protocol; 30: sources of funding) were adequately reported in less than 30% of the studies. Only four items showed a statistically significant improvement over time: missing data (16), baseline characteristics of participants (20), estimates of diagnostic accuracy (24) and sources of funding (30). Adherence to STARD 2015 among DTA studies in glaucoma research is incomplete, and only modestly increasing over time.

  17. 21 CFR 660.52 - Reference preparations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Reference preparations. 660.52 Section 660.52 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Anti-Human Globulin § 660.52 Reference...

  18. 21 CFR 660.3 - Reference panel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

  19. 21 CFR 660.3 - Reference panel.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

  20. 21 CFR 660.3 - Reference panel.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center for... used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen. [40 FR...

  1. 21 CFR 660.3 - Reference panel.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

  2. 21 CFR 660.3 - Reference panel.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.3 Reference panel. A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Center... shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen...

  3. Standard surface-reflectance model and illuminant estimation

    NASA Technical Reports Server (NTRS)

    Tominaga, Shoji; Wandell, Brian A.

    1989-01-01

    A vector analysis technique was adopted to test the standard reflectance model. A computational model was developed to determine the components of the observed spectra and an estimate of the illuminant was obtained without using a reference white standard. The accuracy of the standard model is evaluated.

  4. Reference Standards for Cardiorespiratory Fitness Measured With Cardiopulmonary Exercise Testing Using Cycle Ergometry: Data From the Fitness Registry and the Importance of Exercise National Database (FRIEND) Registry.

    PubMed

    Kaminsky, Leonard A; Imboden, Mary T; Arena, Ross; Myers, Jonathan

    2017-02-01

    The importance of cardiorespiratory fitness (CRF) is well established. This report provides newly developed standards for CRF reference values derived from cardiopulmonary exercise testing (CPX) using cycle ergometry in the United States. Ten laboratories in the United States experienced in CPX administration with established quality control procedures contributed to the "Fitness Registry and the Importance of Exercise: A National Database" (FRIEND) Registry from April 2014 through May 2016. Data from 4494 maximal (respiratory exchange ratio, ≥1.1) cycle ergometer tests from men and women (20-79 years) from 27 states, without cardiovascular disease, were used to develop these references values. Percentiles of maximum oxygen consumption (VO 2max ) for men and women were determined for each decade from age 20 years through age 79 years. Comparisons of VO 2max were made to reference data established with CPX data from treadmill data in the FRIEND Registry and previously published reports. As expected, there were significant differences between sex and age groups for VO 2max (P<.01). For cycle tests within the FRIEND Registry, the 50th percentile VO 2max of men and women aged 20 to 29 years declined from 41.9 and 31.0 mLO 2 /kg/min to 19.5 and 14.8 mLO 2 /kg/min for ages 70 to 79 years, respectively. The rate of decline in this cohort was approximately 10% per decade. The FRIEND Registry reference data will be useful in providing more accurate interpretations for the US population of CPX-measured VO 2max from exercise tests using cycle ergometry compared with previous approaches based on estimations of standard differences from treadmill testing reference values. Copyright © 2016 Mayo Foundation for Medical Education and Research. All rights reserved.

  5. 40 CFR 792.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

  6. 40 CFR 792.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

  7. 40 CFR 792.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

  8. 40 CFR 792.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... according to written standard operating procedures, which provide for periodic analysis of each batch. (b... SUBSTANCES CONTROL ACT (CONTINUED) GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances...

  9. Collaborative study for the establishment of the WHO 3(rd) International Standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354.

    PubMed

    Findlay, L; Desai, T; Heath, A; Poole, S; Crivellone, M; Hauck, W; Ambrose, M; Morris, T; Daas, A; Rautmann, G; Buchheit, K H; Spieser, J M; Terao, E

    2015-01-01

    An international collaborative study was organised jointly by the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC), the United States Pharmacopeia (USP) and the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe) for the establishment of harmonised replacement endotoxin standards for these 3 organisations. Thirty-five laboratories worldwide, including Official Medicines Control Laboratories (OMCLs) and manufacturers enrolled in the study. Three candidate preparations (10/178, 10/190 and 10/196) were produced with the same material and same formulation as the current reference standards with the objective of generating a new (3(rd)) International Standard (IS) with the same potency (10 000 IU/vial) as the current (2(nd)) IS, as well as new European Pharmacopoeia (Ph. Eur.). and USP standards. The suitability of the candidate preparations to act as the reference standard in assays for endotoxin performed according to compendial methods was evaluated. Their potency was calibrated against the WHO 2(nd) IS for Endotoxin (94/580). Gelation and photometric methods produced similar results for each of the candidate preparations. The overall potency estimates for the 3 batches were comparable. Given the intrinsic assay precision, the observed differences between the batches may be considered unimportant for the intended use of these materials. Overall, these results were in line with those generated for the establishment of the current preparations of reference standards. Accelerated degradation testing of vials stored at elevated temperatures supported the long-term stability of the 3 candidate preparations. It was agreed between the 3 organisations that batch 10/178 be shared between WHO and EDQM and that batches 10/190 and 10/196 be allocated to USP, with a common assigned value of 10 000 IU/vial. This value maintains the continuity of the global harmonisation of reference materials and unitage for the testing of endotoxins in parenteral pharmaceutical products. Based on the results of the collaborative study, batch 10/178 was established by the European Pharmacopoeia Commission as the Ph. Eur. Endotoxin Biological Reference Preparation (BRP) batch 5. The same batch was also established by the Expert Committee on Biological Standardisation (ECBS) of WHO as the WHO 3(rd) IS for Endotoxin. Batch 10/190 was adopted as the USP Endotoxin Reference Standard, lot H0K354 and vials from this same batch (10/190) will serve as the United States Food and Drug Administration (USFDA) Endotoxin Standard, EC-7.

  10. 40 CFR 90.7 - Reference materials.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... EMISSIONS FROM NONROAD SPARK-IGNITION ENGINES AT OR BELOW 19 KILOWATTS General § 90.7 Reference materials... Fuels by the Research Method Appendix A to subpart D, Table 3. ASTM D2700-92: Standard Test Method for...

  11. 40 CFR 90.7 - Reference materials.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... EMISSIONS FROM NONROAD SPARK-IGNITION ENGINES AT OR BELOW 19 KILOWATTS General § 90.7 Reference materials... Fuels by the Research Method Appendix A to subpart D, Table 3. ASTM D2700-92: Standard Test Method for...

  12. 40 CFR 90.7 - Reference materials.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... EMISSIONS FROM NONROAD SPARK-IGNITION ENGINES AT OR BELOW 19 KILOWATTS General § 90.7 Reference materials... Fuels by the Research Method Appendix A to subpart D, Table 3. ASTM D2700-92: Standard Test Method for...

  13. Measurement of the depth of narrow slotted sections in eddy current reference standards

    NASA Astrophysics Data System (ADS)

    Kim, Young-Joo; Kim, Young-gil; Ahn, Bongyoung; Yoon, Dong-Jin

    2007-02-01

    The dimensions of the slots in eddy current (EC) reference standards are too narrow to be measured by general depth measurement methods such as the optical (laser) or stylus methods. However, measurement of the dimensions of the machined slots is a prerequisite to using the blocks as references. The present paper suggests a measurement method for the slotted section using an ultrasonic test. The width and depth of the slots measured in our study are roughly 0.1 mm and 0.5 mm, respectively. The time of flight (TOF) of the ultrasonic wave was measured precisely. The ultrasonic velocity in the material of the EC reference standard was calculated with the measured values of the TOF and its thickness. Reflected waves from the tip of the slot and the bottom surface of the EC standard were successfully classified. Using this method we have successfully determined the depth of the slotted section.

  14. 40 CFR 91.6 - Reference materials.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... EMISSIONS FROM MARINE SPARK-IGNITION ENGINES General § 91.6 Reference materials. (a) Incorporation by... the Research Method Appendix A to Subpart D. ASTM D2700-92: Standard Test Method for Knock... 40 CFR part 91 reference SAE J1228/ISO 8665 November 1991 Small Craft-Marine Propulsion Engine and...

  15. 40 CFR 91.6 - Reference materials.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... EMISSIONS FROM MARINE SPARK-IGNITION ENGINES General § 91.6 Reference materials. (a) Incorporation by... the Research Method Appendix A to Subpart D. ASTM D2700-92: Standard Test Method for Knock... 40 CFR part 91 reference SAE J1228/ISO 8665 November 1991 Small Craft-Marine Propulsion Engine and...

  16. 40 CFR 91.6 - Reference materials.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... EMISSIONS FROM MARINE SPARK-IGNITION ENGINES General § 91.6 Reference materials. (a) Incorporation by... the Research Method Appendix A to Subpart D. ASTM D2700-92: Standard Test Method for Knock... 40 CFR part 91 reference SAE J1228/ISO 8665 November 1991 Small Craft-Marine Propulsion Engine and...

  17. 46 CFR 160.176-4 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the sections affected are: American Society for Testing and Materials (ASTM) 100 Barr Harbor Drive... Institute of Standards and Technology (NIST) (formerly National Bureau of Standards) C/O Superintendent of...

  18. 46 CFR 160.176-4 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the sections affected are: American Society for Testing and Materials (ASTM) 100 Barr Harbor Drive... Institute of Standards and Technology (NIST) (formerly National Bureau of Standards) C/O Superintendent of...

  19. Improved ultrasonic standard reference blocks

    NASA Technical Reports Server (NTRS)

    Eitzen, D. G.

    1975-01-01

    A program to improve the quality, reproducibility and reliability of nondestructive testing through the development of improved ASTM-type ultrasonic reference standards is described. Reference blocks of aluminum, steel, and titanium alloys were considered. Equipment representing the state-of-the-art in laboratory and field ultrasonic equipment was obtained and evaluated. Some RF and spectral data on ten sets of ultrasonic reference blocks were taken as part of a task to quantify the variability in response from nominally identical blocks. Techniques for residual stress, preferred orientation, and microstructural measurements were refined and are applied to a reference block rejected by the manufacturer during fabrication in order to evaluate the effect of metallurgical condition on block response.

  20. 40 CFR 1060.810 - What materials does this part reference?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... (a) ASTM material. Table 1 to this section lists material from the American Society for Testing and..., West Conshohocken, PA 19428 or http://www.astm.com. Table 1 follows: Table 1 to § 1060.810—ASTM Materials Document number and name Part 1060reference ASTM D471-06, Standard Test Method for Rubber Property...

  1. 40 CFR 160.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

  2. 40 CFR 160.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

  3. 40 CFR 160.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

  4. 40 CFR 160.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

  5. 40 CFR 160.113 - Mixtures of substances with carriers.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... standard operating procedures, which provide for periodic analysis of each batch. (b) Where any of the...) PESTICIDE PROGRAMS GOOD LABORATORY PRACTICE STANDARDS Test, Control, and Reference Substances § 160.113...

  6. 10 CFR 431.303 - Materials incorporated by reference.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, 6th..._standards/. Standards can be obtained from the sources listed below. (b) ASTM. American Society for Testing...

  7. TREAT Asia Quality Assessment Scheme (TAQAS) to standardize the outcome of HIV genotypic resistance testing in a group of Asian laboratories

    PubMed Central

    Land, Sally; Cunningham, Philip; Zhou, Jialun; Frost, Kevin; Katzenstein, David; Kantor, Rami; Chen, Yi-Ming Arthur; Oka, Shinichi; DeLong, Allison; Sayer, David; Smith, Jeffery; Dax, Elizabeth M.; Law, Matthew

    2010-01-01

    The TREAT Asia (Therapeutics, Research, Education, and AIDS Training in Asia) Network is building capacity for Human Immunodeficiency Virus Type-1 (HIV-1) drug resistance testing in the region. The objective of the TREAT Asia Quality Assessment Scheme – designated TAQAS – is to standardize HIV-1 genotypic resistance testing (HIV genotyping) among laboratories to permit rigorous comparison of results from different clinics and testing centres. TAQAS has evaluated three panels of HIV-1-positive plasma from clinical material or low-passage, culture supernatant for up to 10 Asian laboratories. Laboratory participants used their standard protocols to perform HIV genotyping. Assessment was in comparison to a target genotype derived from all participants and the reference laboratory’s result. Agreement between most participants at the edited nucleotide sequence level was high (>98%). Most participants performed to the reference laboratory standard in detection of drug resistance mutations (DRMs). However, there was variation in the detection of nucleotide mixtures (0–83%) and a significant correlation with the detection of DRMs (p < 0.01). Interpretation of antiretroviral resistance showed ~70% agreement among participants when different interpretation systems were used but >90% agreement with a common interpretation system, within the Stanford University Drug Resistance Database. Using the principles of external quality assessment and a reference laboratory, TAQAS has demonstrated high quality HIV genotyping results from Asian laboratories. PMID:19490972

  8. Nominal ISOMERs (Incorrect Spellings Of Medicines Eluding Researchers)—variants in the spellings of drug names in PubMed: a database review

    PubMed Central

    Aronson, Jeffrey K

    2016-01-01

    Objective To examine how misspellings of drug names could impede searches for published literature. Design Database review. Data source PubMed. Review methods The study included 30 drug names that are commonly misspelt on prescription charts in hospitals in Birmingham, UK (test set), and 30 control names randomly chosen from a hospital formulary (control set). The following definitions were used: standard names—the international non-proprietary names, variant names—deviations in spelling from standard names that are not themselves standard names in English language nomenclature, and hidden reference variants—variant spellings that identified publications in textword (tw) searches of PubMed or other databases, and which were not identified by textword searches for the standard names. Variant names were generated from standard names by applying letter substitutions, omissions, additions, transpositions, duplications, deduplications, and combinations of these. Searches were carried out in PubMed (30 June 2016) for “standard name[tw]” and “variant name[tw] NOT standard name[tw].” Results The 30 standard names of drugs in the test set gave 325 979 hits in total, and 160 hidden reference variants gave 3872 hits (1.17%). The standard names of the control set gave 470 064 hits, and 79 hidden reference variants gave 766 hits (0.16%). Letter substitutions (particularly i to y and vice versa) and omissions together accounted for 2924 (74%) of the variants. Amitriptyline (8530 hits) yielded 18 hidden reference variants (179 (2.1%) hits). Names ending in “in,” “ine,” or “micin” were commonly misspelt. Failing to search for hidden reference variants of “gentamicin,” “amitriptyline,” “mirtazapine,” and “trazodone” would miss at least 19 systematic reviews. A hidden reference variant related to Christmas, “No-el”, was rare; variants of “X-miss” were rarer. Conclusion When performing searches, researchers should include misspellings of drug names among their search terms. PMID:27974346

  9. Nominal ISOMERs (Incorrect Spellings Of Medicines Eluding Researchers)-variants in the spellings of drug names in PubMed: a database review.

    PubMed

    Ferner, Robin E; Aronson, Jeffrey K

    2016-12-14

     To examine how misspellings of drug names could impede searches for published literature.  Database review.  PubMed.  The study included 30 drug names that are commonly misspelt on prescription charts in hospitals in Birmingham, UK (test set), and 30 control names randomly chosen from a hospital formulary (control set). The following definitions were used: standard names-the international non-proprietary names, variant names-deviations in spelling from standard names that are not themselves standard names in English language nomenclature, and hidden reference variants-variant spellings that identified publications in textword (tw) searches of PubMed or other databases, and which were not identified by textword searches for the standard names. Variant names were generated from standard names by applying letter substitutions, omissions, additions, transpositions, duplications, deduplications, and combinations of these. Searches were carried out in PubMed (30 June 2016) for "standard name[tw]" and "variant name[tw] NOT standard name[tw]."  The 30 standard names of drugs in the test set gave 325 979 hits in total, and 160 hidden reference variants gave 3872 hits (1.17%). The standard names of the control set gave 470 064 hits, and 79 hidden reference variants gave 766 hits (0.16%). Letter substitutions (particularly i to y and vice versa) and omissions together accounted for 2924 (74%) of the variants. Amitriptyline (8530 hits) yielded 18 hidden reference variants (179 (2.1%) hits). Names ending in "in," "ine," or "micin" were commonly misspelt. Failing to search for hidden reference variants of "gentamicin," "amitriptyline," "mirtazapine," and "trazodone" would miss at least 19 systematic reviews. A hidden reference variant related to Christmas, "No-el", was rare; variants of "X-miss" were rarer.  When performing searches, researchers should include misspellings of drug names among their search terms. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. Linking English-Language Test Scores onto the Common European Framework of Reference: An Application of Standard-Setting Methodology. TOEFL iBT Research Report TOEFL iBt-06. ETS RR-08-34

    ERIC Educational Resources Information Center

    Tannenbaum, Richard J.; Wylie, E. Caroline

    2008-01-01

    The Common European Framework of Reference (CEFR) describes language proficiency in reading, writing, speaking, and listening on a 6-level scale. In this study, English-language experts from across Europe linked CEFR levels to scores on three tests: the TOEFL® iBT test, the TOEIC® assessment, and the TOEIC "Bridge"™ test.…

  11. Position Measurement Standard Evaluation

    DOT National Transportation Integrated Search

    1975-02-01

    The objectives of the Position Measurement Standard Program were to collect navigation data from three DME receivers and a low-frequency GLOBAL Navigation system, and evaluate their relative performance against a reference radar. Flight test data dur...

  12. Fuel and Fuel System Materials Compatibility Test Program for A JP-8+100 Fuel Additive. Volume 1: Thermal Stability Additive Package BetzDearborn Spec Aid(Registered) 8Q462

    DTIC Science & Technology

    2001-10-01

    SAE Rings, Sealing, Butadiene-Acrylonitrile ( NBR ), Rubber Fuel and Low Temperature Resistant 60 - 70 MIL-R-83248C Rubber , Fluorocarbon...KAPTON/TEFLON (COMPOSITE) WIRE I.I.10 34 VI. REFERENCE DOCUMENTS Non-Metallics MIL-HDBK-149B Military Standardization Hand Book Rubber ...ASTM D-1414 Standard Test Methods for Rubber O-Rings ASTM D-412 Type II Standard Test Methods for Vulcanized Rubber and Thermoplastic

  13. 40 CFR 75.6 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., Standard Test Method for Sulfur in Petroleum Products (General Bomb Method), for appendices A and D of this part. (2) D240-00, Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb... Fuels by Bomb Calorimeter (Precision Method), for appendices D and F of this part. (47) ASTM D5865-01a...

  14. 9 CFR 113.119 - Erysipelothrix Rhusiopathiae Bacterin.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... potency using the mouse protection test provided in this paragraph. A mouse dose shall be 1/10 of the... ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference...) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each...

  15. 9 CFR 113.122 - Salmonella Choleraesuis Bacterin.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other... protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by...

  16. 9 CFR 113.120 - Salmonella Typhimurium Bacterin.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals... mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or...

  17. 9 CFR 113.122 - Salmonella Choleraesuis Bacterin.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other... protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by...

  18. 9 CFR 113.120 - Salmonella Typhimurium Bacterin.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals... mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or...

  19. 9 CFR 113.119 - Erysipelothrix Rhusiopathiae Bacterin.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... potency using the mouse protection test provided in this paragraph. A mouse dose shall be 1/10 of the... ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference...) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each...

  20. 9 CFR 113.119 - Erysipelothrix Rhusiopathiae Bacterin.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... potency using the mouse protection test provided in this paragraph. A mouse dose shall be 1/10 of the... ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference...) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each...

  1. 9 CFR 113.122 - Salmonella Choleraesuis Bacterin.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other... protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by...

  2. 9 CFR 113.119 - Erysipelothrix Rhusiopathiae Bacterin.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... potency using the mouse protection test provided in this paragraph. A mouse dose shall be 1/10 of the... ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference...) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each...

  3. 9 CFR 113.120 - Salmonella Typhimurium Bacterin.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals... mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or...

  4. 9 CFR 113.120 - Salmonella Typhimurium Bacterin.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals... mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or...

  5. 9 CFR 113.122 - Salmonella Choleraesuis Bacterin.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other... protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by...

  6. 9 CFR 113.119 - Erysipelothrix Rhusiopathiae Bacterin.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... potency using the mouse protection test provided in this paragraph. A mouse dose shall be 1/10 of the... ability of the bacterin being tested (Unknown) to protect mice shall be compared with a Standard Reference...) For each dilution of the Standard and each dilution of an Unknown, a group of at least 20 mice, each...

  7. 9 CFR 113.120 - Salmonella Typhimurium Bacterin.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other animals... mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by or...

  8. 9 CFR 113.122 - Salmonella Choleraesuis Bacterin.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... container samples of completed product from each serial shall be tested for potency using the mouse test provided in this paragraph. A mouse dose shall be 1/20 of the least dose recommended on the label for other... protect mice shall be compared with a Standard Reference Bacterin (Standard) which is either supplied by...

  9. Linking School Goals and Learning Standards to Teacher Evaluation and Compensation.

    ERIC Educational Resources Information Center

    Mathis, William J.

    It is possible to tie teacher compensation to professional growth, without reference to standardized test scores. Tying pay to students' achievement scores does not account for the different levels of students, and teacher testing does not separate good teachers from bad. In Rutland Northeast, Vermont, each school has its own locally elected…

  10. The GRE and the Minority Student: A Perspective.

    ERIC Educational Resources Information Center

    Nieves, Luis

    Alternate admission systems are reviewed in respect to the minority applicant in an attempt to assess the nature of the bias frequently referred to in connection with standardized testing. The connection between the use of the Graduate Record Examinations (GRE) as a standardized test and the admission system was explored, concluding that the role…

  11. A REFORMULATED, RECONSTITUTED WATER FOR TESTING THE FRESHWATER AMPHIPOD, HYALELLA AZTECA

    EPA Science Inventory

    Toxicity testing with the freshwater amphipod, Hyalella azteca, has routinely been conducted using nonstandard waters. Four waters tested for acceptability for aqueous reference toxicant testing with H. azteca. These included three formulated (standardized) waters: moderately har...

  12. [Characterization and comparison of interferon reference standards using UPLC-MS].

    PubMed

    Tao, Lei; Pei, De-ning; Han, Chun-mei; Chen, Wei; Rao, Chun-ming; Wang, Jun-zhi

    2015-01-01

    The study aims to characterize and compare interferon reference standards from 5 manufacturers. By testing molecular mass and trypsin-digested peptide mass mapping, the amino acid sequence was verified and post-translational modifications such as disulfide bond were identified. Results show that the molecular mass and amino acid sequence were consistent with theory; the disulfide bonds of 4 lots of interferon were Cys1-Cys98/Cys29-Cys138, 1 lot was Cys29-Cys139/Cys86-Cys99; N-terminal "+Met", acetyl N-terminal and Met oxidation were identified in part of the sample. UPLC-MS can be used to characterize and compare interferon reference standards from different manufacturers.

  13. Insights from analysis for harmful and potentially harmful constituents (HPHCs) in tobacco products.

    PubMed

    Oldham, Michael J; DeSoi, Darren J; Rimmer, Lonnie T; Wagner, Karl A; Morton, Michael J

    2014-10-01

    A total of 20 commercial cigarette and 16 commercial smokeless tobacco products were assayed for 96 compounds listed as harmful and potentially harmful constituents (HPHCs) by the US Food and Drug Administration. For each product, a single lot was used for all testing. Both International Organization for Standardization and Health Canada smoking regimens were used for cigarette testing. For those HPHCs detected, measured levels were consistent with levels reported in the literature, however substantial assay variability (measured as average relative standard deviation) was found for most results. Using an abbreviated list of HPHCs, statistically significant differences for most of these HPHCs occurred when results were obtained 4-6months apart (i.e., temporal variability). The assay variability and temporal variability demonstrate the need for standardized analytical methods with defined repeatability and reproducibility for each HPHC using certified reference standards. Temporal variability also means that simple conventional comparisons, such as two-sample t-tests, are inappropriate for comparing products tested at different points in time from the same laboratory or from different laboratories. Until capable laboratories use standardized assays with established repeatability, reproducibility, and certified reference standards, the resulting HPHC data will be unreliable for product comparisons or other decision making in regulatory science. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. 30 CFR 250.901 - What industry standards must your platform meet?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., (incorporated by reference as specified in § 250.198); (15) American Society for Testing and Materials (ASTM... Welding Code—Steel, including Commentary, (incorporated by reference as specified in § 250.198); (21) AWS D1.4, Structural Welding Code—Reinforcing Steel, (incorporated by reference as specified in § 250.198...

  15. Incorporating geographical factors with artificial neural networks to predict reference values of erythrocyte sedimentation rate

    PubMed Central

    2013-01-01

    Background The measurement of the Erythrocyte Sedimentation Rate (ESR) value is a standard procedure performed during a typical blood test. In order to formulate a unified standard of establishing reference ESR values, this paper presents a novel prediction model in which local normal ESR values and corresponding geographical factors are used to predict reference ESR values using multi-layer feed-forward artificial neural networks (ANN). Methods and findings Local normal ESR values were obtained from hospital data, while geographical factors that include altitude, sunshine hours, relative humidity, temperature and precipitation were obtained from the National Geographical Data Information Centre in China. The results show that predicted values are statistically in agreement with measured values. Model results exhibit significant agreement between training data and test data. Consequently, the model is used to predict the unseen local reference ESR values. Conclusions Reference ESR values can be established with geographical factors by using artificial intelligence techniques. ANN is an effective method for simulating and predicting reference ESR values because of its ability to model nonlinear and complex relationships. PMID:23497145

  16. Incorporating geographical factors with artificial neural networks to predict reference values of erythrocyte sedimentation rate.

    PubMed

    Yang, Qingsheng; Mwenda, Kevin M; Ge, Miao

    2013-03-12

    The measurement of the Erythrocyte Sedimentation Rate (ESR) value is a standard procedure performed during a typical blood test. In order to formulate a unified standard of establishing reference ESR values, this paper presents a novel prediction model in which local normal ESR values and corresponding geographical factors are used to predict reference ESR values using multi-layer feed-forward artificial neural networks (ANN). Local normal ESR values were obtained from hospital data, while geographical factors that include altitude, sunshine hours, relative humidity, temperature and precipitation were obtained from the National Geographical Data Information Centre in China.The results show that predicted values are statistically in agreement with measured values. Model results exhibit significant agreement between training data and test data. Consequently, the model is used to predict the unseen local reference ESR values. Reference ESR values can be established with geographical factors by using artificial intelligence techniques. ANN is an effective method for simulating and predicting reference ESR values because of its ability to model nonlinear and complex relationships.

  17. We-Measure: Toward a low-cost portable posturography for patients with multiple sclerosis using the commercial Wii balance board.

    PubMed

    Castelli, Letizia; Stocchi, Luca; Patrignani, Maurizio; Sellitto, Giovanni; Giuliani, Manuela; Prosperini, Luca

    2015-12-15

    This study was aimed at investigating whether postural sway measures derived from a standard force platform were similar to those generated by a custom-written software ("We-Measure") acquiring and processing data from a commercial Nintendo balance board (BB). For this purpose, 90 patients with multiple sclerosis (MS) and 50 healthy controls (HC) were tested in a single-day session with a reference standard force platform and a BB-based system. Despite its acceptable between-device agreement (tested by visual evaluation of Bland-Altman plot), the low-cost BB-based system tended to overestimate postural sway when compared to the reference standard force platform in both MS and HC groups (on average +30% and +54%, respectively). Between-device reliability was just adequate (MS: 66%, HC: 47%), while test-retest reliability was excellent (MS: 84%, HC: 88%). Concurrent validity evaluation showed similar performance between the reference standard force platform and the BB-based system in discriminating fallers and non-fallers among patients with MS. All these findings may encourage the use of this balance board-based new device in longitudinal study, rather than in cross-sectional design, thus providing a potential useful tool for multicenter settings. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Validity of administrative data claim-based methods for identifying individuals with diabetes at a population level.

    PubMed

    Southern, Danielle A; Roberts, Barbara; Edwards, Alun; Dean, Stafford; Norton, Peter; Svenson, Lawrence W; Larsen, Erik; Sargious, Peter; Lau, David C W; Ghali, William A

    2010-01-01

    This study assessed the validity of a widely-accepted administrative data surveillance methodology for identifying individuals with diabetes relative to three laboratory data reference standard definitions for diabetes. We used a combination of linked regional data (hospital discharge abstracts and physician data) and laboratory data to test the validity of administrative data surveillance definitions for diabetes relative to a laboratory data reference standard. The administrative discharge data methodology includes two definitions for diabetes: a strict administrative data definition of one hospitalization code or two physician claims indicating diabetes; and a more liberal definition of one hospitalization code or a single physician claim. The laboratory data, meanwhile, produced three reference standard definitions based on glucose levels +/- HbA1c levels. Sensitivities ranged from 68.4% to 86.9% for the administrative data definitions tested relative to the three laboratory data reference standards. Sensitivities were higher for the more liberal administrative data definition. Positive predictive values (PPV), meanwhile, ranged from 53.0% to 88.3%, with the liberal administrative data definition producing lower PPVs. These findings demonstrate the trade-offs of sensitivity and PPV for selecting diabetes surveillance definitions. Centralized laboratory data may be of value to future surveillance initiatives that use combined data sources to optimize case detection.

  19. Recommendations for a Standardized Pulmonary Function Report. An Official American Thoracic Society Technical Statement.

    PubMed

    Culver, Bruce H; Graham, Brian L; Coates, Allan L; Wanger, Jack; Berry, Cristine E; Clarke, Patricia K; Hallstrand, Teal S; Hankinson, John L; Kaminsky, David A; MacIntyre, Neil R; McCormack, Meredith C; Rosenfeld, Margaret; Stanojevic, Sanja; Weiner, Daniel J

    2017-12-01

    The American Thoracic Society committee on Proficiency Standards for Pulmonary Function Laboratories has recognized the need for a standardized reporting format for pulmonary function tests. Although prior documents have offered guidance on the reporting of test data, there is considerable variability in how these results are presented to end users, leading to potential confusion and miscommunication. A project task force, consisting of the committee as a whole, was approved to develop a new Technical Standard on reporting pulmonary function test results. Three working groups addressed the presentation format, the reference data supporting interpretation of results, and a system for grading quality of test efforts. Each group reviewed relevant literature and wrote drafts that were merged into the final document. This document presents a reporting format in test-specific units for spirometry, lung volumes, and diffusing capacity that can be assembled into a report appropriate for a laboratory's practice. Recommended reference sources are updated with data for spirometry and diffusing capacity published since prior documents. A grading system is presented to encourage uniformity in the important function of test quality assessment. The committee believes that wide adoption of these formats and their underlying principles by equipment manufacturers and pulmonary function laboratories can improve the interpretation, communication, and understanding of test results.

  20. 46 CFR 163.003-3 - ASTM standard.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false ASTM standard. 163.003-3 Section 163.003-3 Shipping...: SPECIFICATIONS AND APPROVAL CONSTRUCTION Pilot Ladder § 163.003-3 ASTM standard. The following standard of the American Society for Testing and Materials (ASTM) is incorporated by reference into this subpart: ASTM D...

  1. Workshop on standards in biomass for energy and chemicals: proceedings

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

    Milne, T.A.

    1984-11-01

    In the course of reviewing standards literature, visiting prominent laboratories and research groups, attending biomass meetings and corresponding widely, a whole set of standards needs was identified, the most prominent of which were: biomass standard reference materials, research materials and sample banks; special collections of microorganisms, clonal material, algae, etc.; standard methods of characterization of substrates and biomass fuels; standard tests and methods for the conversion and end-use of biomass; standard protocols for the description, harvesting, preparation, storage, and measurement of productivity of biomass materials in the energy context; glossaries of terms; development of special tests for assay of enzymaticmore » activity and related processes. There was also a recognition of the need for government, professional and industry support of concensus standards development and the dissemination of information on standards. Some 45 biomass researchers and managers met with key NBS staff to identify and prioritize standards needs. This was done through three working panels: the Panel on Standard Reference Materials (SRM's), Research Materials (RM's), and Sample Banks; the Panel on Production and Characterization; and the Panel on Tests and Methods for Conversion and End Use. This report gives a summary of the action items in standards development recommended unanimously by the workshop attendees. The proceedings of the workshop, and an appendix, contain an extensive written record of the findings of the workshop panelists and others regarding presently existing standards and standards issues and needs. Separate abstracts have been prepared for selected papers for inclusion in the Energy Database.« less

  2. Digital antimicrobial susceptibility testing using the MilliDrop technology.

    PubMed

    Jiang, L; Boitard, L; Broyer, P; Chareire, A-C; Bourne-Branchu, P; Mahé, P; Tournoud, M; Franceschi, C; Zambardi, G; Baudry, J; Bibette, J

    2016-03-01

    We present the MilliDrop Analyzer (MDA), a droplet-based millifluidic system for digital antimicrobial susceptibility testing (D-AST), which enables us to determine minimum inhibitory concentrations (MICs) precisely and accurately. The MilliDrop technology was validated by using resazurin for fluorescence readout, for comparison with standard methodology, and for conducting reproducibility studies. In this first assessment, the susceptibility of a reference Gram-negative strain Escherichia coli ATCC 25922 to gentamicin, chloramphenicol, and nalidixic acid were tested by the MDA, VITEK®2, and broth microdilution as a reference standard. We measured the susceptibility of clinically relevant Gram-positive strains of Staphylococcus aureus to vancomycin, including vancomycin-intermediate S. aureus (VISA), heterogeneous vancomycin-intermediate S. aureus (hVISA), and vancomycin-susceptible S. aureus (VSSA) strains. The MDA provided results which were much more accurate than those of VITEK®2 and standard broth microdilution. The enhanced accuracy enabled us to reliably discriminate between VSSA and hVISA strains.

  3. Improved ultrasonic standard reference blocks

    NASA Technical Reports Server (NTRS)

    Eitzen, D. G.; Sushinsky, G. F.; Chwirut, D. J.; Bechtoldt, C. J.; Ruff, A. W.

    1976-01-01

    A program to improve the quality, reproducibility and reliability of nondestructive testing through the development of improved ASTM-type ultrasonic reference standards is described. Reference blocks of aluminum, steel, and titanium alloys are to be considered. Equipment representing the state-of-the-art in laboratory and field ultrasonic equipment was obtained and evaluated. RF and spectral data on ten sets of ultrasonic reference blocks have been taken as part of a task to quantify the variability in response from nominally identical blocks. Techniques for residual stress, preferred orientation, and micro-structural measurements were refined and are applied to a reference block rejected by the manufacturer during fabrication in order to evaluate the effect of metallurgical condition on block response. New fabrication techniques for reference blocks are discussed and ASTM activities are summarized.

  4. Standardization of Laboratory Methods for the PERCH Study

    PubMed Central

    Karron, Ruth A.; Morpeth, Susan C.; Bhat, Niranjan; Levine, Orin S.; Baggett, Henry C.; Brooks, W. Abdullah; Feikin, Daniel R.; Hammitt, Laura L.; Howie, Stephen R. C.; Knoll, Maria Deloria; Kotloff, Karen L.; Madhi, Shabir A.; Scott, J. Anthony G.; Thea, Donald M.; Adrian, Peter V.; Ahmed, Dilruba; Alam, Muntasir; Anderson, Trevor P.; Antonio, Martin; Baillie, Vicky L.; Dione, Michel; Endtz, Hubert P.; Gitahi, Caroline; Karani, Angela; Kwenda, Geoffrey; Maiga, Abdoul Aziz; McClellan, Jessica; Mitchell, Joanne L.; Morailane, Palesa; Mugo, Daisy; Mwaba, John; Mwansa, James; Mwarumba, Salim; Nyongesa, Sammy; Panchalingam, Sandra; Rahman, Mustafizur; Sawatwong, Pongpun; Tamboura, Boubou; Toure, Aliou; Whistler, Toni; O’Brien, Katherine L.; Murdoch, David R.

    2017-01-01

    Abstract The Pneumonia Etiology Research for Child Health study was conducted across 7 diverse research sites and relied on standardized clinical and laboratory methods for the accurate and meaningful interpretation of pneumonia etiology data. Blood, respiratory specimens, and urine were collected from children aged 1–59 months hospitalized with severe or very severe pneumonia and community controls of the same age without severe pneumonia and were tested with an extensive array of laboratory diagnostic tests. A standardized testing algorithm and standard operating procedures were applied across all study sites. Site laboratories received uniform training, equipment, and reagents for core testing methods. Standardization was further assured by routine teleconferences, in-person meetings, site monitoring visits, and internal and external quality assurance testing. Targeted confirmatory testing and testing by specialized assays were done at a central reference laboratory. PMID:28575358

  5. 40 CFR 98.324 - Monitoring and QA/QC requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Tracking System Handbook Number: PH-08-V-1, January 1, 2008 (incorporated by reference, see § 98.7). You... paragraphs (d)(1) through (d)(2) of this section. (1) ASTM D1945-03, Standard Test Method for Analysis of... Reformed Gas by Gas Chromatography; ASTM D4891-89 (Reapproved 2006), Standard Test Method for Heating Value...

  6. 46 CFR 164.120-5 - Incorporation by reference.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...), IBR approved for § 164.120-7 (“ASTM D 543”). (2) ASTM D 570-98 (Reapproved 2005), Standard Test Method for Water Absorption of Plastics, (approved November 1, 2005), IBR approved for § 164.120-7 (“ASTM D 570”). (3) ASTM D 638-08, Standard Test Method for Tensile Properties of Plastics, (approved April 1...

  7. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

    PubMed

    Ozarda, Yesim; Ichihara, Kiyoshi; Barth, Julian H; Klee, George

    2013-05-01

    The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

  8. Evolution of activities in international biological standardization since the early days of the Health Organisation of the League of Nations.

    PubMed

    Sizaret, P

    1988-01-01

    The main activities in international biological standardization during the 18 years that followed the first international biological standardization meeting in London in 1921 were concerned with expressing the potencies of test preparations in comparison with reference materials. After the Second World War, however, it became clear that the testing of biological substances against international reference materials was only one among several measures for obtaining safe and potent products. The activities in international biological standardization were therefore widened so that, by the strict observance of specific manufacturing and control requirements, it was possible to gain further in safety and efficacy. At the end of 1987, 42 international requirements for biological substances were available and were being used as national requirements, sometimes after minor modification, by the majority of WHO's Member States. This is of utmost importance for the worldwide use of safe and potent biological products, including vaccines.

  9. The uncertainty of reference standards--a guide to understanding factors impacting uncertainty, uncertainty calculations, and vendor certifications.

    PubMed

    Gates, Kevin; Chang, Ning; Dilek, Isil; Jian, Huahua; Pogue, Sherri; Sreenivasan, Uma

    2009-10-01

    Certified solution standards are widely used in forensic toxicological, clinical/diagnostic, and environmental testing. Typically, these standards are purchased as ampouled solutions with a certified concentration. Vendors present concentration and uncertainty differently on their Certificates of Analysis. Understanding the factors that impact uncertainty and which factors have been considered in the vendor's assignment of uncertainty are critical to understanding the accuracy of the standard and the impact on testing results. Understanding these variables is also important for laboratories seeking to comply with ISO/IEC 17025 requirements and for those preparing reference solutions from neat materials at the bench. The impact of uncertainty associated with the neat material purity (including residual water, residual solvent, and inorganic content), mass measurement (weighing techniques), and solvent addition (solution density) on the overall uncertainty of the certified concentration is described along with uncertainty calculations.

