Test Validation

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12 record(s) found




ID Author(s) Title / Description Publication Year
9408 LabCompliance

Analytical Methods Validation FDA and International Guidelines and Private Publications
Analytical Methods Validation FDA and International Guidelines and Private Publications
URL: http://www.labcompliance.com/info/links/methods/guidelines.aspx

This website consolidates several links on test validation. Test validation confirms that the analytical procedure employed for a specific test is suitable for its intended use. FDA regulations such…

This website consolidates several links on test validation. Test validation confirms that the analytical procedure employed for a specific test is suitable for its intended use. FDA regulations such as GMP, GLP and GCP and quality standards such as ISO17025 require analytical methods to be validated before and during routine use. There are no specific regulations on method validations but the FDA, other agencies and industry task forces have developed guidelines for method validation. This site provides links to such guidelines.

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Source: LabCompliance

Keywords:

analytical methods, Food and Drug Administration, testing, validity

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n/a
9407 Thompson, M.; Ellison, S.; Wood, R.; International Union of Pure and Applied Chemistry

Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)
Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC Technical Report)
URL: http://www.iupac.org/objID/Article/pac7405x0835

This IUPAC technical report is the result of the Symposium on Harmonization of Quality Assurance Systems for Analytical Laboratories, held in Budapest, Hungary, 4-5 November 1999, under the sponsorship…

This IUPAC technical report is the result of the Symposium on Harmonization of Quality Assurance Systems for Analytical Laboratories, held in Budapest, Hungary, 4-5 November 1999, under the sponsorship of IUPAC, ISO, and AOAC International.

Method validation is one of the measures universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry. This technical report provides background information, existing protocols, standards, and guides, definitions and terminology, methods validation, uncertainty, and quality assurance, basic principles of method validation, and the conduct and extent of validation studies. These guidelines provide minimum recommendations on procedures that should be employed to ensure adequate validation of analytical methods.

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Source: Pure Appl. Chem., Vol. 74, No. 5, 2002, p. 835-855.

Keywords:

detection limit, laboratory techniques, model validation, monitoring, terminology, testing, validity

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20020000
2002
8258 Greiner, M.; Gardner, I.A.

Epidemiologic issues in the validation of veterinary diagnostic tests
Epidemiologic issues in the validation of veterinary diagnostic tests
URL: http://dx.doi.org/10.1016/S0167-5877(00)00114-8

In this review, the authors critically discuss the objectives, methods and limitations of different approaches for the validation of diagnostic tests. Also, the writers show (based on published data…

In this review, the authors critically discuss the objectives, methods and limitations of different approaches for the validation of diagnostic tests. Also, the writers show (based on published data and our own experiences) that estimates for the diagnostic sensitivity and specificity may vary among populations and/or subpopulations of animals, conditional on the distribution of influential covariates.

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Source: Preventive Veterinary Medicine., Vol. 45, No. 1-2, May 30, 2000, p. 3-22.

Keywords:

animal diseases, animal health, diagnostic sensitivity, diagnostic specificity, epidemiology, model validation, validity

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20000530
2000
8255 Gardner, I.A.; Stryhn, H.; Lind, P.; Collins, M.T.

Conditional dependence between tests affects the diagnosis and surveillance of animal diseases
Conditional dependence between tests affects the diagnosis and surveillance of animal diseases
URL: http://dx.doi.org/10.1016/S0167-5877(00)00119-7

This study calculates conditional covariances as a measure of dependence between binary tests and shows their relationship. The writers use published data for toxoplasmosis and brucellosis in swine, and…

This study calculates conditional covariances as a measure of dependence between binary tests and shows their relationship. The writers use published data for toxoplasmosis and brucellosis in swine, and Johne’s disease in cattle to illustrate calculation methods and to indicate the likely magnitude of the dependence between serologic tests used for diagnosis and surveillance of animal diseases.

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Source: Preventive Veterinary Medicine, Vol. 45, No. 1-2, May 30, 2000, p. 107-122.

Keywords:

animal diseases, bacteria, Brucella, cattle, monitoring, pathogens, pork, Protozoa, swine, Toxoplasma gondii

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20000530
2000
8254 Pouillo, R.; Gerbier, G.; Gardner, I.A.

