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AIDS. 2016 Jul 31;30(12):1951-60. doi: 10.1097/QAD.0000000000001134.

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

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aNational Skin Centre, Singapore, Singapore bMelbourne Sexual Health Centre, Alfred Health, Carlton cCentral Clinical School, Monash University, Melbourne, Victoria, Australia.



Determine the sensitivity of HIV rapid tests compared with fourth-generation enzyme immunoassays (EIA) or nucleic acid amplification tests (NAAT) in clinical settings.


Systematic review and meta-analysis.


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.


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).


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.Supplementary video link:

[Indexed for MEDLINE]

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