  10. [Diagnostic kits in parasitology: which controls?].

    PubMed

    Rossi, P

    2004-06-01

    The development of new diagnostic tools particularly for some parasitic "neglected diseases", is slowed or even hindered by limited resources assigned for basic and applied research in public institution and private sector. Even if the time-line and costs needed for developing a new In Vitro Diagnostic (IVD) test are generally lower compared to vaccines or new drugs, industry is poorly engaged in investing resources due to the perception of limited markets. To accelerate the development of diagnostics for the world's most deadly diseases, the World Health Organization's (WHO) Special Programme for Research and Training in Tropical Diseases (TDR), the United Nations Development Programme, the World Bank and the Gates Foundation, last year launched a new initiative, FIND (Foundation for Innovative New Diagnostics, www.finddiagnostics.org). The aim is to "apply the latest biotechnology innovations to develop and validate affordable diagnostic tests for diseases of the developing world". Ideally, a new diagnostic test should be accurately evaluated prior to use in medical practice. The first step would be a pre-clinical evaluation, an analytic study to determine its laboratory performance. A crucial point in this phase is the calibration of reagents (antigens, antibodies, DNA probes, etc.) against a standard reference preparation. WHO, through the WHO International Laboratories for Biological Standards, "provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit" (www.who.int/biologicals/IBRP/index.htm). Standardization allows "comparison of biological measurements worldwide" and ensures the reliability of diagnostic procedures. These preparations are generally intended for use in the characterization of the activity of secondary reference preparations (regional, national or in-house working standards). Unfortunately, international reference standards for parasitic diseases are not available at present, except for Toxoplasma antibodies. The first international standard reagent for Anti-Toxoplasma Serum was established in 1968 and at present, an international standard reference serum, Anti-toxoplasma serum, human TOXM is available at the National Institute for Biological Standards and Control (NIBSC) in UK. Several collaborative, multicenter studies were carried out to assess the performance of different methods and commercial tests for the diagnosis of toxoplasmosis, by providing to participating laboratories a panel of well-defined sera to be tested. A four-phase process following well-accepted methodological standards for the development of diagnostics, analogous to those internationally accepted for drugs and vaccines was recently proposed. The pre-clinical evaluation, the analytic study to assess sensitivity, specificity, predictive values in laboratory (phase I), should be followed by a proof of principle study to distinguish diseased from healthy persons in easily accessible populations (phase II). The evaluation of test performance in populations of intended use (phase III), and finally the delineation of cost-effectiveness and societal impact of new tests in comparison with existing tools (phase IV) should complete the validation procedure. In this context, national regulatory agencies play a major role in pre-market approval and post-market surveillance of IVDs. The European Community in 1998 approved a directive (Directive 98/79/EC) which rules the marketing of IVD medical devices, in order to harmonise the performance levels and standards in European countries. But, among IVDs for parasitic diseases, only those to detect congenital toxoplasmosis are submitted to defined procedures to provide the verification of products before their placing on the market and the surveillance after their marketing by a notified body, which perform appropriate examinations, tests and inspections to production facilities to verify if the device meets the requirements of the directive. In U.S.A., the Food and Drug Administration (FDA), through the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), provides a comprehensive and regulatory activity for IVDs through pre-market evaluation and post-market surveillance. In developing countries, the scarcity of resources limits the procedures through which the national control authority can assure safety, quality and efficacy of products marketed, both imported and locally manufactured.

  11. 77 FR 32465 - Technical Standards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... minimum odds for Class II games; amend standards for test labs; remove references to the Federal... the Play of Class II Games. 73 FR 60508. The rule added a new part to the Commission's regulations establishing a process for ensuring the integrity of electronic Class II games and aids. The standards were...

  12. 40 CFR 63.3951 - How do I demonstrate initial compliance with the emission limitations?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES National Emission Standards for Hazardous Air Pollutants for Surface Coating..., “Standard Test Method for Density of Liquid Coatings, Inks, and Related Products” (incorporated by reference...

  13. 46 CFR 160.171-3 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (b) of this section, notice of change must be published in the Federal Register and the material made..., Standard Test Method for Initial Tear Resistance of Plastic Film and Sheeting—160.171-17 Federal Standards... Resistance of Cloth, Oscillatory Cylinder (Wyzenbeek) Method, dated July 9, 1971. Federal Standard No. 751a...

  14. Empirical Learner Language and the Levels of the "Common European Framework of Reference"

    ERIC Educational Resources Information Center

    Wisniewski, Katrin

    2017-01-01

    The "Common European Framework of Reference" (CEFR) is the most widespread reference tool for linking language tests, curricula, and national educational standards to levels of foreign language proficiency in Europe. In spite of this, little is known about how the CEFR levels (A1-C2) relate to empirical learner language(s). This article…

  15. Operator's Manual for Waveform Generator Model RPG-6236-A

    DOT National Transportation Integrated Search

    1988-02-01

    The waveform generator, described in this manual, provides a reference signal standard for use in testing the performance of crash test data acquisition systems. During the test, the waveform generator provides the signal inputs to the data acquisiti...

  16. Added value of cost-utility analysis in simple diagnostic studies of accuracy: (18)F-fluoromethylcholine PET/CT in prostate cancer staging.

    PubMed

    Gerke, Oke; Poulsen, Mads H; Høilund-Carlsen, Poul Flemming

    2015-01-01

    Diagnostic studies of accuracy targeting sensitivity and specificity are commonly done in a paired design in which all modalities are applied in each patient, whereas cost-effectiveness and cost-utility analyses are usually assessed either directly alongside to or indirectly by means of stochastic modeling based on larger randomized controlled trials (RCTs). However the conduct of RCTs is hampered in an environment such as ours, in which technology is rapidly evolving. As such, there is a relatively limited number of RCTs. Therefore, we investigated as to which extent paired diagnostic studies of accuracy can be also used to shed light on economic implications when considering a new diagnostic test. We propose a simple decision tree model-based cost-utility analysis of a diagnostic test when compared to the current standard procedure and exemplify this approach with published data from lymph node staging of prostate cancer. Average procedure costs were taken from the Danish Diagnosis Related Groups Tariff in 2013 and life expectancy was estimated for an ideal 60 year old patient based on prostate cancer stage and prostatectomy or radiation and chemotherapy. Quality-adjusted life-years (QALYs) were deduced from the literature, and an incremental cost-effectiveness ratio (ICER) was used to compare lymph node dissection with respective histopathological examination (reference standard) and (18)F-fluoromethylcholine positron emission tomography/computed tomography (FCH-PET/CT). Lower bounds of sensitivity and specificity of FCH-PET/CT were established at which the replacement of the reference standard by FCH-PET/CT comes with a trade-off between worse effectiveness and lower costs. Compared to the reference standard in a diagnostic accuracy study, any imperfections in accuracy of a diagnostic test imply that replacing the reference standard generates a loss in effectiveness and utility. We conclude that diagnostic studies of accuracy can be put to a more extensive use, over and above a mere indication of sensitivity and specificity of an imaging test, and that health economic considerations should be undertaken when planning a prospective diagnostic accuracy study. These endeavors will prove especially fruitful when comparing several imaging techniques with one another, or the same imaging technique using different tracers, with an independent reference standard for the evaluation of results.

  17. 46 CFR 164.120-5 - Incorporation by reference.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...), Standard Test Method for Apparent Viscosity of Plastisols and Organosols at Low Shear Rates, (approved...—Determination of apparent viscosity by the Brookfield test method, Second Edition (February 1, 1989, Corrected...

  18. 46 CFR 164.120-5 - Incorporation by reference.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...), Standard Test Method for Apparent Viscosity of Plastisols and Organosols at Low Shear Rates, (approved...—Determination of apparent viscosity by the Brookfield test method, Second Edition (February 1, 1989, Corrected...

  19. Predicting acute uncomplicated urinary tract infection in women: a systematic review of the diagnostic accuracy of symptoms and signs

    PubMed Central

    2010-01-01

    Background Acute urinary tract infections (UTI) are one of the most common bacterial infections among women presenting to primary care. However, there is a lack of consensus regarding the optimal reference standard threshold for diagnosing UTI. The objective of this systematic review is to determine the diagnostic accuracy of symptoms and signs in women presenting with suspected UTI, across three different reference standards (102 or 103 or 105 CFU/ml). We also examine the diagnostic value of individual symptoms and signs combined with dipstick test results in terms of clinical decision making. Methods Searches were performed through PubMed (1966 to April 2010), EMBASE (1973 to April 2010), Cochrane library (1973 to April 2010), Google scholar and reference checking. Studies that assessed the diagnostic accuracy of symptoms and signs of an uncomplicated UTI using a urine culture from a clean-catch or catherised urine specimen as the reference standard, with a reference standard of at least ≥ 102 CFU/ml were included. Synthesised data from a high quality systematic review were used regarding dipstick results. Studies were combined using a bivariate random effects model. Results Sixteen studies incorporating 3,711 patients are included. The weighted prior probability of UTI varies across diagnostic threshold, 65.1% at ≥ 102 CFU/ml; 55.4% at ≥ 103 CFU/ml and 44.8% at ≥ 102 CFU/ml ≥ 105 CFU/ml. Six symptoms are identified as useful diagnostic symptoms when a threshold of ≥ 102 CFU/ml is the reference standard. Presence of dysuria (+LR 1.30 95% CI 1.20-1.41), frequency (+LR 1.10 95% CI 1.04-1.16), hematuria (+LR 1.72 95%CI 1.30-2.27), nocturia (+LR 1.30 95% CI 1.08-1.56) and urgency (+LR 1.22 95% CI 1.11-1.34) all increase the probability of UTI. The presence of vaginal discharge (+LR 0.65 95% CI 0.51-0.83) decreases the probability of UTI. Presence of hematuria has the highest diagnostic utility, raising the post-test probability of UTI to 75.8% at ≥ 102 CFU/ml and 67.4% at ≥ 103 CFU/ml. Probability of UTI increases to 93.3% and 90.1% at ≥ 102 CFU/ml and ≥ 103 CFU/ml respectively when presence of hematuria is combined with a positive dipstick result for nitrites. Subgroup analysis shows improved diagnostic accuracy using lower reference standards ≥ 102 CFU/ml and ≥ 103 CFU/ml. Conclusions Individual symptoms and signs have a modest ability to raise the pretest-risk of UTI. Diagnostic accuracy improves considerably when combined with dipstick tests particularly tests for nitrites. PMID:20969801

  20. Predicting acute uncomplicated urinary tract infection in women: a systematic review of the diagnostic accuracy of symptoms and signs.

    PubMed

    Giesen, Leonie G M; Cousins, Gráinne; Dimitrov, Borislav D; van de Laar, Floris A; Fahey, Tom

    2010-10-24

    Acute urinary tract infections (UTI) are one of the most common bacterial infections among women presenting to primary care. However, there is a lack of consensus regarding the optimal reference standard threshold for diagnosing UTI. The objective of this systematic review is to determine the diagnostic accuracy of symptoms and signs in women presenting with suspected UTI, across three different reference standards (10(2) or 10(3) or 10(5) CFU/ml). We also examine the diagnostic value of individual symptoms and signs combined with dipstick test results in terms of clinical decision making. Searches were performed through PubMed (1966 to April 2010), EMBASE (1973 to April 2010), Cochrane library (1973 to April 2010), Google scholar and reference checking.Studies that assessed the diagnostic accuracy of symptoms and signs of an uncomplicated UTI using a urine culture from a clean-catch or catherised urine specimen as the reference standard, with a reference standard of at least ≥ 10(2) CFU/ml were included. Synthesised data from a high quality systematic review were used regarding dipstick results. Studies were combined using a bivariate random effects model. Sixteen studies incorporating 3,711 patients are included. The weighted prior probability of UTI varies across diagnostic threshold, 65.1% at ≥ 10(2) CFU/ml; 55.4% at ≥ 10(3) CFU/ml and 44.8% at ≥ 10(2) CFU/ml ≥ 10(5) CFU/ml. Six symptoms are identified as useful diagnostic symptoms when a threshold of ≥ 10(2) CFU/ml is the reference standard. Presence of dysuria (+LR 1.30 95% CI 1.20-1.41), frequency (+LR 1.10 95% CI 1.04-1.16), hematuria (+LR 1.72 95%CI 1.30-2.27), nocturia (+LR 1.30 95% CI 1.08-1.56) and urgency (+LR 1.22 95% CI 1.11-1.34) all increase the probability of UTI. The presence of vaginal discharge (+LR 0.65 95% CI 0.51-0.83) decreases the probability of UTI. Presence of hematuria has the highest diagnostic utility, raising the post-test probability of UTI to 75.8% at ≥ 10(2) CFU/ml and 67.4% at ≥ 10(3) CFU/ml. Probability of UTI increases to 93.3% and 90.1% at ≥ 10(2) CFU/ml and ≥ 10(3) CFU/ml respectively when presence of hematuria is combined with a positive dipstick result for nitrites. Subgroup analysis shows improved diagnostic accuracy using lower reference standards ≥ 10(2) CFU/ml and ≥ 10(3) CFU/ml. Individual symptoms and signs have a modest ability to raise the pretest-risk of UTI. Diagnostic accuracy improves considerably when combined with dipstick tests particularly tests for nitrites.

  1. Development of a reference material of a single DNA molecule for the quality control of PCR testing.

    PubMed

    Mano, Junichi; Hatano, Shuko; Futo, Satoshi; Yoshii, Junji; Nakae, Hiroki; Naito, Shigehiro; Takabatake, Reona; Kitta, Kazumi

    2014-09-02

    We developed a reference material of a single DNA molecule with a specific nucleotide sequence. The double-strand linear DNA which has PCR target sequences at the both ends was prepared as a reference DNA molecule, and we named the PCR targets on each side as confirmation sequence and standard sequence. The highly diluted solution of the reference molecule was dispensed into 96 wells of a plastic PCR plate to make the average number of molecules in a well below one. Subsequently, the presence or absence of the reference molecule in each well was checked by real-time PCR targeting for the confirmation sequence. After an enzymatic treatment of the reaction mixture in the positive wells for the digestion of PCR products, the resultant solution was used as the reference material of a single DNA molecule with the standard sequence. PCR analyses revealed that the prepared samples included only one reference molecule with high probability. The single-molecule reference material developed in this study will be useful for the absolute evaluation of a detection limit of PCR-based testing methods, the quality control of PCR analyses, performance evaluations of PCR reagents and instruments, and the preparation of an accurate calibration curve for real-time PCR quantitation.

  2. Functional integrity of the interrenal tissue of yellow perch from contaminated sites tested in vivo

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

    Girard, C.; Brodeur, J.C.; Hontela, A.

    1995-12-31

    The normal activation of the hypothalamo-pituitary-interrenal axis (HPI axis) in response to capture is disrupted in fish subjected to life-long exposure to heavy metals, PCBs and PAHs. The ability to increase plasma cortisol in yellow perch (Perca flavescens) from sites contaminated by heavy metals and organic compounds, and from a reference site was assessed by the Capture stress test and by the ACTH Challenge test, a new standardized in vivo method designed for field studies. The effects of seasonal factors, such as temperature and gonadal maturity on these tests were investigated. Measures of liver and muscle glycogen and histopathology weremore » made to further characterize the biochemical and structural changes that may occur along with hormonal changes. The Capture stress test showed that an acute source of stress induced a lower cortisol response in fish from the highly contaminated site compared to the reference site, revealing a functional impairment of the HPI axis. The ACTH Challenge test showed that the hormonal responsiveness of the cortisol-secreting interrenal tissue, stimulated by a standard dose of ACTH injected i.p., was lower in fish from the highly contaminated site than the reference site. Spring is the season during which the impairment was the most evident. The possibility of using the reduced capacity of feral fish to respond to a standardized ACTH Challenge as an early bioindicator of toxic stress is discussed.« less

  3. UV disinfection in drinking water supplies.

    PubMed

    Hoyer, O

    2000-01-01

    UV disinfection has become a practical and safely validatable disinfection procedure by specifying the requirements for testing and monitoring in DVGW standard W 294. A standardized biodosimetric testing procedure and monitoring with standardized UV sensors is introduced and successfully applied. On-line monitoring of irradiance can be counterchecked with handheld reference sensors and makes it possible that UV systems can be used for drinking water disinfection with the same level of confidence and safety as is conventional chemical disinfection.

  4. Physical tests for shoulder impingements and local lesions of bursa, tendon or labrum that may accompany impingement.

    PubMed

    Hanchard, Nigel C A; Lenza, Mário; Handoll, Helen H G; Takwoingi, Yemisi

    2013-04-30

    Impingement is a common cause of shoulder pain. Impingement mechanisms may occur subacromially (under the coraco-acromial arch) or internally (within the shoulder joint), and a number of secondary pathologies may be associated. These include subacromial-subdeltoid bursitis (inflammation of the subacromial portion of the bursa, the subdeltoid portion, or both), tendinopathy or tears affecting the rotator cuff or the long head of biceps tendon, and glenoid labral damage. Accurate diagnosis based on physical tests would facilitate early optimisation of the clinical management approach. Most people with shoulder pain are diagnosed and managed in the primary care setting. To evaluate the diagnostic accuracy of physical tests for shoulder impingements (subacromial or internal) or local lesions of bursa, rotator cuff or labrum that may accompany impingement, in people whose symptoms and/or history suggest any of these disorders. We searched electronic databases for primary studies in two stages. In the first stage, we searched MEDLINE, EMBASE, CINAHL, AMED and DARE (all from inception to November 2005). In the second stage, we searched MEDLINE, EMBASE and AMED (2005 to 15 February 2010). Searches were delimited to articles written in English. We considered for inclusion diagnostic test accuracy studies that directly compared the accuracy of one or more physical index tests for shoulder impingement against a reference test in any clinical setting. We considered diagnostic test accuracy studies with cross-sectional or cohort designs (retrospective or prospective), case-control studies and randomised controlled trials. Two pairs of review authors independently performed study selection, assessed the study quality using QUADAS, and extracted data onto a purpose-designed form, noting patient characteristics (including care setting), study design, index tests and reference standard, and the diagnostic 2 x 2 table. We presented information on sensitivities and specificities with 95% confidence intervals (95% CI) for the index tests. Meta-analysis was not performed. We included 33 studies involving 4002 shoulders in 3852 patients. Although 28 studies were prospective, study quality was still generally poor. Mainly reflecting the use of surgery as a reference test in most studies, all but two studies were judged as not meeting the criteria for having a representative spectrum of patients. However, even these two studies only partly recruited from primary care.The target conditions assessed in the 33 studies were grouped under five main categories: subacromial or internal impingement, rotator cuff tendinopathy or tears, long head of biceps tendinopathy or tears, glenoid labral lesions and multiple undifferentiated target conditions. The majority of studies used arthroscopic surgery as the reference standard. Eight studies utilised reference standards which were potentially applicable to primary care (local anaesthesia, one study; ultrasound, three studies) or the hospital outpatient setting (magnetic resonance imaging, four studies). One study used a variety of reference standards, some applicable to primary care or the hospital outpatient setting. In two of these studies the reference standard used was acceptable for identifying the target condition, but in six it was only partially so. The studies evaluated numerous standard, modified, or combination index tests and 14 novel index tests. There were 170 target condition/index test combinations, but only six instances of any index test being performed and interpreted similarly in two studies. Only two studies of a modified empty can test for full thickness tear of the rotator cuff, and two studies of a modified anterior slide test for type II superior labrum anterior to posterior (SLAP) lesions, were clinically homogenous. Due to the limited number of studies, meta-analyses were considered inappropriate. Sensitivity and specificity estimates from each study are presented on forest plots for the 170 target condition/index test combinations grouped according to target condition. There is insufficient evidence upon which to base selection of physical tests for shoulder impingements, and local lesions of bursa, tendon or labrum that may accompany impingement, in primary care. The large body of literature revealed extreme diversity in the performance and interpretation of tests, which hinders synthesis of the evidence and/or clinical applicability.

  5. Results of the U. S. Geological Survey's analytical evaluation program for standard reference samples distributed in April 2001

    USGS Publications Warehouse

    Woodworth, M.T.; Connor, B.F.

    2001-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-165 (trace constituents), M-158 (major constituents), N-69 (nutrient constituents), N-70 (nutrient constituents), P-36 (low ionic-strength constituents), and Hg-32 (mercury) -- that were distributed in April 2001 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 73 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  6. Results of the U. S. Geological Survey's Analytical Evaluation Program for Standard Reference Samples Distributed in March 2002

    USGS Publications Warehouse

    Woodworth, M.T.; Conner, B.F.

    2002-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T- 169 (trace constituents), M- 162 (major constituents), N-73 (nutrient constituents), N-74 (nutrient constituents), P-38 (low ionic-strength constituents), and Hg-34 (mercury) -- that were distributed in March 2002 to laboratories enrolled in the U.S. Geological Survey sponsored intedaboratory testing program. Analytical data received from 93 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  7. Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in September 2002

    USGS Publications Warehouse

    Woodworth, Mark T.; Connor, Brooke F.

    2003-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-171 (trace constituents), M-164 (major constituents), N-75 (nutrient constituents), N-76 (nutrient constituents), P-39 (low ionic-strength constituents), and Hg-35 (mercury) -- that were distributed in September 2002 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 102 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  8. Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in September 2001

    USGS Publications Warehouse

    Woodworth, Mark T.; Connor, Brooke F.

    2002-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-167 (trace constituents), M-160 (major constituents), N-71 (nutrient constituents), N-72 (nutrient constituents), P-37 (low ionic-strength constituents), and Hg-33 (mercury) -- that were distributed in September 2001 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 98 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  9. Results of the U.S. Geological Survey's Analytical Evaluation Program for Standard Reference Samples Distributed in March 2000

    USGS Publications Warehouse

    Farrar, Jerry W.; Copen, Ashley M.

    2000-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-161 (trace constituents), M-154 (major constituents), N-65 (nutrient constituents), N-66 nutrient constituents), P-34 (low ionic strength constituents), and Hg-30 (mercury) -- that were distributed in March 2000 to 144 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 132 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  10. Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in October 1999

    USGS Publications Warehouse

    Farrar, T.W.

    2000-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-159 (trace constituents), M-152 (major constituents), N-63 (nutrient constituents), N-64 (nutrient constituents), P-33 (low ionic strength constituents), and Hg-29 (mercury) -- that were distributed in October 1999 to 149 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 131 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  11. Results of the U.S. Geological Survey's analytical evaluation program for standard reference samples distributed in March 2003

    USGS Publications Warehouse

    Woodworth, Mark T.; Connor, Brooke F.

    2003-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-173 (trace constituents), M-166 (major constituents), N-77 (nutrient constituents), N-78 (nutrient constituents), P-40 (low ionic-strength constituents), and Hg-36 (mercury) -- that were distributed in March 2003 to laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 110 laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  12. Results of the U. S. Geological Survey's analytical evaluation program for standard reference samples distributed in October 2000

    USGS Publications Warehouse

    Connor, B.F.; Currier, J.P.; Woodworth, M.T.

    2001-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-163 (trace constituents), M-156 (major constituents), N-67 (nutrient constituents), N-68 (nutrient constituents), P-35 (low ionic strength constituents), and Hg-31 (mercury) -- that were distributed in October 2000 to 126 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 122 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  13. 21 CFR 660.4 - Potency test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.4 Potency test. To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent...

  14. 21 CFR 660.4 - Potency test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.4 Potency test. To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent...

  15. 21 CFR 660.43 - Potency test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.43 Potency test. To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the...

  16. 21 CFR 660.43 - Potency test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.43 Potency test. To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the...

  17. 21 CFR 660.4 - Potency test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.4 Potency test. To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent...

  18. 21 CFR 660.43 - Potency test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.43 Potency test. To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the...

  19. 21 CFR 660.4 - Potency test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Antibody to Hepatitis B Surface Antigen § 660.4 Potency test. To be satisfactory for release, each filling of Antibody to Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Surface Antigen Panel and shall be sufficiently potent...

  20. 21 CFR 660.43 - Potency test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.43 Potency test. To be satisfactory for release, each filling of Hepatitis B Surface Antigen shall be tested against the Reference Hepatitis B Antiserum Panel and shall be sufficiently potent to be able to detect the...

  1. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2009-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products.

  2. Accuracy of a Rapid Diagnostic Test (Cypress Chagas Quick Test®) for the Diagnosis of Chronic Chagas Disease in a Nonendemic Area: A Retrospective Longitudinal Study.

    PubMed

    Angheben, Andrea; Staffolani, Silvia; Anselmi, Mariella; Tais, Stefano; Degani, Monica; Gobbi, Federico; Buonfrate, Dora; Gobbo, Maria; Bisoffi, Zeno

    2017-11-01

    We analyzed the accuracy of Chagas Quick Test ® , a rapid diagnostic test, for the diagnosis of chronic Chagas disease through a retrospective study on a cohort of 669 patients consecutively examined at a single reference center in Italy, during a 7-year period. We observed high concordance with serological reference standard but low accuracy for screening purposes (sensitivity/specificity: 82.8%/98.7%) at least in our nonendemic context.

  3. 46 CFR 114.600 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... for Building and Classing Steel Vessels Under 61 Meters (200 Feet) in Length, 1983 116.300 Rules for...) Apparatus 114.400 ASTM B 122/B 122M-95, Standard Specification for Copper-Nickel-Tin Alloy , Copper-Nickel..., Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester 114.400 ASTM D 635-97, Standard...

  4. 10 CFR 431.15 - Materials incorporated by reference.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ....03, IBR approved for § 431.12. (2) Institute of Electrical and Electronics Engineers, Inc., Standard... INDUSTRIAL EQUIPMENT Electric Motors Test Procedures, Materials Incorporated and Methods of Determining... provisions of National Electrical Manufacturers Association Standards Publication MG1-1993, Motors and...

  5. Standardization of UV LED measurements

    NASA Astrophysics Data System (ADS)

    Eppeldauer, G. P.; Larason, T. C.; Yoon, H. W.

    2015-09-01

    Traditionally used source spectral-distribution or detector spectral-response based standards cannot be applied for accurate UV LED measurements. Since the CIE standardized rectangular-shape spectral response function for UV measurements cannot be realized with small spectral mismatch when using filtered detectors, the UV measurement errors can be several times ten percent or larger. The UV LEDs produce broadband radiation and both their peaks or spectral bandwidths can change significantly. The detectors used for the measurement of these LEDs also have different spectral bandwidths. In the discussed example, where LEDs with 365 nm peak are applied for fluorescent crack-recognition using liquid penetrant (non-destructive) inspection, the broadband radiometric LED (signal) measurement procedure is standardized. A UV LED irradiance-source was calibrated against an FEL lamp standard to determine its spectral irradiance. The spectral irradiance responsivity of a reference UV meter was also calibrated. The output signal of the reference UV meter was calculated from the spectral irradiance of the UV source and the spectral irradiance responsivity of the reference UV meter. From the output signal, both the integrated irradiance (in the reference plane of the reference meter) and the integrated responsivity of the reference meter were determined. Test UV meters calibrated for integrated responsivity against the reference UV meter, can be used to determine the integrated irradiance from a field UV source. The obtained 5 % (k=2) measurement uncertainty can be decreased when meters with spectral response close to a constant value are selected.

  6. Evaluation of the SD Bioline Cholera Rapid Diagnostic Test During the 2016 Cholera Outbreak in Lusaka, Zambia.

    PubMed

    Mwaba, John; Ferreras, Eva; Chizema-Kawesa, Elizabeth; Mwimbe, Daniel; Tafirenyika, Francis; Rauzier, Jean; Blake, Alexandre; Rakesh, Ankur; Poncin, Marc; Stoitsova, Savina; Kwenda, Geoffrey; Azman, Andrew S; Chewe, Orbrie; Serafini, Micaela; Lukwesa-Musyani, Chileshe; Cohuet, Sandra; Quilici, Marie-Laure; Luquero, Francisco J; Page, Anne-Laure

    2018-05-31

    To assess the performance of the SD Bioline Cholera Ag O1/O139 rapid diagnostic test (RDT) compared to a reference standard combining culture and PCR for the diagnosis of cholera cases during an outbreak. RDT and bacterial culture were performed on site using fresh stools collected from cholera suspected cases, and from stools enriched in alkaline peptone water. Dried stool samples on filter paper were tested for V. cholerae by PCR in Lusaka (as part of a laboratory technology transfer project) and at a reference laboratory in Paris, France. A sample was considered positive for cholera by the reference standard if any of the culture or PCR tests was positive for V. cholerae O1 or O139. Among the 170 samples tested with SD Bioline and compared to the reference standard, the RDT showed a sensitivity of 90.9% (95% CI: 81.3-96.6) and specificity of 95.0% (95% CI: 89.1-98.4). After enrichment, the sensitivity was 95.5% (95% CI: 87.3-99.1) and specificity 100% (5% CI: 96.5-100). The observed sensitivity and specificity were within recommendations set by the Global Task Force for Cholera Control on the use of cholera RDT (sensitivity=90% : specificity=85%). Although the sample size was small, our findings suggest that the SD Bioline RDT could be used in the field to rapidly alert public health officials to the likely presence of cholera cases when an outbreak is suspected. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  7. Revision of the SNPforID 34-plex forensic ancestry test: Assay enhancements, standard reference sample genotypes and extended population studies.

    PubMed

    Fondevila, M; Phillips, C; Santos, C; Freire Aradas, A; Vallone, P M; Butler, J M; Lareu, M V; Carracedo, A

    2013-01-01

    A revision of an established 34 SNP forensic ancestry test has been made by swapping the under-performing rs727811 component SNP with the highly informative rs3827760 that shows a near-fixed East Asian specific allele. We collated SNP variability data for the revised SNP set in 66 reference populations from 1000 Genomes and HGDP-CEPH panels and used this as reference data to analyse four U.S. populations showing a range of admixture patterns. The U.S. Hispanics sample in particular displayed heterogeneous values of co-ancestry between European, Native American and African contributors, likely to reflect in part, the way this disparate group is defined using cultural as well as population genetic parameters. The genotyping of over 700 U.S. population samples also provided the opportunity to thoroughly gauge peak mobility variation and peak height ratios observed from routine use of the single base extension chemistry of the 34-plex test. Finally, the genotyping of the widely used DNA profiling Standard Reference Material samples plus other control DNAs completes the audit of the 34-plex assay to allow forensic practitioners to apply this test more readily in their own laboratories. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  8. Tests of the standard (30 hz) NCER FM multiplex telemetry system, augmented by two timing channels and a compensation reference signal, used to record multiplexed seismic network data on magnetic tape

    USGS Publications Warehouse

    Eaton, Jerry P.

    1976-01-01

    The application of subtractive compensation to USGS seismic magnetic tape recording and playback systems was examined in a recent USGS Open-file report (1). It was found, for the standard (30 Hz) NCER multiplex system, that subtractive compensation utilizing a 4688 Hz reference signal multiplexed onto each data track was more effective than that utilizing a 3125 Hz reference signal recorded separately on a different track. Moreover, it was found that the portion of the spectrum between the uppermost data channel (3060 Hz + or - 125 Hz) and the compensation reference signal (4688 Hz) could be used to record an additional timing signal, with a center frequency of 3700 Hz and a broader playback bandwidth (ca 0 to 100 Hz) than that of the standard data channels. Accordingly, for the tests described in that report, the standard 8-datachannel multiplex system was augmented by one additional timing channel with a center frequency of 3700 Hz. The 3700 Hz discriminator used in those tests was not successfully set up to utilize subtractive compensation; so its output from a tape playback was quite noisy. Subsequently, further tests have been carried out on the application of subtractive compensation to a 4-channel broad-band multiplex system and to the standard multiplex system, both recorded on field tape recorders with relatively poor tape speed control (2), (3). In the course of these experiments, it was discovered that two separate timing channe1s, not just one, can be inserted between the uppermost data channel and the compensation reference signal, Furthermore, it was possible to adjust the discriminators used to playback these timing channels so that they profited significantly from subtractive compensation even though the playback bandwidth was 0 to 100 Hz (for short rise times of square wave timing signals). The advantages of recording two timing signals on each data track include: 1) one standard time signal to be used for critical timing, e.g. IRIG E, can be recorded with the data on each track, eliminating any problem that might arise from tape head misalignment if the timing base were recorded on a separate track from the data signals being timed, 2) other essential timing signals e.g. WWVB and IRIG C, can each be recorded on several tracks, to insure more reliable recording through redundancy, without displacing data from standard data channels, 3) the broader playback bandwidth of the special timing channels reproduces the sharp-edged timing codes with much less distortion than is obtained from the standard data channels. In order to implement subtractive compensation with the 4688 Hz multiplexed signal and to record timing signals on the proposed special timing channels, it was necessary to design and build a signal generator/multiplexer unit. The functions of this unit are: 1) generate a stable (x-tal controlled) compensation reference frequency (4688 Hz), 2) generate two timing channel subcarriers (3500 Hz and 3950 Hz) and provide for their modulation by appropriate timing signals, 3) separately, for each of th~14 tape tracks, adjust the relative levels of the timing and compensation subcarriers and multiplex them, at the appropriate level, with the incoming multiplexed data signals for introduction to the tape system direct record amplifiers. These units will be described in detail by Gray Jensen, who designed and built them, as well as being shown diagrammatically in this report. This report continues the work described in reference (1), and it should be read as a supplement to that report rather than as an independent effort. It introduces changes in the multiplex system and test circuits employed in the tests and then repeats the tests from the earlier report that are required to illustrate the characteristics of the modified system.

  9. Quality evaluation of no-reference MR images using multidirectional filters and image statistics.

    PubMed

    Jang, Jinseong; Bang, Kihun; Jang, Hanbyol; Hwang, Dosik

    2018-09-01

    This study aimed to develop a fully automatic, no-reference image-quality assessment (IQA) method for MR images. New quality-aware features were obtained by applying multidirectional filters to MR images and examining the feature statistics. A histogram of these features was then fitted to a generalized Gaussian distribution function for which the shape parameters yielded different values depending on the type of distortion in the MR image. Standard feature statistics were established through a training process based on high-quality MR images without distortion. Subsequently, the feature statistics of a test MR image were calculated and compared with the standards. The quality score was calculated as the difference between the shape parameters of the test image and the undistorted standard images. The proposed IQA method showed a >0.99 correlation with the conventional full-reference assessment methods; accordingly, this proposed method yielded the best performance among no-reference IQA methods for images containing six types of synthetic, MR-specific distortions. In addition, for authentically distorted images, the proposed method yielded the highest correlation with subjective assessments by human observers, thus demonstrating its superior performance over other no-reference IQAs. Our proposed IQA was designed to consider MR-specific features and outperformed other no-reference IQAs designed mainly for photographic images. Magn Reson Med 80:914-924, 2018. © 2018 International Society for Magnetic Resonance in Medicine. © 2018 International Society for Magnetic Resonance in Medicine.

  10. A multi‐centre evaluation of nine rapid, point‐of‐care syphilis tests using archived sera

    PubMed Central

    Herring, A J; Ballard, R C; Pope, V; Adegbola, R A; Changalucha, J; Fitzgerald, D W; Hook, E W; Kubanova, A; Mananwatte, S; Pape, J W; Sturm, A W; West, B; Yin, Y P; Peeling, R W

    2006-01-01

    Objectives To evaluate nine rapid syphilis tests at eight geographically diverse laboratory sites for their performance and operational characteristics. Methods Tests were compared “head to head” using locally assembled panels of 100 archived (50 positive and 50 negative) sera at each site using as reference standards the Treponema pallidum haemagglutination or the T pallidum particle agglutination test. In addition inter‐site variation, result stability, test reproducibility and test operational characteristics were assessed. Results All nine tests gave good performance relative to the reference standard with sensitivities ranging from 84.5–97.7% and specificities from 84.5–98%. Result stability was variable if result reading was delayed past the recommended period. All the tests were found to be easy to use, especially the lateral flow tests. Conclusions All the tests evaluated have acceptable performance characteristics and could make an impact on the control of syphilis. Tests that can use whole blood and do not require refrigeration were selected for further evaluation in field settings. PMID:17118953

  11. 10 CFR 431.95 - Materials incorporated by reference.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Energy Efficiency and Renewable Energy, Hearings and Dockets, “Test Procedures and Efficiency Standards... 10 Energy 3 2012-01-01 2012-01-01 false Materials incorporated by reference. 431.95 Section 431.95 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND...

  12. 40 CFR 761.19 - References.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... incorporated by reference, and is available for inspection at the National Archives and Records Administration...://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. These incorporations... Products (General Bomb Method) § 761.71(b)(2)(vi) ASTM D 240-87 Standard Test Method for Heat of Combustion...

  13. A proposed protocol for acceptance and constancy control of computed tomography systems: a Nordic Association for Clinical Physics (NACP) work group report.

    PubMed

    Kuttner, Samuel; Bujila, Robert; Kortesniemi, Mika; Andersson, Henrik; Kull, Love; Østerås, Bjørn Helge; Thygesen, Jesper; Tarp, Ivanka Sojat

    2013-03-01

    Quality assurance (QA) of computed tomography (CT) systems is one of the routine tasks for medical physicists in the Nordic countries. However, standardized QA protocols do not yet exist and the QA methods, as well as the applied tolerance levels, vary in scope and extent at different hospitals. To propose a standardized protocol for acceptance and constancy testing of CT scanners in the Nordic Region. Following a Nordic Association for Clinical Physics (NACP) initiative, a group of medical physicists, with representatives from four Nordic countries, was formed. Based on international literature and practical experience within the group, a comprehensive standardized test protocol was developed. The proposed protocol includes tests related to the mechanical functionality, X-ray tube, detector, and image quality for CT scanners. For each test, recommendations regarding the purpose, equipment needed, an outline of the test method, the measured parameter, tolerance levels, and the testing frequency are stated. In addition, a number of optional tests are briefly discussed that may provide further information about the CT system. Based on international references and medical physicists' practical experiences, a comprehensive QA protocol for CT systems is proposed, including both acceptance and constancy tests. The protocol may serve as a reference for medical physicists in the Nordic countries.

  14. Clinical Validation of Targeted Next Generation Sequencing for Colon and Lung Cancers

    PubMed Central

    D’Haene, Nicky; Le Mercier, Marie; De Nève, Nancy; Blanchard, Oriane; Delaunoy, Mélanie; El Housni, Hakim; Dessars, Barbara; Heimann, Pierre; Remmelink, Myriam; Demetter, Pieter; Tejpar, Sabine; Salmon, Isabelle

    2015-01-01

    Objective Recently, Next Generation Sequencing (NGS) has begun to supplant other technologies for gene mutation testing that is now required for targeted therapies. However, transfer of NGS technology to clinical daily practice requires validation. Methods We validated the Ion Torrent AmpliSeq Colon and Lung cancer panel interrogating 1850 hotspots in 22 genes using the Ion Torrent Personal Genome Machine. First, we used commercial reference standards that carry mutations at defined allelic frequency (AF). Then, 51 colorectal adenocarcinomas (CRC) and 39 non small cell lung carcinomas (NSCLC) were retrospectively analyzed. Results Sensitivity and accuracy for detecting variants at an AF >4% was 100% for commercial reference standards. Among the 90 cases, 89 (98.9%) were successfully sequenced. Among the 86 samples for which NGS and the reference test were both informative, 83 showed concordant results between NGS and the reference test; i.e. KRAS and BRAF for CRC and EGFR for NSCLC, with the 3 discordant cases each characterized by an AF <10%. Conclusions Overall, the AmpliSeq colon/lung cancer panel was specific and sensitive for mutation analysis of gene panels and can be incorporated into clinical daily practice. PMID:26366557

  15. 21 CFR 660.43 - Potency test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Potency test. 660.43 Section 660.43 Food and Drugs... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.43 Potency test... antibody in the appropriate sera of the reference panel by all test methods recommended by the manufacturer...

