Rapid Point-of-Care First-Line Screening Tests for Hepatitis B Infection: A Meta-Analysis of Diagnostic Accuracy (1980–2010)

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OBJECTIVES:Three-hundred fifty million people worldwide are chronically infected with Hepatitis B, with four million acute infections annually. With infection concentrated in hard-to-reach populations and low resource settings, rapid point-of-care (POC) tests offer an efficient screening alternative to laboratory tests. We conducted a meta-analysis to evaluate accuracy of rapid POC tests screening for Hepatitis B.METHODS:Two reviewers searched four databases, critiqued quality. A hierarchical Bayesian meta-analysis correcting for imperfect reference standards was used. Based on components of the antigen–antibody response, 17 studies were stratified into three subgroups: (i) Hepatitis B surface antigen (HBsAg) tests; (ii) anti-HBsAg tests, and (iii) HBs+eAg tests. Further, we pooled estimates on individual tests with sufficient data.RESULTS:In subgroup 1, the pooled sensitivity (Sn) was 94.76% (95% credible interval (CrI): 90.08–98.23%) and specificity (Sp) was 99.54% (95% CrI: 99.03–99.95%). The Determine test reported a pooled Sn 98.2% (95% CrI: 94.7, 99.9) and Sp 99.9% (95% CrI: 99.3, 100); in subgroup 2, Sn 93.2% (95% CrI: 85.1, 98.5), Sp 93.1% (95% CrI: 81.9, 99.9); and in subgroup 3, the Binax test showed Sn 95.5% (95% CrI: 88.9, 99.4), Sp 99.8% (95% CrI: 99.3, 100).CONCLUSIONS:HBsAg tests, including Determine, and the HBs+eAg test, Binax showed high accuracy. Improvements in sensitivity of antibody-based tests will enhance their potential for global first-line screening.

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