PMID: 11337207May 5, 2001Paper

A comparative meta-analysis on the variability in test performance among FDA-licensed enzyme immunosorbent assays for HIV antibody testing

Journal of Clinical Epidemiology
J KowalskiM Pagano

Abstract

Although independently published studies have compared diagnostic test performance among various manufactured enzyme immunosorbent assays (EIAs) used in HIV antibody testing, none have attempted to formally synthesize such results through a comparative meta-analysis. In particular, no estimates of post-FDA approval test performance, in terms of sensitivity and specificity, and their associated variability within each manufacturer, has been reported in the literature, along with an analysis of the relative differences in manufacturer test performance in practice (after FDA approval). Retrieval of studies was done using several searching strategies, while retrieval of manufacturer information was done through package inserts and direct contacts. Comparisons of HIV antibody test performance across manufacturers and within a single manufacturer were made based on 16 estimates (from 11 articles) and 33 estimates (from 19 articles), respectively. A generalized linear model, based upon Bayes estimates of sensitivity and specificity, was used to assess the impact of several study-level covariates on the performance of these EIAs, with overall estimates of manufacturer test performance and associated variability obtained based on genera...Continue Reading

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Citations

Feb 10, 2006·Clinical and Vaccine Immunology : CVI·Elias Zintzaras, Anastasios E Germenis
Apr 28, 2009·Infectious Disease Clinics of North America·Mario Cruciani, Carlo Mengoli
Feb 24, 2011·Expert Review of Anti-infective Therapy·Gláucia Fernandes CotaMarcos Roberto de Sousa

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