  16. OSI: Will It Ever See the Light of Day?

    ERIC Educational Resources Information Center

    Moloney, Peter

    1997-01-01

    Examines issues of viability and necessity regarding the Open System Interconnections (OSI) reference service model with a view on future developments. Discusses problems with the standards; conformance testing; OSI bureaucracy; standardized communications; security; the transport level; applications; the stakeholders (communications providers,…

  17. [Development and application of reference materials containing mixed degradation products of amoxicillin and ampicillin].

    PubMed

    Li, Wei; Zhang, Wei-Qing; Li, Xiang; Hu, Chang-Qin

    2014-09-01

    Reference materials containing mixed degradation products of amoxicillin and ampicillin were developed after optimization of preparation processes. The target impurities were obtained by controlled stress testing, and each major component was identified with HPLC-MS and compared with single traceable reference standard each. The developed reference materials were applied to system suitability test for verifying HPLC system performed in accordance with set forth in China Pharmacopeia and identification of major impurities in samples based on retention and spectra information, which have advantages over the methods put forth in foreign pharmacopoeias. The development and application of the reference materials offer an effective way for rapid identification of impurities in chromatograms, and provide references for analyzing source of impurities and evaluation of drug quality.

  18. Measuring the activity of BioBrick promoters using an in vivo reference standard

    PubMed Central

    Kelly, Jason R; Rubin, Adam J; Davis, Joseph H; Ajo-Franklin, Caroline M; Cumbers, John; Czar, Michael J; de Mora, Kim; Glieberman, Aaron L; Monie, Dileep D; Endy, Drew

    2009-01-01

    Background The engineering of many-component, synthetic biological systems is being made easier by the development of collections of reusable, standard biological parts. However, the complexity of biology makes it difficult to predict the extent to which such efforts will succeed. As a first practical example, the Registry of Standard Biological Parts started at MIT now maintains and distributes thousands of BioBrick™ standard biological parts. However, BioBrick parts are only standardized in terms of how individual parts are physically assembled into multi-component systems, and most parts remain uncharacterized. Standardized tools, techniques, and units of measurement are needed to facilitate the characterization and reuse of parts by independent researchers across many laboratories. Results We found that the absolute activity of BioBrick promoters varies across experimental conditions and measurement instruments. We choose one promoter (BBa_J23101) to serve as an in vivo reference standard for promoter activity. We demonstrated that, by measuring the activity of promoters relative to BBa_J23101, we could reduce variation in reported promoter activity due to differences in test conditions and measurement instruments by ~50%. We defined a Relative Promoter Unit (RPU) in order to report promoter characterization data in compatible units and developed a measurement kit so that researchers might more easily adopt RPU as a standard unit for reporting promoter activity. We distributed a set of test promoters to multiple labs and found good agreement in the reported relative activities of promoters so measured. We also characterized the relative activities of a reference collection of BioBrick promoters in order to further support adoption of RPU-based measurement standards. Conclusion Relative activity measurements based on an in vivoreference standard enables improved measurement of promoter activity given variation in measurement conditions and instruments. These improvements are sufficient to begin to support the measurement of promoter activities across many laboratories. Additional in vivo reference standards for other types of biological functions would seem likely to have similar utility, and could thus improve research on the design, production, and reuse of standard biological parts. PMID:19298678

  19. A systematic review and meta-analysis of the diagnostic accuracy of point-of-care tests for the detection of hyperketonemia in dairy cows.

    PubMed

    Tatone, Elise H; Gordon, Jessica L; Hubbs, Jessie; LeBlanc, Stephen J; DeVries, Trevor J; Duffield, Todd F

    2016-08-01

    Several rapid tests for use on farm have been validated for the detection of hyperketonemia (HK) in dairy cattle, however the reported sensitivity and specificity of each method varies and no single study has compared them all. Meta-analysis of diagnostic test accuracy is becoming more common in human medical literature but there are few veterinary examples. The objective of this work was to perform a systematic review and meta-analysis to determine the point-of-care testing method with the highest combined sensitivity and specificity, the optimal threshold for each method, and to identify gaps in the literature. A comprehensive literature search resulted in 5196 references. After removing duplicates and performing relevance screening, 23 studies were included for the qualitative synthesis and 18 for the meta-analysis. The three index tests evaluated in the meta-analysis were: the Precision Xtra(®) handheld device measuring beta-hydroxybutyrate (BHB) concentration in whole blood, and Ketostix(®) and KetoTest(®) semi-quantitative strips measuring the concentration of acetoacetate in urine and BHB in milk, respectively. The diagnostic accuracy of the 3 index tests relative to the reference standard measurement of BHB in serum or whole blood between 1.0-1.4mmol/L was compared using the hierarchical summary receiver operator characteristic (HSROC) method. Subgroup analysis was conducted for each index test to examine the accuracy at different thresholds. The impact of the reference standard threshold, the reference standard method, the prevalence of HK in the population, the primary study source and risk of bias of the primary study was explored using meta-regression. The Precision Xtra(®) device had the highest summary sensitivity in whole blood BHB at 1.2mmol/L, 94.8% (CI95%: 92.6-97.0), and specificity, 97.5% (CI95%: 96.9-98.1). The threshold employed (1.2-1.4mmol/L) did not impact the diagnostic accuracy of the test. The Ketostix(®) and KetoTest(®) strips had the highest summary sensitivity and specificity when the trace and weak positive thresholds were used, respectively. Controlling for the source of publication, HK prevalence and reference standard employed did not impact the estimated sensitivity and specificity of the tests. Including only peer-reviewed studies reduced the number of primary studies evaluating the Precision Xtra(®) by 43% and Ketostix(®) by 33%. Diagnosing HK with blood, urine or milk are valid options, however, the diagnostic inaccuracy of urine and milk should be considered when making economic and treatment decisions. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Evidence-Based Diagnosis and Treatment of the Painful Sacroiliac Joint

    PubMed Central

    Laslett, Mark

    2008-01-01

    Sacroiliac joint (SIJ) pain refers to the pain arising from the SIJ joint structures. SIJ dysfunction generally refers to aberrant position or movement of SIJ structures that may or may not result in pain. This paper aims to clarify the difference between these clinical concepts and present current available evidence regarding diagnosis and treatment of SIJ disorders. Tests for SIJ dysfunction generally have poor inter-examiner reliability. A reference standard for SIJ dysfunction is not readily available, so validity of the tests for this disorder is unknown. Tests that stress the SIJ in order to provoke familiar pain have acceptable inter-examiner reliability and have clinically useful validity against an acceptable reference standard. It is unknown if provocation tests can reliably identify extra-articular SIJ sources of pain. Three or more positive pain provocation SIJ tests have sensitivity and specificity of 91% and 78%, respectively. Specificity of three or more positive tests increases to 87% in patients whose symptoms cannot be made to move towards the spinal midline, i.e., centralize. In chronic back pain populations, patients who have three or more positive provocation SIJ tests and whose symptoms cannot be made to centralize have a probability of having SIJ pain of 77%, and in pregnant populations with back pain, a probability of 89%. This combination of test findings could be used in research to evaluate the efficacy of specific treatments for SIJ pain. Treatments most likely to be effective are specific lumbopelvic stabilization training and injections of corticosteroid into the intra-articular space. PMID:19119403

  1. 40 CFR 98.254 - Monitoring and QA/QC requirements.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) ASTM D1945-03 Standard Test Method for Analysis of Natural Gas by Gas Chromatography (incorporated by... by Gas Chromatography (incorporated by reference, see § 98.7). (4) GPA 2261-00 Analysis for Natural Gas and Similar Gaseous Mixtures by Gas Chromatography (incorporated by reference, see § 98.7). (5...

  2. 7 CFR 801.12 - Design requirements incorporated by reference.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... reference: General Code (1.10.) G-S.5.5. Money Values, Mathematical Agreement G-T.1. Acceptance Tolerances G.... Tolerance Values T.3. For Test Weight Per Bushel Indications or Recorded Representations UR.3.2. Other... Standards and Technology's (NIST) Handbook 44, “Specifications, Tolerances, and Other Technical Requirements...

  3. 40 CFR 53.4 - Applications for reference or equivalent method determinations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... using information such as service reports and customer complaints to eliminate potential causes of... standards of good practice and by qualified personnel. Test anomalies or irregularities shall be documented... designated as a reference or equivalent method, to ensure that all analyzers or samplers offered for sale...

  4. 40 CFR 98.254 - Monitoring and QA/QC requirements.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Bomb Calorimeter (Precision Method) (incorporated by reference, see § 98.7). (2) ASTM D240-02 (Reapproved 2007) Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter... Carbon, Hydrogen, and Nitrogen in Petroleum Products and Lubricants (incorporated by reference, see § 98...

  5. 40 CFR 98.254 - Monitoring and QA/QC requirements.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Bomb Calorimeter (Precision Method) (incorporated by reference, see § 98.7). (2) ASTM D240-02 (Reapproved 2007) Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter... Carbon, Hydrogen, and Nitrogen in Petroleum Products and Lubricants (incorporated by reference, see § 98...

  6. 40 CFR 98.254 - Monitoring and QA/QC requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Bomb Calorimeter (Precision Method) (incorporated by reference, see § 98.7). (2) ASTM D240-02 (Reapproved 2007) Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter... Carbon, Hydrogen, and Nitrogen in Petroleum Products and Lubricants (incorporated by reference, see § 98...

  7. Joint Entropy for Space and Spatial Frequency Domains Estimated from Psychometric Functions of Achromatic Discrimination

    PubMed Central

    Silveira, Vladímir de Aquino; Souza, Givago da Silva; Gomes, Bruno Duarte; Rodrigues, Anderson Raiol; Silveira, Luiz Carlos de Lima

    2014-01-01

    We used psychometric functions to estimate the joint entropy for space discrimination and spatial frequency discrimination. Space discrimination was taken as discrimination of spatial extent. Seven subjects were tested. Gábor functions comprising unidimensionalsinusoidal gratings (0.4, 2, and 10 cpd) and bidimensionalGaussian envelopes (1°) were used as reference stimuli. The experiment comprised the comparison between reference and test stimulithat differed in grating's spatial frequency or envelope's standard deviation. We tested 21 different envelope's standard deviations around the reference standard deviation to study spatial extent discrimination and 19 different grating's spatial frequencies around the reference spatial frequency to study spatial frequency discrimination. Two series of psychometric functions were obtained for 2%, 5%, 10%, and 100% stimulus contrast. The psychometric function data points for spatial extent discrimination or spatial frequency discrimination were fitted with Gaussian functions using the least square method, and the spatial extent and spatial frequency entropies were estimated from the standard deviation of these Gaussian functions. Then, joint entropy was obtained by multiplying the square root of space extent entropy times the spatial frequency entropy. We compared our results to the theoretical minimum for unidimensional Gábor functions, 1/4π or 0.0796. At low and intermediate spatial frequencies and high contrasts, joint entropy reached levels below the theoretical minimum, suggesting non-linear interactions between two or more visual mechanisms. We concluded that non-linear interactions of visual pathways, such as the M and P pathways, could explain joint entropy values below the theoretical minimum at low and intermediate spatial frequencies and high contrasts. These non-linear interactions might be at work at intermediate and high contrasts at all spatial frequencies once there was a substantial decrease in joint entropy for these stimulus conditions when contrast was raised. PMID:24466158

  8. Joint entropy for space and spatial frequency domains estimated from psychometric functions of achromatic discrimination.

    PubMed

    Silveira, Vladímir de Aquino; Souza, Givago da Silva; Gomes, Bruno Duarte; Rodrigues, Anderson Raiol; Silveira, Luiz Carlos de Lima

    2014-01-01

    We used psychometric functions to estimate the joint entropy for space discrimination and spatial frequency discrimination. Space discrimination was taken as discrimination of spatial extent. Seven subjects were tested. Gábor functions comprising unidimensionalsinusoidal gratings (0.4, 2, and 10 cpd) and bidimensionalGaussian envelopes (1°) were used as reference stimuli. The experiment comprised the comparison between reference and test stimulithat differed in grating's spatial frequency or envelope's standard deviation. We tested 21 different envelope's standard deviations around the reference standard deviation to study spatial extent discrimination and 19 different grating's spatial frequencies around the reference spatial frequency to study spatial frequency discrimination. Two series of psychometric functions were obtained for 2%, 5%, 10%, and 100% stimulus contrast. The psychometric function data points for spatial extent discrimination or spatial frequency discrimination were fitted with Gaussian functions using the least square method, and the spatial extent and spatial frequency entropies were estimated from the standard deviation of these Gaussian functions. Then, joint entropy was obtained by multiplying the square root of space extent entropy times the spatial frequency entropy. We compared our results to the theoretical minimum for unidimensional Gábor functions, 1/4π or 0.0796. At low and intermediate spatial frequencies and high contrasts, joint entropy reached levels below the theoretical minimum, suggesting non-linear interactions between two or more visual mechanisms. We concluded that non-linear interactions of visual pathways, such as the M and P pathways, could explain joint entropy values below the theoretical minimum at low and intermediate spatial frequencies and high contrasts. These non-linear interactions might be at work at intermediate and high contrasts at all spatial frequencies once there was a substantial decrease in joint entropy for these stimulus conditions when contrast was raised.

  9. 76 FR 59769 - Clarification on the Division 1.1 Fireworks Approvals Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... test laboratory if the firework device is manufactured in accordance with APA Standard 87-1 (IBR, see... certify that the firework device conforms to the APA Standard 87-1 and that the descriptions and technical... issuing the EX approval. While APA Standard 87-1 references two instances where Division 1.1 fireworks may...

  10. Reference values for the muscle power sprint test in 6- to 12-year-old children.

    PubMed

    Douma-van Riet, Danielle; Verschuren, Olaf; Jelsma, Dorothee; Kruitwagen, Cas; Smits-Engelsman, Bouwien; Takken, Tim

    2012-01-01

    The aims of this study were (1) to develop centile reference values for anaerobic performance of Dutch children tested using the Muscle Power Sprint Test (MPST) and (2) to examine the test-retest reliability of the MPST. Children who were developing typically (178 boys and 201 girls) and aged 6 to 12 years (mean = 8.9 years) were recruited. The MPST was administered to 379 children, and test-retest reliability was examined in 47 children. MPST scores were transformed into centile curves, which were created using generalized additive models for location, scale, and shape. Height-related reference curves were created for both genders. Excellent (intraclass correlation coefficient = 0.98) test-retest reliability was demonstrated. The reference values for the MPST of children who are developing typically and aged 6 to 12 years can serve as a clinical standard in pediatric physical therapy practice. The MPST is a reliable and practical method for determining anaerobic performance in children.

  11. Characterization of the International Humic Substances Society standard and reference fulvic and humic acids by solution state carbon-13 (13C) and hydrogen-1 (1H) nuclear magnetic resonance spectrometry

    USGS Publications Warehouse

    Thorn, Kevin A.; Folan, Daniel W.; MacCarthy, Patrick

    1989-01-01

    Standard and reference samples of the International Humic Substances Society have been characterized by solution state carbon-13 and hydrogen-1 nuclear magnetic resonance (NMR) spectrometry. Samples included the Suwannee River, soil, and peat standard fulvic and humic acids, the Leonardite standard humic acid, the Nordic aquatic reference fulvic and humic acids, and the Summit Hill soil reference humic acid. Aqueous-solution carbon-13 NMR analyses included the measurement of spin-lattice relaxation times, measurement of nuclear Overhauser enhancement factors, measurement of quantitative carbon distributions, recording of attached proton test spectra, and recording of spectra under nonquantitative conditions. Distortionless enhancement by polarization transfer carbon-13 NMR spectra also were recorded on the Suwannee River fulvic acid in deuterated dimethyl sulfoxide. Hydrogen-1 NMR spectra were recorded on sodium salts of the samples in deuterium oxide. The carbon aromaticities of the samples ranged from 0.24 for the Suwannee River fulvic acid to 0.58 for the Leonardite humic acid.

  12. Chapter 23: International Standard reagents for harmonization of HPV serology and DNA assays--an update.

    PubMed

    Pagliusi, Sonia R; Dillner, Joakim; Pawlita, Michael; Quint, Wim G V; Wheeler, Cosette M; Ferguson, M

    2006-08-31

    International reference materials such as International Standard reagents facilitate quality assurance of essential biopharmaceutical products and related in vitro diagnostic tests. Standardization of antibody and DNA measurements and harmonization of laboratory procedures are key to the success of cancer prevention strategies through screening methods as well as for development and implementation of vaccination against the human papillomavirus (HPV). The WHO supported the preparation and initial analysis of a panel of candidate serological and DNA reference reagents aimed at facilitating inter-laboratory comparisons and detection of HPV worldwide. Two international collaborative studies assessed the performance of various HPV antibody and HPV-DNA detection assays and examined the feasibility of generating HPV antibody and DNA standard reagents. These studies showed that improvement in performance and comparability of assays is urgently needed and that the use of the same International Standard reference reagent could significantly improve performance and comparability. It is hoped that the establishment of International Units and International Standards for HPV antibody and DNA analysis will be pursued with high priority.

  13. 78 FR 66078 - National Institute of Standards and Technology, Gaithersburg, Maryland

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... and Technology, Gaithersburg, Maryland AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Standards and Technology (NIST), which uses licensed materials for research, development, calibration, and testing activities. ADDRESSES: Please refer to Docket ID NRC-2012-0091 when contacting the NRC about the...

  14. Primary hypolactasia diagnosis: Comparison between the gaxilose test, shortened lactose tolerance test, and clinical parameters corresponding to the C/T-13910 polymorphism.

    PubMed

    Domínguez Jiménez, José Luis; Fernández Suárez, Antonio; Muñoz Colmenero, Aurora Úrsula; Fatela Cantillo, Daniel; López Pelayo, Iratxe

    2017-04-01

    There is no consensus on the most accurate method to diagnose primary hypolactasia. We aimed to compare the diagnostic accuracy of the new gaxilose test with 2 traditional tests (lactose tolerance test and clinical criteria) for the diagnosis of primary hypolactasia using the C/T-13910 polymorphism as a reference standard. Patients with a clinical suspicion of lactose intolerance were subjected to gaxilose tests, shortened lactose tolerance tests, and symptom questionnaires before and after overload with 50 g lactose and after a lactose-free diet. The diagnostic accuracy and degree of agreement and correlation were assessed using a genetic test (C/T-13910 polymorphism) as a reference standard and their respective 95% confidence intervals. Thirty consecutive patients (70% women) participated in the study. The genetic test confirmed the C/T-13910 polymorphism in 11 patients (36.8%). The presence of diarrhoea and the symptom score after lactose overload, along with the tolerance test, were the variables with the highest degree of agreement (κ > 0.60). Area under the ROC curve was >0.82 (p < 0.05), with sensitivity and specificity values of >0.80. However, the gaxilose test obtained lower values: κ, 0.47; area under curve, 0.75 (0.57-0.94); sensitivity, 0.82 (0.55-1); and specificity, 0.68 (0.45-0.92). The multivariate analysis showed an association between the post-overload symptom questionnaire and the results of the genetic test (odds ratio: 1.17; 1.04-1.31; p < 0.01). The presence of diarrhoea and the symptom score after overload with 50 g lactose showed a higher degree of agreement and diagnostic accuracy for primary hypolactasia than the gaxilose test when the genetic test is used as a reference standard. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  15. Circulating antigen tests and urine reagent strips for diagnosis of active schistosomiasis in endemic areas.

    PubMed

    Ochodo, Eleanor A; Gopalakrishna, Gowri; Spek, Bea; Reitsma, Johannes B; van Lieshout, Lisette; Polman, Katja; Lamberton, Poppy; Bossuyt, Patrick M M; Leeflang, Mariska M G

    2015-03-11

    Point-of-care (POC) tests for diagnosing schistosomiasis include tests based on circulating antigen detection and urine reagent strip tests. If they had sufficient diagnostic accuracy they could replace conventional microscopy as they provide a quicker answer and are easier to use. To summarise the diagnostic accuracy of: a) urine reagent strip tests in detecting active Schistosoma haematobium infection, with microscopy as the reference standard; and b) circulating antigen tests for detecting active Schistosoma infection in geographical regions endemic for Schistosoma mansoni or S. haematobium or both, with microscopy as the reference standard. We searched the electronic databases MEDLINE, EMBASE, BIOSIS, MEDION, and Health Technology Assessment (HTA) without language restriction up to 30 June 2014. We included studies that used microscopy as the reference standard: for S. haematobium, microscopy of urine prepared by filtration, centrifugation, or sedimentation methods; and for S. mansoni, microscopy of stool by Kato-Katz thick smear. We included studies on participants residing in endemic areas only. Two review authors independently extracted data, assessed quality of the data using QUADAS-2, and performed meta-analysis where appropriate. Using the variability of test thresholds, we used the hierarchical summary receiver operating characteristic (HSROC) model for all eligible tests (except the circulating cathodic antigen (CCA) POC for S. mansoni, where the bivariate random-effects model was more appropriate). We investigated heterogeneity, and carried out indirect comparisons where data were sufficient. Results for sensitivity and specificity are presented as percentages with 95% confidence intervals (CI). We included 90 studies; 88 from field settings in Africa. The median S. haematobium infection prevalence was 41% (range 1% to 89%) and 36% for S. mansoni (range 8% to 95%). Study design and conduct were poorly reported against current standards. Tests for S. haematobium Urine reagent test strips versus microscopyCompared to microscopy, the detection of microhaematuria on test strips had the highest sensitivity and specificity (sensitivity 75%, 95% CI 71% to 79%; specificity 87%, 95% CI 84% to 90%; 74 studies, 102,447 participants). For proteinuria, sensitivity was 61% and specificity was 82% (82,113 participants); and for leukocyturia, sensitivity was 58% and specificity 61% (1532 participants). However, the difference in overall test accuracy between the urine reagent strips for microhaematuria and proteinuria was not found to be different when we compared separate populations (P = 0.25), or when direct comparisons within the same individuals were performed (paired studies; P = 0.21).When tests were evaluated against the higher quality reference standard (when multiple samples were analysed), sensitivity was marginally lower for microhaematuria (71% vs 75%) and for proteinuria (49% vs 61%). The specificity of these tests was comparable. Antigen assayCompared to microscopy, the CCA test showed considerable heterogeneity; meta-analytic sensitivity estimate was 39%, 95% CI 6% to 73%; specificity 78%, 95% CI 55% to 100% (four studies, 901 participants). Tests for S. mansoni Compared to microscopy, the CCA test meta-analytic estimates for detecting S. mansoni at a single threshold of trace positive were: sensitivity 89% (95% CI 86% to 92%); and specificity 55% (95% CI 46% to 65%; 15 studies, 6091 participants) Against a higher quality reference standard, the sensitivity results were comparable (89% vs 88%) but specificity was higher (66% vs 55%). For the CAA test, sensitivity ranged from 47% to 94%, and specificity from 8% to 100% (4 studies, 1583 participants). Among the evaluated tests for S. haematobium infection, microhaematuria correctly detected the largest proportions of infections and non-infections identified by microscopy.The CCA POC test for S. mansoni detects a very large proportion of infections identified by microscopy, but it misclassifies a large proportion of microscopy negatives as positives in endemic areas with a moderate to high prevalence of infection, possibly because the test is potentially more sensitive than microscopy.

  16. Effectiveness of Cool Roof Coatings with Ceramic Particles

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

    Brehob, Ellen G; Desjarlais, Andre Omer; Atchley, Jerald Allen

    2011-01-01

    Liquid applied coatings promoted as cool roof coatings, including several with ceramic particles, were tested at Oak Ridge National Laboratory (ORNL), Oak Ridge, Tenn., for the purpose of quantifying their thermal performances. Solar reflectance measurements were made for new samples and aged samples using a portable reflectometer (ASTM C1549, Standard Test Method for Determination of Solar Reflectance Near Ambient Temperature Using a Portable Solar Reflectometer) and for new samples using the integrating spheres method (ASTM E903, Standard Test Method for Solar Absorptance, Reflectance, and Transmittance of Materials Using Integrating Spheres). Thermal emittance was measured for the new samples using amore » portable emissometer (ASTM C1371, Standard Test Method for Determination of Emittance of Materials Near Room 1 Proceedings of the 2011 International Roofing Symposium Temperature Using Portable Emissometers). Thermal conductivity of the coatings was measured using a FOX 304 heat flow meter (ASTM C518, Standard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus). The surface properties of the cool roof coatings had higher solar reflectance than the reference black and white material, but there were no significant differences among coatings with and without ceramics. The coatings were applied to EPDM (ethylene propylene diene monomer) membranes and installed on the Roof Thermal Research Apparatus (RTRA), an instrumented facility at ORNL for testing roofs. Roof temperatures and heat flux through the roof were obtained for a year of exposure in east Tennessee. The field tests showed significant reduction in cooling required compared with the black reference roof (~80 percent) and a modest reduction in cooling compared with the white reference roof (~33 percent). The coating material with the highest solar reflectivity (no ceramic particles) demonstrated the best overall thermal performance (combination of reducing the cooling load cost and not incurring a large heating penalty cost) and suggests solar reflectivity is the significant characteristic for selecting cool roof coatings.« less

  17. NASA/NBS (National Aeronautics and Space Administration/National Bureau of Standards) standard reference model for telerobot control system architecture (NASREM)

    NASA Technical Reports Server (NTRS)

    Albus, James S.; Mccain, Harry G.; Lumia, Ronald

    1989-01-01

    The document describes the NASA Standard Reference Model (NASREM) Architecture for the Space Station Telerobot Control System. It defines the functional requirements and high level specifications of the control system for the NASA space Station document for the functional specification, and a guideline for the development of the control system architecture, of the 10C Flight Telerobot Servicer. The NASREM telerobot control system architecture defines a set of standard modules and interfaces which facilitates software design, development, validation, and test, and make possible the integration of telerobotics software from a wide variety of sources. Standard interfaces also provide the software hooks necessary to incrementally upgrade future Flight Telerobot Systems as new capabilities develop in computer science, robotics, and autonomous system control.

  18. Assessment of the Validity of the Research Diagnostic Criteria for Temporomandibular Disorders: Overview and Methodology

    PubMed Central

    Schiffman, Eric L.; Truelove, Edmond L.; Ohrbach, Richard; Anderson, Gary C.; John, Mike T.; List, Thomas; Look, John O.

    2011-01-01

    AIMS The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. An overview is presented, including Axis I and II methodology and descriptive statistics for the study participant sample. This paper details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. Validity testing for the Axis II biobehavioral instruments was based on previously validated reference standards. METHODS The Axis I reference standards were based on the consensus of 2 criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion exam reliability was also assessed within study sites. RESULTS Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas ≥ 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion exam agreement with reference standards was excellent (k ≥ 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). CONCLUSION The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods. PMID:20213028

  19. 40 CFR 261.21 - Characteristic of ignitability.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... determined by a Pensky-Martens Closed Cup Tester, using the test method specified in ASTM Standard D 93-79 or D 93-80 (incorporated by reference, see § 260.11), or a Setaflash Closed Cup Tester, using the test...

  20. 40 CFR 261.21 - Characteristic of ignitability.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... determined by a Pensky-Martens Closed Cup Tester, using the test method specified in ASTM Standard D 93-79 or D 93-80 (incorporated by reference, see § 260.11), or a Setaflash Closed Cup Tester, using the test...

  1. 40 CFR 86.1810-17 - General requirements.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... waive only SC03 testing, substitute the SC03 emission result using the standard test fuel for gasoline... the emission measurements with the gasoline test fuel specified in 40 CFR 1065.710. (i) Where we... refer to test procedures set forth in subpart C of this part and 40 CFR part 1066, subpart H. All other...

  2. Specular gloss scales comparison between the SIMT and the NIST

    NASA Astrophysics Data System (ADS)

    Yin, Dejin; Li, Tiecheng; Huang, Biyong; Cheng, Weihai; Lin, Fangsheng

    2016-09-01

    Specular gloss is the fraction of light reflected in the specular direction for specified incident and receptor apertures, it is the perception by an observer of the mirror-like appearance of a surface. The measurement of specular gloss consists of comparing the luminous reflectance from a test sample to that from a calibrated gloss standard which generally is a polished piece of black glass, under the same experimental conditions. Gloss is a dimensionless quantity whose accurate determination requires standardized experimental conditions such as spectral distribution of the incident beam of light, incident and viewing angles, and a gloss standard. The Shanghai Institute of Measurement and Testing Technology (SIMT) provides test service to calibrate gloss reference standards. This facility is built around a reference goniophotometer, containing an instrument that measures flux as a function of angles of illumination or observation and a primary gloss standard, which is a piece of three wedges of highly polished, high-quality optical glass. The system has an overall (k=2) uncertainty of 0.5 Gloss Unit(GU). The service offers calibration measurements of working gloss standards at the geometries of 20°, 60°, and 85°, in compliance with the ISO 2813 and the ASTM D523 documentary standards. This article describes a bilateral comparison of specular gloss scales between SIMT and the National Institute of Standards and Technology (NIST) that has been performed. The results of this comparison show agreement within the combined uncertainties for the measurement of specular gloss of highly polished black glass.

  3. 76 FR 47436 - Virginia Graeme Baker Pool and Spa Safety Act; Incorporation by Reference of Successor Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    .... Ultraviolet Light Exposure Test The Ultraviolet Light Exposure Test (UV test) subjects the plastic drain....'' ANSI/ASME A112.19.8-2007 indicates that ``cover'' is an obsolete term.) Tests for the structural.... The structural integrity tests subject the drain fitting to forces expected under normal use and to...

  4. The Third International Reference Preparation of Egg Lecithin

    PubMed Central

    Krag, P.; Bentzon, M. Weis

    1961-01-01

    The Third International Reference Preparation of Egg Lecithin was produced (in a quantity of 5000 ml) at the WHO Serological Reference Centre, Copenhagen, and assayed in 1958 against the Second International Reference Preparation by four laboratories in three countries. Complement-fixation and slide-flocculation tests were used. The new preparation was found acceptable, and its establishment was authorized by the WHO Expert Committee on Biological Standardization. The average log10 titres and results of analyses of variances are shown. The variances were of the usual order of magnitude, and the differences in titre between antigens containing the Second and the Third International Reference Preparations varied from -0.011 to 0.116; only one of the differences exceeded the 5% limit of significance. The use of the Third International Reference Preparation in tests for the acceptability of lecithin preparations is described. PMID:13753864

  5. German translation, cross-cultural adaptation and diagnostic test accuracy of three frailty screening tools : PRISMA-7, FRAIL scale and Groningen Frailty Indicator.

    PubMed

    Braun, Tobias; Grüneberg, Christian; Thiel, Christian

    2018-04-01

    Routine screening for frailty could be used to timely identify older people with increased vulnerability und corresponding medical needs. The aim of this study was the translation and cross-cultural adaptation of the PRISMA-7 questionnaire, the FRAIL scale and the Groningen Frailty Indicator (GFI) into the German language as well as a preliminary analysis of the diagnostic test accuracy of these instruments used to screen for frailty. A diagnostic cross-sectional study was performed. The instrument translation into German followed a standardized process. Prefinal versions were clinically tested on older adults who gave structured in-depth feedback on the scales in order to compile a final revision of the German language scale versions. For the analysis of diagnostic test accuracy (criterion validity), PRISMA-7, FRAIL scale and GFI were considered the index tests. Two reference tests were applied to assess frailty, either based on Fried's model of a Physical Frailty Phenotype or on the model of deficit accumulation, expressed in a Frailty Index. Prefinal versions of the German translations of each instrument were produced and completed by 52 older participants (mean age: 73 ± 6 years). Some minor issues concerning comprehensibility and semantics of the scales were identified and resolved. Using the Physical Frailty Phenotype (frailty prevalence: 4%) criteria as a reference standard, the accuracy of the instruments was excellent (area under the curve AUC >0.90). Taking the Frailty Index (frailty prevalence: 23%) as the reference standard, the accuracy was good (AUC between 0.73 and 0.88). German language versions of PRISMA-7, FRAIL scale and GFI have been established and preliminary results indicate sufficient diagnostic test accuracy that needs to be further established.

  6. Standard Samples and Reference Standards Issued by the National Bureau of Standards

    DTIC Science & Technology

    1954-08-31

    precision and accuracy of control testing in the melting - point , density, index of refraction, heat rubber industry. of combustion, color, and gloss...pH (approx.) 1.7 65 2.50 Melting - Point Standards 44d Aluminum ---------------------------- 659.70 C...calculating the best frequencies for communication between any two points in the world at any time during the given month. The data are important to all

  7. 40 CFR 63.750 - Test methods and procedures.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 11 2014-07-01 2014-07-01 false Test methods and procedures. 63.750...) National Emission Standards for Aerospace Manufacturing and Rework Facilities § 63.750 Test methods and... engineering reference texts, or other equivalent methods. (2) The composite vapor pressure of a blended hand...

  8. Relationships of Declining Test Scores and Grade Inflation.

    ERIC Educational Resources Information Center

    Bellott, Fred K.

    The relationship between declining scores on national standardized tests and grade inflation is explored. Grade inflation refers to the indicated measure of evaluation of student performance having higher placement than is usual based on the performances. Data for this study were taken from the American College Testing (ACT) Program Class Profile…

  9. Quantitative Imaging Biomarkers: A Review of Statistical Methods for Computer Algorithm Comparisons

    PubMed Central

    2014-01-01

    Quantitative biomarkers from medical images are becoming important tools for clinical diagnosis, staging, monitoring, treatment planning, and development of new therapies. While there is a rich history of the development of quantitative imaging biomarker (QIB) techniques, little attention has been paid to the validation and comparison of the computer algorithms that implement the QIB measurements. In this paper we provide a framework for QIB algorithm comparisons. We first review and compare various study designs, including designs with the true value (e.g. phantoms, digital reference images, and zero-change studies), designs with a reference standard (e.g. studies testing equivalence with a reference standard), and designs without a reference standard (e.g. agreement studies and studies of algorithm precision). The statistical methods for comparing QIB algorithms are then presented for various study types using both aggregate and disaggregate approaches. We propose a series of steps for establishing the performance of a QIB algorithm, identify limitations in the current statistical literature, and suggest future directions for research. PMID:24919829

  10. Report on the U.S. Geological Survey's Evaluation Program Standard Reference Samples Distributed in October 1995: T-137 (Trace Constituents), M-136 (Major Constituents), N-47 (Nutrient Constituents), N-48 (Nutrient Constituents), P-25 (Low Ionic Strength Constituents), and Hg-21 (Mercury)

    USGS Publications Warehouse

    Farrar, Jerry W.; Long, H. Keith

    1996-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for 6 standard reference samples--T-137 (trace constituents), M-136 (major constituents), N-47 (nutrient constituents), N-48 (nutrient constituents), P-25 (low ionic strength constituents), and Hg-21 (mercury)--that were distributed in October 1995 to 149 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 136 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  11. Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in April 1994; T-129 (trace constituents), M-130 (major constituents), N-42 (nutrients), P-22 (low ionic strength), and Hg-18 (mercury)

    USGS Publications Warehouse

    Long, H. Keith; Farrar, Jerry W.

    1994-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for five standard reference samples--T-129 (trace constituents), M-130 (major constituents), N-42 (nutrients), P-22 (low ionic strength), Hg-18(mercury),--that were distributed in April 1994 to 157 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 133 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the five reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the five standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  12. Report of the U.S. Geological Survey's evaluation program for standard reference samples distributed in April 1993; T-123 (trace constituents), T-125 (trace constituents), M-126 (major constituents, N-38 (nutrients), N-39 (nutrients), P-20 (low ionic strength, and Hg-16 (mercury)

    USGS Publications Warehouse

    Long, H.K.; Farrar, J.W.

    1993-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for seven standard reference samples--T-123 (trace constituents), T-125 (trace constituents), M-126 (major constituents), N-38 (nutrients), N-39 (Nutrients), P-20 (precipitation-low ionic strength), and Hg-16 (mercury)--that were distributed in April 1993 to 175 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data received from 131 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the 7 reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  13. Results of the U.S. Geological Survey's Analytical Evaluation Program for standard reference samples distributed in March 1999

    USGS Publications Warehouse

    Farrar, Jerry W.; Chleboun, Kimberly M.

    1999-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for 8 standard reference samples -- T-157 (trace constituents), M-150 (major constituents), N-61 (nutrient constituents), N-62 (nutrient constituents), P-32 (low ionic strength constituents), GWT-5 (ground-water trace constituents), GWM- 4 (ground-water major constituents),and Hg-28 (mercury) -- that were distributed in March 1999 to 120 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 111 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the 8 standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  14. Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis

    PubMed Central

    Nash, Madlen; Huddart, Sophie; Badar, Sayema; Baliga, Shrikala; Saravu, Kavitha

    2018-01-01

    ABSTRACT Viral load (VL) is the preferred treatment-monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale, CA) is a new, automated molecular test, and it can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of 12 articles (13 studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified. Study quality was generally high, but substantial variability was observed in the number and type of agreement measures reported. Correlation coefficients between Xpert and reference assays were high, with a pooled Pearson correlation (n = 8) of 0.94 (95% confidence interval [CI], 0.89, 0.97) and Spearman correlation (n = 3) of 0.96 (95% CI, 0.86, 0.99). Bland-Altman metrics (n = 11) all were within 0.35 log copies/ml of perfect agreement. Overall, Xpert HIV-1 VL performed well compared to current reference tests. The minimal training and infrastructure requirements for the Xpert HIV-1 VL assay make it attractive for use in resource-constrained settings, where point-of-care VL testing is most needed. PMID:29386266

  15. Performance of the Xpert HIV-1 Viral Load Assay: a Systematic Review and Meta-analysis.

    PubMed

    Nash, Madlen; Huddart, Sophie; Badar, Sayema; Baliga, Shrikala; Saravu, Kavitha; Pai, Madhukar

    2018-04-01

    Viral load (VL) is the preferred treatment-monitoring approach for HIV-positive patients. However, more rapid, near-patient, and low-complexity assays are needed to scale up VL testing. The Xpert HIV-1 VL assay (Cepheid, Sunnyvale, CA) is a new, automated molecular test, and it can leverage the GeneXpert systems that are being used widely for tuberculosis diagnosis. We systematically reviewed the evidence on the performance of this new tool in comparison to established reference standards. A total of 12 articles (13 studies) in which HIV patient VLs were compared between Xpert HIV VL assay and a reference standard VL assay were identified. Study quality was generally high, but substantial variability was observed in the number and type of agreement measures reported. Correlation coefficients between Xpert and reference assays were high, with a pooled Pearson correlation ( n = 8) of 0.94 (95% confidence interval [CI], 0.89, 0.97) and Spearman correlation ( n = 3) of 0.96 (95% CI, 0.86, 0.99). Bland-Altman metrics ( n = 11) all were within 0.35 log copies/ml of perfect agreement. Overall, Xpert HIV-1 VL performed well compared to current reference tests. The minimal training and infrastructure requirements for the Xpert HIV-1 VL assay make it attractive for use in resource-constrained settings, where point-of-care VL testing is most needed. Copyright © 2018 Nash et al.

