Sensitivity of HIV rapid tests compared with fourth-generation enzyme immunoassays or HIV RNA tests

Objective: Determine the sensitivity of HIV rapid tests compared with fourthgeneration enzyme immunoassays (EIA) or nucleic acid amplification tests (NAAT) in clinical settings. 

Design: Systematic review and meta-analysis. 

Methods: Medline, PubMed, Embase, Cochrane Controlled Trials Register, Cochrane reviews and Cumulative Index to Nursing and Allied Health Literature were searched until 14 July 2015 for studies of adults comparing point-of-care HIV rapid tests to fourth-generation HIV EIA antibody/p24 antigen or HIV NAAT. 

Results: From 953 titles, 18 studies were included, involving 110 122 HIV rapid test results. Compared with EIA, the estimated sensitivity (random effects) of HIV rapid tests was 94.5% [95% confidence interval (CI): 87.4–97.7]. Compared with NAAT, the sensitivity of HIV rapid tests was 93.7% (95% CI: 88.7–96.5). The sensitivity of HIV rapid tests in high-income countries was 85.7% (95% CI: 81.9–88.9) and in low-income countries was 97.7% (95% CI: 95.2–98.9) compared with either EIA or NAAT (P < 0.01 for difference between settings). Proportions of antibody negative acute infections were 13.6 (95% CI: 10.1–18.0) and 4.7% (95% CI: 2.8–7.7) in studies from high-income and low-income countries, respectively (P < 0.01). 

Conclusion: In clinical settings, HIV rapid tests were less sensitive in high-income countries compared with low-income countries, missing about one in seven infections, possibly because of the larger proportion of acute infections in targeted populations. This suggests that in high-income countries, HIV rapid tests should be used in combination with fourth-generation EIA or NAAT tests, except in special circumstances. Prospective Registration of Systematic Reviews registration number CRD42015020154.