“TAGS”, a program for the evaluation of test accuracy in the absence of a gold standard
“TAGS”, a program for the evaluation of test accuracy in the absence of a gold standard
URL: http://dx.doi.org/10.1016/S0167-5877(01)00272-0

The investigators describe the development of a program (implemented in R and S-Plus software) for this purpose that yields maximum-likelihood estimates of sensitivity, specificity and prevalence. Also implemented includes…

The investigators describe the development of a program (implemented in R and S-Plus software) for this purpose that yields maximum-likelihood estimates of sensitivity, specificity and prevalence. Also implemented includes an HTML form, which submits data to a web-based interface to R.

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Source: Preventive Veterinary Medicine, Vol. 53, No. 1-2, Feb. 14, 2002, p. 67-81.

Keywords:

animal health, diagnostic sensitivity, diagnostic specificity, diagnostic techniques, infection, reference standards

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20020214
2002
8253 Hanson, T.; Johnson, W.O.; Gardner, I.A.

Hierarchical Models for Estimating Herd Prevalence and Test Accuracy in the Absence of a Gold Standard
Hierarchical Models for Estimating Herd Prevalence and Test Accuracy in the Absence of a Gold Standard
URL: http://faculty.vetmed.ucdavis.edu/faculty/iagardner/diagnostictests/pub-hanson.pdf

In this study, the authors propose a class of hierarchical models for the purpose of estimating the herd-level prevalence distribution and the accuracies of two tests in the absence…

In this study, the authors propose a class of hierarchical models for the purpose of estimating the herd-level prevalence distribution and the accuracies of two tests in the absence of a gold standard when several exchangeable populations with differing disease prevalence are available for sampling, relaxing the assumption of conditional independence between tests. The models are used to estimate the prevalence of bovine brucellosis in Mexican cow herds and to estimate the error rates of two tests for the detection of swine pneumonia.

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Source: Journal of Agricultural, Biological, and Environmental Statistics, Vol. 8, No. 2, Jun. 1, 2003, p. 223-239.

Keywords:

animal diseases, beef cows, Brucella, cattle, detection, diagnostic techniques, disease prevalence, models, pork, reference standards, statistics, swine

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20030601
2003
8249 Su, C.; Gardner, I.A.; Johnson, W.O.

Diagnostic test accuracy and prevalence inferences based on joint and sequential testing with finite population sampling
Diagnostic test accuracy and prevalence inferences based on joint and sequential testing with finite population sampling
URL: http://www3.interscience.wiley.com/journal/109085308/abstract

In this paper, the writers develop statistical methods for evaluating diagnostic test accuracy and prevalence estimation based on finite sample data in the absence of a gold standard. Moreover,…

In this paper, the writers develop statistical methods for evaluating diagnostic test accuracy and prevalence estimation based on finite sample data in the absence of a gold standard. Moreover, two tests are often applied simultaneously for the purpose of obtaining a joint testing strategy that has either higher overall sensitivity or specificity than either of the two tests considered singly. Sequential versions of such strategies are often applied in order to reduce the cost of testing. Thus, joint (simultaneous and sequential) testing strategies and inference for them are discussed.

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Source: Statistics in Medicine, Vol. 23, No. 14, Jun. 29, 2004, p. 2237 - 2255.

Keywords:

animal diseases, animal health, cattle, diagnostic sensitivity, diagnostic specificity, diagnostic techniques, disease prevalence, population characteristics, reference standards

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20040629
2004
8247 Branscum, A.J.; Johnson, W.O.; Gardner, I.A.

Estimation of diagnostic-test sensitivity and specificity through Bayesian modeling
Estimation of diagnostic-test sensitivity and specificity through Bayesian modeling
URL: http://dx.doi.org/10.1016/j.prevetmed.2004.12.005

Here, recent Bayesian approaches to estimation (based on cross-sectional sampling designs) of the sensitivity and specificity of one or more diagnostic tests are reviewed. The primary goal is to…

Here, recent Bayesian approaches to estimation (based on cross-sectional sampling designs) of the sensitivity and specificity of one or more diagnostic tests are reviewed. The primary goal is to provide veterinary researchers with a concise presentation of the computational aspects involved in using the Bayesian framework for test evaluation. The authors consider estimation of diagnostic-test sensitivity and specificity in the following settings: (i) one test in one population, (ii) two conditionally independent tests in two or more populations, (iii) two correlated tests in two or more populations, and (iv) three tests in two or more populations, where two tests are correlated but jointly independent of the third test.

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Source: Preventive Veterinary Medicine, Vol. 68, No. 2-4, May 10, 2005, p. 145-163.