  16. Detecting Intrajudge Inconsistency in Standard Setting Using Test Items with a Selected-Response Format. Research Report.

    ERIC Educational Resources Information Center

    van der Linden, Wim J.; Vos, Hans J.; Chang, Lei

    In judgmental standard setting experiments, it may be difficult to specify subjective probabilities that adequately take the properties of the items into account. As a result, these probabilities are not consistent with each other in the sense that they do not refer to the same borderline level of performance. Methods to check standard setting…

  17. 49 CFR 193.2321 - Nondestructive tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., see § 193.2013), except that 100 percent of welds that are both longitudinal (or meridional) and... Vessel Code (Section VIII Division 1) (incorporated by reference, see § 193.2013). (b) For storage tanks... § 193.2013); (2) Appendices Q and C of API 620 Standard (incorporated by reference, see § 193.2013); (c...

  18. Use of gelatin gels as a reference material for performance evaluation of meat shear force measurements

    USDA-ARS?s Scientific Manuscript database

    Establishing standards for meat tenderness based on Warner-Bratzler shear force (WBSF) is complicated by the lack of methods for certifying WBSF testing among texture systems or laboratories. The objective of this study was to determine the suitability of using gelatin gels as a reference material ...

  19. Rotating pressure measurement system using an on board calibration standard

    NASA Technical Reports Server (NTRS)

    Senyitko, Richard G.; Blumenthal, Philip Z.; Freedman, Robert J.

    1991-01-01

    A computer-controlled multichannel pressure measurement system was developed to acquire detailed flow field measurements on board the Large Low Speed Centrifugal Compressor Research Facility at the NASA Lewis Research Center. A pneumatic slip ring seal assembly is used to transfer calibration pressures to a reference standard transducer on board the compressor rotor in order to measure very low differential pressures with the high accuracy required. A unique data acquisition system was designed and built to convert the analog signal from the reference transducer to the variable frequency required by the multichannel pressure measurement system and also to provide an output for temperature control of the reference transducer. The system also monitors changes in test cell barometric pressure and rotating seal leakage and provides an on screen warning to the operator if limits are exceeded. The methods used for the selection and testing of the the reference transducer are discussed, and the data acquisition system hardware and software design are described. The calculated and experimental data for the system measurement accuracy are also presented.

  20. Fibrinolysis standards: a review of the current status.

    PubMed

    Thelwell, C

    2010-07-01

    Biological standards are used to calibrate measurements of components of the fibrinolytic system, either for assigning potency values to therapeutic products, or to determine levels in human plasma as an indicator of thrombotic risk. Traditionally WHO International Standards are calibrated in International Units based on consensus values from collaborative studies. The International Unit is defined by the response activity of a given amount of the standard in a bioassay, independent of the method used. Assay validity is based on the assumption that both standard and test preparation contain the same analyte, and the response in an assay is a true function of this analyte. This principle is reflected in the diversity of source materials used to prepare fibrinolysis standards, which has depended on the contemporary preparations they were employed to measure. With advancing recombinant technology, and improved analytical techniques, a reference system based on reference materials and associated reference methods has been recommended for future fibrinolysis standards. Careful consideration and scientific judgement must however be applied when deciding on an approach to develop a new standard, with decisions based on the suitability of a standard to serve its purpose, and not just to satisfy a metrological ideal. 2010 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

  1. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): reference data for the trunk and application in patients with chronic postherpetic neuralgia.

    PubMed

    Pfau, Doreen B; Krumova, Elena K; Treede, Rolf-Detlef; Baron, Ralf; Toelle, Thomas; Birklein, Frank; Eich, Wolfgang; Geber, Christian; Gerhardt, Andreas; Weiss, Thomas; Magerl, Walter; Maier, Christoph

    2014-05-01

    Age- and gender-matched reference values are essential for the clinical use of quantitative sensory testing (QST). To extend the standard test sites for QST-according to the German Research Network on Neuropathic Pain-to the trunk, we collected QST profiles on the back in 162 healthy subjects. Sensory profiles for standard test sites were within normal interlaboratory differences. QST revealed lower sensitivity on the upper back than the hand, and higher sensitivity on the lower back than the foot, but no systematic differences between these trunk sites. Age effects were significant for most parameters. Females exhibited lower pressure pain thresholds (PPT) than males, which was the only significant gender difference. Values outside the 95% confidence interval of healthy subjects (considered abnormal) required temperature changes of >3.3-8.2 °C for thermal detection. For cold pain thresholds, confidence intervals extended mostly beyond safety cutoffs, hence only relative reference data (left-right differences, hand-trunk differences) were sufficiently sensitive. For mechanical detection and pain thresholds, left-right differences were 1.5-2.3 times more sensitive than absolute reference data. The most sensitive parameter was PPT, where already side-to-side differences >35% were abnormal. Compared to trunk reference data, patients with postherpetic neuralgia exhibited thermal and tactile deficits and dynamic mechanical allodynia, mostly without reduced mechanical pain thresholds. This pattern deviates from other types of neuropathic pain. QST reference data for the trunk will also be useful for patients with postthoracotomy pain or chronic back pain. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  2. Fusion of Three-Dimensional Echocardiographic Regional Myocardial Strain with Cardiac Computed Tomography for Noninvasive Evaluation of the Hemodynamic Impact of Coronary Stenosis in Patients with Chest Pain.

    PubMed

    Mor-Avi, Victor; Patel, Mita B; Maffessanti, Francesco; Singh, Amita; Medvedofsky, Diego; Zaidi, S Javed; Mediratta, Anuj; Narang, Akhil; Nazir, Noreen; Kachenoura, Nadjia; Lang, Roberto M; Patel, Amit R

    2018-06-01

    Combined evaluation of coronary stenosis and the extent of ischemia is essential in patients with chest pain. Intermediate-grade stenosis on computed tomographic coronary angiography (CTCA) frequently triggers downstream nuclear stress testing. Alternative approaches without stress and/or radiation may have important implications. Myocardial strain measured from echocardiographic images can be used to detect subclinical dysfunction. The authors recently tested the feasibility of fusion of three-dimensional (3D) echocardiography-derived regional resting longitudinal strain with coronary arteries from CTCA to determine the hemodynamic significance of stenosis. The aim of the present study was to validate this approach against accepted reference techniques. Seventy-eight patients with chest pain referred for CTCA who also underwent 3D echocardiography and regadenoson stress computed tomography were prospectively studied. Left ventricular longitudinal strain data (TomTec) were used to generate fused 3D displays and detect resting strain abnormalities (RSAs) in each coronary territory. Computed tomographic coronary angiographic images were interpreted for the presence and severity of stenosis. Fused 3D displays of subendocardial x-ray attenuation were created to detect stress perfusion defects (SPDs). In patients with stenosis >25% in at least one artery, fractional flow reserve was quantified (HeartFlow). RSA as a marker of significant stenosis was validated against two different combined references: stenosis >50% on CTCA and SPDs seen in the same territory (reference standard A) and fractional flow reserve < 0.80 and SPDs in the same territory (reference standard B). Of the 99 arteries with no stenosis >50% and no SPDs, considered as normal, 19 (19%) had RSAs. Conversely, with stenosis >50% and SPDs, RSAs were considerably more frequent (17 of 24 [71%]). The sensitivity, specificity, and accuracy of RSA were 0.71, 0.81, and 0.79, respectively, against reference standard A and 0.83, 0.81, and 0.82 against reference standard B. Fusion of CTCA and 3D echocardiography-derived resting myocardial strain provides combined displays, which may be useful in determination of the hemodynamic or functional impact of coronary abnormalities, without additional ionizing radiation or stress testing. Copyright © 2018 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.

  3. Preservation and Restoration of Authenticity in Sound Recordings--To Standards.

    ERIC Educational Resources Information Center

    Welch, Walter L.

    1981-01-01

    Describes Thomas Edison's struggle to establish standards for authenticity in recording phonograph discs and cylinders, including the tone tests he conducted from 1915 to 1927, and describes the various types of discs and cylinders produced by Edison Laboratories during that period. Four references are included. (EJS)

  4. 40 CFR 1065.1010 - Incorporation by reference.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... approved for § 1065.701(f). (43) ASTM D6751-12, Standard Specification for Biodiesel Fuel Blend Stock (B100... D7039-13, Standard Test Method for Sulfur in Gasoline, Diesel Fuel, Jet Fuel, Kerosine, Biodiesel, Biodiesel Blends, and Gasoline-Ethanol Blends by Monochromatic Wavelength Dispersive X-ray Fluorescence...

  5. Expressed Sequence Reference Standards for Evaluating Stage-specific Gene Expression in Southern Green Lacewings, Chrysoperla rufilabris

    USDA-ARS?s Scientific Manuscript database

    Five developmental stages of Chrysoperla rufilabris were tested using nine primer pairs. Three sequences were highly expressed at all life stages and six were differentially expressed. These primer pairs may be used as standards to quantitate functional gene expression associated with physiological ...

  6. Integration of nursing assessment concepts into the medical entities dictionary using the LOINC semantic structure as a terminology model.

    PubMed

    Cieslowski, B J; Wajngurt, D; Cimino, J J; Bakken, S

    2001-01-01

    Recent investigations have tested the applicability of various terminology models for the representing nursing concepts including those related to nursing diagnoses, nursing interventions, and standardized nursing assessments as a prerequisite for building a reference terminology that supports the nursing domain. We used the semantic structure of Clinical LOINC (Logical Observations, Identifiers, Names, and Codes) as a reference terminology model to support the integration of standardized assessment terms from two nursing terminologies into the Medical Entities Dictionary (MED), the concept-oriented, metadata dictionary at New York Presbyterian Hospital. Although the LOINC semantic structure was used previously to represent laboratory terms in the MED, selected hierarchies and semantic slots required revisions in order to incorporate the nursing assessment concepts. This project was an initial step in integrating nursing assessment concepts into the MED in a manner consistent with evolving standards for reference terminology models. Moreover, the revisions provide the foundation for adding other types of standardized assessments to the MED.

  7. Integration of nursing assessment concepts into the medical entities dictionary using the LOINC semantic structure as a terminology model.

    PubMed Central

    Cieslowski, B. J.; Wajngurt, D.; Cimino, J. J.; Bakken, S.

    2001-01-01

    Recent investigations have tested the applicability of various terminology models for the representing nursing concepts including those related to nursing diagnoses, nursing interventions, and standardized nursing assessments as a prerequisite for building a reference terminology that supports the nursing domain. We used the semantic structure of Clinical LOINC (Logical Observations, Identifiers, Names, and Codes) as a reference terminology model to support the integration of standardized assessment terms from two nursing terminologies into the Medical Entities Dictionary (MED), the concept-oriented, metadata dictionary at New York Presbyterian Hospital. Although the LOINC semantic structure was used previously to represent laboratory terms in the MED, selected hierarchies and semantic slots required revisions in order to incorporate the nursing assessment concepts. This project was an initial step in integrating nursing assessment concepts into the MED in a manner consistent with evolving standards for reference terminology models. Moreover, the revisions provide the foundation for adding other types of standardized assessments to the MED. PMID:11825165

  8. Protocol for determining the diagnostic validity of physical examination maneuvers for shoulder pathology.

    PubMed

    Somerville, Lyndsay; Bryant, Dianne; Willits, Kevin; Johnson, Andrew

    2013-02-08

    Shoulder complaints are the third most common musculoskeletal problem in the general population. There are an abundance of physical examination maneuvers for diagnosing shoulder pathology. The validity of these maneuvers has not been adequately addressed. We propose a large Phase III study to investigate the accuracy of these tests in an orthopaedic setting. We will recruit consecutive new shoulder patients who are referred to two tertiary orthopaedic clinics. We will select which physical examination tests to include using a modified Delphi process. The physician will take a thorough history from the patient and indicate their certainty about each possible diagnosis (certain the diagnosis is absent, present or requires further testing). The clinician will only perform the physical examination maneuvers for diagnoses where uncertainty remains. We will consider arthroscopy the reference standard for patients who undergo surgery within 8 months of physical examination and magnetic resonance imaging with arthrogram for patients who do not. We will calculate the sensitivity, specificity and positive and negative likelihood ratios and investigate whether combinations of the top tests provide stronger predictions of the presence or absence of disease. There are several considerations when performing a diagnostic study to ensure that the results are applicable in a clinical setting. These include, 1) including a representative sample, 2) selecting an appropriate reference standard, 3) avoiding verification bias, 4) blinding the interpreters of the physical examination tests to the interpretation of the gold standard and, 5) blinding the interpreters of the gold standard to the interpretation of the physical examination tests. The results of this study will inform clinicians of which tests, or combination of tests, successfully reduce diagnostic uncertainty, which tests are misleading and how physical examination may affect the magnitude of the confidence the clinician feels about their diagnosis. The results of this study may reduce the number of costly and invasive imaging studies (MRI, CT or arthrography) that are requisitioned when uncertainty about diagnosis remains following history and physical exam. We also hope to reduce the variability between specialists in which maneuvers are used during physical examination and how they are used, all of which will assist in improving consistency of care between centres.

  9. Patch testing custom isocyanate materials from the workplace.

    PubMed

    Burrows, Dianne; Houle, Marie-Claude; Holness, D Linn; DeKoven, Joel; Skotnicki, Sandy

    2015-01-01

    Patch testing with standard trays of commercially available allergens is the current practice for investigating suspected cases of isocyanate-induced allergic contact dermatitis (ACD). In some facilities, these standard trays are further supplemented with custom preparations of isocyanate-containing materials. The aim was to determine whether added value exists in patch testing patients to custom isocyanate preparations in suspected cases of ACD. We performed a retrospective analysis of 11 patients referred to our specialty clinic between January 2003 and March 2011 for suspected patients of ACD who had custom testing with isocyanate materials from their workplace. In addition to standard trays of allergens, all patients were patch tested with custom isocyanate materials from their workplaces. Three (27%) of 11 patients showed an added value in testing to custom isocyanate allergens. Of these 3 patients, one had a reaction that reinforced positive reactions to the standard isocyanate tray, but the other 2 (18%) had no reactions to any of the commercially available allergens. Because of the high proportion of reactions (27%), we recommend the use of custom testing to workplace isocyanate products as a supplement to current standard patch testing procedures.

  10. A multicenter nationwide reference intervals study for common biochemical analytes in Turkey using Abbott analyzers.

    PubMed

    Ozarda, Yesim; Ichihara, Kiyoshi; Aslan, Diler; Aybek, Hulya; Ari, Zeki; Taneli, Fatma; Coker, Canan; Akan, Pinar; Sisman, Ali Riza; Bahceci, Onur; Sezgin, Nurzen; Demir, Meltem; Yucel, Gultekin; Akbas, Halide; Ozdem, Sebahat; Polat, Gurbuz; Erbagci, Ayse Binnur; Orkmez, Mustafa; Mete, Nuriye; Evliyaoglu, Osman; Kiyici, Aysel; Vatansev, Husamettin; Ozturk, Bahadir; Yucel, Dogan; Kayaalp, Damla; Dogan, Kubra; Pinar, Asli; Gurbilek, Mehmet; Cetinkaya, Cigdem Damla; Akin, Okhan; Serdar, Muhittin; Kurt, Ismail; Erdinc, Selda; Kadicesme, Ozgur; Ilhan, Necip; Atali, Dilek Sadak; Bakan, Ebubekir; Polat, Harun; Noyan, Tevfik; Can, Murat; Bedir, Abdulkerim; Okuyucu, Ali; Deger, Orhan; Agac, Suret; Ademoglu, Evin; Kaya, Ayşem; Nogay, Turkan; Eren, Nezaket; Dirican, Melahat; Tuncer, GulOzlem; Aykus, Mehmet; Gunes, Yeliz; Ozmen, Sevda Unalli; Kawano, Reo; Tezcan, Sehavet; Demirpence, Ozlem; Degirmen, Elif

    2014-12-01

    A nationwide multicenter study was organized to establish reference intervals (RIs) in the Turkish population for 25 commonly tested biochemical analytes and to explore sources of variation in reference values, including regionality. Blood samples were collected nationwide in 28 laboratories from the seven regions (≥400 samples/region, 3066 in all). The sera were collectively analyzed in Uludag University in Bursa using Abbott reagents and analyzer. Reference materials were used for standardization of test results. After secondary exclusion using the latent abnormal values exclusion method, RIs were derived by a parametric method employing the modified Box-Cox formula and compared with the RIs by the non-parametric method. Three-level nested ANOVA was used to evaluate variations among sexes, ages and regions. Associations between test results and age, body mass index (BMI) and region were determined by multiple regression analysis (MRA). By ANOVA, differences of reference values among seven regions were significant in none of the 25 analytes. Significant sex-related and age-related differences were observed for 10 and seven analytes, respectively. MRA revealed BMI-related changes in results for uric acid, glucose, triglycerides, high-density lipoprotein (HDL)-cholesterol, alanine aminotransferase, and γ-glutamyltransferase. Their RIs were thus derived by applying stricter criteria excluding individuals with BMI >28 kg/m2. Ranges of RIs by non-parametric method were wider than those by parametric method especially for those analytes affected by BMI. With the lack of regional differences and the well-standardized status of test results, the RIs derived from this nationwide study can be used for the entire Turkish population.

  11. Clinical diagnostic model for sciatica developed in primary care patients with low back-related leg pain

    PubMed Central

    Konstantinou, Kika; Ogollah, Reuben; Hay, Elaine M.; Dunn, Kate M.

    2018-01-01

    Background Identification of sciatica may assist timely management but can be challenging in clinical practice. Diagnostic models to identify sciatica have mainly been developed in secondary care settings with conflicting reference standard selection. This study explores the challenges of reference standard selection and aims to ascertain which combination of clinical assessment items best identify sciatica in people seeking primary healthcare. Methods Data on 394 low back-related leg pain consulters were analysed. Potential sciatica indicators were seven clinical assessment items. Two reference standards were used: (i) high confidence sciatica clinical diagnosis; (ii) high confidence sciatica clinical diagnosis with confirmatory magnetic resonance imaging findings. Multivariable logistic regression models were produced for both reference standards. A tool predicting sciatica diagnosis in low back-related leg pain was derived. Latent class modelling explored the validity of the reference standard. Results Model (i) retained five items; model (ii) retained six items. Four items remained in both models: below knee pain, leg pain worse than back pain, positive neural tension tests and neurological deficit. Model (i) was well calibrated (p = 0.18), discrimination was area under the receiver operating characteristic curve (AUC) 0.95 (95% CI 0.93, 0.98). Model (ii) showed good discrimination (AUC 0.82; 0.78, 0.86) but poor calibration (p = 0.004). Bootstrapping revealed minimal overfitting in both models. Agreement between the two latent classes and clinical diagnosis groups defined by model (i) was substantial, and fair for model (ii). Conclusion Four clinical assessment items were common in both reference standard definitions of sciatica. A simple scoring tool for identifying sciatica was developed. These criteria could be used clinically and in research to improve accuracy of identification of this subgroup of back pain patients. PMID:29621243

  12. Tests in Print II: An Index to Tests, Test Reviews, and the Literature on Specific Tests.

    ERIC Educational Resources Information Center

    Buros, Oscar K., Ed.

    Tests in Print II is a comprehensive, annotated bibliography of all in-print tests published as separates for use with English-speaking subjects. The 1,155 two-column pages list 2,467 tests in print as of early 1974; 16,574 references through 1971 on specific tests; a reprinting of the 1974 APA-AERA-NCME Standards for Educational andPsychological…

  13. Evaluation of Test Methods To Determine the Impact Resistance of Exterior Insulation and Finish Systems (EIFS).

    DTIC Science & Technology

    1992-07-01

    be used effectively in new construction or retrofit applications. These systems usually contain: 1. Molded expanded polystyrene insulation board (MEPS...commonly referred to as "bead board," or extruded expanded polystyrene insulation board (XEPS), commonly referred to as "blue board." 2. An...Walls ( Expanded Polystyrene Insulation Faced with a Thin Rendering), M.O.A.T. n 22, June 1988. 7 ASTM D3029-90. "Standard Test Methods for Impact

  14. [The planning of resource support of secondary medical care in hospital].

    PubMed

    Kungurov, N V; Zil'berberg, N V

    2010-01-01

    The Ural Institute of dermatovenerology and immunopathology developed and implemented the software concerning the personalized total recording of medical services and pharmaceuticals. The Institute also presents such software as listing of medical services, software module of calculation of financial costs of implementing full standards of secondary medical care in case of chronic dermatopathy, reference book of standards of direct specific costs on laboratory and physiotherapy services, reference book of pharmaceuticals, testing systems and consumables. The unified information system of management recording is a good technique to substantiate the costs of the implementation of standards of medical care, including high-tech care with taking into account the results of total calculation of provided medical services.

  15. 49 CFR 195.307 - Pressure testing aboveground breakout tanks.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... placed in service after October 2, 2000, pneumatic testing must be in accordance with section 5.3 of API Specification 12 F (incorporated by reference, see § 195.3). (b) For aboveground breakout tanks built to API Standard 620 and first placed in service after October 2, 2000, hydrostatic and pneumatic testing must be...

  16. Necklace: combining reference and assembled transcriptomes for more comprehensive RNA-Seq analysis.

    PubMed

    Davidson, Nadia M; Oshlack, Alicia

    2018-05-01

    RNA sequencing (RNA-seq) analyses can benefit from performing a genome-guided and de novo assembly, in particular for species where the reference genome or the annotation is incomplete. However, tools for integrating an assembled transcriptome with reference annotation are lacking. Necklace is a software pipeline that runs genome-guided and de novo assembly and combines the resulting transcriptomes with reference genome annotations. Necklace constructs a compact but comprehensive superTranscriptome out of the assembled and reference data. Reads are subsequently aligned and counted in preparation for differential expression testing. Necklace allows a comprehensive transcriptome to be built from a combination of assembled and annotated transcripts, which results in a more comprehensive transcriptome for the majority of organisms. In addition RNA-seq data are mapped back to this newly created superTranscript reference to enable differential expression testing with standard methods.

  17. Measurements for certification of chlortetracycline reference materials within the European Union Standards, Measurements and Testing programme.

    PubMed

    Juhel-Gaugain, M; McEvoy, J D; VanGinkel, L A

    2000-12-01

    The experimental design of a material certification programme is described. The matrix reference materials (RMs) comprised chlortetracycline (CTC)-containing and CTC-free lyophilised porcine liver, kidney and muscle produced under the European Commission's Standards Measurements and Testing (SMT) programme. The aim of the certification programme was to determine accurately and precisely the concentration of CTC and 4-epi-chlortetracycline (epi-CTC) contained in the RMs. A multi-laboratory approach was used to certify analyte concentrations. Participants (n = 19) were instructed to strictly adhere to previously established guidelines. Following the examination of analytical performance criteria, statistical manipulation of results submitted by 13 laboratories, (6 withdrew) allowed an estimate to be made of the true value of the analyte content. The Nalimov test was used for detection of outlying results. The Cochran and Bartlett tests were employed for testing the homogeneity of variances. The normality of results distribution was tested according to the Kolmogorov-Smirnov-Lilliefors test. One-way analysis of variance (ANOVA) was employed to calculate the within and between-laboratory standard deviations, the overall mean and confidence interval for the CTC and epi-CTC content of each of the RMs. Certified values were within or very close to the target concentration ranges specified in the SMT contract. These studies have demonstrated the successful production and certification of CTC-containing and CTC-free porcine RMs.

  18. The distribution of the indicator height for age of Mexican children and adolescents with Down syndrome according to different reference standards.

    PubMed

    Peña Rivera, Adriana Graciela; Vásquez Garibay, Edgar Manuel; Troyo Sanromán, Rogelio; Romero Velarde, Enrique; Caro Sabido, Erika; Ramírez Díaz, Joanie

    2015-06-01

    To compare the indicator height for age in Mexican children with Down Syndrome (DS) with two different reference patterns of growth (American and Spanish) that might be suitable for the Mexican population. A cross-sectional study was performed including 235 Mexican children and adolescents of both sexes with DS aged 45 days to 16 years enrolled in two specialized schools in the metropolitan area of Guadalajara. The dependent variables were weight/age; height/age; weight/ height and BMI. The data expressed was percentiles and the chi-square test was used to compare the distribution of the height/age index with American and Spanish reference patterns. In addition, a chi-square test was performed for the goodness of fit of the height/age index, with breakpoints lower and greater than the 50th percentile. The percentage of participants who were below the 50th percentile in the height/age index was significantly higher with the Spanish vs. the American reference pattern. The chi-square test for goodness of fit showed that the frequency of cases located below the 50th percentile in the height/age index was significantly higher with the American pattern in the age groups of 0 to 36 months (p = 0.022) and 37 to 72 months (p <0.001), but it was not significant (p = 0.225) in the older than 72 months age group. The American reference pattern is a better fit for the growth of Mexican children with DS compared with the Spanish reference pattern, and the distribution profile obtained with the standard growth and WHO reference was not suitable for the assessment of children with Down syndrome. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  19. Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.

    PubMed

    Sun, Hsin-Yun; Liao, Hsiao-Wei; Sheng, Meng-Huei; Tai, Hui-Min; Kuo, Ching-Hua; Sheng, Wang-Huei

    2016-07-01

    Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. A new IRT-based standard setting method: application to eCat-listening.

    PubMed

    García, Pablo Eduardo; Abad, Francisco José; Olea, Julio; Aguado, David

    2013-01-01

    Criterion-referenced interpretations of tests are highly necessary, which usually involves the difficult task of establishing cut scores. Contrasting with other Item Response Theory (IRT)-based standard setting methods, a non-judgmental approach is proposed in this study, in which Item Characteristic Curve (ICC) transformations lead to the final cut scores. eCat-Listening, a computerized adaptive test for the evaluation of English Listening, was administered to 1,576 participants, and the proposed standard setting method was applied to classify them into the performance standards of the Common European Framework of Reference for Languages (CEFR). The results showed a classification closely related to relevant external measures of the English language domain, according to the CEFR. It is concluded that the proposed method is a practical and valid standard setting alternative for IRT-based tests interpretations.

  1. 40 CFR 92.5 - Reference materials.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... § 92.113 ASTM D 1945-91, Standard Test Method for Analysis of Natural Gas by Gas Chromatography § 92... Supercritical Fluid Chromatography § 92.113 ASTM E 29-93a, Standard Practice for Using Significant Digits in....119 SAE Recommended Practice J244, Measurement of Intake Air or Exhaust Gas Flow of Diesel Engines...

  2. 49 CFR 195.3 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Fittings Industry, Inc. (MSS), 127 Park Street, NE., Vienna, VA 22180. 5. American Society for Testing and...)) §§ 195.205(b)(1); 195.432(b). (12) API Standard 1104, “Welding of Pipelines and Related Facilities” (20th....307(e). (7) 2007 ASME Boiler & Pressure Vessel Code, Section IX: “Qualification Standard for Welding...

  3. 10 CFR 431.85 - Materials incorporated by reference.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (GAMA) merged in 2008 with the Air-Conditioning and Refrigeration Institute to become the Air-Conditioning, Heating, and Refrigeration Institute (AHRI). The Hydronics Institute BTS-2000 Testing Standard...

  4. 10 CFR 431.85 - Materials incorporated by reference.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (GAMA) merged in 2008 with the Air-Conditioning and Refrigeration Institute to become the Air-Conditioning, Heating, and Refrigeration Institute (AHRI). The Hydronics Institute BTS-2000 Testing Standard...

  5. 10 CFR 431.85 - Materials incorporated by reference.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (GAMA) merged in 2008 with the Air-Conditioning and Refrigeration Institute to become the Air-Conditioning, Heating, and Refrigeration Institute (AHRI). The Hydronics Institute BTS-2000 Testing Standard...

  6. 10 CFR 431.85 - Materials incorporated by reference.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (GAMA) merged in 2008 with the Air-Conditioning and Refrigeration Institute to become the Air-Conditioning, Heating, and Refrigeration Institute (AHRI). The Hydronics Institute BTS-2000 Testing Standard...

  7. 10 CFR 431.85 - Materials incorporated by reference.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (GAMA) merged in 2008 with the Air-Conditioning and Refrigeration Institute to become the Air-Conditioning, Heating, and Refrigeration Institute (AHRI). The Hydronics Institute BTS-2000 Testing Standard...

  8. An approach to an acute emotional stress reference scale.

    PubMed

    Garzon-Rey, J M; Arza, A; de-la-Camara, C; Lobo, A; Armario, A; Aguilo, J

    2017-06-16

    The clinical diagnosis aims to identify the degree of affectation of the psycho-physical state of the patient as a guide to therapeutic intervention. In stress, the lack of a measurement tool based on a reference makes it difficult to quantitatively assess this degree of affectation. To define and perform a primary assessment of a standard reference in order to measure acute emotional stress from the markers identified as indicators of the degree. Psychometric tests and biochemical variables are, in general, the most accepted stress measurements by the scientific community. Each one of them probably responds to different and complementary processes related to the reaction to a stress stimulus. The reference that is proposed is a weighted mean of these indicators by assigning them relative weights in accordance with a principal components analysis. An experimental study was conducted on 40 healthy young people subjected to the psychosocial stress stimulus of the Trier Social Stress Test in order to perform a primary assessment and consistency check of the proposed reference. The proposed scale clearly differentiates between the induced relax and stress states. Accepting the subjectivity of the definition and the lack of a subsequent validation with new experimental data, the proposed standard differentiates between a relax state and an emotional stress state triggered by a moderate stress stimulus, as it is the Trier Social Stress Test. The scale is robust. Although the variations in the percentage composition slightly affect the score, but they do not affect the valid differentiation between states.

  9. 10 CFR 431.76 - Uniform test method for the measurement of energy efficiency of commercial warm air furnaces.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Gases), 2.5 (Test Pressures and Burner Adjustments), 2.6 (Static Pressure and Air Flow Adjustments), 2... pressure, as specified in Section 2.5.1 of ANSI Standard Z21.47-1998, (Incorporated by reference, see § 431... thermal efficiency test), 41 (Initial Test Conditions), 42 (Combustion Test—Burner and Furnace), 43.2...

  10. 10 CFR 431.76 - Uniform test method for the measurement of energy efficiency of commercial warm air furnaces.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Gases), 2.5 (Test Pressures and Burner Adjustments), 2.6 (Static Pressure and Air Flow Adjustments), 2... pressure, as specified in Section 2.5.1 of ANSI Standard Z21.47-1998, (Incorporated by reference, see § 431... thermal efficiency test), 41 (Initial Test Conditions), 42 (Combustion Test—Burner and Furnace), 43.2...

  11. Palm-Based Standard Reference Materials for Iodine Value and Slip Melting Point

    PubMed Central

    Tarmizi, Azmil Haizam Ahmad; Lin, Siew Wai; Kuntom, Ainie

    2008-01-01

    This work described study protocols on the production of Palm-Based Standard Reference Materials for iodine value and slip melting point. Thirty-three laboratories collaborated in the inter-laboratory proficiency tests for characterization of iodine value, while thirty-two laboratories for characterization of slip melting point. The iodine value and slip melting point of palm oil, palm olein and palm stearin were determined in accordance to MPOB Test Methods p3.2:2004 and p4.2:2004, respectively. The consensus values and their uncertainties were based on the acceptability of statistical agreement of results obtained from collaborating laboratories. The consensus values and uncertainties for iodine values were 52.63 ± 0.14 Wijs in palm oil, 56.77 ± 0.12 Wijs in palm olein and 33.76 ± 0.18 Wijs in palm stearin. For the slip melting points, the consensus values and uncertainties were 35.6 ± 0.3 °C in palm oil, 22.7 ± 0.4 °C in palm olein and 53.4 ± 0.2 °C in palm stearin. Repeatability and reproducibility relative standard deviations were found to be good and acceptable, with values much lower than that of 10%. Stability of Palm-Based Standard Reference Materials remained stable at temperatures of −20 °C, 0 °C, 6 °C and 24 °C upon storage for one year. PMID:19609396

  12. Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laboratories

    PubMed Central

    2011-01-01

    Background There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval. Methods Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology. Results Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory. Conclusions In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods. PMID:21477356

  13. Collaborative studies on the development of national reference standards for potency determination of H7N9 influenza vaccine

    PubMed Central

    Li, Changgui; Xu, Kangwei; Hashem, Anwar; Shao, Ming; Liu, Shuzhen; Zou, Yong; Gao, Qiang; Zhang, Yongchao; Yuan, Liyong; Xu, Miao; Li, Xuguang; Wang, Junzhi

    2015-01-01

    The outbreak of human infections of a novel avian influenza virus A (H7N9) prompted the development of the vaccines against this virus. Like all types of influenza vaccines, H7N9 vaccine must be tested for its potency prior to being used in humans. However, the unavailability of international reference reagents for the potency determination of H7N9 vaccines substantially hinders the progress in vaccine development. To facilitate clinical development, we enlisted 5 participants in a collaborative study to develop critical reagents used in Single Radial Immunodiffusion (SRID), the currently acceptable assay for potency determination of influenza vaccine. Specifically, the hemagglutinin (HA) content of one vaccine bulk for influenza A (H7N9), herein designated as Primary Liquid Standard (PLS), was determined by SDS-PAGE. In addition, the freeze-dried antigen references derived from PLS were prepared to enhance the stability for long term storage. The final HA content of lyophilized antigen references were calibrated against PLS by SRID assay in a collaborative study. Importantly, application of these national reference standards to potency analyses greatly facilitated the development of H7N9 vaccines in China. PMID:25970793

  14. More is still not better: testing the perturbation model of temporal reference memory across different modalities and tasks.

    PubMed

    Ogden, Ruth S; Jones, Luke A

    2009-05-01

    The ability of the perturbation model (Jones & Wearden, 2003) to account for reference memory function in a visual temporal generalization task and auditory and visual reproduction tasks was examined. In all tasks the number of presentations of the standard was manipulated (1, 3, or 5), and its effect on performance was compared. In visual temporal generalization the number of presentations of the standard did not affect the number of times the standard was correctly identified, nor did it affect the overall temporal generalization gradient. In auditory reproduction there was no effect of the number of times the standard was presented on mean reproductions. In visual reproduction mean reproductions were shorter when the standard was only presented once; however, this effect was reduced when a visual cue was provided before the first presentation of the standard. Whilst the results of all experiments are best accounted for by the perturbation model there appears to be some attentional benefit to multiple presentations of the standard in visual reproduction.

  15. A synthetic zero air standard

    NASA Astrophysics Data System (ADS)

    Pearce, Ruth

    2016-04-01

    A Synthetic Zero Air Standard R. E. Hill-Pearce, K. V. Resner, D. R. Worton, P. J. Brewer The National Physical Laboratory Teddington, Middlesex TW11 0LW UK We present work towards providing traceability for measurements of high impact greenhouse gases identified by the World Meteorological Organisation (WMO) as critical for global monitoring. Standards for these components are required with challengingly low uncertainties to improve the quality assurance and control processes used for the global networks to better assess climate trends. Currently the WMO compatibility goals require reference standards with uncertainties of < 100 nmolmol-1 for CO2 (northern hemisphere) and < 2 nmolmol-1 for CH4 and CO. High purity zero gas is required for both the balance gas in the preparation of reference standards and for baseline calibrations of instrumentation. Quantification of the amount fraction of the target components in the zero gas is a significant contributor to the uncertainty and is challenging due to limited availability of reference standard at the amount fraction of the measurand and limited analytical techniques with sufficient detection limits. A novel dilutor was used to blend NPL Primary Reference Gas Mixtures containing CO2, CH4 and CO at atmospheric amount fractions with a zero gas under test. Several mixtures were generated with nominal dilution ratios ranging from 2000:1 to 350:1. The baseline of two cavity ring down spectrometers was calibrated using the zero gas under test after purification by oxidative removal of CO and hydrocarbons to < 1 nmolmol-1 (SAES PS15-GC50) followed by the removal of CO2 and water vapour to < 100 pmolmol-1 (SAES MC190). Using the standard addition method.[1] we have quantified the amount fraction of CO, CO2, and CH4 in scrubbed whole air (Scott Marrin) and NPL synthetic zero air. This is the first synthetic zero air standard with a matrix of N2, O2 and Ar closely matching ambient composition with gravimetrically assigned values and with accurate quantification of the CO, CO2, and CH4 impurities. [1] Brown, R.J.C et al.,Analytica Chimica Acta 587, 158-163 (2007)

  16. 46 CFR 58.03-1 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Test Method for Flash and Fire Points by Cleveland Open Cup (“ASTM D 92”), 58.30-10; (8) ASTM D 93-97, Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester (“ASTM D 93”), 58.01-10; and (9...

  17. 46 CFR 58.03-1 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Test Method for Flash and Fire Points by Cleveland Open Cup (“ASTM D 92”), 58.30-10; (8) ASTM D 93-97, Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester (“ASTM D 93”), 58.01-10; and (9...

  18. Survey of Ophthalmologists Regarding Practice Patterns for Dry Eye and Sjogren Syndrome.

    PubMed

    Bunya, Vatinee Y; Fernandez, Karen B; Ying, Gui-Shuang; Massaro-Giordano, Mina; Macchi, Ilaria; Sulewski, Michael E; Hammersmith, Kristin M; Nagra, Parveen K; Rapuano, Christopher J; Orlin, Stephen E

    2018-01-15

    To survey ophthalmologists about current practice patterns regarding the evaluation of dry eye patients and referrals for a Sjogren syndrome (SS) workup. An online survey was sent to ophthalmologists affiliated with the Scheie Eye Institute or Wills Eye Hospital using REDCap in August 2015. Descriptive statistics were used to summarize the data. Four hundred seventy-four survey invitations were sent out and 101 (21%) ophthalmologists completed the survey. The common traditional dry eye test performed was corneal fluorescein staining (62%) and the most common newer dry eye test performed was tear osmolarity (18%). Half of respondents (51%) refer fewer than 5% of their dry eye patients for SS workups, with 18% reporting that they never refer any patients. The most common reasons for referrals included positive review of systems (60%), severe dry eye symptoms (51%) or ocular signs (47%), or dry eye that is refractory to treatment (42%). The majority (83%) felt that there is a need for an evidence-based standardized screening tool for dry eye patients to decide who should be referred for evaluation for SS. Ophthalmologists continue to prefer the use of traditional dry eye tests in practice, with the most common test being corneal fluorescein staining. There is an underreferral of dry eye patients for SS workups, which is contributing to the continued underdiagnosis of the disease. Most respondents felt that there was a need for an evidence-based standardized screening tool to decide which dry eye patients should be referred for SS evaluations.

  19. Towards standardized testing methodologies for optical properties of components in concentrating solar thermal power plants

    NASA Astrophysics Data System (ADS)

    Sallaberry, Fabienne; Fernández-García, Aránzazu; Lüpfert, Eckhard; Morales, Angel; Vicente, Gema San; Sutter, Florian

    2017-06-01

    Precise knowledge of the optical properties of the components used in the solar field of concentrating solar thermal power plants is primordial to ensure their optimum power production. Those properties are measured and evaluated by different techniques and equipment, in laboratory conditions and/or in the field. Standards for such measurements and international consensus for the appropriate techniques are in preparation. The reference materials used as a standard for the calibration of the equipment are under discussion. This paper summarizes current testing methodologies and guidelines for the characterization of optical properties of solar mirrors and absorbers.

