TY - JOUR
T1 - A comparative meta-analysis on the variability in test performance among FDA-licensed enzyme immunosorbent assays for HIV antibody testing
AU - Kowalski, J.
AU - Tu, X. M.
AU - Jia, G.
AU - Pagano, M.
N1 - Funding Information:
We are very grateful to the many informal contacts at the Multicenter AIDS Cohort Study, Pittsburgh site and the Pittsburgh Central Blood Bank and to the numerous technical support people at Abbott Laboratories, Genetic Systems, Organon Teknika, Murex Diagnostics, and Cambridge BioTech for discussions and retrieval of package insert information on each of their manufactured EIA's over the years for HIV antibody testing. We are also very indebted to Les Irwig and one anonymous reviewer for their constructive comments that led to a much improved presentation and to editor Dr. Feinstein for support in the revision of the paper. This research was supported in part by an NIAID award AI36627 (Kowalski and Tu) and an AIDS grant A07358 (Pagano).
PY - 2001
Y1 - 2001
N2 - Background. 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). Methods. 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 generalized estimating equations. Results. Estimates of test performance were obtained across studies, with a significant (P < 0.01) difference between manufacturers. The test performance of each manufacturer significantly interacted (P < 0.05) with the following study-level covariates: type of population screened, year of diagnostic testing and study quality. Among a single manufacturer, Abbott, significant improvement in estimates of test sensitivity (P < 0.01) and specificity (P < 0.01) was observed with each newly produced antibody kit. Conclusion. Estimates on the relative differences in test performance within each manufacturer may be used for guiding decisions on the choice 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 HIV prevalence when used as prior information within a Bayesian framework or for standardizing test results among various manufacturers.
AB - Background. 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). Methods. 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 generalized estimating equations. Results. Estimates of test performance were obtained across studies, with a significant (P < 0.01) difference between manufacturers. The test performance of each manufacturer significantly interacted (P < 0.05) with the following study-level covariates: type of population screened, year of diagnostic testing and study quality. Among a single manufacturer, Abbott, significant improvement in estimates of test sensitivity (P < 0.01) and specificity (P < 0.01) was observed with each newly produced antibody kit. Conclusion. Estimates on the relative differences in test performance within each manufacturer may be used for guiding decisions on the choice 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 HIV prevalence when used as prior information within a Bayesian framework or for standardizing test results among various manufacturers.
KW - Diagnostic test
KW - Enzyme immunosorbent assay
KW - HIV
KW - Meta-analysis
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U2 - 10.1016/S0895-4356(00)00320-6
DO - 10.1016/S0895-4356(00)00320-6
M3 - Article
C2 - 11337207
AN - SCOPUS:0035031434
SN - 0895-4356
VL - 54
SP - 448
EP - 461
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 5
ER -