Keywords:

animal diseases, animal health, animal-based foods, Bayesian theory, diagnostic sensitivity, diagnostic specificity, population characteristics, pork, Protozoa, statistics, swine, Toxoplasma gondii, viruses

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20050510
2005
8246 Georgiadis, M.P.; Johnson, W.O.; Gardner, I.A.

Sample size determination for estimation of the accuracy of two conditionally independent tests in the absence of a gold standard
Sample size determination for estimation of the accuracy of two conditionally independent tests in the absence of a gold standard
URL: http://dx.doi.org/10.1016/j.prevetmed.2005.04.004

Here, the authors developed an Excel spreadsheet template to calculate sample sizes to estimate sensitivity and specificity with desired precision in the absence of a gold standard. Calculations are…

Here, the authors developed an Excel spreadsheet template to calculate sample sizes to estimate sensitivity and specificity with desired precision in the absence of a gold standard. Calculations are predicated on the use of two conditionally independent tests for screening animals from two populations and are based on the methods produced by a previous study.

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Source: Preventive Veterinary Medicine, Vol. 71, No. 1-2, Sep. 30, 2005, p. 1-10.

Keywords:

animal health, bovine tuberculosis, cattle, diagnostic sensitivity, diagnostic specificity, diagnostic techniques, population characteristics, reference standards, statistics

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20090930
2009
8244 Kostoulas, P.; Leontides, L.; Browne, W.J.; Gardner, I.A.

Bayesian estimation of variance partition coefficients adjusted for imperfect test sensitivity and specificity
Bayesian estimation of variance partition coefficients adjusted for imperfect test sensitivity and specificity
URL: http://dx.doi.org/10.1016/j.prevetmed.2009.02.008

This article presents a Bayesian discrete mixed model for the estimation of covariate-pattern-specific variance partition coefficient (VPCs) when measurement of the infection/disease is based on an imperfect test. The…

This article presents a Bayesian discrete mixed model for the estimation of covariate-pattern-specific variance partition coefficient (VPCs) when measurement of the infection/disease is based on an imperfect test. The utility of the presented model is demonstrated with three applications.

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Source: Preventive Veterinary Medicine, Vol. 89, No. 3-4, Jun 1, 2009, p.155-162 .

Keywords:

animal diseases, Bayesian theory, diagnostic sensitivity, diagnostic specificity, epidemiology, infection, public health

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20090601
2009
8242 Johnson, W.O.; Gardner, I.A.; Metoyer, C.N.; Branscum, A.J.

On the interpretation of test sensitivity in the two-test two-population problem: Assumptions matter
On the interpretation of test sensitivity in the two-test two-population problem: Assumptions matter
URL: http://dx.doi.org/10.1016/j.prevetmed.2009.06.006

In the present study, the authors provided analytical formulae that give insight into the effect of assuming constant sensitivity when this assumption was false. To further investigate the effect…

In the present study, the authors provided analytical formulae that give insight into the effect of assuming constant sensitivity when this assumption was false. To further investigate the effect of failure of the assumption of constant sensitivity, the investigators also simulated several data sets under the assumption that the first test's sensitivity varied in the two populations.

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Source: Preventive Veterinary Medicine, Vol. 91, No. 2-4, Oct. 1, 2009, p. 116-121.

Keywords:

analytical methods, animal diseases, bacteria, infection, pathogens, population characteristics

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20091001
2009
4064 Environmental Protection Agency (EPA)

Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; National Primary Drinking Water Regulations; and National Secondary Drinking Water Regulations; Analysis and Sampling Procedures; Proposed Rule
Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act; National Primary Drinking Water Regulations; and National Secondary Drinking Water Regulations; Analysis and Sampling Procedures; Proposed Rule
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2004_register&docid=fr06ap04-55

Proposed rule to change analysis and sampling procedures in wastewater regulations and to change methods in drinking water analysis and monitoring. There is also a request for comments on…

Proposed rule to change analysis and sampling procedures in wastewater regulations and to change methods in drinking water analysis and monitoring. There is also a request for comments on "EPA Microbiological Alternate Test Procedure (ATP) Protocol for Drinking Water, Ambient Water, and Wastewater Monitoring Methods"

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Source: Federal Register, Vol. 69, No. 66, Apr. 6, 2004, p. 18165-18226./GPO Access, U.S. Government Printing Office

Keywords:

analytical methods, chemical hazards, drinking water, guidelines, issues and policy, methodology, risk management

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20040406
2004