  20. Comparison of Three Different Methods for Pile Integrity Testing on a Cylindrical Homogeneous Polyamide Specimen

    NASA Astrophysics Data System (ADS)

    Lugovtsova, Y. D.; Soldatov, A. I.

    2016-01-01

    Three different methods for pile integrity testing are proposed to compare on a cylindrical homogeneous polyamide specimen. The methods are low strain pile integrity testing, multichannel pile integrity testing and testing with a shaker system. Since the low strain pile integrity testing is well-established and standardized method, the results from it are used as a reference for other two methods.

  1. Proposed Reference Spectral Irradiance Standards to Improve Photovoltaic Concentrating System Design and Performance Evaluation: Preprint

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

    Myers, D. R.; Emery, K. E.; Gueymard, C.

    2002-05-01

    This conference paper describes the American Society for Testing and Materials (ASTM), the International Electrotechnical Commission (IEC), and the International Standards Organization (ISO) standard solar terrestrial spectra (ASTM G-159, IEC-904-3, ISO 9845-1) provide standard spectra for photovoltaic performance applications. Modern terrestrial spectral radiation models and knowledge of atmospheric physics are applied to develop suggested revisions to update the reference spectra. We use a moderately complex radiative transfer model (SMARTS2) to produce the revised spectra. SMARTS2 has been validated against the complex MODTRAN radiative transfer code and spectral measurements. The model is proposed as an adjunct standard to reproduce the referencemore » spectra. The proposed spectra represent typical clear sky spectral conditions associated with sites representing reasonable photovoltaic energy production and weathering and durability climates. The proposed spectra are under consideration by ASTM.« less

  2. Determination of isoflavones in soy and selected foods containing soy by extraction, saponification, and liquid chromatography: collaborative study.

    PubMed

    Klump, S P; Allred, M C; MacDonald, J L; Ballam, J M

    2001-01-01

    Isoflavones are biologically active compounds occurring naturally in a variety of plants, with relatively high levels found in soybeans. Twelve laboratories participated in a collaborative study to determine the aglycon isoflavone content of 8 test samples of soy and foods containing soy. The analytical method for the determination of isoflavones incorporates a mild saponification step that reduces the number of analytes measured and permits quantitation versus commercially available, stable reference standards. Test samples were extracted at 65 degrees C with methanol-water (80 + 20), saponified with dilute sodium hydroxide solution, and analyzed by reversed-phase liquid chromatography with UV detection at 260 nm. Isoflavone results were reported as microg/aglycon/g or microg aglycon equivalents/g. The 8 test samples included 2 blind duplicates and 4 single test samples with total isoflavone concentrations ranging from approximately 50 to 3000 microg/g. Test samples of soy ingredients and products made with soy were distributed to collaborators with appropriate reference standards. Collaborators were asked to analyze test samples in duplicate on 2 separate days. The data were analyzed for individual isoflavone components, subtotals of daidzin-daidzein, glycitin-glycitein, and genistin-genistein, and total isoflavones. The relative standard deviation (RSD) for repeatability was 1.8-7.1%, and the RSD for reproducibility was 3.2-16.1% for total isoflavone values of 47-3099 microg/g.

  3. The additional benefit of the ML Flow test to classify leprosy patients.

    PubMed

    Bührer-Sékula, Samira; Illarramendi, Ximena; Teles, Rose B; Penna, Maria Lucia F; Nery, José Augusto C; Sales, Anna Maria; Oskam, Linda; Sampaio, Elizabeth P; Sarno, Euzenir N

    2009-08-01

    The use of the skin lesion counting classification leads to both under and over diagnosis of leprosy in many instances. Thus, there is a need to complement this classification with another simple and robust test for use in the field. Data of 202 untreated leprosy patients diagnosed at FIOCRUZ, Rio de Janeiro, Brazil, was analyzed. There were 90 patients classified as PB and 112 classified as MB according to the reference standard. The BI was positive in 111 (55%) patients and the ML Flow test in 116 (57.4%) patients. The ML Flow test was positive in 95 (86%) of the patients with a positive BI. The lesion counting classification was confirmed by both BI and ML Flow tests in 65% of the 92 patients with 5 or fewer lesions, and in 76% of the 110 patients with 6 or more lesions. The combination of skin lesion counting and the ML Flow test results yielded a sensitivity of 85% and a specificity of 87% for MB classification, and correctly classified 86% of the patients when compared to the standard reference. A considerable proportion of the patients (43.5%) with discordant test results in relation to standard classification was in reaction. The use of any classification system has limitations, especially those that oversimplify a complex disease such as leprosy. In the absence of an experienced dermatologist and slit skin smear, the ML Flow test could be used to improve treatment decisions in field conditions.

  4. Integrated Data Collection Analysis (IDCA) Program - RDX Type II Class 5 Standard, Data Set 1

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

    Sandstrom, Mary M.; Brown, Geoffrey W.; Preston, Daniel N.

    This document describes the results of the first reference sample material—RDX Type II Class 5—examined in the proficiency study for small-scale safety and thermal (SSST) testing of explosive materials for the Integrated Data Collection Analysis (IDCA) Program. The IDCA program is conducting proficiency testing on homemade explosives (HMEs). The reference sample materials are being studied to establish the accuracy of traditional explosives safety testing for each performing laboratory. These results will be used for comparison to results from testing HMEs. This effort, funded by the Department of Homeland Security (DHS), ultimately will put the issues of safe handling of thesemore » materials in perspective with standard military explosives. The results of the study will add SSST testing results for a broad suite of different HMEs to the literature, potentially suggest new guidelines and methods for HME testing, and possibly establish what are the needed accuracies in SSST testing to develop safe handling practices. Described here are the results for impact, friction, electrostatic discharge, and scanning calorimetry analysis of a reference sample of RDX Type II Class 5. The results from each participating testing laboratory are compared using identical test material and preparation methods wherever possible. Note, however, the test procedures differ among the laboratories. These results are then compared to historical data from various sources. The performers involved are Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Air Force Research Laboratory/ RXQL (AFRL), Indian Head Division, Naval Surface Warfare Center, (IHD-NSWC), and Sandia National Laboratories (SNL). These tests are conducted as a proficiency study in order to establish some consistency in test protocols, procedures, and experiments and to understand how to compare results when test protocols are not identical.« less

  5. Hydrogen slush density reference system

    NASA Technical Reports Server (NTRS)

    Weitzel, D. H.; Lowe, L. T.; Ellerbruch, D. A.; Cruz, J. E.; Sindt, C. F.

    1971-01-01

    A hydrogen slush density reference system was designed for calibration of field-type instruments and/or transfer standards. The device is based on the buoyancy principle of Archimedes. The solids are weighed in a low-mass container so arranged that solids and container are buoyed by triple-point liquid hydrogen during the weighing process. Several types of hydrogen slush density transducers were developed and tested for possible use as transfer standards. The most successful transducers found were those which depend on change in dielectric constant, after which the Clausius-Mossotti function is used to relate dielectric constant and density.

  6. Nasal potential difference measurements in diagnosis of cystic fibrosis: an international survey.

    PubMed

    Naehrlich, Lutz; Ballmann, Manfred; Davies, Jane; Derichs, Nico; Gonska, Tanja; Hjelte, Lena; van Konigsbruggen-Rietschel, Silke; Leal, Teresinha; Melotti, Paola; Middleton, Peter; Tümmler, Burkhard; Vermeulen, Francois; Wilschanski, Michael

    2014-01-01

    The role of nasal potential difference (NPD) measurement as a diagnostic test for cystic fibrosis (CF) is a subject of global controversy because of the lack of validation studies, clear reference values, and standardized protocols for diagnostic NPD. To determine diagnostic NPD frequency, protocols, interpretation, and rater agreement, we surveyed the 18 NPD centres of the European Cystic Fibrosis Society Diagnostic Network Working Group. Fifteen centres reported performing 373 diagnostic NPDs in 2012. Most use the CFF-TDN-SOP (67%) and the chloride-free + isoproterenol response of the side with the largest response (47%) as diagnostic criteria and use centre-specific reference ranges. Rater agreement for five NPD tracings - in general - was good, but poor in tracings with different responses between the two nostrils. NPD is frequently used as a diagnostic and research tool for CF. Performance is highly standardized, centre-specific reference ranges are established, and rater agreement - in general - is good. Centre-independent diagnostic criteria and reference ranges must be defined by multicentre validation studies to improve standardized interpretation for diagnostic use. © 2013.

  7. Quantitative imaging biomarkers: a review of statistical methods for computer algorithm comparisons.

    PubMed

    Obuchowski, Nancy A; Reeves, Anthony P; Huang, Erich P; Wang, Xiao-Feng; Buckler, Andrew J; Kim, Hyun J Grace; Barnhart, Huiman X; Jackson, Edward F; Giger, Maryellen L; Pennello, Gene; Toledano, Alicia Y; Kalpathy-Cramer, Jayashree; Apanasovich, Tatiyana V; Kinahan, Paul E; Myers, Kyle J; Goldgof, Dmitry B; Barboriak, Daniel P; Gillies, Robert J; Schwartz, Lawrence H; Sullivan, Daniel C

    2015-02-01

    Quantitative biomarkers from medical images are becoming important tools for clinical diagnosis, staging, monitoring, treatment planning, and development of new therapies. While there is a rich history of the development of quantitative imaging biomarker (QIB) techniques, little attention has been paid to the validation and comparison of the computer algorithms that implement the QIB measurements. In this paper we provide a framework for QIB algorithm comparisons. We first review and compare various study designs, including designs with the true value (e.g. phantoms, digital reference images, and zero-change studies), designs with a reference standard (e.g. studies testing equivalence with a reference standard), and designs without a reference standard (e.g. agreement studies and studies of algorithm precision). The statistical methods for comparing QIB algorithms are then presented for various study types using both aggregate and disaggregate approaches. We propose a series of steps for establishing the performance of a QIB algorithm, identify limitations in the current statistical literature, and suggest future directions for research. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  8. Results of the U.S. Geological Survey's Analytical Evaluation Program for standard reference samples: T-155 (trace constituents), M-148 (major constituents), N-59 (nutrient constituents), N-60 (nutrient constituents), P-31 (low ionic strength constituents), GWT-4 (ground-water trace constituents) and Hg-27 (Mercury) distributed in September 1998

    USGS Publications Warehouse

    Farrar, Jerry W.

    1999-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for seven standard reference samples -- T-155 (trace constituents), M-148 (major constituents), N-59 (nutrient constituents), N-60 (nutrient constituents), P-31 (low ionic strength constituents), GWT-4 (ground-water trace constituents), and Hg- 27 (mercury) -- which were distributed in September 1998 to 162 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 136 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  9. Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in October 1993 : T-127 (trace constituents), M-128 (major constituents), N-40 (nutrients), N-41 (nutrients), P-21 (low ionic strength), Hg-17 (mercury), AMW-3 (acid mine water), and WW-1 (whole water)

    USGS Publications Warehouse

    Long, H.K.; Farrar, J.W.

    1994-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for eight standard reference samples--T-127 (trace constituents), M-128 (major constituents), N-40 (nutrients), N-41 (nutrients), P-21 (low ionic strength), Hg-17 (mercury), AMW-3 (acid mine water), and WW-1 (whole water)--that were distributed in October 1993 to 158 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 145 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the eight reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the eight standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  10. Report on the U.S. Geological Survey's evaluation program for standard reference samples distributed in October 1994 : T-131 (trace constituents), T-133 (trace constituents), M-132 (major constituents), N-43 (nutrients), N-44 (nutrients), P-23 (low ionic strength) and Hg-19 (mercury)

    USGS Publications Warehouse

    Long, H. Keith; Farrar, Jerry W.

    1995-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for 7 standard reference samples--T-131 (trace constituents), T-133 (trace constituents), M-132 (major constituents), N-43 (nutrients), N-44 (nutrients), P-23 (low ionic strength), and Hg-19 (mercury). The samples were distributed in October 1994 to 131 laboratories registered in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 121 of the laboratories were evaluated with respect to: overall laboratory performance and relative laboratory performance for each analyte in the seven reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the seven standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  11. Preliminary development of an ultrabrief two-item bedside test for delirium.

    PubMed

    Fick, Donna M; Inouye, Sharon K; Guess, Jamey; Ngo, Long H; Jones, Richard N; Saczynski, Jane S; Marcantonio, Edward R

    2015-10-01

    Delirium is common, morbid, and costly, yet is greatly under-recognized among hospitalized older adults. To identify the best single and pair of mental status test items that predict the presence of delirium. Diagnostic test evaluation study that enrolled medicine inpatients aged 75 years or older at an academic medical center. Patients underwent a clinical reference standard assessment involving a patient interview, medical record review, and interviews with family members and nurses to determine the presence or absence of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition defined delirium. Participants also underwent the three-dimensional Confusion Assessment Method (3D-CAM), a brief, validated assessment for delirium. Individual items and pairs of items from the 3D-CAM were evaluated to determine sensitivity and specificity relative to the reference standard delirium diagnosis. Of the 201 participants (mean age 84 years, 62% female), 42 (21%) had delirium based on the clinical reference standard. The single item with the best test characteristics was "months of the year backwards" with a sensitivity of 83% (95% confidence interval [CI]: 69%-93%) and specificity of 69% (95% CI: 61%-76%). The best 2-item screen was the combination of "months of the year backwards" and "what is the day of the week?" with a sensitivity of 93% (95% CI: 81%-99%) and specificity of 64% (95% CI: 56%-70%). We identified a single item with >80% and pair of items with >90% sensitivity for delirium. If validated prospectively, these items will serve as an initial innovative screening step for delirium identification in hospitalized older adults. © 2015 Society of Hospital Medicine.

  12. Calibration of helical tomotherapy machine using EPR/alanine dosimetry.

    PubMed

    Perichon, Nicolas; Garcia, Tristan; François, Pascal; Lourenço, Valérie; Lesven, Caroline; Bordy, Jean-Marc

    2011-03-01

    Current codes of practice for clinical reference dosimetry of high-energy photon beams in conventional radiotherapy recommend using a 10 x 10 cm2 square field, with the detector at a reference depth of 10 cm in water and 100 cm source to surface distance (SSD) (AAPM TG-51) or 100 cm source-to-axis distance (SAD) (IAEA TRS-398). However, the maximum field size of a helical tomotherapy (HT) machine is 40 x 5 cm2 defined at 85 cm SAD. These nonstandard conditions prevent a direct implementation of these protocols. The purpose of this study is twofold: To check the absorbed dose in water and dose rate calibration of a tomotherapy unit as well as the accuracy of the tomotherapy treatment planning system (TPS) calculations for a specific test case. Both topics are based on the use of electron paramagnetic resonance (EPR) using alanine as transfer dosimeter between the Laboratoire National Henri Becquerel (LNHB) 60Co-gamma-ray reference beam and the Institut Curie's HT beam. Irradiations performed in the LNHB reference 60Co-gamma-ray beam allowed setting up the calibration method, which was then implemented and tested at the LNHB 6 MV linac x-ray beam, resulting in a deviation of 1.6% (at a 1% standard uncertainty) relative to the reference value determined with the standard IAEA TRS-398 protocol. HT beam dose rate estimation shows a difference of 2% with the value stated by the manufacturer at a 2% standard uncertainty. A 4% deviation between measured dose and the calculation from the tomotherapy TPS was found. The latter was originated by an inadequate representation of the phantom CT-scan values and, consequently, mass densities within the phantom. This difference has been explained by the mass density values given by the CT-scan and used by the TPS which were not the true ones. Once corrected using Monte Carlo N-Particle simulations to validate the accuracy of this process, the difference between corrected TPS calculations and alanine measured dose values was then found to be around 2% (with 2% standard uncertainty on TPS doses and 1.5% standard uncertainty on EPR measurements). Beam dose rate estimation results were found to be in good agreement with the reference value given by the manufacturer at 2% standard uncertainty. Moreover, the dose determination method was set up with a deviation around 2% (at a 2% standard uncertainty).

  13. 40 CFR 59.110 - Incorporations by Reference.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Register. (1) ASTM D 1613-96, Standard Test Method for Acidity in Volatile Solvents and Chemical Intermediates Used in Paint, Varnish, Lacquer, and Related Products, IBR approved for § 59.104(d). (2) ASTM D... Society for Testing and Materials (ASTM), 100 Barr Harbor Drive, West Conshohocken, PA, 19428, telephone...

  14. 40 CFR 1065.715 - Natural gas.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... PROCEDURES Engine Fluids, Test Fuels, Analytical Gases and Other Calibration Standards § 1065.715 Natural gas... specifications in the following table: Table 1 of § 1065.715—Test Fuel Specifications for Natural Gas Property....051 mol/mol. 1 Demonstrate compliance with fuel specifications based on the reference procedures in...

  15. A New Look at Bias in Aptitude Tests.

    ERIC Educational Resources Information Center

    Scheuneman, Janice Dowd

    1981-01-01

    Statistical bias in measurement and ethnic-group bias in testing are discussed, reviewing predictive and construct validity studies. Item bias is reconceptualized to include distance of item content from respondent's experience. Differing values of mean and standard deviation for bias parameter are analyzed in a simulation. References are…

  16. 40 CFR 60.17 - Incorporations by reference.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... (C267-01), U.S. EPA, Research Triangle Park, NC or at the National Archives and Records Administration... Testing and Materials (ASTM), 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428...) ASTM D86-96, Standard Test Method for Distillation of Petroleum Products (Approved April 10, 1996), IBR...

  17. Testing for change in structural elements of forest inventories

    Treesearch

    Melinda Vokoun; David Wear; Robert Abt

    2009-01-01

    In this article we develop a methodology to test for changes in the underlying relationships between measures of forest productivity (structural elements) and site characteristics, herein referred to as structural changes, using standard forest inventories. Changes in measures of forest growing stock volume and number of trees for both...

  18. 33 CFR 164.03 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... inspection at the Navigation Systems Division (CG-553), Coast Guard Headquarters, 2100 2nd St. SW., Stop 7580, Washington, DC 20593-7580 and at the National Archives and Records Administration (NARA). For information on... Testing Fiber Ropes 164.74 Cordage Institute, 350 Lincoln Street, Hingham, MA 02043 CIA-3, Standard Test...

  19. Standards and Criteria. Paper #10 in Occasional Paper Series.

    ERIC Educational Resources Information Center

    Glass, Gene V.

    The logical and psychological bases for setting cutting scores for criterion-referenced tests are examined; they are found to be intrinsically arbitrary and are often examples of misdirected precision and axiomatization. The term, criterion referenced, originally referred to a technique for making test scores meaningful by controlling the test…

  20. 46 CFR 114.600 - Incorporation by reference.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... supplement—Safety Glazing Materials For Glazing Motor Vehicles Operating on Land Highways 116.1030 American... Test Method for Rate of Burning and/or Extent and Time of Burning of Plastics in a Horizontal Position... Burning Characteristics of Building Materials 116.405; 116.422; 116.423 ASTM E 648-97, Standard Test...

  1. Sonoclot evaluation of whole blood coagulation in healthy adult dogs.

    PubMed

    Babski, Danielle M; Brainard, Benjamin M; Krimer, Paula M; Ralph, Alan G; Pittman, Jennifer R; Koenig, Amie

    2012-12-01

    To establish a standard protocol for analysis of canine whole blood and generate reference intervals for healthy dogs using the Sonoclot analyzer, and to compare Sonoclot values to standard and viscoelastic coagulation tests. Prospective study. Veterinary University research facility and teaching hospital. Twelve healthy random source dogs and 52 healthy dogs from the general veterinary school population. Blood sampling for viscoelastic coagulation testing. Blood was collected from 12 healthy adult dogs by jugular venipuncture. After a rest period at room temperature of 30, 60, or 120 minutes, 340 μL of citrated blood was added to 20 μL of 0.2 M CaCl(2) in 1 of 2 cuvette types warmed to 37° C. Cuvettes contained a magnetic stir-bar with glass beads (gbACT+) or only a magnetic stir-bar (nonACT). Reference interval samples were collected from 52 healthy adult dogs and analyzed in duplicate. The ACT, CR, and PF were not affected by duration of rest period for either cuvette type. ACT variability was decreased when using gbACT+ cuvettes (P < 0.05). In normal dogs reference intervals (mean ± 2 SD) using gbACT+ cuvettes were: ACT 56.0-154.0 seconds, CR 14.85-46.0, and PF 2.1-4.05. ACT correlated to TEG R-time, K-time, and angle, while CR correlated with all TEG parameters. Fibrinogen correlated with ACT, CR, and PF. Sonoclot did not correlate with other common coagulation tests. Sonoclot provides viscoelastic evaluation of canine whole blood coagulation and correlated to several TEG parameters and fibrinogen. A standard protocol and reference intervals were established. © Veterinary Emergency and Critical Care Society 2012.

  2. Long working distance interference microscope

    DOEpatents

    Sinclair, Michael B.; DeBoer, Maarten P.; Smith, Norman F.

    2004-04-13

    Disclosed is a long working distance interference microscope suitable for three-dimensional imaging and metrology of MEMS devices and test structures on a standard microelectronics probe station. The long working distance of 10-30 mm allows standard probes or probe cards to be used. This enables nanometer-scale 3-D height profiles of MEMS test structures to be acquired across an entire wafer. A well-matched pair of reference/sample objectives is not required, significantly reducing the cost of this microscope, as compared to a Linnik microinterferometer.

  3. 46 CFR 174.007 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... are: American Society for Testing and Materials (ASTM) 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959. ASTM F 1196-94, Standard Specification for Sliding Watertight Door Assemblies—174.100 ASTM F...

  4. Airport Fire and Rescue Personnel Protective Clothing

    DOT National Transportation Integrated Search

    1995-07-13

    This advisory circular (AC) identifies minimum standards for design, performance, : testing, and safety of personnel protective equipment (PPE), frequently referred : to as personnel protective clothing for airport firefighting. This AC also : assist...

  5. DISCUSSION AND EVALUATION OF THE VOLATILITY TEST FOR EQUIVALENCY OF OTHER METHODS TO THE FEDERAL REFERENCE METHOD FOR FINE PARTICULATE MATTER

    EPA Science Inventory

    In July 1997, EPA promulgated a new National Ambient Air Quality Standard (NAAQS) for fine particulate matter (PM2.5). This new standard was based on collection of an integrated mass sample on a filter. Field studies have demonstrated that the collection of semivolatile compoun...

  6. 46 CFR 164.018-5 - Specifications and standards incorporated by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Specification MIL-C-43006 E (March 24, 1978), entitled “Cloth and Strip Laminated, Vinyl Nylon High Strength... amended by Amendment 2 of December 2, 1976. (2) Federal Specification L-S-300 B (July 12, 1974), entitled...” as amended May 1, 1974). (6) Federal Test Method Standard 370 (March 1, 1977), entitled “Instrumental...

  7. Co-Educational Tutorial Classes and Their Significance on Gendered Test Scores of Wollo University Students: A Before-After Analyses

    ERIC Educational Resources Information Center

    Gidey, Mu'uz

    2015-01-01

    This action research is carried out in a practical class room setting to devise an innovative way of administering tutorial classes to improve students' learning competence with particular reference to gendered test scores. A before-after test score analyses of mean and standard deviations along with t-statistical tests of hypotheses of second…

  8. Development of a standard reference material containing 22 chlorinated hydrocarbon gases at 1 μmol/mol in nitrogen.

    PubMed

    Li, Ning; Du, Jian; Yang, Jing; Fan, Qiang; Tian, Wen

    2017-11-01

    A gas standard mixture containing 22 chlorinated hydrocarbons in high purity nitrogen was prepared using a two-step weighing method and a gasifying apparatus developed in-house. The concentration of each component was determined using a gas chromatograph with flame ionization detection (GC/FID). Linear regression analysis of every component was performed using the gas standard mixture with concentrations ranging from 1 to 10 μmol/mol, showing the complete gasification of volatile organic compound (VOCs) species in a selected cylinder. Repeatability was also examined to ensure the reliability of the preparation method. In addition, no significant difference was observed between domestic treated and imported treated cylinders, which were conducive to reduction of the cost of raw materials. Moreover, the results of stability testing at different pressures and long-term stability tests indicated that the gas standard at 1 μmol/mol level with relative expanded uncertainties of 5% was stable above 2 MPa for a minimum of 12 months. Finally, a quantity comparison was conducted between the gas standard and a commercial gas standard from Scott Specialty Gases (now Air Liquide America Specialty Gases). The excellent agreement of every species suggested the favorable accuracy of our gas standard. Therefore, this reference material can be applied to routine observation of VOCs and for other purposes.

  9. 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.

  10. Interagency comparison of iodometric methods for ozone determination

    NASA Technical Reports Server (NTRS)

    Demore, W. B.; Romanovsky, J. C.; Feldstein, M.; Mueller, P. K.; Hamming, W. J.

    1976-01-01

    The California Air Resources Board appointed an Oxidant Calibration Committee for the purpose of evaluating the accuracy of the different agency calibration procedures. The committee chose UV absorption photometry as the reference method for ozone measurement. Interagency comparisons of the various iodometric methods were conducted relative to the ultraviolet standard. The tests included versions of the iodometric methods as employed by the Air Resources Board, the Los Angeles Air Pollution Control District, and the EPA. An alternative candidate reference method for ozone measurement, gas phase titration, was also included in the test series.

  11. Requirement for a standard language for test and ground operations

    NASA Technical Reports Server (NTRS)

    Medlock, J. R.

    1971-01-01

    The basic requirements for a standard test and checkout language applicable to all phases of the space shuttle test and ground operations are determined. The general characteristics outlined here represent the integration of selected ideas and concepts from operational elements within Kennedy Space Center (KSC) that represent diverse disciplines associated with space vehicle testing and launching operations. Special reference is made to two studies conducted in this area for KSC as authorized by the Advanced Development Element of the Office of Manned Space Flight (MSF). Information contained in reports from these studies have contributed significantly to the final selection of language features depicted in this technical report.

  12. Propulsion Test Handbook: MSFC and SSC. Draft 01

    NASA Technical Reports Server (NTRS)

    Hammond, John M.

    2010-01-01

    This Handbook was prepared to provide Propulsion Test Personnel a central source of fundamental reference material. The Testing Process, which is a three-part process of pre-test activities, testing, and post-test activities, involves a collaborative effort from the mechanical, electrical, safety, and environmental disciplines in the test environment. Pre-test activities, testing, and post-test activities processes will vary, per test requirements; however, the content of this Handbook should cover basic procedures and standards that are shared across Centers.

  13. Airway physical examination tests for detection of difficult airway management in apparently normal adult patients.

    PubMed

    Roth, Dominik; Pace, Nathan L; Lee, Anna; Hovhannisyan, Karen; Warenits, Alexandra-Maria; Arrich, Jasmin; Herkner, Harald

    2018-05-15

    The unanticipated difficult airway is a potentially life-threatening event during anaesthesia or acute conditions. An unsuccessfully managed upper airway is associated with serious morbidity and mortality. Several bedside screening tests are used in clinical practice to identify those at high risk of difficult airway. Their accuracy and benefit however, remains unclear. The objective of this review was to characterize and compare the diagnostic accuracy of the Mallampati classification and other commonly used airway examination tests for assessing the physical status of the airway in adult patients with no apparent anatomical airway abnormalities. We performed this individually for each of the four descriptors of the difficult airway: difficult face mask ventilation, difficult laryngoscopy, difficult tracheal intubation, and failed intubation. We searched major electronic databases including CENTRAL, MEDLINE, Embase, ISI Web of Science, CINAHL, as well as regional, subject specific, and dissertation and theses databases from inception to 16 December 2016, without language restrictions. In addition, we searched the Science Citation Index and checked the references of all the relevant studies. We also handsearched selected journals, conference proceedings, and relevant guidelines. We updated this search in March 2018, but we have not yet incorporated these results. We considered full-text diagnostic test accuracy studies of any individual index test, or a combination of tests, against a reference standard. Participants were adults without obvious airway abnormalities, who were having laryngoscopy performed with a standard laryngoscope and the trachea intubated with a standard tracheal tube. Index tests included the Mallampati test, modified Mallampati test, Wilson risk score, thyromental distance, sternomental distance, mouth opening test, upper lip bite test, or any combination of these. The target condition was difficult airway, with one of the following reference standards: difficult face mask ventilation, difficult laryngoscopy, difficult tracheal intubation, and failed intubation. We performed screening and selection of the studies, data extraction and assessment of methodological quality (using QUADAS-2) independently and in duplicate. We designed a Microsoft Access database for data collection and used Review Manager 5 and R for data analysis. For each index test and each reference standard, we assessed sensitivity and specificity. We produced forest plots and summary receiver operating characteristic (ROC) plots to summarize the data. Where possible, we performed meta-analyses to calculate pooled estimates and compare test accuracy indirectly using bivariate models. We investigated heterogeneity and performed sensitivity analyses. We included 133 (127 cohort type and 6 case-control) studies involving 844,206 participants. We evaluated a total of seven different prespecified index tests in the 133 studies, as well as 69 non-prespecified, and 32 combinations. For the prespecified index tests, we found six studies for the Mallampati test, 105 for the modified Mallampati test, six for the Wilson risk score, 52 for thyromental distance, 18 for sternomental distance, 34 for the mouth opening test, and 30 for the upper lip bite test. Difficult face mask ventilation was the reference standard in seven studies, difficult laryngoscopy in 92 studies, difficult tracheal intubation in 50 studies, and failed intubation in two studies. Across all studies, we judged the risk of bias to be variable for the different domains; we mostly observed low risk of bias for patient selection, flow and timing, and unclear risk of bias for reference standard and index test. Applicability concerns were generally low for all domains. For difficult laryngoscopy, the summary sensitivity ranged from 0.22 (95% confidence interval (CI) 0.13 to 0.33; mouth opening test) to 0.67 (95% CI 0.45 to 0.83; upper lip bite test) and the summary specificity ranged from 0.80 (95% CI 0.74 to 0.85; modified Mallampati test) to 0.95 (95% CI 0.88 to 0.98; Wilson risk score). The upper lip bite test for diagnosing difficult laryngoscopy provided the highest sensitivity compared to the other tests (P < 0.001). For difficult tracheal intubation, summary sensitivity ranged from 0.24 (95% CI 0.12 to 0.43; thyromental distance) to 0.51 (95% CI 0.40 to 0.61; modified Mallampati test) and the summary specificity ranged from 0.87 (95% CI 0.82 to 0.91; modified Mallampati test) to 0.93 (0.87 to 0.96; mouth opening test). The modified Mallampati test had the highest sensitivity for diagnosing difficult tracheal intubation compared to the other tests (P < 0.001). For difficult face mask ventilation, we could only estimate summary sensitivity (0.17, 95% CI 0.06 to 0.39) and specificity (0.90, 95% CI 0.81 to 0.95) for the modified Mallampati test. Bedside airway examination tests, for assessing the physical status of the airway in adults with no apparent anatomical airway abnormalities, are designed as screening tests. Screening tests are expected to have high sensitivities. We found that all investigated index tests had relatively low sensitivities with high variability. In contrast, specificities were consistently and markedly higher than sensitivities across all tests. The standard bedside airway examination tests should be interpreted with caution, as they do not appear to be good screening tests. Among the tests we examined, the upper lip bite test showed the most favourable diagnostic test accuracy properties. Given the paucity of available data, future research is needed to develop tests with high sensitivities to make them useful, and to consider their use for screening difficult face mask ventilation and failed intubation. The 27 studies in 'Studies awaiting classification' may alter the conclusions of the review, once we have assessed them.

  14. Toxicity of sediments from lead-zinc mining areas to juvenile freshwater mussels (Lampsilis siliquoidea) compared to standard test organisms

    USGS Publications Warehouse

    Besser, John M.; Ingersoll, Christopher G.; Brumbaugh, William G.; Kemble, Nile E.; May, Thomas W.; Wang, Ning; MacDonald, Donald D.; Roberts, Andrew D.

    2015-01-01

    Sediment toxicity tests compared chronic effects on survival, growth, and biomass of juvenile freshwater mussels (28-d exposures with Lampsilis siliquoidea) to the responses of standard test organisms—amphipods (28-d exposures with Hyalella azteca) and midges (10-d exposures with Chironomus dilutus)—in sediments from 2 lead–zinc mining areas: the Tri-State Mining District and Southeast Missouri Mining District. Mussel tests were conducted in sediments sieved to <0.25 mm to facilitate recovery of juvenile mussels (2–4 mo old). Sediments were contaminated primarily with lead, zinc, and cadmium, with greater zinc and cadmium concentrations in Tri-State sediments and greater lead concentrations in southeast Missouri sediments. The frequency of highly toxic responses (reduced 10% or more relative to reference sites) in Tri-State sediments was greatest for amphipod survival (25% of samples), midge biomass (20%), and mussel survival (14%). In southeast Missouri sediments, the frequency of highly toxic samples was greatest for mussel biomass (25%) and amphipod biomass (13%). Thresholds for metal toxicity to mussels, expressed as hazard quotients based on probable effect concentrations, were lower for southeast Missouri sediments than for Tri-State sediments. Southeast Missouri sites with toxic sediments had 2 or fewer live mussel taxa in a concurrent mussel population survey, compared with 7 to 26 taxa at reference sites. These results demonstrate that sediment toxicity tests with juvenile mussels can be conducted reliably by modifying existing standard methods; that the sensitivity of mussels to metals can be similar to or greater than standard test organisms; and that responses of mussels in laboratory toxicity tests are consistent with effects on wild mussel populations.

  15. The development of European standard (CEN) methods in support of European Directives for plastics materials and articles intended to come into contact with foodstuff.

    PubMed

    Ashby, R

    1994-01-01

    CEC Directives have been implemented for plastics materials and articles intended to come into contact with foodstuffs. These introduce limits upon the overall migration from plastics into food and food simulants. In addition, specific migration limits or composition limits for free monomer in the final article, have been set for some monomers. Agreed test methods are required to allow these Directives to be respected. CEN, the European Committee for Standardization, has created a working group to develop suitable test methods. This is 'Working Group 5, Chemical Methods of Test', of CEN Technical Committee TC 194, Utensils in contact with food. This group has drafted a ten part standard for determining overall migration into aqueous and fatty food simulants by total immersion, by standard cell, by standard pouch and by filling. This draft standard has been approved by CEN TC 194 for circulation for public comment as a provisional standard, i.e. as an ENV. Further parts of this standard are in preparation for determining overall migration at high temperatures, etc. Simultaneously, Working Group 5 is cooperating with the BCR (Community Bureau of Reference) to produce reference materials with certified values of overall migration. CEN TC 194 Working Group 5 is also drafting methods for monomers subject to limitation in Directive 90/128/EEC. Good progress is being made on the monomers of highest priority but it is recognized that developing methods for all the monomers subject to limitation would take many years. Therefore, collaboration with the BCR, the Council of Europe and others is taking place to accelerate method development.

  16. Optimum free energy in the reference functional approach for the integral equations theory

    NASA Astrophysics Data System (ADS)

    Ayadim, A.; Oettel, M.; Amokrane, S.

    2009-03-01

    We investigate the question of determining the bulk properties of liquids, required as input for practical applications of the density functional theory of inhomogeneous systems, using density functional theory itself. By considering the reference functional approach in the test particle limit, we derive an expression of the bulk free energy that is consistent with the closure of the Ornstein-Zernike equations in which the bridge functions are obtained from the reference system bridge functional. By examining the connection between the free energy functional and the formally exact bulk free energy, we obtain an improved expression of the corresponding non-local term in the standard reference hypernetted chain theory derived by Lado. In this way, we also clarify the meaning of the recently proposed criterion for determining the optimum hard-sphere diameter in the reference system. This leads to a theory in which the sole input is the reference system bridge functional both for the homogeneous system and the inhomogeneous one. The accuracy of this method is illustrated with the standard case of the Lennard-Jones fluid and with a Yukawa fluid with very short range attraction.

  17. 40 CFR 92.5 - Reference materials.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., or at http://www.ansi.org. (1) ANSI B109.1-1992, Diaphragm Type Gas Displacment Meters, IBR approved..., Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method), IBR...

  18. 40 CFR 92.5 - Reference materials.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., or at http://www.ansi.org. (1) ANSI B109.1-1992, Diaphragm Type Gas Displacment Meters, IBR approved..., Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method), IBR...

  19. 40 CFR 92.5 - Reference materials.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., or at http://www.ansi.org. (1) ANSI B109.1-1992, Diaphragm Type Gas Displacment Meters, IBR approved..., Standard Test Method for API Gravity of Crude Petroleum and Petroleum Products (Hydrometer Method), IBR...

  20. 40 CFR 85.2207 - On-board diagnostics test standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Code Definitions, (MAR92). This incorporation by reference was approved by the Director of the Federal... Society of Automotive Engineers, Inc., 400 Commonwealth Drive, Warrendale, PA 15096-0001. Copies may be...

  1. 40 CFR 98.34 - Monitoring and QA/QC requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... D4809-06 Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter... Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter (incorporated by reference...

  2. Spinning angle optical calibration apparatus

    DOEpatents

    Beer, Stephen K.; Pratt, II, Harold R.

    1991-01-01

    An optical calibration apparatus is provided for calibrating and reproducing spinning angles in cross-polarization, nuclear magnetic resonance spectroscopy. An illuminated magnifying apparatus enables optical setting an accurate reproducing of spinning "magic angles" in cross-polarization, nuclear magnetic resonance spectroscopy experiments. A reference mark scribed on an edge of a spinning angle test sample holder is illuminated by a light source and viewed through a magnifying scope. When the "magic angle" of a sample material used as a standard is attained by varying the angular position of the sample holder, the coordinate position of the reference mark relative to a graduation or graduations on a reticle in the magnifying scope is noted. Thereafter, the spinning "magic angle" of a test material having similar nuclear properties to the standard is attained by returning the sample holder back to the originally noted coordinate position.

  3. Official USP Reference Standards: metrology concepts, overview, and scientific issues and opportunities.

    PubMed

    Williams, Roger L

    2006-01-23

    The United States Pharmacopeia (USP) is a private standards-setting body created in 1820 by practitioners who wished to promote the quality of therapeutic products in commerce. The principal product of USP, then and now, is the United StatesPharmacopeia (USP), to which was added the National Formulary (NF) in 1975. The two compendia are published as a combined text annually (USP-NF). Originally a book of process standards, USP-NF evolved over time into compendia containing primarily product standards that are expressed in monographs for therapeutic ingredients, products, and excipients. As a public health service, USP supplies official USP Reference Standards to manufacturers and others who wish to test an article according to selected procedures of a monograph or General Chapter. During the past decade, understanding of USP monographs and official USP Reference Standards as a means of controlling the quality of a therapeutic article has evolved, based on advances in metrology, on activities in the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), and on considerations by the USP Council of Experts and its Expert Committees and USP staff. This article discusses the evolution of this understanding, focusing on drug substances and excipients for well-characterized small molecules and their corresponding dosage forms.

