Sensitivity of HIV rapid tests compared to fourth generation enzyme immunoassays or HIV RNA tests – A systematic review and meta-analysis


OBJECTIVE: Determine the sensitivity of rapid HIV tests (RT) compared to fourth generation 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 CINAHL were searched until 14 July 2015 for studies of adults comparing point-of-care HIV RTs to fourth generation HIV EIA Antibody/p24 Antigen or HIV NAAT. RESULTS: From 953 titles, 18 studies were included, involving 110,122 RT results. Compared to EIA, the estimated sensitivity (random effects) of RTs was 94.5% (95% CI: 87.4-97.7). Compared to NAAT, the sensitivity of RTs was 93.7% (95% CI: 88.7-96.5). The sensitivity of RTs 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 to 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 and low income countries respectively (p < 0.01). CONCLUSIONS: In clinical settings RTs were less sensitive in high income countries compared to low income countries, missing about one in seven infections, possibly due to the larger proportion of acute infections in targeted populations. This suggests that in high income countries RTs should be used in combination with fourth generation EIA or NAAT tests, except in special circumstances.


Tan WS, Chow EP, Fairley CK, Chen MY, Bradshaw CS, Read TR.




  • Population(s)
    • Other
  • Testing
    • Testing


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