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

Background. Although independently published studies have compared diagnost ic test performance among various manufactured enzyme immunosorbent assays (EIAs) used in HIV antibody testing, none have attempted to formally synthe size such results through a comparative meta-analysis. In particular, no es timates 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 di fferences in manufacturer test performance in practice (after FDA approval) . Methods. Retrieval of studies was done using several searching strategies , while retrieval of manufacturer information was done through package inse rts and direct contacts. Comparisons of HIV antibody test performance acros s manufacturers and within a single manufacturer were made based on 16 esti mates (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 covariate s on the performance of these EIAs, with overall estimates of manufacturer test performance and associated variability obtained based on generalized e stimating equations. Results. Estimates of test performance were obtained a cross studies, with a significant (P < 0.01) difference between manufacture rs. The test performance of each manufacturer significantly interacted (P < 0.05) with the following study-level covariates: type of population screen ed, year of diagnostic testing and study quality. Among a single manufactur er, Abbott, significant improvement in estimates of test sensitivity (P < 0 .01) and specificity (P < 0.01) was observed with each newly produced antib ody kit. Conclusion. Estimates on the relative differences in test performa nce within each manufacturer may be used for guiding decisions on the choic e of EIA test kit for HIV antibodies, given the type of population screened , as well as cost and time considerations. In addition, the results of this meta-analysis may be used in modeling HTV prevalence when used as prior in formation within a Bayesian framework or for standardizing test results amo ng various manufacturers. <(c)> 2001 Elsevier Science Inc. All rights reser ved.