  4. Validity of clinical outcome measures to evaluate ankle range of motion during the weight-bearing lunge test.

    PubMed

    Hall, Emily A; Docherty, Carrie L

    2017-07-01

    To determine the concurrent validity of standard clinical outcome measures compared to laboratory outcome measure while performing the weight-bearing lunge test (WBLT). Cross-sectional study. Fifty participants performed the WBLT to determine dorsiflexion ROM using four different measurement techniques: dorsiflexion angle with digital inclinometer at 15cm distal to the tibial tuberosity (°), dorsiflexion angle with inclinometer at tibial tuberosity (°), maximum lunge distance (cm), and dorsiflexion angle using a 2D motion capture system (°). Outcome measures were recorded concurrently during each trial. To establish concurrent validity, Pearson product-moment correlation coefficients (r) were conducted, comparing each dependent variable to the 2D motion capture analysis (identified as the reference standard). A higher correlation indicates strong concurrent validity. There was a high correlation between each measurement technique and the reference standard. Specifically the correlation between the inclinometer placement at 15cm below the tibial tuberosity (44.9°±5.5°) and the motion capture angle (27.0°±6.0°) was r=0.76 (p=0.001), between the inclinometer placement at the tibial tuberosity angle (39.0°±4.6°) and the motion capture angle was r=0.71 (p=0.001), and between the distance from the wall clinical measure (10.3±3.0cm) to the motion capture angle was r=0.74 (p=0.001). This study determined that the clinical measures used during the WBLT have a high correlation with the reference standard for assessing dorsiflexion range of motion. Therefore, obtaining maximum lunge distance and inclinometer angles are both valid assessments during the weight-bearing lunge test. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  5. Protocol for determining the diagnostic validity of physical examination maneuvers for shoulder pathology

    PubMed Central

    2013-01-01

    Background Shoulder complaints are the third most common musculoskeletal problem in the general population. There are an abundance of physical examination maneuvers for diagnosing shoulder pathology. The validity of these maneuvers has not been adequately addressed. We propose a large Phase III study to investigate the accuracy of these tests in an orthopaedic setting. Methods We will recruit consecutive new shoulder patients who are referred to two tertiary orthopaedic clinics. We will select which physical examination tests to include using a modified Delphi process. The physician will take a thorough history from the patient and indicate their certainty about each possible diagnosis (certain the diagnosis is absent, present or requires further testing). The clinician will only perform the physical examination maneuvers for diagnoses where uncertainty remains. We will consider arthroscopy the reference standard for patients who undergo surgery within 8 months of physical examination and magnetic resonance imaging with arthrogram for patients who do not. We will calculate the sensitivity, specificity and positive and negative likelihood ratios and investigate whether combinations of the top tests provide stronger predictions of the presence or absence of disease. Discussion There are several considerations when performing a diagnostic study to ensure that the results are applicable in a clinical setting. These include, 1) including a representative sample, 2) selecting an appropriate reference standard, 3) avoiding verification bias, 4) blinding the interpreters of the physical examination tests to the interpretation of the gold standard and, 5) blinding the interpreters of the gold standard to the interpretation of the physical examination tests. The results of this study will inform clinicians of which tests, or combination of tests, successfully reduce diagnostic uncertainty, which tests are misleading and how physical examination may affect the magnitude of the confidence the clinician feels about their diagnosis. The results of this study may reduce the number of costly and invasive imaging studies (MRI, CT or arthrography) that are requisitioned when uncertainty about diagnosis remains following history and physical exam. We also hope to reduce the variability between specialists in which maneuvers are used during physical examination and how they are used, all of which will assist in improving consistency of care between centres. PMID:23394210

  6. Evaluation Plan for the Computerized Adaptive Vocational Aptitude Battery

    DTIC Science & Technology

    1982-05-15

    Educational and Psychological Tests published by the American Psychological Association, the American Educational Research Association, and the National...Psychometric Society Meetings, May 1981. References 71 American Psychological Association. Standards for educational and psychological tests . Washington, D.C...Methods Program, Dept. of Psychology , Uni- versity of Minnesota, MN, September, 1981. Koch, W.R. & Reckase, M.D. A live tailored testing comparison study

  7. Identifying and processing the gap between perceived and actual agreement in breast pathology interpretation.

    PubMed

    Carney, Patricia A; Allison, Kimberly H; Oster, Natalia V; Frederick, Paul D; Morgan, Thomas R; Geller, Berta M; Weaver, Donald L; Elmore, Joann G

    2016-07-01

    We examined how pathologists' process their perceptions of how their interpretations on diagnoses for breast pathology cases agree with a reference standard. To accomplish this, we created an individualized self-directed continuing medical education program that showed pathologists interpreting breast specimens how their interpretations on a test set compared with a reference diagnosis developed by a consensus panel of experienced breast pathologists. After interpreting a test set of 60 cases, 92 participating pathologists were asked to estimate how their interpretations compared with the standard for benign without atypia, atypia, ductal carcinoma in situ and invasive cancer. We then asked pathologists their thoughts about learning about differences in their perceptions compared with actual agreement. Overall, participants tended to overestimate their agreement with the reference standard, with a mean difference of 5.5% (75.9% actual agreement; 81.4% estimated agreement), especially for atypia and were least likely to overestimate it for invasive breast cancer. Non-academic affiliated pathologists were more likely to more closely estimate their performance relative to academic affiliated pathologists (77.6 vs 48%; P=0.001), whereas participants affiliated with an academic medical center were more likely to underestimate agreement with their diagnoses compared with non-academic affiliated pathologists (40 vs 6%). Before the continuing medical education program, nearly 55% (54.9%) of participants could not estimate whether they would overinterpret the cases or underinterpret them relative to the reference diagnosis. Nearly 80% (79.8%) reported learning new information from this individualized web-based continuing medical education program, and 23.9% of pathologists identified strategies they would change their practice to improve. In conclusion, when evaluating breast pathology specimens, pathologists do a good job of estimating their diagnostic agreement with a reference standard, but for atypia cases, pathologists tend to overestimate diagnostic agreement. Many participants were able to identify ways to improve.

  8. 76 FR 58345 - Energy Conservation Program: Test Procedures for Residential Dishwashers, Dehumidifiers, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

    ...Where appropriate, the U.S. Department of Energy (DOE) has proposed to amend its test procedures for residential dishwashers, dehumidifiers, and conventional cooking products (which includes cooktops, ovens, and ranges) to include provisions for measuring standby mode and off mode energy consumption, as required by the Energy Independence and Security Act of 2007 (EISA 2007). These test procedure amendments would incorporate by reference certain provisions of the International Electrotechnical Commission (IEC) Standard 62301, ``Household electrical appliances--Measurement of standby power.'' Since publication of DOE's initial proposal in December 2010, the IEC has replaced the First Edition of this standard with the current Second Edition. This supplemental notice of proposed rulemaking proposes to incorporate the latest edition of IEC Standard 62301.

  9. Statistical considerations for harmonization of the global multicenter study on reference values.

    PubMed

    Ichihara, Kiyoshi

    2014-05-15

    The global multicenter study on reference values coordinated by the Committee on Reference Intervals and Decision Limits (C-RIDL) of the IFCC was launched in December 2011, targeting 45 commonly tested analytes with the following objectives: 1) to derive reference intervals (RIs) country by country using a common protocol, and 2) to explore regionality/ethnicity of reference values by aligning test results among the countries. To achieve these objectives, it is crucial to harmonize 1) the protocol for recruitment and sampling, 2) statistical procedures for deriving the RI, and 3) test results through measurement of a panel of sera in common. For harmonized recruitment, very lenient inclusion/exclusion criteria were adopted in view of differences in interpretation of what constitutes healthiness by different cultures and investigators. This policy may require secondary exclusion of individuals according to the standard of each country at the time of deriving RIs. An iterative optimization procedure, called the latent abnormal values exclusion (LAVE) method, can be applied to automate the process of refining the choice of reference individuals. For global comparison of reference values, test results must be harmonized, based on the among-country, pair-wise linear relationships of test values for the panel. Traceability of reference values can be ensured based on values assigned indirectly to the panel through collaborative measurement of certified reference materials. The validity of the adopted strategies is discussed in this article, based on interim results obtained to date from five countries. Special considerations are made for dissociation of RIs by parametric and nonparametric methods and between-country difference in the effect of body mass index on reference values. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. An approach to analyzing a single subject's scores obtained in a standardized test with application to the Aachen Aphasia Test (AAT).

    PubMed

    Willmes, K

    1985-08-01

    Methods for the analysis of a single subject's test profile(s) proposed by Huber (1973) are applied to the Aachen Aphasia Test (AAT). The procedures are based on the classical test theory model (Lord & Novick, 1968) and are suited for any (achievement) test with standard norms from a large standardization sample and satisfactory reliability estimates. Two test profiles of a Wernicke's aphasic, obtained before and after a 3-month period of speech therapy, are analyzed using inferential comparisons between (groups of) subtest scores on one test application and between two test administrations for single (groups of) subtests. For each of these comparisons, the two aspects of (i) significant (reliable) differences in performance beyond measurement error and (ii) the diagnostic validity of that difference in the reference population of aphasic patients are assessed. Significant differences between standardized subtest scores and a remarkably better preserved reading and writing ability could be found for both test administrations using the multiple test procedure of Holm (1979). Comparison of both profiles revealed an overall increase in performance for each subtest as well as changes in level of performance relations between pairs of subtests.

  11. The development of STS payload environmental engineering standards

    NASA Technical Reports Server (NTRS)

    Bangs, W. F.

    1982-01-01

    The presently reported effort to provide a single set of standards for the design, analysis and testing of Space Transportation System (STS) payloads throughout the NASA organization must be viewed as essentially experimental, since the concept of incorporating the diverse opinions and experiences of several separate field research centers may in retrospect be judged too ambitious or perhaps even naive. While each STS payload may have unique characteristics, and the project should formulate its own criteria for environmental design, testing and evaluation, a reference source document providing coordinated standards is expected to minimize the duplication of effort and limit random divergence of practices among the various NASA payload programs. These standards would provide useful information to all potential STS users, and offer a degree of standardization to STS users outside the NASA organization.

  12. Temperature Effects on the Magnetic Properties of Silicon-Steel Sheets Using Standardized Toroidal Frame

    PubMed Central

    Wu, Cheng-Ju; Lin, Shih-Yu; Chou, Shang-Chin; Tsai, Chia-Yun; Yen, Jia-Yush

    2014-01-01

    This study designed a detachable and standardized toroidal test frame to measure the electromagnetic characteristic of toroidal laminated silicon steel specimens. The purpose of the design was to provide the measurements with standardized and controlled environment. The device also can withstand high temperatures (25–300°C) for short time period to allow high temperature tests. The accompanying driving circuit facilitates testing for high frequency (50–5,000 Hz) and high magnetic flux (0.2–1.8 T) conditions and produces both sinusoidal and nonsinusoidal test waveforms. The thickness of the stacked laminated silicon-steel sheets must be 30~31 mm, with an internal diameter of 72 mm and an outer diameter of 90 mm. With the standardized setup, it is possible to carry out tests for toroidal specimen in high temperature and high flux operation. The test results show that there is a tendency of increased iron loss under high temperature operation. The test results with various driving waveforms also provide references to the required consideration in engineering designs. PMID:25525629

  13. Temperature effects on the magnetic properties of silicon-steel sheets using standardized toroidal frame.

    PubMed

    Wu, Cheng-Ju; Lin, Shih-Yu; Chou, Shang-Chin; Tsai, Chia-Yun; Yen, Jia-Yush

    2014-01-01

    This study designed a detachable and standardized toroidal test frame to measure the electromagnetic characteristic of toroidal laminated silicon steel specimens. The purpose of the design was to provide the measurements with standardized and controlled environment. The device also can withstand high temperatures (25-300°C) for short time period to allow high temperature tests. The accompanying driving circuit facilitates testing for high frequency (50-5,000 Hz) and high magnetic flux (0.2-1.8 T) conditions and produces both sinusoidal and nonsinusoidal test waveforms. The thickness of the stacked laminated silicon-steel sheets must be 30~31 mm, with an internal diameter of 72 mm and an outer diameter of 90 mm. With the standardized setup, it is possible to carry out tests for toroidal specimen in high temperature and high flux operation. The test results show that there is a tendency of increased iron loss under high temperature operation. The test results with various driving waveforms also provide references to the required consideration in engineering designs.

  14. Simply Gifted: Their Attributes through the Eyes of College Students

    ERIC Educational Resources Information Center

    Gentry, Ruben; Lackey, Tracy Knight

    2011-01-01

    For years, scores on IQ tests and standardized achievement tests were the principal means for determining whether or not persons were gifted. Early literature often referred to them as fluent, flexible, original, and elaborate thinkers; as persons who were extremely curious, sensitive, attracted to aesthetic values; and as individuals who could…

  15. Ultrasonic Testing, Aviation Quality Control (Advanced): 9227.03.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    This unit of instruction covers the theory of ultrasonic sound, methods of applying soundwaves to test specimens and interpreting results, calibrating the ultrasonic equipment, and the use of standards. Study periods, group discussions, and extensive use of textbooks and training manuals are to be used. These are listed along with references and…

  16. 33 CFR 164.03 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... inspection at the Navigation Systems Division (CG-5413), Coast Guard Headquarters, 2100 2nd St. SW., Stop... information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov... Testing Fiber Ropes 164.74 Cordage Institute, 350 Lincoln Street, Hingham, MA 02043 CIA-3, Standard Test...

  17. Alignment of Standards and Assessments as an Accountability Criterion. ERIC Digest.

    ERIC Educational Resources Information Center

    La Marca, Paul M.

    This digest provides an overview of the concept of alignment and the role it plays in assessment and accountability systems. It also discusses methodological issues affecting the study of alignment and explores the relationship between alignment and test score interpretation. Alignment refers to the degree of match between test content and subject…

  18. The fourth radiation transfer model intercomparison (RAMI-IV): Proficiency testing of canopy reflectance models with ISO-13528

    NASA Astrophysics Data System (ADS)

    Widlowski, J.-L.; Pinty, B.; Lopatka, M.; Atzberger, C.; Buzica, D.; Chelle, M.; Disney, M.; Gastellu-Etchegorry, J.-P.; Gerboles, M.; Gobron, N.; Grau, E.; Huang, H.; Kallel, A.; Kobayashi, H.; Lewis, P. E.; Qin, W.; Schlerf, M.; Stuckens, J.; Xie, D.

    2013-07-01

    The radiation transfer model intercomparison (RAMI) activity aims at assessing the reliability of physics-based radiative transfer (RT) models under controlled experimental conditions. RAMI focuses on computer simulation models that mimic the interactions of radiation with plant canopies. These models are increasingly used in the development of satellite retrieval algorithms for terrestrial essential climate variables (ECVs). Rather than applying ad hoc performance metrics, RAMI-IV makes use of existing ISO standards to enhance the rigor of its protocols evaluating the quality of RT models. ISO-13528 was developed "to determine the performance of individual laboratories for specific tests or measurements." More specifically, it aims to guarantee that measurement results fall within specified tolerance criteria from a known reference. Of particular interest to RAMI is that ISO-13528 provides guidelines for comparisons where the true value of the target quantity is unknown. In those cases, "truth" must be replaced by a reliable "conventional reference value" to enable absolute performance tests. This contribution will show, for the first time, how the ISO-13528 standard developed by the chemical and physical measurement communities can be applied to proficiency testing of computer simulation models. Step by step, the pre-screening of data, the identification of reference solutions, and the choice of proficiency statistics will be discussed and illustrated with simulation results from the RAMI-IV "abstract canopy" scenarios. Detailed performance statistics of the participating RT models will be provided and the role of the accuracy of the reference solutions as well as the choice of the tolerance criteria will be highlighted.

  19. Validity of linear measurements of the jaws using ultralow-dose MDCT and the iterative techniques of ASIR and MBIR.

    PubMed

    Al-Ekrish, Asma'a A; Al-Shawaf, Reema; Schullian, Peter; Al-Sadhan, Ra'ed; Hörmann, Romed; Widmann, Gerlig

    2016-10-01

    To assess the comparability of linear measurements of dental implant sites recorded from multidetector computed tomography (MDCT) images obtained using standard-dose filtered backprojection (FBP) technique with those from various ultralow doses combined with FBP, adaptive statistical iterative reconstruction (ASIR), and model-based iterative reconstruction (MBIR) techniques. The results of the study may contribute to MDCT dose optimization for dental implant site imaging. MDCT scans of two cadavers were acquired using a standard reference protocol and four ultralow-dose test protocols (TP). The volume CT dose index of the different dose protocols ranged from a maximum of 30.48-36.71 mGy to a minimum of 0.44-0.53 mGy. All scans were reconstructed using FBP, ASIR-50, ASIR-100, and MBIR, and either a bone or standard reconstruction kernel. Linear measurements were recorded from standardized images of the jaws by two examiners. Intra- and inter-examiner reliability of the measurements were analyzed using Cronbach's alpha and inter-item correlation. Agreement between the measurements obtained with the reference-dose/FBP protocol and each of the test protocols was determined with Bland-Altman plots and linear regression. Statistical significance was set at a P-value of 0.05. No systematic variation was found between the linear measurements obtained with the reference protocol and the other imaging protocols. The only exceptions were TP3/ASIR-50 (bone kernel) and TP4/ASIR-100 (bone and standard kernels). The mean measurement differences between these three protocols and the reference protocol were within ±0.1 mm, with the 95 % confidence interval limits being within the range of ±1.15 mm. A nearly 97.5 % reduction in dose did not significantly affect the height and width measurements of edentulous jaws regardless of the reconstruction algorithm used.

  20. A Descriptive Analysis of Exercise Tolerance Test at Seremban Hospital : An Audit for the Year 2001

    PubMed Central

    Mohamed, Abdul Latiff; Nee, Chan Chee; Azzad, Ahmed

    2004-01-01

    Our purpose is to report on the epidemiological variables and their association with the results of the exercise tolerance test (ETT) in the series of patients referred for standard diagnostic ETT at Seremban Hospital during the year 2001. ETT is widely performed, but, in Malaysia, an analysis of the associations between the epidemiological data and the results of the ETT has not been presented. All patients referred for ETT at Seremban Hospital who underwent exercise treadmill tests for the year 2001 were taken as the study population. Demographic details and patients with established heart disease (i.e. prior coronary bypass surgery, myocardial infarction, or congestive heart failure) were noted. Clinical and ETT variables were collected retrospectively from the hospital records. Testing and data management were performed in a standardized fashion with a computer-assisted protocol. This study showed that there was no significant predictive epidemiological variable on the results of the ETT. However, it was found that there was statistically significant difference between the peak exercise time of males and females undergoing the ETT. PMID:22973128

  1. Building Energy Simulation Test for Existing Homes (BESTEST-EX) (Presentation)

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

    Judkoff, R.; Neymark, J.; Polly, B.

    2011-12-01

    This presentation discusses the goals of NREL Analysis Accuracy R&D; BESTEST-EX goals; what BESTEST-EX is; how it works; 'Building Physics' cases; 'Building Physics' reference results; 'utility bill calibration' cases; limitations and potential future work. Goals of NREL Analysis Accuracy R&D are: (1) Provide industry with the tools and technical information needed to improve the accuracy and consistency of analysis methods; (2) Reduce the risks associated with purchasing, financing, and selling energy efficiency upgrades; and (3) Enhance software and input collection methods considering impacts on accuracy, cost, and time of energy assessments. BESTEST-EX Goals are: (1) Test software predictions of retrofitmore » energy savings in existing homes; (2) Ensure building physics calculations and utility bill calibration procedures perform up to a minimum standard; and (3) Quantify impact of uncertainties in input audit data and occupant behavior. BESTEST-EX is a repeatable procedure that tests how well audit software predictions compare to the current state of the art in building energy simulation. There is no direct truth standard. However, reference software have been subjected to validation testing, including comparisons with empirical data.« less

  2. 46 CFR 30.01-3 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... and Materials (ASTM), 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, telephone 610-832-9585, http://www.astm.org. (1) ASTM D 323-94, Standard Test Method for Vapor Pressure of Petroleum Products...

  3. 40 CFR 90.7 - Reference materials.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Appendix A to subpart D, Table 3. ASTM D2699-92: Standard Test Method for Knock Characteristics of Motor... Knock Characteristics of Motor and Aviation Fuels by the Motor Method Appendix A to subpart D, Table 3...

  4. 40 CFR 90.7 - Reference materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Appendix A to subpart D, Table 3. ASTM D2699-92: Standard Test Method for Knock Characteristics of Motor... Knock Characteristics of Motor and Aviation Fuels by the Motor Method Appendix A to subpart D, Table 3...

  5. 46 CFR 163.003-3 - ASTM standard.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... American Society for Testing and Materials (ASTM) is incorporated by reference into this subpart: ASTM D... Society at 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959. [USCG-1999-5151, 64 FR 67185, Dec. 1...

  6. Reference equation for prediction of a total distance during six-minute walk test using Indonesian anthropometrics.

    PubMed

    Nusdwinuringtyas, Nury; Widjajalaksmi; Yunus, Faisal; Alwi, Idrus

    2014-04-01

    to develop a reference equation for prediction of the total distance walk using Indonesian anthropometrics of sedentary healthy subjects. Subsequently, the prediction obtained was compared to those calculated by the Caucasian-based Enright prediction equation. the cross-sectional study was conducted among 123 healthy Indonesian adults with sedentary life style (58 male and 65 female subjects in an age range between 18 and 50 years). Heart rate was recorded using Polar with expectation in the sub-maximal zone (120-170 beats per minute). The subjects performed two six-minute walk tests, the first one on a 15-meter track according to the protocol developed by the investigator. The second walk was carried out on Biodex®gait trainer as gold standard. an average total distance of 547±54.24 m was found, not significantly different from the gold standard of 544.72±54.11 m (p>0.05). Multiple regression analysis was performed to develop the new equation. the reference equation for prediction of the total distance using Indonesian anthropometrics is more applicable in Indonesia.

  7. Current Practices of Measuring and Reference Range Reporting of Free and Total Testosterone in the United States.

    PubMed

    Le, Margaret; Flores, David; May, Danica; Gourley, Eric; Nangia, Ajay K

    2016-05-01

    The evaluation and management of male hypogonadism should be based on symptoms and on serum testosterone levels. Diagnostically this relies on accurate testing and reference values. Our objective was to define the distribution of reference values and assays for free and total testosterone by clinical laboratories in the United States. Upper and lower reference values, assay methodology and source of published reference ranges were obtained from laboratories across the country. A standardized survey was reviewed with laboratory staff via telephone. Descriptive statistics were used to tabulate results. We surveyed a total of 120 laboratories in 47 states. Total testosterone was measured in house at 73% of laboratories. At the remaining laboratories studies were sent to larger centralized reference facilities. The mean ± SD lower reference value of total testosterone was 231 ± 46 ng/dl (range 160 to 300) and the mean upper limit was 850 ± 141 ng/dl (range 726 to 1,130). Only 9% of laboratories where in-house total testosterone testing was performed created a reference range unique to their region. Others validated the instrument recommended reference values in a small number of internal test samples. For free testosterone 82% of laboratories sent testing to larger centralized reference laboratories where equilibrium dialysis and/or liquid chromatography with mass spectrometry was done. The remaining laboratories used published algorithms to calculate serum free testosterone. Reference ranges for testosterone assays vary significantly among laboratories. The ranges are predominantly defined by limited population studies of men with unknown medical and reproductive histories. These poorly defined and variable reference values, especially the lower limit, affect how clinicians determine treatment. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  8. Gap Analysis for Chinese Drug Control Institutes to Achieve the Standards of World Health Organization Medicine Prequalification.

    PubMed

    Mao, Xin; Yang, Yue

    2017-02-01

    The study aims to explore the challenges and the gaps faced by Chinese Drug Control Institutes in achieving the standards of World Health Organization (WHO) Medicine Prequalification. The study was undertaken with 6 Provincial Drug Control Institutes in China from November 2012 to November 2013. The study assessed key elements required to comply with WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL). For GPPQCL, the study found gaps in quality management system, control of documentation, data-processing equipment, premises and equipment, contracts, reagents (water), reference substances and reference materials, calibration, verification of performance and qualification of equipment, instruments and other devices, analytical worksheet, evaluation of test results, personnel, and validation of analytical procedures. The study indicates that gaps are attributed to differences between the standards of Chinese Accreditation Standards and WHO-GPPQCL. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  9. Direct Field Acoustic Testing

    NASA Technical Reports Server (NTRS)

    Larkin, Paul; Goldstein, Bob

    2008-01-01

    This paper presents an update to the methods and procedures used in Direct Field Acoustic Testing (DFAT). The paper will discuss some of the recent techniques and developments that are currently being used and the future publication of a reference standard. Acoustic testing using commercial sound system components is becoming a popular and cost effective way of generating a required acoustic test environment both in and out of a reverberant chamber. This paper will present the DFAT test method, the usual setup and procedure and the development and use of a closed-loop, narrow-band control system. Narrow-band control of the acoustic PSD allows all standard techniques and procedures currently used in random control to be applied to acoustics and some examples are given. The paper will conclude with a summary of the development of a standard practice guideline that is hoped to be available in the first quarter of next year.

  10. Do European Standard Disinfectant tests truly simulate in-use microbial and organic soiling conditions on food preparation surfaces?

    PubMed

    Meyer, B; Morin, V N; Rödger, H-J; Holah, J; Bird, C

    2010-04-01

    The results from European standard disinfectant tests are used as one basis to approve the use of disinfectants in Europe. The design of these laboratory-based tests should thus simulate as closely as possible the practical conditions and challenges that the disinfectants would encounter in use. No evidence is available that the organic and microbial loading in these tests simulates actual levels in the food service sector. Total organic carbon (TOC) and total viable count (TVC) were determined on 17 visibly clean and 45 visibly dirty surfaces in two restaurants and the food preparation surfaces of a large retail store. These values were compared to reference values recovered from surfaces soiled with the organic and microbial loading, following the standard conditions of the European Surface Test for bactericidal efficacy, EN 13697. The TOC reference values for clean and dirty conditions were higher than the data from practice, but cannot be regarded as statistical outliers. This was considered as a conservative assessment; however, as additional nine TOC samples from visibly dirty surfaces were discarded from the analysis, as their loading made them impossible to process. Similarly, the recovery of test organisms from surfaces contaminated according to EN 13697 was higher than the TVC from visibly dirty surfaces in practice; though they could not be regarded as statistical outliers of the whole data field. No correlation was found between TVC and TOC in the sampled data, which re-emphasizes the potential presence of micro-organisms on visibly clean surfaces and thus the need for the same degree of disinfection as visibly dirty surfaces. The organic soil and the microbial burden used in EN disinfectant standards represent a realistic worst-case scenario for disinfectants used in the food service and food-processing areas.

  11. Using a Standardized Clinical Quantitative Sensory Testing Battery to Judge the Clinical Relevance of Sensory Differences Between Adjacent Body Areas.

    PubMed

    Dimova, Violeta; Oertel, Bruno G; Lötsch, Jörn

    2017-01-01

    Skin sensitivity to sensory stimuli varies among different body areas. A standardized clinical quantitative sensory testing (QST) battery, established for the diagnosis of neuropathic pain, was used to assess whether the magnitude of differences between test sites reaches clinical significance. Ten different sensory QST measures derived from thermal and mechanical stimuli were obtained from 21 healthy volunteers (10 men) and used to create somatosensory profiles bilateral from the dorsum of the hands (the standard area for the assessment of normative values for the upper extremities as proposed by the German Research Network on Neuropathic Pain) and bilateral at volar forearms as a neighboring nonstandard area. The parameters obtained were statistically compared between test sites. Three of the 10 QST parameters differed significantly with respect to the "body area," that is, warmth detection, thermal sensory limen, and mechanical pain thresholds. After z-transformation and interpretation according to the QST battery's standard instructions, 22 abnormal values were obtained at the hand. Applying the same procedure to parameters assessed at the nonstandard site forearm, that is, z-transforming them to the reference values for the hand, 24 measurements values emerged as abnormal, which was not significantly different compared with the hand (P=0.4185). Sensory differences between neighboring body areas are statistically significant, reproducing prior knowledge. This has to be considered in scientific assessments where a small variation of the tested body areas may not be an option. However, the magnitude of these differences was below the difference in sensory parameters that is judged as abnormal, indicating a robustness of the QST instrument against protocol deviations with respect to the test area when using the method of comparison with a 95 % confidence interval of a reference dataset.

  12. [Tasks and duties of veterinary reference laboratories for food borne zoonoses].

    PubMed

    Ellerbroek, Lüppo; Alter, T; Johne, R; Nöckler, K; Beutin, L; Helmuth, R

    2009-02-01

    Reference laboratories are of central importance for consumer protection. Field expertise and high scientific competence are basic requirements for the nomination of a national reference laboratory. To ensure a common approach in the analysis of zoonotic hazards, standards have been developed by the reference laboratories together with national official laboratories on the basis of Art. 33 of Directive (EG) No. 882/2004. Reference laboratories function as arbitrative boards in the case of ambivalent or debatable results. New methods for detection of zoonotic agents are developed and validated to provide tools for analysis, e. g., in legal cases, if results from different parties are disputed. Besides these tasks, national reference laboratories offer capacity building and advanced training courses and control the performance of ring trials to ensure consistency in the quality of analyses in official laboratories. All reference laboratories work according to the ISO standard 17025 which defines the grounds for strict laboratory quality rules and in cooperation with the respective Community Reference Laboratories (CRL). From the group of veterinary reference laboratories for food-borne zoonoses, the national reference laboratories are responsible for Listeria monocytogenes, for Campylobacter, for the surveillance and control of viral and bacterial contamination of bivalve molluscs, for E. coli, for the performance of analysis and tests on zoonoses (Salmonella), and from the group of parasitological zoonotic agents, the national reference laboratory for Trichinella.

  13. Sixty-five years since the New York heat wave: advances in sweat testing for cystic fibrosis.

    PubMed

    Collie, Jake T B; Massie, R John; Jones, Oliver A H; LeGrys, Vicky A; Greaves, Ronda F

    2014-02-01

    The sweat test remains important as a diagnostic test for cystic fibrosis (CF) and has contributed greatly to our understanding of CF as a disease of epithelial electrolyte transport. The standardization of the sweat test, by Gibson and Cooke [Gibson and Cooke (1959) Pediatrics 1959;23:5], followed observations of excessive dehydration amongst patients with CF and confirmed the utility as a diagnostic test. Quantitative pilocarpine iontophoresis remains the gold standard for sweat induction, but there are a number of collection and analytical methods. The pathophysiology of electrolyte transport in sweat was described by Quinton [Quinton (1983) Nature 1983;301:421-422], and this complemented the developments in genetics that discovered the cystic fibrosis transmembrane conductance regulator (CFTR), an epithelial-based electrolyte transport protein. Knowledge of CF has since increased rapidly and further developments in sweat testing include: new collection methods, further standardization of the technique with international recommendations and age related reference intervals. More recently, sweat chloride values have been used as proof of effect for the new drugs that activate CFTR. However, there remain issues with adherence to sweat test guidelines in many countries and there are gaps in our knowledge, including reference intervals for some age groups and stability of sweat samples in transport. Furthermore, modern methods of elemental quantification need to be explored as alternatives to the original analytical methods for sweat electrolyte measurement. The purpose of this review is therefore to describe the development of the sweat test and consider future directions. © 2013 Wiley Periodicals, Inc.

  14. The FBI compression standard for digitized fingerprint images

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

    Brislawn, C.M.; Bradley, J.N.; Onyshczak, R.J.

    1996-10-01

    The FBI has formulated national standards for digitization and compression of gray-scale fingerprint images. The compression algorithm for the digitized images is based on adaptive uniform scalar quantization of a discrete wavelet transform subband decomposition, a technique referred to as the wavelet/scalar quantization method. The algorithm produces archival-quality images at compression ratios of around 15 to 1 and will allow the current database of paper fingerprint cards to be replaced by digital imagery. A compliance testing program is also being implemented to ensure high standards of image quality and interchangeability of data between different implementations. We will review the currentmore » status of the FBI standard, including the compliance testing process and the details of the first-generation encoder.« less

  15. FBI compression standard for digitized fingerprint images

    NASA Astrophysics Data System (ADS)

    Brislawn, Christopher M.; Bradley, Jonathan N.; Onyshczak, Remigius J.; Hopper, Thomas

    1996-11-01

    The FBI has formulated national standards for digitization and compression of gray-scale fingerprint images. The compression algorithm for the digitized images is based on adaptive uniform scalar quantization of a discrete wavelet transform subband decomposition, a technique referred to as the wavelet/scalar quantization method. The algorithm produces archival-quality images at compression ratios of around 15 to 1 and will allow the current database of paper fingerprint cards to be replaced by digital imagery. A compliance testing program is also being implemented to ensure high standards of image quality and interchangeability of data between different implementations. We will review the current status of the FBI standard, including the compliance testing process and the details of the first-generation encoder.

  16. Content validity of manual spinal palpatory exams - A systematic review

    PubMed Central

    Najm, Wadie I; Seffinger, Michael A; Mishra, Shiraz I; Dickerson, Vivian M; Adams, Alan; Reinsch, Sibylle; Murphy, Linda S; Goodman, Arnold F

    2003-01-01

    Background Many health care professionals use spinal palpatory exams as a primary and well-accepted part of the evaluation of spinal pathology. However, few studies have explored the validity of spinal palpatory exams. To evaluate the status of the current scientific evidence, we conducted a systematic review to assess the content validity of spinal palpatory tests used to identify spinal neuro-musculoskeletal dysfunction. Methods Review of eleven databases and a hand search of peer-reviewed literature, published between 1965–2002, was undertaken. Two blinded reviewers abstracted pertinent data from the retrieved papers, using a specially developed quality-scoring instrument. Five papers met the inclusion/exclusion criteria. Results Three of the five papers included in the review explored the content validity of motion tests. Two of these papers focused on identifying the level of fixation (decreased mobility) and one focused on range of motion. All three studies used a mechanical model as a reference standard. Two of the five papers included in the review explored the validity of pain assessment using the visual analogue scale or the subjects' own report as reference standards. Overall the sensitivity of studies looking at range of motion tests and pain varied greatly. Poor sensitivity was reported for range of motion studies regardless of the examiner's experience. A slightly better sensitivity (82%) was reported in one study that examined cervical pain. Conclusions The lack of acceptable reference standards may have contributed to the weak sensitivity findings. Given the importance of spinal palpatory tests as part of the spinal evaluation and treatment plan, effort is required by all involved disciplines to create well-designed and implemented studies in this area. PMID:12734016

  17. Evaluation of the OnSite (Pf/Pan) rapid diagnostic test for diagnosis of clinical malaria.

    PubMed

    Mohon, Abu Naser; Elahi, Rubayet; Podder, Milka Patracia; Mohiuddin, Khaja; Hossain, Mohammad Sharif; Khan, Wasif A; Haque, Rashidul; Alam, Mohammad Shafiul

    2012-12-12

    Accurate diagnosis of malaria is an essential prerequisite for proper treatment and drug resistance monitoring. Microscopy is considered the gold standard for malaria diagnosis but has limitations. ELISA, PCR, and Real Time PCR are also used to diagnose malaria in reference laboratories, although their application at the field level is currently not feasible. Rapid diagnostic tests (RDTs) however, have been brought into field operation and widely adopted in recent days. This study evaluates OnSite (Pf/Pan) antigen test, a new RDT introduced by CTK Biotech Inc, USA for malaria diagnosis in a reference setting. Blood samples were collected from febrile patients referred for malaria diagnosis by clinicians. Subjects were included in this study from two different Upazila Health Complexes (UHCs) situated in two malaria endemic districts of Bangladesh. Microscopy and nested PCR were considered the gold standard in this study. OnSite (Pf/Pan) RDT was performed on preserved whole blood samples. In total, 372 febrile subjects were included in this study. Of these subjects, 229 (61.6%) tested positive for Plasmodium infection detected by microscopy and nested PCR. OnSite (Pf/Pan) RDT was 94.2% sensitive (95% CI, 89.3-97.3) and 99.5% specific (95% CI, 97.4-00.0) for Plasmodium falciparum diagnosis and 97.3% sensitive (95% CI, 90.5-99.7) and 98.7% specific (95% CI, 96.6-99.6) for Plasmodium vivax diagnosis. Sensitivity varied with differential parasite count for both P. falciparum and P. vivax. The highest sensitivity was observed in febrile patients with parasitaemia that ranged from 501-1,000 parasites/μL regardless of the Plasmodium species. The new OnSite (Pf/Pan) RDT is both sensitive and specific for symptomatic malaria diagnosis in standard laboratory conditions.

  18. Effect of Transitioning from Standard Reference Material 2806a to Standard Reference Material 2806b for Light Obscuration Particle Countering

    DTIC Science & Technology

    2016-04-01

    Reference Material 2806b for Light Obscuration Particle Countering April 2016 UNCLASSIFIED UNCLASSIFIED Joel Schmitigal 27809 Standard Form 298 (Rev...Standard Reference Material 2806b for Light Obscuration Particle Countering 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6...Reference Material 2806a to Standard Reference Material 2806b for Light Obscuration Particle Countering Joel Schmitigal Force Projection

  19. 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

  20. SSI-ARC Flight Test 3 Data Review

    NASA Technical Reports Server (NTRS)

    Gong, Chester; Wu, Minghong G.

    2015-01-01

    The "Unmanned Aircraft System (UAS) Integration into the National Airspace System (NAS)" Project conducted flight test program, referred to as Flight Test 3, at Armstrong Flight Research Center from June - August 2015. Four flight test days were dedicated to the NASA Ames-developed Detect and Avoid (DAA) System referred to as Autoresolver. The encounter scenarios, which involved NASA's Ikhana UAS and a manned intruder aircraft, were designed to collect data on DAA system performance in real-world conditions and uncertainties with four different surveillance sensor systems. Resulting flight test data and analysis results will be used to evaluate the DAA system performance (e.g., trajectory prediction accuracy, threat detection) and to add fidelity to simulation models used to inform Minimum Operating Performance Standards (MOPS) for integrating UAS into routine NAS operations.

  1. Inductively Coupled Plasma Mass Spectrometry: Sample Analysis of Zirconium and Ruthenium in Metal Organic Frameworks

    DTIC Science & Technology

    2018-02-01

    international proficiency testing sponsored by the Organisation for the Prohibition of Chemical Weapons (The Hague, Netherlands). Traditionally...separate batch of standards at each level for a total of six analyses at each calibration level. Concentrations of the tested calibration levels are...and ruthenium at each calibration level. 11 REFERENCES 1. General Requirements for the Competence of Testing and Calibration Laboratories

  2. Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature.

    PubMed

    Tang, Weiming; Chen, Wen; Amini, Ali; Boeras, Debi; Falconer, Jane; Kelly, Helen; Peeling, Rosanna; Varsaneux, Olivia; Tucker, Joseph D; Easterbrook, Philippa

    2017-11-01

    Although direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and therefore untreated. While there are a wide range of HCV serological tests available, there is a lack of formal assessment of their diagnostic performance. We undertook a systematic review and meta-analysis to evaluate he diagnostic accuracy of available rapid diagnostic tests (RDT) and laboratory based EIA assays in detecting antibodies to HCV. We used the PRISMA checklist and Cochrane guidance to develop our search protocol. The search strategy was registered in PROSPERO (CRD42015023567). The search focused on hepatitis C, diagnostic tests, and diagnostic accuracy within eight databases (MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Science Citation Index Expanded, Conference Proceedings Citation Index-Science, SCOPUS, Literatura Latino-Americana e do Caribe em Ciências da Saúde and WHO Global Index Medicus. Studies were included if they evaluated an assay to determine the sensitivity and specificity of HCV antibody (HCV Ab) in humans. Two reviewers independently extracted data and performed a quality assessment of the studies using the QUADAS tool. We pooled test estimates using the DerSimonian-Laird method, by using the software R and RevMan. 5.3. A total of 52 studies were identified that included 52,673 unique test measurements. Based on five studies, the pooled sensitivity and specificity of HCV Ab rapid diagnostic tests (RDTs) were 98% (95% CI 98-100%) and 100% (95% CI 100-100%) compared to an enzyme immunoassay (EIA) reference standard. High HCV Ab RDTs sensitivity and specificity were observed across screening populations (general population, high risk populations, and hospital patients) using different reference standards (EIA, nucleic acid testing, immunoblot). There were insufficient studies to undertake subanalyses based on HIV co-infection. Oral HCV Ab RDTs also had excellent sensitivity and specificity compared to blood reference tests, respectively at 94% (95% CI 93-96%) and 100% (95% CI 100-100%). Among studies that assessed individual oral RDTs, the eight studies revealed that OraQuick ADVANCE® had a slightly higher sensitivity (98%, 95% CI 97-98%) compared to the other oral brands (pooled sensitivity: 88%, 95% CI 84-92%). RDTs, including oral tests, have excellent sensitivity and specificity compared to laboratory-based methods for HCV antibody detection across a wide range of settings. Oral HCV Ab RDTs had good sensitivity and specificity compared to blood reference standards.

  3. Standardization, evaluation and early-phase method validation of an analytical scheme for batch-consistency N-glycosylation analysis of recombinant produced glycoproteins.

    PubMed

    Zietze, Stefan; Müller, Rainer H; Brecht, René

    2008-03-01

    In order to set up a batch-to-batch-consistency analytical scheme for N-glycosylation analysis, several sample preparation steps including enzyme digestions and fluorophore labelling and two HPLC-methods were established. The whole method scheme was standardized, evaluated and validated according to the requirements on analytical testing in early clinical drug development by usage of a recombinant produced reference glycoprotein (RGP). The standardization of the methods was performed by clearly defined standard operation procedures. During evaluation of the methods, the major interest was in the loss determination of oligosaccharides within the analytical scheme. Validation of the methods was performed with respect to specificity, linearity, repeatability, LOD and LOQ. Due to the fact that reference N-glycan standards were not available, a statistical approach was chosen to derive accuracy from the linearity data. After finishing the validation procedure, defined limits for method variability could be calculated and differences observed in consistency analysis could be separated into significant and incidental ones.

  4. Current status of antifungal susceptibility testing methods.

    PubMed

    Arikan, Sevtap

    2007-11-01

    Antifungal susceptibility testing is a very dynamic field of medical mycology. Standardization of in vitro susceptibility tests by the Clinical and Laboratory Standards Institute (CLSI) and the European Committee for Antimicrobial Susceptibility Testing (EUCAST), and current availability of reference methods constituted the major remarkable steps in the field. Based on the established minimum inhibitory concentration (MIC) breakpoints, it is now possible to determine the susceptibilities of Candida strains to fluconazole, itraconazole, voriconazole, and flucytosine. Moreover, utility of fluconazole antifungal susceptibility tests as an adjunct in optimizing treatment of candidiasis has now been validated. While the MIC breakpoints and clinical significance of susceptibility testing for the remaining fungi and antifungal drugs remain yet unclear, modifications of the available methods as well as other methodologies are being intensively studied to overcome the present drawbacks and limitations. Among the other methods under investigation are Etest, colorimetric microdilution, agar dilution, determination of fungicidal activity, flow cytometry, and ergosterol quantitation. Etest offers the advantage of practical application and favorable agreement rates with the reference methods that are frequently above acceptable limits. However, MIC breakpoints for Etest remain to be evaluated and established. Development of commercially available, standardized colorimetric panels that are based on CLSI method parameters has added more to the antifungal susceptibility testing armamentarium. Flow cytometry, on the other hand, appears to offer rapid susceptibility testing but requires specified equipment and further evaluation for reproducibility and standardization. Ergosterol quantitation is another novel approach, which appears potentially beneficial particularly in discrimination of azole-resistant isolates from heavy trailers. The method is yet investigational and requires to be further studied. Developments in methodology and applications of antifungal susceptibility testing will hopefully provide enhanced utility in clinical guidance of antifungal therapy. However, and particularly in immunosuppressed host, in vitro susceptibility is and will remain only one of several factors that influence clinical outcome.

  5. ASME B89.4.19 Performance Evaluation Tests and Geometric Misalignments in Laser Trackers

    PubMed Central

    Muralikrishnan, B.; Sawyer, D.; Blackburn, C.; Phillips, S.; Borchardt, B.; Estler, W. T.

    2009-01-01

    Small and unintended offsets, tilts, and eccentricity of the mechanical and optical components in laser trackers introduce systematic errors in the measured spherical coordinates (angles and range readings) and possibly in the calculated lengths of reference artifacts. It is desirable that the tests described in the ASME B89.4.19 Standard [1] be sensitive to these geometric misalignments so that any resulting systematic errors are identified during performance evaluation. In this paper, we present some analysis, using error models and numerical simulation, of the sensitivity of the length measurement system tests and two-face system tests in the B89.4.19 Standard to misalignments in laser trackers. We highlight key attributes of the testing strategy adopted in the Standard and propose new length measurement system tests that demonstrate improved sensitivity to some misalignments. Experimental results with a tracker that is not properly error corrected for the effects of the misalignments validate claims regarding the proposed new length tests. PMID:27504211

  6. Establishing the traceability of a uranyl nitrate solution to a standard reference material

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

    Jackson, C.H.; Clark, J.P.

    1978-01-01

    A uranyl nitrate solution for use as a Working Calibration and Test Material (WCTM) was characterized, using a statistically designed procedure to document traceability to National Bureau of Standards Reference Material (SPM-960). A Reference Calibration and Test Material (PCTM) was prepared from SRM-960 uranium metal to approximate the acid and uranium concentration of the WCTM. This solution was used in the characterization procedure. Details of preparing, handling, and packaging these solutions are covered. Two outside laboratories, each having measurement expertise using a different analytical method, were selected to measure both solutions according to the procedure for characterizing the WCTM. Twomore » different methods were also used for the in-house characterization work. All analytical results were tested for statistical agreement before the WCTM concentration and limit of error values were calculated. A concentration value was determined with a relative limit of error (RLE) of approximately 0.03% which was better than the target RLE of 0.08%. The use of this working material eliminates the expense of using SRMs to fulfill traceability requirements for uranium measurements on this type material. Several years' supply of uranyl nitrate solution with NBS traceability was produced. The cost of this material was less than 10% of an equal quantity of SRM-960 uranium metal.« less

  7. 46 CFR 30.10-59 - Reid vapor pressure-TB/ALL.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... described in the American Society for Testing Materials Standard D 323 (incorporated by reference, see § 30... Headquarters for reading purposes or it may be purchased from the Society at 100 Barr Harbor Drive, West...

  8. Spinning angle optical calibration apparatus

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

    Beer, S.K.; Pratt, H.R. II.

    1989-09-12

    An optical calibration apparatus is provided for calibrating and reproducing spinning angles in cross-polarization, nuclear magnetic resonance spectroscopy. An illuminated magnifying apparatus enables optical setting and accurate reproducing of spinning magic angles in cross-polarization, nuclear magnetic resonance spectroscopy experiments. A reference mark scribed on an edge of a spinning angle test sample holder is illuminated by a light source and viewed through a magnifying scope. When the magic angle of a sample material used as a standard is attained by varying the angular position of the sample holder, the coordinate position of the reference mark relative to a graduation ormore » graduations on a reticle in the magnifying scope is noted. Thereafter, the spinning magic angle of a test material having similar nuclear properties to the standard is attained by returning the sample holder back to the originally noted coordinate position. 2 figs.« less

  9. Reference NO2 calibration system for ground-based intercomparisons during NASA's GTE/CITE 2 mission

    NASA Technical Reports Server (NTRS)

    Fried, Alan; Nunnermacker, Linda; Cadoff, Barry; Sams, Robert; Yates, Nathan

    1990-01-01

    An NO2 calibration system, based on a permeation device and a two-stage dynamic dilution system, was designed, constructed, and characterized at the National Bureau of Standards. In this system, calibrant flow entering the second stage was controlled without contacting a metal flow controller, and permeation oven temperature and flow were continuously maintained, even during transport. The system performance and the permeation emission rate were characterized by extensive laboratory tests. This system was capable of accurately delivering known NO2 concentrations in the ppbv and sub-ppbv concentration range with a total uncertainty of approximately 10 percent. The calibration system was placed on board NASA research aircraft at both the Wallops Island and Ames research facilities. There it was employed as the reference standard in NASA's Global Tropospheric Experiment/Chemical Instrumental Test and Evaluation 2 mission in August 1986.

  10. Manganese recycling in the United States in 1998

    USGS Publications Warehouse

    Jones, Thomas S.

    2003-01-01

    This report presents the results of the U.S. Geological Survey's analytical evaluation program for six standard reference samples -- T-163 (trace constituents), M-156 (major constituents), N-67 (nutrient constituents), N-68 (nutrient constituents), P-35 (low ionic strength constituents), and Hg-31 (mercury) -- that were distributed in October 2000 to 126 laboratories enrolled in the U.S. Geological Survey sponsored interlaboratory testing program. Analytical data that were received from 122 of the laboratories were evaluated with respect to overall laboratory performance and relative laboratory performance for each analyte in the six reference samples. Results of these evaluations are presented in tabular form. Also presented are tables and graphs summarizing the analytical data provided by each laboratory for each analyte in the six standard reference samples. The most probable value for each analyte was determined using nonparametric statistics.

  11. Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

    PubMed Central

    Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

    2014-01-01

    Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

  12. Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific.

    PubMed

    Ashraf, Sania; Kao, Angie; Hugo, Cecilia; Christophel, Eva M; Fatunmbi, Bayo; Luchavez, Jennifer; Lilley, Ken; Bell, David

    2012-10-24

    Malaria diagnosis has received renewed interest in recent years, associated with the increasing accessibility of accurate diagnosis through the introduction of rapid diagnostic tests and new World Health Organization guidelines recommending parasite-based diagnosis prior to anti-malarial therapy. However, light microscopy, established over 100 years ago and frequently considered the reference standard for clinical diagnosis, has been neglected in control programmes and in the malaria literature and evidence suggests field standards are commonly poor. Microscopy remains the most accessible method for parasite quantitation, for drug efficacy monitoring, and as a reference of assessing other diagnostic tools. This mismatch between quality and need highlights the importance of the establishment of reliable standards and procedures for assessing and assuring quality. This paper describes the development, function and impact of a multi-country microscopy external quality assurance network set up for this purpose in Asia. Surveys were used for key informants and past participants for feedback on the quality assurance programme. Competency scores for each country from 14 participating countries were compiled for analyses using paired sample t-tests. In-depth interviews were conducted with key informants including the programme facilitators and national level microscopists. External assessments and limited retraining through a formalized programme based on a reference slide bank has demonstrated an increase in standards of competence of senior microscopists over a relatively short period of time, at a potentially sustainable cost. The network involved in the programme now exceeds 14 countries in the Asia-Pacific, and the methods are extended to other regions. While the impact on national programmes varies, it has translated in some instances into a strengthening of national microscopy standards and offers a possibility both for supporting revival of national microcopy programmes, and for the development of globally recognized standards of competency needed both for patient management and field research.

  13. Developing standards for malaria microscopy: external competency assessment for malaria microscopists in the Asia-Pacific

    PubMed Central

    2012-01-01

    Background Malaria diagnosis has received renewed interest in recent years, associated with the increasing accessibility of accurate diagnosis through the introduction of rapid diagnostic tests and new World Health Organization guidelines recommending parasite-based diagnosis prior to anti-malarial therapy. However, light microscopy, established over 100 years ago and frequently considered the reference standard for clinical diagnosis, has been neglected in control programmes and in the malaria literature and evidence suggests field standards are commonly poor. Microscopy remains the most accessible method for parasite quantitation, for drug efficacy monitoring, and as a reference of assessing other diagnostic tools. This mismatch between quality and need highlights the importance of the establishment of reliable standards and procedures for assessing and assuring quality. This paper describes the development, function and impact of a multi-country microscopy external quality assurance network set up for this purpose in Asia. Methods Surveys were used for key informants and past participants for feedback on the quality assurance programme. Competency scores for each country from 14 participating countries were compiled for analyses using paired sample t-tests. In-depth interviews were conducted with key informants including the programme facilitators and national level microscopists. Results External assessments and limited retraining through a formalized programme based on a reference slide bank has demonstrated an increase in standards of competence of senior microscopists over a relatively short period of time, at a potentially sustainable cost. The network involved in the programme now exceeds 14 countries in the Asia-Pacific, and the methods are extended to other regions. Conclusions While the impact on national programmes varies, it has translated in some instances into a strengthening of national microscopy standards and offers a possibility both for supporting revival of national microcopy programmes, and for the development of globally recognized standards of competency needed both for patient management and field research. PMID:23095668

  14. Proposal and evaluation of subordinate standard solar irradiance spectra for applications in solar energy systems

    DOE PAGES

    Jessen, Wilko; Wilbert, Stefan; Gueymard, Christian A.; ...

    2018-04-10

    Reference solar irradiance spectra are needed to specify key parameters of solar technologies such as photovoltaic cell efficiency, in a comparable way. The IEC 60904-3 and ASTM G173 standards present such spectra for Direct Normal Irradiance (DNI) and Global Tilted Irradiance (GTI) on a 37 degrees tilted sun-facing surface for one set of clear-sky conditions with an air mass of 1.5 and low aerosol content. The IEC/G173 standard spectra are the widely accepted references for these purposes. Hence, the authors support the future replacement of the outdated ISO 9845 spectra with the IEC spectra within the ongoing update of thismore » ISO standard. The use of a single reference spectrum per component of irradiance is important for clarity when comparing and rating solar devices such as PV cells. However, at some locations the average spectra can differ strongly from those defined in the IEC/G173 standards due to widely different atmospheric conditions and collector tilt angles. Therefore, additional subordinate standard spectra for other atmospheric conditions and tilt angles are of interest for a rough comparison of product performance under representative field conditions, in addition to using the main standard spectrum for product certification under standard test conditions. This simplifies the product selection for solar power systems when a fully-detailed performance analysis is not feasible (e.g. small installations). Also, the effort for a detailed yield analyses can be reduced by decreasing the number of initial product options. After appropriate testing, this contribution suggests a number of additional spectra related to eight sets of atmospheric conditions and tilt angles that are currently considered within ASTM and ISO working groups. The additional spectra, called subordinate standard spectra, are motivated by significant spectral mismatches compared to the IEC/G173 spectra (up to 6.5%, for PV at 37 degrees tilt and 10-15% for CPV). These mismatches correspond to potential accuracy improvements for a quick estimation of the average efficiency by applying the appropriate subordinate standard spectrum instead of the IEC/G173 spectra. The applicability of these spectra for PV performance analyses is confirmed at five test sites, for which subordinate spectra could be intuitively selected based on the average atmospheric aerosol optical depth (AOD) and precipitable water vapor at those locations. The development of subordinate standard spectra for DNI and concentrating solar power (CSP) and concentrating PV (CPV) is also considered. However, it is found that many more sets of atmospheric conditions would be required to allow the intuitive selection of DNI spectra for the five test sites, due in particular to the stronger effect of AOD on DNI compared to GTI. The matrix of subordinate GTI spectra described in this paper are recommended to appear as an option in the annex of future standards, in addition to the obligatory use of the main spectrum from the ASTM G173 and IEC 60904 standards.« less

  15. Proposal and evaluation of subordinate standard solar irradiance spectra for applications in solar energy systems

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

    Jessen, Wilko; Wilbert, Stefan; Gueymard, Christian A.

    Reference solar irradiance spectra are needed to specify key parameters of solar technologies such as photovoltaic cell efficiency, in a comparable way. The IEC 60904-3 and ASTM G173 standards present such spectra for Direct Normal Irradiance (DNI) and Global Tilted Irradiance (GTI) on a 37 degrees tilted sun-facing surface for one set of clear-sky conditions with an air mass of 1.5 and low aerosol content. The IEC/G173 standard spectra are the widely accepted references for these purposes. Hence, the authors support the future replacement of the outdated ISO 9845 spectra with the IEC spectra within the ongoing update of thismore » ISO standard. The use of a single reference spectrum per component of irradiance is important for clarity when comparing and rating solar devices such as PV cells. However, at some locations the average spectra can differ strongly from those defined in the IEC/G173 standards due to widely different atmospheric conditions and collector tilt angles. Therefore, additional subordinate standard spectra for other atmospheric conditions and tilt angles are of interest for a rough comparison of product performance under representative field conditions, in addition to using the main standard spectrum for product certification under standard test conditions. This simplifies the product selection for solar power systems when a fully-detailed performance analysis is not feasible (e.g. small installations). Also, the effort for a detailed yield analyses can be reduced by decreasing the number of initial product options. After appropriate testing, this contribution suggests a number of additional spectra related to eight sets of atmospheric conditions and tilt angles that are currently considered within ASTM and ISO working groups. The additional spectra, called subordinate standard spectra, are motivated by significant spectral mismatches compared to the IEC/G173 spectra (up to 6.5%, for PV at 37 degrees tilt and 10-15% for CPV). These mismatches correspond to potential accuracy improvements for a quick estimation of the average efficiency by applying the appropriate subordinate standard spectrum instead of the IEC/G173 spectra. The applicability of these spectra for PV performance analyses is confirmed at five test sites, for which subordinate spectra could be intuitively selected based on the average atmospheric aerosol optical depth (AOD) and precipitable water vapor at those locations. The development of subordinate standard spectra for DNI and concentrating solar power (CSP) and concentrating PV (CPV) is also considered. However, it is found that many more sets of atmospheric conditions would be required to allow the intuitive selection of DNI spectra for the five test sites, due in particular to the stronger effect of AOD on DNI compared to GTI. The matrix of subordinate GTI spectra described in this paper are recommended to appear as an option in the annex of future standards, in addition to the obligatory use of the main spectrum from the ASTM G173 and IEC 60904 standards.« less

  16. 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.

  17. Impact of a product-specific reference standard for the measurement of a PEGylated rFVIII activity: the Swiss Multicentre Field Study.

    PubMed

    Bulla, O; Poncet, A; Alberio, L; Asmis, L M; Gähler, A; Graf, L; Nagler, M; Studt, J-D; Tsakiris, D A; Fontana, P

    2017-07-01

    Measuring factor VIII (FVIII) activity can be challenging when it has been modified, such as when FVIII is pegylated to increase its circulating half-life. Use of a product-specific reference standard may help avoid this issue. Evaluate the impact of using a product-specific reference standard for measuring the FVIII activity of BAX 855 - a pegylated FVIII - in eight of Switzerland's main laboratories. Factor VIII-deficient plasma, spiked with five different concentrations of BAX 855, plus a control FVIII sample, was sent to the participating laboratories. They measured FVIII activity by using either with a one-stage (OSA) or the chromogenic assay (CA) against their local or a product-specific reference standard. When using a local reference standard, there was an overestimation of BAX 855 activity compared to the target concentrations, both with the OSA and CA. The use of a product-specific reference standard reduced this effect: mean recovery ranged from 127.7% to 213.5% using the OSA with local reference standards, compared to 110% to 183.8% with a product-specific reference standard, and from 146.3% to 182.4% using the CA with local reference standards compared to 72.7% to 103.7% with a product-specific reference standard. In this in vitro study, the type of reference standard had a major impact on the measurement of BAX 855 activity. Evaluation was more accurate and precise when using a product-specific reference standard. © 2017 John Wiley & Sons Ltd.

  18. An Enclosed Laser Calibration Standard

    NASA Astrophysics Data System (ADS)

    Adams, Thomas E.; Fecteau, M. L.

    1985-02-01

    We have designed, evaluated and calibrated an enclosed, safety-interlocked laser calibration standard for use in US Army Secondary Reference Calibration Laboratories. This Laser Test Set Calibrator (LTSC) represents the Army's first-generation field laser calibration standard. Twelve LTSC's are now being fielded world-wide. The main requirement on the LTSC is to provide calibration support for the Test Set (TS3620) which, in turn, is a GO/NO GO tester of the Hand-Held Laser Rangefinder (AN/GVS-5). However, we believe it's design is flexible enough to accommodate the calibration of other laser test, measurement and diagnostic equipment (TMDE) provided that single-shot capability is adequate to perform the task. In this paper we describe the salient aspects and calibration requirements of the AN/GVS-5 Rangefinder and the Test Set which drove the basic LTSC design. Also, we detail our evaluation and calibration of the LTSC, in particular, the LTSC system standards. We conclude with a review of our error analysis from which uncertainties were assigned to the LTSC calibration functions.

  19. The Comparison of Iranian Normative Reference Data with Five Countries ‎Across Variables in Eight Rorschach Comprehensive System (CS) Clusters

    PubMed Central

    Hosseininasab, Abufazel; Mohammadi, Mohammadreza; Jouzi, Samira; Esmaeilinasab, Maryam; Delavar, Ali

    2016-01-01

    Objective: This study aimed to provide a normative study documenting how 114 five-seven year-old non-‎patient Iranian children respond to the Rorschach test. We compared this especial sample to ‎international normative reference values for the Comprehensive System (CS).‎ Method: One hundred fourteen 5- 7- year-old non-patient Iranian children were recruited from public ‎schools. Using five child and adolescent samples from five countries, we compared Iranian ‎Normative Reference Data- based on reference means and standard deviations for each sample.‎ Results: Findings revealed that how the scores in each sample were distributed and how the samples were ‎compared across variables in eight Rorschach Comprehensive System (CS) clusters. We reported ‎all descriptive statistics such as reference mean and standard deviation for all variables.‎ Conclusion: Iranian clinicians could rely on country specific or “local norms” when assessing children. We ‎discourage Iranian clinicians to use many CS scores to make nomothetic, score-based inferences ‎about psychopathology in children and adolescents.‎ PMID:27928247

  20. Proposed Clinical Decision Rules to Diagnose Acute Rhinosinusitis Among Adults in Primary Care.

    PubMed

    Ebell, Mark H; Hansen, Jens Georg

    2017-07-01

    To reduce inappropriate antibiotic prescribing, we sought to develop a clinical decision rule for the diagnosis of acute rhinosinusitis and acute bacterial rhinosinusitis. Multivariate analysis and classification and regression tree (CART) analysis were used to develop clinical decision rules for the diagnosis of acute rhinosinusitis, defined using 3 different reference standards (purulent antral puncture fluid or abnormal finding on a computed tomographic (CT) scan; for acute bacterial rhinosinusitis, we used a positive bacterial culture of antral fluid). Signs, symptoms, C-reactive protein (CRP), and reference standard tests were prospectively recorded in 175 Danish patients aged 18 to 65 years seeking care for suspected acute rhinosinusitis. For each reference standard, we developed 2 clinical decision rules: a point score based on a logistic regression model and an algorithm based on a CART model. We identified low-, moderate-, and high-risk groups for acute rhinosinusitis or acute bacterial rhinosinusitis for each clinical decision rule. The point scores each had between 5 and 6 predictors, and an area under the receiver operating characteristic curve (AUROCC) between 0.721 and 0.767. For positive bacterial culture as the reference standard, low-, moderate-, and high-risk groups had a 16%, 49%, and 73% likelihood of acute bacterial rhinosinusitis, respectively. CART models had an AUROCC ranging from 0.783 to 0.827. For positive bacterial culture as the reference standard, low-, moderate-, and high-risk groups had a likelihood of acute bacterial rhinosinusitis of 6%, 31%, and 59% respectively. We have developed a series of clinical decision rules integrating signs, symptoms, and CRP to diagnose acute rhinosinusitis and acute bacterial rhinosinusitis with good accuracy. They now require prospective validation and an assessment of their effect on clinical and process outcomes. © 2017 Annals of Family Medicine, Inc.

  1. 40 CFR 60.17 - Incorporations by reference.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... (C267-01), U.S. EPA, Research Triangle Park, NC or at the National Archives and Records Administration... Testing and Materials (ASTM), 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428...), 60.593(d), 60.593a(d), and 60.633(h). (8) ASTM D129-64, 78, 95, 00, Standard Test Method for Sulfur...

  2. 40 CFR 60.17 - Incorporations by reference.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... (C267-01), U.S. EPA, Research Triangle Park, NC or at the National Archives and Records Administration... Testing and Materials (ASTM), 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, PA 19428...), 60.593(d), 60.593a(d), and 60.633(h). (8) ASTM D129-64, 78, 95, 00, Standard Test Method for Sulfur...

  3. 38 CFR 17.74 - Standards applicable to medical foster homes.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... detectors, and all other elements of a fire alarm system, must be inspected, tested, and maintained in... § 17.1). (h) Sprinkler systems. (1) If a sprinkler system is installed, it must be inspected, tested... sprinkler system is installed in accordance with NFPA 13D (incorporated by reference, see § 17.1). If a...

  4. 38 CFR 17.74 - Standards applicable to medical foster homes.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... detectors, and all other elements of a fire alarm system, must be inspected, tested, and maintained in... § 17.1). (h) Sprinkler systems. (1) If a sprinkler system is installed, it must be inspected, tested... sprinkler system is installed in accordance with NFPA 13D (incorporated by reference, see § 17.1). If a...

  5. 77 FR 19155 - Federal Motor Vehicle Safety Standards; Seat Belt Assembly Anchorages; Incorporation by Reference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... representative of a human form than the upper torso and pelvic body blocks. As noted in the docketed test reports... anchorage system during compliance tests of anchorage strength. The device represents a human torso and... proposing this amendment because the devices are significantly easier to use than the current body blocks...

  6. 46 CFR 175.600 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Vessels Under 61 Meters (200 feet) in Length, 1983 (“ABS Steel Vessel Rules (Meters)”) 177.300. Rules..., Standard Practice for Operating Salt Spray (Fog) Apparatus (“ASTM B 117”) 175.400. ASTM B 122/B 122M-95... (“ASTM D 93”) 175.400. ASTM D 635-97, Standard test Method for Rate of Burning and or Extent and Time of...

  7. 40 CFR 80.1468 - Incorporation by reference.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ....astm.org). (1) ASTM D 1250-08 (“ASTM D 1250”), Standard Guide for Use of the Petroleum Measurement Tables, Approved 2008; IBR approved for § 80.1426(f)(8)(ii)(B). (2) ASTM D 4442-07 (“ASTM D 4442... 2007; IBR approved for § 80.1426(f)(7)(v)(B). (3) ASTM D 4444-08 (“ASTM D 4444”), Standard Test Method...

  8. Modeling Canadian Quality Control Test Program for Steroid Hormone Receptors in Breast Cancer: Diagnostic Accuracy Study.

    PubMed

    Pérez, Teresa; Makrestsov, Nikita; Garatt, John; Torlakovic, Emina; Gilks, C Blake; Mallett, Susan

    The Canadian Immunohistochemistry Quality Control program monitors clinical laboratory performance for estrogen receptor and progesterone receptor tests used in breast cancer treatment management in Canada. Current methods assess sensitivity and specificity at each time point, compared with a reference standard. We investigate alternative performance analysis methods to enhance the quality assessment. We used 3 methods of analysis: meta-analysis of sensitivity and specificity of each laboratory across all time points; sensitivity and specificity at each time point for each laboratory; and fitting models for repeated measurements to examine differences between laboratories adjusted by test and time point. Results show 88 laboratories participated in quality control at up to 13 time points using typically 37 to 54 histology samples. In meta-analysis across all time points no laboratories have sensitivity or specificity below 80%. Current methods, presenting sensitivity and specificity separately for each run, result in wide 95% confidence intervals, typically spanning 15% to 30%. Models of a single diagnostic outcome demonstrated that 82% to 100% of laboratories had no difference to reference standard for estrogen receptor and 75% to 100% for progesterone receptor, with the exception of 1 progesterone receptor run. Laboratories with significant differences to reference standard identified with Generalized Estimating Equation modeling also have reduced performance by meta-analysis across all time points. The Canadian Immunohistochemistry Quality Control program has a good design, and with this modeling approach has sufficient precision to measure performance at each time point and allow laboratories with a significantly lower performance to be targeted for advice.

  9. 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

  10. Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.

    PubMed

    Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li'an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

    2016-03-01

    A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box-Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China.

  11. Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China

    PubMed Central

    Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li’an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

    2016-01-01

    Abstract A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box–Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China. PMID:26945390

  12. External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe.

    PubMed

    Perich, C; Ricós, C; Alvarez, V; Biosca, C; Boned, B; Cava, F; Doménech, M V; Fernández-Calle, P; Fernández-Fernández, P; García-Lario, J V; Minchinela, J; Simón, M; Jansen, R

    2014-05-15

    Current external quality assurance schemes have been classified into six categories, according to their ability to verify the degree of standardization of the participating measurement procedures. SKML (Netherlands) is a Category 1 EQA scheme (commutable EQA materials with values assigned by reference methods), whereas SEQC (Spain) is a Category 5 scheme (replicate analyses of non-commutable materials with no values assigned by reference methods). The results obtained by a group of Spanish laboratories participating in a pilot study organized by SKML are examined, with the aim of pointing out the improvements over our current scheme that a Category 1 program could provide. Imprecision and bias are calculated for each analyte and laboratory, and compared with quality specifications derived from biological variation. Of the 26 analytes studied, 9 had results comparable with those from reference methods, and 10 analytes did not have comparable results. The remaining 7 analytes measured did not have available reference method values, and in these cases, comparison with the peer group showed comparable results. The reasons for disagreement in the second group can be summarized as: use of non-standard methods (IFCC without exogenous pyridoxal phosphate for AST and ALT, Jaffé kinetic at low-normal creatinine concentrations and with eGFR); non-commutability of the reference material used to assign values to the routine calibrator (calcium, magnesium and sodium); use of reference materials without established commutability instead of reference methods for AST and GGT, and lack of a systematic effort by manufacturers to harmonize results. Results obtained in this work demonstrate the important role of external quality assurance programs using commutable materials with values assigned by reference methods to correctly monitor the standardization of laboratory tests with consequent minimization of risk to patients. Copyright © 2013 Elsevier B.V. All rights reserved.

  13. Nonvolatile, semivolatile, or volatile: redefining volatile for volatile organic compounds.

    PubMed

    Võ, Uyên-Uyén T; Morris, Michael P

    2014-06-01

    Although widely used in air quality regulatory frameworks, the term "volatile organic compound" (VOC) is poorly defined. Numerous standardized tests are currently used in regulations to determine VOC content (and thus volatility), but in many cases the tests do not agree with each other, nor do they always accurately represent actual evaporation rates under ambient conditions. The parameters (time, temperature, reference material, column polarity, etc.) used in the definitions and the associated test methods were created without a significant evaluation of volatilization characteristics in real world settings. Not only do these differences lead to varying VOC content results, but occasionally they conflict with one another. An ambient evaporation study of selected compounds and a few formulated products was conducted and the results were compared to several current VOC test methodologies: SCAQMD Method 313 (M313), ASTM Standard Test Method E 1868-10 (E1868), and US. EPA Reference Method 24 (M24). The ambient evaporation study showed a definite distinction between nonvolatile, semivolatile, and volatile compounds. Some low vapor pressure (LVP) solvents, currently considered exempt as VOCs by some methods, volatilize at ambient conditions nearly as rapidly as the traditional high-volatility solvents they are meant to replace. Conversely, bio-based and heavy hydrocarbons did not readily volatilize, though they often are calculated as VOCs in some traditional test methods. The study suggests that regulatory standards should be reevaluated to more accurately reflect real-world emission from the use of VOC containing products. The definition of VOC in current test methods may lead to regulations that exclude otherwise viable alternatives or allow substitutions of chemicals that may limit the environmental benefits sought in the regulation. A study was conducted to examine volatility of several compounds and a few formulated products under several current VOC test methodologies and ambient evaporation. This paper provides ample evidence to warrant a reevaluation of regulatory standards and provides a framework for progressive developments based on reasonable and scientifically justifiable definitions of VOCs.

  14. 78 FR 66932 - Scientific Information Request on Core Needle and Open Surgical Biopsy for Diagnosis of Breast...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug... biopsy technique (each index test) will be quantified versus the reference standard \\b\\. The comparative...

  15. REGULATORY METHODS PROGRAM SUPPORT FOR NAAQSS

    EPA Science Inventory

    This task supports attainment determinations of the National Ambient Air Quality Standards (NAAQS) for particulate matter (PM) in the areas of development, testing, and improvement of new and current PM Federal Reference Methods (FRMs) and Federal Equivalent Methods (FEMs). The ...

  16. Comparison of analytical methods for the determination of histamine in reference canned fish samples

    NASA Astrophysics Data System (ADS)

    Jakšić, S.; Baloš, M. Ž.; Mihaljev, Ž.; Prodanov Radulović, J.; Nešić, K.

    2017-09-01

    Two screening methods for histamine in canned fish, an enzymatic test and a competitive direct enzyme-linked immunosorbent assay (CD-ELISA), were compared with the reversed-phase liquid chromatography (RP-HPLC) standard method. For enzymatic and CD-ELISA methods, determination was conducted according to producers’ manuals. For RP-HPLC, histamine was derivatized with dansyl-chloride, followed by RP-HPLC and diode array detection. Results of analysis of canned fish, supplied as reference samples for proficiency testing, showed good agreement when histamine was present at higher concentrations (above 100 mg kg-1). At a lower level (16.95 mg kg-1), the enzymatic test produced some higher results. Generally, analysis of four reference samples according to CD-ELISA and RP-HPLC showed good agreement for histamine determination (r=0.977 in concentration range 16.95-216 mg kg-1) The results show that the applied enzymatic test and CD-ELISA appeared to be suitable screening methods for the determination of histamine in canned fish.

  17. Development of an integrated electrochemical system for in vitro yeast viability testing.

    PubMed

    Adami, Andrea; Ress, Cristina; Collini, Cristian; Pedrotti, Severino; Lorenzelli, Leandro

    2013-02-15

    This work describes the development and testing of a microfabricated sensor for rapid cell growth monitoring, especially focused on yeast quality assessment for wine applications. The device consists of a NMOS ISFET sensor with Si(3)N(4) gate, able to indirectly monitor extracellular metabolism through pH variation of the medium, and a solid-state reference electrode implemented with PVC membranes doped with lipophilic salts (tetrabutylammonium-tetrabutylborate (TBA-TBB) and Potassium tetrakis(4-chlorphenyl)borate (KTClpB)). The use of a solid state reference electrode enables the implementation of a large number of cell assays in parallel, without the need of external conventional reference electrodes. Microbial growth testing has been performed both in standard culture conditions and on chip at different concentrations of ethanol in order to carry out a commonly used screening of wine yeast strains. Cell growth tests can be performed in few hours, providing a fast, sensitive and low cost analysis with respect to the conventional procedures. Copyright © 2012 Elsevier B.V. All rights reserved.

  18. Protocol standards and implementation within the digital engineering laboratory computer network (DELNET) using the universal network interface device (UNID). Part 2

    NASA Astrophysics Data System (ADS)

    Phister, P. W., Jr.

    1983-12-01

    Development of the Air Force Institute of Technology's Digital Engineering Laboratory Network (DELNET) was continued with the development of an initial draft of a protocol standard for all seven layers as specified by the International Standards Organization's (ISO) Reference Model for Open Systems Interconnections. This effort centered on the restructuring of the Network Layer to perform Datagram routing and to conform to the developed protocol standards and actual software module development of the upper four protocol layers residing within the DELNET Monitor (Zilog MCZ 1/25 Computer System). Within the guidelines of the ISO Reference Model the Transport Layer was developed utilizing the Internet Header Format (IHF) combined with the Transport Control Protocol (TCP) to create a 128-byte Datagram. Also a limited Application Layer was created to pass the Gettysburg Address through the DELNET. This study formulated a first draft for the DELNET Protocol Standard and designed, implemented, and tested the Network, Transport, and Application Layers to conform to these protocol standards.

  19. Operating and environmental characteristics of Sigma Tau hydrogen masers used in the Very Long Baseline Array (VLBA)

    NASA Technical Reports Server (NTRS)

    Tucker, T. K.

    1989-01-01

    Presented here are the results obtained from performance evaluation of a pair of Sigma Tau Standards Corporation Model VLBA-112 active hydrogen maser frequency standards. These masers were manufactured for the National Radio Astronomy Observatory (NRAO) for use on the Very Long Baseline Array (VLBA) project and were furnished to the Jet Propulsion Laboratory (JPL) for the purpose of these tests. Tests on the two masers were performed in the JPL Frequency Standards Laboratory (FSL) and included the characterization of output frequency stability versus environmental factors such as temperature, humidity, magnetic field, and barometric pressure. The performance tests also included the determination of phase noise and Allan variance using both FSL and Sigma Tau masers as references. All tests were conducted under controlled laboratory conditions, with only the desired environmental and operational parameters varied to determine sensitivity to external environment.

  20. Nondestructive Evaluation of Airport Pavements. Volume I. Program References,

    DTIC Science & Technology

    1979-09-01

    greater than its original capacity (see test 13 on Fig. 2.5). During the material tests by Majidzadeh, the dynamic E-value of frozen subgrade soil was...Sample the base and subbase material by conventional spoon and identify the material by standard soil -aggregate classification and penetration...such as shaker table. The new testing specification is designed for all paving materials including subgrade soils . The specifications of material

  1. A new bioimpedance research device (BIRD) for measuring the electrical impedance of acupuncture meridians.

    PubMed

    Wong, Felix Wu Shun; Lim, Chi Eung Danforn; Smith, Warren

    2010-03-01

    The aim of this article is to introduce an electrical bioimpedance device that uses an old and little-known impedance measuring technique to study the impedance of the meridian and nonmeridian tissue segments. Three (3) pilot experimental studies involving both a tissue phantom (a cucumber) and 3 human subjects were performed using this BIRD-I (Bioimpedance Research Device) device. This device consists of a Fluke RCL meter, a multiplexer box, a laptop computer, and a medical-grade isolation transformer. Segment and surface sheath (or local) impedances were estimated using formulae first published in the 1930s, in an approach that differs from that of the standard four-electrode technique used in most meridian studies to date. Our study found that, when using a quasilinear four-electrode arrangement, the reference electrodes should be positioned at least 10 cm from the test electrodes to ensure that the segment (or core) impedance estimation is not affected by the proximity of the reference electrodes. A tissue phantom was used to determine the repeatability of segment (core) impedance measurement by the device. An applied frequency of 100 kHz was found to produce the best repeatability among the various frequencies tested. In another preliminary study, with a segment of the triple energizer meridian on the lower arm selected as reference segment, core resistance-based profiles around the lower arm showed three of the other five meridians to exist as local resistance minima relative to neighboring nonmeridian segments. The profiles of the 2 subjects tested were very similar, suggesting that the results are unlikely to be spurious. In electrical bioimpedance studies, it is recommended that the measuring technique and device be clearly defined and standardized to provide optimal working conditions. In our study using the BIRD I device, we defined our standard experimental conditions as a test frequency of 100 kHz and the position of the reference electrodes of at least 10 cm from the test electrodes. Our device has demonstrated potential for use in quantifying the degree of electrical interconnection between any two surface-defined test meridian or nonmeridian segments. Issues arising from use of this device and the measurement Horton and van Ravenswaay technique were also presented.

  2. Synthesis and Screening of New Antimalarial Drugs

    DTIC Science & Technology

    1987-10-30

    correlate well with the known pIharmacokinetics of thie drug. 3. fhe blood schizonticidal properties of chloroquine (active at 3 mg/kg/day x 7 days) were...Reference drug chloroquine has shown consistently curative action at 3 mg/kg (base) x 7 days. No escalation of chloroquine curative dose has been...from patent infection has been used from time to time for standardization of blood schizontocidal test using chloroquine diphosphate as the reference

  3. Reference-free automatic quality assessment of tracheoesophageal speech.

    PubMed

    Huang, Andy; Falk, Tiago H; Chan, Wai-Yip; Parsa, Vijay; Doyle, Philip

    2009-01-01

    Evaluation of the quality of tracheoesophageal (TE) speech using machines instead of human experts can enhance the voice rehabilitation process for patients who have undergone total laryngectomy and voice restoration. Towards the goal of devising a reference-free TE speech quality estimation algorithm, we investigate the efficacy of speech signal features that are used in standard telephone-speech quality assessment algorithms, in conjunction with a recently introduced speech modulation spectrum measure. Tests performed on two TE speech databases demonstrate that the modulation spectral measure and a subset of features in the standard ITU-T P.563 algorithm estimate TE speech quality with better correlation (up to 0.9) than previously proposed features.

  4. Standard Specimen Reference Set: Pancreatic — EDRN Public Portal

    Cancer.gov

    The primary objective of the EDRN Pancreatic Cancer Working Group Proposal is to create a reference set consisting of well-characterized serum/plasma specimens to use as a resource for the development of biomarkers for the early detection of pancreatic adenocarcinoma. The testing of biomarkers on the same sample set permits direct comparison among them; thereby, allowing the development of a biomarker panel that can be evaluated in a future validation study. Additionally, the establishment of an infrastructure with core data elements and standardized operating procedures for specimen collection, processing and storage, will provide the necessary preparatory platform for larger validation studies when the appropriate marker/panel for pancreatic adenocarcinoma has been identified.

  5. Accuracy of real-time PCR, Gram stain and culture for Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae meningitis diagnosis.

    PubMed

    Wu, Henry M; Cordeiro, Soraia M; Harcourt, Brian H; Carvalho, Mariadaglorias; Azevedo, Jailton; Oliveira, Tainara Q; Leite, Mariela C; Salgado, Katia; Reis, Mitermayer G; Plikaytis, Brian D; Clark, Thomas A; Mayer, Leonard W; Ko, Albert I; Martin, Stacey W; Reis, Joice N

    2013-01-22

    Although cerebrospinal fluid (CSF) culture is the diagnostic reference standard for bacterial meningitis, its sensitivity is limited, particularly when antibiotics were previously administered. CSF Gram staining and real-time PCR are theoretically less affected by antibiotics; however, it is difficult to evaluate these tests with an imperfect reference standard. CSF from patients with suspected meningitis from Salvador, Brazil were tested with culture, Gram stain, and real-time PCR using S. pneumoniae, N. meningitidis, and H. influenzae specific primers and probes. An antibiotic detection disk bioassay was used to test for the presence of antibiotic activity in CSF. The diagnostic accuracy of tests were evaluated using multiple methods, including direct evaluation of Gram stain and real-time PCR against CSF culture, evaluation of real-time PCR against a composite reference standard, and latent class analysis modeling to evaluate all three tests simultaneously. Among 451 CSF specimens, 80 (17.7%) had culture isolation of one of the three pathogens (40 S. pneumoniae, 36 N. meningitidis, and 4 H. influenzae), and 113 (25.1%) were real-time PCR positive (51 S. pneumoniae, 57 N. meningitidis, and 5 H. influenzae). Compared to culture, real-time PCR sensitivity and specificity were 95.0% and 90.0%, respectively. In a latent class analysis model, the sensitivity and specificity estimates were: culture, 81.3% and 99.7%; Gram stain, 98.2% and 98.7%; and real-time PCR, 95.7% and 94.3%, respectively. Gram stain and real-time PCR sensitivity did not change significantly when there was antibiotic activity in the CSF. Real-time PCR and Gram stain were highly accurate in diagnosing meningitis caused by S. pneumoniae, N. meningitidis, and H. influenzae, though there were few cases of H. influenzae. Furthermore, real-time PCR and Gram staining were less affected by antibiotic presence and might be useful when antibiotics were previously administered. Gram staining, which is inexpensive and commonly available, should be encouraged in all clinical settings.

  6. Monitoring on-orbit calibration stability of the Terra MODIS and Landsat 7 ETM+ sensors using pseudo-invariant test sites

    USGS Publications Warehouse

    Chander, G.; Xiong, X.(J.); Choi, T.(J.); Angal, A.

    2010-01-01

    The ability to detect and quantify changes in the Earth's environment depends on sensors that can provide calibrated, consistent measurements of the Earth's surface features through time. A critical step in this process is to put image data from different sensors onto a common radiometric scale. This work focuses on monitoring the long-term on-orbit calibration stability of the Terra Moderate Resolution Imaging Spectroradiometer (MODIS) and the Landsat 7 (L7) Enhanced Thematic Mapper Plus (ETM+) sensors using the Committee on Earth Observation Satellites (CEOS) reference standard pseudo-invariant test sites (Libya 4, Mauritania 1/2, Algeria 3, Libya 1, and Algeria 5). These sites have been frequently used as radiometric targets because of their relatively stable surface conditions temporally. This study was performed using all cloud-free calibrated images from the Terra MODIS and the L7 ETM+ sensors, acquired from launch to December 2008. Homogeneous regions of interest (ROI) were selected in the calibrated images and the mean target statistics were derived from sensor measurements in terms of top-of-atmosphere (TOA) reflectance. For each band pair, a set of fitted coefficients (slope and offset) is provided to monitor the long-term stability over very stable pseudo-invariant test sites. The average percent differences in intercept from the long-term trends obtained from the ETM + TOA reflectance estimates relative to the MODIS for all the CEOS reference standard test sites range from 2.5% to 15%. This gives an estimate of the collective differences due to the Relative Spectral Response (RSR) characteristics of each sensor, bi-directional reflectance distribution function (BRDF), spectral signature of the ground target, and atmospheric composition. The lifetime TOA reflectance trends from both sensors over 10 years are extremely stable, changing by no more than 0.4% per year in its TOA reflectance over the CEOS reference standard test sites.

  7. Basic and Morphological Properties of Bukit Goh Bauxite

    NASA Astrophysics Data System (ADS)

    Hasan, Muzamir; Nor Azmi, Ahmad Amirul Faez Ahmad; Tam, Weng Long; Phang, Biao Yu; Azizul Moqsud, M.

    2018-03-01

    Investigation conducted by International Maritime Organization (IMO) concluded that the loss of the Bulk Jupiter that carrying bauxite from Kuantan has uncovered evidence to suggest liquefaction led to loss of stability. This research analysed Bukit Goh bauxite and comparison was made with International Maritime Solid Bulk Cargoes (IMSBC Code) standard. To analyse these characteristics of the bauxite, four samples were selected at Bukit Goh, Kuantan ; two of the samples from the Bukit Goh mine and two samples from the stock piles were tested to identify the bauxite basic and morphological properties by referring to GEOSPEC 3 : Model Specification for Soil Testing ; particle size distribution, moisture content and specific gravity and its morphological properties. Laboratory tests involved including Hydrometer test, Small Pycnometer test, Dry Sieve test and Field Emission Scanning Electron Microscop (FESEM) test. The results show that the average moisture content of raw Bukit Goh bauxite is 20.64% which exceeded the recomended value of maximum 10%. Average fine material for raw bauxite is 37.75% which should not be greater than 30% per IMSBC standard. By that, the bauxite from Bukit Goh mine do not achieved the minimum requirements and standards of the IMSBC standard and need to undergo beneficiation process for better quality and safety.

  8. Comparative High Voltage Impulse Measurement

    PubMed Central

    FitzPatrick, Gerald J.; Kelley, Edward F.

    1996-01-01

    A facility has been developed for the determination of the ratio of pulse high voltage dividers over the range from 10 kV to 300 kV using comparative techniques with Kerr electro-optic voltage measurement systems and reference resistive voltage dividers. Pulse voltage ratios of test dividers can be determined with relative expanded uncertainties of 0.4 % (coverage factor k = 2 and thus a two standard deviation estimate) or less using the complementary resistive divider/Kerr cell reference systems. This paper describes the facility and specialized procedures used at NIST for the determination of test voltage divider ratios through comparative techniques. The error sources and special considerations in the construction and use of reference voltage dividers to minimize errors are discussed, and estimates of the measurement uncertainties are presented. PMID:27805083

  9. Identification of suitable qPCR reference genes in leaves of Brassica oleracea under abiotic stresses.

    PubMed

    Brulle, Franck; Bernard, Fabien; Vandenbulcke, Franck; Cuny, Damien; Dumez, Sylvain

    2014-04-01

    Real-time quantitative PCR is nowadays a standard method to study gene expression variations in various samples and experimental conditions. However, to interpret results accurately, data normalization with appropriate reference genes appears to be crucial. The present study describes the identification and the validation of suitable reference genes in Brassica oleracea leaves. Expression stability of eight candidates was tested following drought and cold abiotic stresses by using three different softwares (BestKeeper, NormFinder and geNorm). Four genes (BolC.TUB6, BolC.SAND1, BolC.UBQ2 and BolC.TBP1) emerged as the most stable across the tested conditions. Further gene expression analysis of a drought- and a cold-responsive gene (BolC.DREB2A and BolC.ELIP, respectively), confirmed the stability and the reliability of the identified reference genes when used for normalization in the leaves of B. oleracea. These four genes were finally tested upon a benzene exposure and all appeared to be useful reference genes along this toxicological condition. These results provide a good starting point for future studies involving gene expression measurement on leaves of B. oleracea exposed to environmental modifications.

  10. Standardization of Terminology in Laboratory Medicine II

    PubMed Central

    Lee, Kap No; Yoon, Jong-Hyun; Min, Won Ki; Lim, Hwan Sub; Song, Junghan; Chae, Seok Lae; Jang, Seongsoo; Ki, Chang-Seok; Bae, Sook Young; Kim, Jang Su; Kwon, Jung-Ah; Lee, Chang Kyu

    2008-01-01

    Standardization of medical terminology is essential in data transmission between health care institutes and in maximizing the benefits of information technology. The purpose of this study was to standardize medical terms for laboratory observations. During the second year of the study, a standard database of concept names for laboratory terms that covered those used in tertiary health care institutes and reference laboratories was developed. The laboratory terms in the Logical Observation Identifier Names and Codes (LOINC) database were adopted and matched with the electronic data interchange (EDI) codes in Korea. A public hearing and a workshop for clinical pathologists were held to collect the opinions of experts. The Korean standard laboratory terminology database containing six axial concept names, components, property, time aspect, system (specimen), scale type, and method type, was established for 29,340 test observations. Short names and mapping tables for EDI codes and UMLS were added. Synonym tables were prepared to help match concept names to common terms used in the fields. We herein described the Korean standard laboratory terminology database for test names, result description terms, and result units encompassing most of the laboratory tests in Korea. PMID:18756062

  11. [Application of traditional Chinese medicine reference standards in quality control of Chinese herbal pieces].

    PubMed

    Lu, Tu-Lin; Li, Jin-Ci; Yu, Jiang-Yong; Cai, Bao-Chang; Mao, Chun-Qin; Yin, Fang-Zhou

    2014-01-01

    Traditional Chinese medicine (TCM) reference standards plays an important role in the quality control of Chinese herbal pieces. This paper overviewed the development of TCM reference standards. By analyzing the 2010 edition of Chinese pharmacopoeia, the application of TCM reference standards in the quality control of Chinese herbal pieces was summarized, and the problems exiting in the system were put forward. In the process of improving the quality control level of Chinese herbal pieces, various kinds of advanced methods and technology should be used to research the characteristic reference standards of Chinese herbal pieces, more and more reasonable reference standards should be introduced in the quality control system of Chinese herbal pieces. This article discussed the solutions in the aspect of TCM reference standards, and future development of quality control on Chinese herbal pieces is prospected.

  12. 40 CFR 600.011-93 - Reference materials.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Standard Test Method for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter 600.113-93, 600... Hydrocarbon Fuels by Bomb Calorimeter, IBR approved for §§ 600.113-93, 600.510-93, 600.113-08, and 600.510-08...

  13. 40 CFR 278.3 - Criteria for use of chat in Federally funded transportation projects.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., incorporated by reference in § 260.11 of this chapter, and the leachate testing results show that concentrations in the leachate do not exceed the National Primary Drinking Water Standards for lead and cadmium...

  14. 40 CFR 278.3 - Criteria for use of chat in Federally funded transportation projects.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., incorporated by reference in § 260.11 of this chapter, and the leachate testing results show that concentrations in the leachate do not exceed the National Primary Drinking Water Standards for lead and cadmium...

  15. 40 CFR 278.3 - Criteria for use of chat in Federally funded transportation projects.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., incorporated by reference in § 260.11 of this chapter, and the leachate testing results show that concentrations in the leachate do not exceed the National Primary Drinking Water Standards for lead and cadmium...

  16. 40 CFR 278.3 - Criteria for use of chat in Federally funded transportation projects.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., incorporated by reference in § 260.11 of this chapter, and the leachate testing results show that concentrations in the leachate do not exceed the National Primary Drinking Water Standards for lead and cadmium...

  17. 46 CFR 160.115-5 - Incorporation by reference.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... for §§ 160.115-7, 160.115-13, and 160.115-15. (4) MSC/Circular 980, Standardized Life-saving Appliance Evaluation and Test Report Forms, (February 13, 2001), IBR approved for § 160.115-13 (“IMO MSC Circ. 980...

  18. First-year university Physics students’ knowledge about direct current circuits: probing improvement in understanding as a function of teaching and learning interventions

    NASA Astrophysics Data System (ADS)

    Newman, Richard; van der Ventel, Brandon; Hanekom, Crischelle

    2017-07-01

    Probing university students’ understanding of direct-current (DC) resistive circuits is still a field of active physics education research. We report here on a study we conducted of this understanding, where the cohort consisted of students in a large-enrollment first-year physics module. This is a non-calculus based physics module for students in the life sciences stream. The study involved 366 students enrolled in the physics (bio) 154 module at Stellenbosch University in 2015. Students’ understanding of DC resistive circuits was probed by means of a standardized test instrument. The instrument comprises 29 multiple choice questions that students have to answer in ~40 min. Students were required to first complete the standardized test at the start of semester (July 2015). For ease of reference we call this test the pre-test. Students answered the pre-test having no university-level formal exposure to DC circuits in theory or practice. The pre-test therefore served to probe students’ school level knowledge of DC circuits. As the semester progressed students were exposed to a practical (E1), lectures, a prescribed textbook, a tutorial and online videos focusing on DC circuits. The E1 practical required students to solve DC circuit problems by means of physically constructing circuits, algebraically using Kirchhoff's Rules and Ohm’s Law, and by means of simulating circuits using the app iCircuit running on iPads (iOS platform). Each E1 practical involved ~50 students in a three hour session. The practical was repeated three afternoons per week over an eight week period. Twenty three iPads were distributed among students on a practical afternoon in order for them to do the circuit simulations in groups (of 4-5 students). At the end of the practical students were again required to do the standardized test on circuits and complete a survey on their experience of the use of the iPad and iCircuit app. For ease of reference we refer to this second test as the post-test. The students’ average score on the post-test was found to be ~25% higher than their pre-test score. The results of the iPad use survey show that the majority of students felt that the iCircuit app enhanced their learning of DC circuits.

  19. Performance and System Validation of a New Cellular-Enabled Blood Glucose Monitoring System Using a New Standard Reference Measurement Procedure of Isotope Dilution UPLC-MRM Mass Spectrometry

    PubMed Central

    Angelides, Kimon; Matsunami, Risë K.; Engler, David A.

    2015-01-01

    Background: We evaluated the accuracy, precision, and linearity of the In Touch® blood glucose monitoring system (BGMS), a new color touch screen and cellular-enabled blood glucose meter, using a new rapid, highly precise and accurate 13C6 isotope-dilution liquid chromatography-mass spectrometry method (IDLC-MS). Methods: Blood glucose measurements from the In Touch® BGMS were referenced to a validated UPLC-MRM standard reference measurement procedure previously shown to be highly accurate and precise. Readings from the In Touch® BGMS were taken over the blood glucose range of 24-640 mg/dL using 12 concentrations of blood glucose. Ten In Touch® BGMS and 3 lots of test strips were used with 10 replicates at each concentration. A lay user study was also performed to assess the ease of use. Results: At blood glucose concentrations <75 mg/dL 100% of the measurements are within ±8 mg/dL from the true reference standard; at blood glucose levels >75 mg/dL 100% of the measurements are within ±15% of the true reference standard. 100% of the results are within category A of the consensus grid. Within-run precision show CV < 3.72% between 24-50 mg/dL and CV<2.22% between 500 and 600 mg/dL. The results show that the In Touch® meter exceeds the minimum criteria of both the ISO 15197:2003 and ISO 15197:2013 standards. The results from a user panel show that 100% of the respondents reported that the color touch screen, with its graphic user interface (GUI), is well labeled and easy to navigate. Conclusions: To our knowledge this is the first touch screen glucose meter and the first study where accuracy of a new BGMS has been measured against a true primary reference standard, namely IDLC-MS. PMID:26002836

  20. Identification and antimicrobial susceptibility testing of Staphylococcus vitulinus by the BD phoenix automated microbiology system.

    PubMed

    Cirković, Ivana; Hauschild, Tomasz; Jezek, Petr; Dimitrijević, Vladimir; Vuković, Dragana; Stepanović, Srdjan

    2008-08-01

    This study evaluated the performance of the BD Phoenix system for the identification (ID) and antimicrobial susceptibility testing (AST) of Staphylococcus vitulinus. Of the 10 S. vitulinus isolates included in the study, 2 were obtained from the Czech Collection of Microorganisms, 5 from the environment, 2 from human clinical samples, and 1 from an animal source. The results of conventional biochemical and molecular tests were used for the reference method for ID, while antimicrobial susceptibility testing performed in accordance with Clinical and Laboratory Standards Institute recommendations and PCR for the mecA gene were the reference for AST. Three isolates were incorrectly identified by the BD Phoenix system; one of these was incorrectly identified to the genus level, and two to the species level. The results of AST by the BD Phoenix system were in agreement with those by the reference method used. While the results of susceptibility testing compared favorably, the 70% accuracy of the Phoenix system for identification of this unusual staphylococcal species was not fully satisfactory.

  1. Standardized protocols for quality control of MRM-based plasma proteomic workflows.

    PubMed

    Percy, Andrew J; Chambers, Andrew G; Smith, Derek S; Borchers, Christoph H

    2013-01-04

    Mass spectrometry (MS)-based proteomics is rapidly emerging as a viable technology for the identification and quantitation of biological samples, such as human plasma--the most complex yet commonly employed biofluid in clinical analyses. The transition from a qualitative to quantitative science is required if proteomics is going to successfully make the transition to a clinically useful technique. MS, however, has been criticized for a lack of reproducibility and interlaboratory transferability. Currently, the MS and plasma proteomics communities lack standardized protocols and reagents to ensure that high-quality quantitative data can be accurately and precisely reproduced by laboratories across the world using different MS technologies. Toward addressing this issue, we have developed standard protocols for multiple reaction monitoring (MRM)-based assays with customized isotopically labeled internal standards for quality control of the sample preparation workflow and the MS platform in quantitative plasma proteomic analyses. The development of reference standards and their application to a single MS platform is discussed herein, along with the results from intralaboratory tests. The tests highlighted the importance of the reference standards in assessing the efficiency and reproducibility of the entire bottom-up proteomic workflow and revealed errors related to the sample preparation and performance quality and deficits of the MS and LC systems. Such evaluations are necessary if MRM-based quantitative plasma proteomics is to be used in verifying and validating putative disease biomarkers across different research laboratories and eventually in clinical laboratories.

  2. Results of the 1978 NASA/JPL balloon flight solar cell calibration program

    NASA Technical Reports Server (NTRS)

    Seaman, C. H.; Sidwell, L. B.

    1979-01-01

    The 1978 scheduled solar cell calibration balloon flight was successfully completed. Thirty six modules were carried to an altitude of above 36 kilometers. Recovery of telemetry and flight packages was without incident. These calibrated standard cells are used as reference standards in simulator testing of cells and arrays with similar spectral response characteristics. The factors affecting the spectral transmission of the atmosphere at various altitudes are summarized.

  3. Adjusting for partial verification or workup bias in meta-analyses of diagnostic accuracy studies.

    PubMed

    de Groot, Joris A H; Dendukuri, Nandini; Janssen, Kristel J M; Reitsma, Johannes B; Brophy, James; Joseph, Lawrence; Bossuyt, Patrick M M; Moons, Karel G M

    2012-04-15

    A key requirement in the design of diagnostic accuracy studies is that all study participants receive both the test under evaluation and the reference standard test. For a variety of practical and ethical reasons, sometimes only a proportion of patients receive the reference standard, which can bias the accuracy estimates. Numerous methods have been described for correcting this partial verification bias or workup bias in individual studies. In this article, the authors describe a Bayesian method for obtaining adjusted results from a diagnostic meta-analysis when partial verification or workup bias is present in a subset of the primary studies. The method corrects for verification bias without having to exclude primary studies with verification bias, thus preserving the main advantages of a meta-analysis: increased precision and better generalizability. The results of this method are compared with the existing methods for dealing with verification bias in diagnostic meta-analyses. For illustration, the authors use empirical data from a systematic review of studies of the accuracy of the immunohistochemistry test for diagnosis of human epidermal growth factor receptor 2 status in breast cancer patients.

  4. NASA software documentation standard software engineering program

    NASA Technical Reports Server (NTRS)

    1991-01-01

    The NASA Software Documentation Standard (hereinafter referred to as Standard) can be applied to the documentation of all NASA software. This Standard is limited to documentation format and content requirements. It does not mandate specific management, engineering, or assurance standards or techniques. This Standard defines the format and content of documentation for software acquisition, development, and sustaining engineering. Format requirements address where information shall be recorded and content requirements address what information shall be recorded. This Standard provides a framework to allow consistency of documentation across NASA and visibility into the completeness of project documentation. This basic framework consists of four major sections (or volumes). The Management Plan contains all planning and business aspects of a software project, including engineering and assurance planning. The Product Specification contains all technical engineering information, including software requirements and design. The Assurance and Test Procedures contains all technical assurance information, including Test, Quality Assurance (QA), and Verification and Validation (V&V). The Management, Engineering, and Assurance Reports is the library and/or listing of all project reports.

  5. Simulation studies of the fidelity of biomolecular structure ensemble recreation

    NASA Astrophysics Data System (ADS)

    Lätzer, Joachim; Eastwood, Michael P.; Wolynes, Peter G.

    2006-12-01

    We examine the ability of Bayesian methods to recreate structural ensembles for partially folded molecules from averaged data. Specifically we test the ability of various algorithms to recreate different transition state ensembles for folding proteins using a multiple replica simulation algorithm using input from "gold standard" reference ensembles that were first generated with a Gō-like Hamiltonian having nonpairwise additive terms. A set of low resolution data, which function as the "experimental" ϕ values, were first constructed from this reference ensemble. The resulting ϕ values were then treated as one would treat laboratory experimental data and were used as input in the replica reconstruction algorithm. The resulting ensembles of structures obtained by the replica algorithm were compared to the gold standard reference ensemble, from which those "data" were, in fact, obtained. It is found that for a unimodal transition state ensemble with a low barrier, the multiple replica algorithm does recreate the reference ensemble fairly successfully when no experimental error is assumed. The Kolmogorov-Smirnov test as well as principal component analysis show that the overlap of the recovered and reference ensembles is significantly enhanced when multiple replicas are used. Reduction of the multiple replica ensembles by clustering successfully yields subensembles with close similarity to the reference ensembles. On the other hand, for a high barrier transition state with two distinct transition state ensembles, the single replica algorithm only samples a few structures of one of the reference ensemble basins. This is due to the fact that the ϕ values are intrinsically ensemble averaged quantities. The replica algorithm with multiple copies does sample both reference ensemble basins. In contrast to the single replica case, the multiple replicas are constrained to reproduce the average ϕ values, but allow fluctuations in ϕ for each individual copy. These fluctuations facilitate a more faithful sampling of the reference ensemble basins. Finally, we test how robustly the reconstruction algorithm can function by introducing errors in ϕ comparable in magnitude to those suggested by some authors. In this circumstance we observe that the chances of ensemble recovery with the replica algorithm are poor using a single replica, but are improved when multiple copies are used. A multimodal transition state ensemble, however, turns out to be more sensitive to large errors in ϕ (if appropriately gauged) and attempts at successful recreation of the reference ensemble with simple replica algorithms can fall short.

  6. Null test fourier domain alignment technique for phase-shifting point diffraction interferometer

    DOEpatents

    Naulleau, Patrick; Goldberg, Kenneth Alan

    2000-01-01

    Alignment technique for calibrating a phase-shifting point diffraction interferometer involves three independent steps where the first two steps independently align the image points and pinholes in rotation and separation to a fixed reference coordinate system, e.g, CCD. Once the two sub-elements have been properly aligned to the reference in two parameters (separation and orientation), the third step is to align the two sub-element coordinate systems to each other in the two remaining parameters (x,y) using standard methods of locating the pinholes relative to some easy to find reference point.

  7. Free-breathing Sparse Sampling Cine MR Imaging with Iterative Reconstruction for the Assessment of Left Ventricular Function and Mass at 3.0 T.

    PubMed

    Sudarski, Sonja; Henzler, Thomas; Haubenreisser, Holger; Dösch, Christina; Zenge, Michael O; Schmidt, Michaela; Nadar, Mariappan S; Borggrefe, Martin; Schoenberg, Stefan O; Papavassiliu, Theano

    2017-01-01

    Purpose To prospectively evaluate the accuracy of left ventricle (LV) analysis with a two-dimensional real-time cine true fast imaging with steady-state precession (trueFISP) magnetic resonance (MR) imaging sequence featuring sparse data sampling with iterative reconstruction (SSIR) performed with and without breath-hold (BH) commands at 3.0 T. Materials and Methods Ten control subjects (mean age, 35 years; range, 25-56 years) and 60 patients scheduled to undergo a routine cardiac examination that included LV analysis (mean age, 58 years; range, 20-86 years) underwent a fully sampled segmented multiple BH cine sequence (standard of reference) and a prototype undersampled SSIR sequence performed during a single BH and during free breathing (non-BH imaging). Quantitative analysis of LV function and mass was performed. Linear regression, Bland-Altman analysis, and paired t testing were performed. Results Similar to the results in control subjects, analysis of the 60 patients showed excellent correlation with the standard of reference for single-BH SSIR (r = 0.93-0.99) and non-BH SSIR (r = 0.92-0.98) for LV ejection fraction (EF), volume, and mass (P < .0001 for all). Irrespective of breath holding, LV end-diastolic mass was overestimated with SSIR (standard of reference: 163.9 g ± 58.9, single-BH SSIR: 178.5 g ± 62.0 [P < .0001], non-BH SSIR: 175.3 g ± 63.7 [P < .0001]); the other parameters were not significantly different (EF: 49.3% ± 11.9 with standard of reference, 48.8% ± 11.8 with single-BH SSIR, 48.8% ± 11 with non-BH SSIR; P = .03 and P = .12, respectively). Bland-Altman analysis showed similar measurement errors for single-BH SSIR and non-BH SSIR when compared with standard of reference measurements for EF, volume, and mass. Conclusion Assessment of LV function with SSIR at 3.0 T is noninferior to the standard of reference irrespective of BH commands. LV mass, however, is overestimated with SSIR. © RSNA, 2016 Online supplemental material is available for this article.

  8. Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs).

    PubMed

    Bailey, Timothy S; Klaff, Leslie J; Wallace, Jane F; Greene, Carmine; Pardo, Scott; Harrison, Bern; Simmons, David A

    2016-07-01

    As blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations. Two clinical studies assessed the performance of a new BGMS, using different reference instrument procedures. BGMS and YSI analyzer results were compared for fingertip blood that was obtained by untrained subjects' self-testing and study staff testing, respectively. YSI analyzer accuracy was monitored using traceable serum controls. In study 1 (N = 136), 94.1% of BGMS results were within International Organization for Standardization (ISO) 15197:2013 accuracy criteria; YSI analyzer serum control results showed a negative bias (-0.64% to -2.48%) at the first site and a positive bias (3.36% to 6.91%) at the other site. In study 2 (N = 329), 97.8% of BGMS results were within accuracy criteria; serum controls showed minimal bias (<0.92%) at both sites. These findings suggest that the ability to demonstrate that a BGMS meets accuracy guidelines is influenced by reference instrument accuracy. © 2016 Diabetes Technology Society.

  9. The Quantitative Science of Evaluating Imaging Evidence.

    PubMed

    Genders, Tessa S S; Ferket, Bart S; Hunink, M G Myriam

    2017-03-01

    Cardiovascular diagnostic imaging tests are increasingly used in everyday clinical practice, but are often imperfect, just like any other diagnostic test. The performance of a cardiovascular diagnostic imaging test is usually expressed in terms of sensitivity and specificity compared with the reference standard (gold standard) for diagnosing the disease. However, evidence-based application of a diagnostic test also requires knowledge about the pre-test probability of disease, the benefit of making a correct diagnosis, the harm caused by false-positive imaging test results, and potential adverse effects of performing the test itself. To assist in clinical decision making regarding appropriate use of cardiovascular diagnostic imaging tests, we reviewed quantitative concepts related to diagnostic performance (e.g., sensitivity, specificity, predictive values, likelihood ratios), as well as possible biases and solutions in diagnostic performance studies, Bayesian principles, and the threshold approach to decision making. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. 40 CFR Appendix Xiv to Part 86 - Determination of Acceptable Durability Test Schedule for Light-Duty Vehicles and Light Light-Duty...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... schedule in step 1 of this appendix. This schedule will be designated as the standard (std) test schedule...)2/Ns))std Where: Xs = Individual mileages at which the vehicle will be tested. Ns = Total number of.... Refer to table I and determine tp at (Np − 2)prop degrees of freedom and ts at (Ns − 2)std. 6. If (Aprop...

  11. 40 CFR Appendix Xiv to Part 86 - Determination of Acceptable Durability Test Schedule for Light-Duty Vehicles and Light Light-Duty...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... schedule in step 1 of this appendix. This schedule will be designated as the standard (std) test schedule...)2/Ns))std Where: Xs = Individual mileages at which the vehicle will be tested. Ns = Total number of.... Refer to table I and determine tp at (Np − 2)prop degrees of freedom and ts at (Ns − 2)std. 6. If (Aprop...

  12. 40 CFR Appendix Xiv to Part 86 - Determination of Acceptable Durability Test Schedule for Light-Duty Vehicles and Light Light-Duty...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... schedule in step 1 of this appendix. This schedule will be designated as the standard (std) test schedule...)2/Ns))std Where: Xs = Individual mileages at which the vehicle will be tested. Ns = Total number of.... Refer to table I and determine tp at (Np − 2)prop degrees of freedom and ts at (Ns − 2)std. 6. If (Aprop...

  13. 40 CFR Appendix Xiv to Part 86 - Determination of Acceptable Durability Test Schedule for Light-Duty Vehicles and Light Light-Duty...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... schedule in step 1 of this appendix. This schedule will be designated as the standard (std) test schedule...)2/Ns))std Where: Xs = Individual mileages at which the vehicle will be tested. Ns = Total number of.... Refer to table I and determine tp at (Np − 2)prop degrees of freedom and ts at (Ns − 2)std. 6. If (Aprop...

  14. Certification of a reference material for determination of total cyanide in soil to support implementation of the International Standard ISO 11262:2011.

    PubMed

    Scharf, Holger; Bremser, Wolfram

    2015-04-01

    Cyanides are among the most important inorganic pollutants to be tested and monitored in environmental compartments. They can be distinguished and determined as free cyanide, weak acid dissociable cyanide or as total cyanide. However, in any case obtained, measurement results are operationally defined referring to the applied analytical method. In 2011, the International Standard ISO 11262 has been published which specifies a normative analytical method for the determination of total cyanide in soil. The objective of the project described in this paper was to provide the first soil reference material (CRM) certified for its mass fraction of total cyanide on the basis of this standard. A total of 12 German laboratories with proven experience in the determination of cyanides in environmental samples participated in the certification study. Measurement results were evaluated in full compliance with the requirements of ISO Guide 35. Taking into account the results of the inter-laboratory comparison as well as the outcome of the homogeneity and stability studies, a certified mass fraction of total cyanide of 21.1 mg/kg and an expanded uncertainty (k = 2) of 1.3 mg/kg were assigned to the material. The reference material has been issued as CRM BAM-U114.

  15. Accuracy of endoscopic and videofluoroscopic evaluations of swallowing for oropharyngeal dysphagia.

    PubMed

    Giraldo-Cadavid, Luis Fernando; Leal-Leaño, Lorena Renata; Leon-Basantes, Guillermo Alfredo; Bastidas, Alirio Rodrigo; Garcia, Rafael; Ovalle, Sergio; Abondano-Garavito, Jorge E

    2017-09-01

    A systematic review and meta-analysis of the literature was conducted to compare the accuracy with which flexible endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallowing study (VFSS) assessed oropharyngeal dysphagia in adults. PubMed, Embase, and the Latin American and Caribbean Health Sciences Literature (LILACS) database. A review of published studies was conducted in parallel by two groups of researchers. We evaluated the methodological quality, homogeneity, threshold effect, and publication bias. The results are presented as originally published, then with each test compared against the other as a reference and both compared against a composite reference standard, and then pooled using a random effects model. Software use consisted of Meta-DiSc and SPSS. The search yielded 5,697 articles. Fifty-two articles were reviewed in full text, and six articles were included in the meta-analysis. FEES showed greater sensitivity than VFSS for aspiration (0.88 vs. 0.77; P = .03), penetration (0.97 vs. 0.83; P = .0002), and laryngopharyngeal residues (0.97 vs. 0.80; P < .0001). Sensitivity to detect pharyngeal premature spillage was similar for both tests (VFSS: 0.80; FEES: 0.69; P = .28). The specificities of both tests were similar (range, 0.93-0.98). In the sensitivity analysis there were statistically significant differences between the tests regarding residues but only marginally significant differences regarding aspiration and penetration. FEES had a slight advantage over VFSS to detect aspiration, penetration, and residues. Prospective studies comparing both tests against an appropriate reference standard are needed to define which test has greater accuracy. 2a Laryngoscope, 127:2002-2010, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

  16. Observational study: microgravity testing of a phase-change reference on the International Space Station

    PubMed Central

    Topham, T Shane; Bingham, Gail E; Latvakoski, Harri; Podolski, Igor; Sychev, Vladimir S; Burdakin, Andre

    2015-01-01

    Background: Orbital sensors to monitor global climate change during the next decade require low-drift rates for onboard thermometry, which is currently unattainable without on-orbit recalibration. Phase-change materials (PCMs), such as those that make up the ITS-90 standard, are seen as the most reliable references on the ground and could be good candidates for orbital recalibration. Space Dynamics Lab (SDL) has been developing miniaturized phase-change references capable of deployment on an orbital blackbody for nearly a decade. Aims: Improvement of orbital temperature measurements for long duration earth observing and remote sensing. Methods: To determine whether and how microgravity will affect the phase transitions, SDL conducted experiments with ITS-90 standard material (gallium, Ga) on the International Space Station (ISS) and compared the phase-change temperature with earth-based measurements. The miniature on-orbit thermal reference (MOTR) experiment launched to the ISS in November 2013 on Soyuz TMA-11M with the Expedition 38 crew and returned to Kazakhstan in March 2014 on the Soyuz TMA-10 spacecraft. Results: MOTR tested melts and freezes of Ga using repeated 6-h cycles. Melt cycles obtained on the ground before and after launch were compared with those obtained on the ISS. Conclusions: To within a few mK uncertainty, no significant difference between the melt temperature of Ga at 1 g and in microgravity was observed. PMID:28725713

  17. Observational study: microgravity testing of a phase-change reference on the International Space Station.

    PubMed

    Topham, T Shane; Bingham, Gail E; Latvakoski, Harri; Podolski, Igor; Sychev, Vladimir S; Burdakin, Andre

    2015-01-01

    Orbital sensors to monitor global climate change during the next decade require low-drift rates for onboard thermometry, which is currently unattainable without on-orbit recalibration. Phase-change materials (PCMs), such as those that make up the ITS-90 standard, are seen as the most reliable references on the ground and could be good candidates for orbital recalibration. Space Dynamics Lab (SDL) has been developing miniaturized phase-change references capable of deployment on an orbital blackbody for nearly a decade. Improvement of orbital temperature measurements for long duration earth observing and remote sensing. To determine whether and how microgravity will affect the phase transitions, SDL conducted experiments with ITS-90 standard material (gallium, Ga) on the International Space Station (ISS) and compared the phase-change temperature with earth-based measurements. The miniature on-orbit thermal reference (MOTR) experiment launched to the ISS in November 2013 on Soyuz TMA-11M with the Expedition 38 crew and returned to Kazakhstan in March 2014 on the Soyuz TMA-10 spacecraft. MOTR tested melts and freezes of Ga using repeated 6-h cycles. Melt cycles obtained on the ground before and after launch were compared with those obtained on the ISS. To within a few mK uncertainty, no significant difference between the melt temperature of Ga at 1 g and in microgravity was observed.

  18. 14 CFR Appendix A to Part 65 - Aircraft Dispatcher Courses

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... school. For the latest technological advancements refer to the Practical Test Standards as published by.... Instrument Approach Procedures. (1) Transition Procedures. (2) Precision Approach Procedures. (3) Non-precision Approach Procedures. (4) Minimums and the relationship to weather. G. Special Navigation and...

  19. 14 CFR Appendix A to Part 65 - Aircraft Dispatcher Courses

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... school. For the latest technological advancements refer to the Practical Test Standards as published by.... Instrument Approach Procedures. (1) Transition Procedures. (2) Precision Approach Procedures. (3) Non-precision Approach Procedures. (4) Minimums and the relationship to weather. G. Special Navigation and...

  20. 14 CFR Appendix A to Part 65 - Aircraft Dispatcher Courses

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... school. For the latest technological advancements refer to the Practical Test Standards as published by.... Instrument Approach Procedures. (1) Transition Procedures. (2) Precision Approach Procedures. (3) Non-precision Approach Procedures. (4) Minimums and the relationship to weather. G. Special Navigation and...

Top