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AbstractHIV rapid diagnostic tests have enabled widespread implementation of HIV programs in resource-limited settings. If the tests used in the diagnostic algorithm are susceptible to the same cause for false positivity, a false-positive diagnosis may result in devastating consequences. In resource-limited settings, the lack of routine confirmatory testing, compounded by incorrect interpretation of weak positive test lines and use of tie-breaker algorithms, can leave a false-positive diagnosis undetected. We propose that heightened CD5+ and early B-lymphocyte response polyclonal cross-reactivity are a major cause of HIV false positivity in certain settings; thus, test performance may vary significantly in different geographical areas and populations. There is an urgent need for policy makers to recognize that HIV rapid diagnostic tests are screening tests and mandate confirmatory testing before reporting an HIV-positive result. In addition, weak positive results should not be recognized as valid except in the screening of blood donors.
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- Authors: Harbertson J, Hale BR, Tran BR, Thomas AG, Grillo MP, Jacobs MB, McAnany J, Shaffer RA
- Issue date: 2017
- The evaluation of a rapid in situ HIV confirmation test in a programme with a high failure rate of the WHO HIV two-test diagnostic algorithm.
- Authors: Klarkowski DB, Wazome JM, Lokuge KM, Shanks L, Mills CF, O'Brien DP
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- False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes.
- Authors: Shanks L, Klarkowski D, O'Brien DP
- Issue date: 2013
- False positivity of non-targeted infections in malaria rapid diagnostic tests: the case of human african trypanosomiasis.
- Authors: Gillet P, Mumba Ngoyi D, Lukuka A, Kande V, Atua B, van Griensven J, Muyembe JJ, Jacobs J, Lejon V
- Issue date: 2013
- Dilution testing using rapid diagnostic tests in a HIV diagnostic algorithm: a novel alternative for confirmation testing in resource limited settings.
- Authors: Shanks L, Siddiqui MR, Abebe A, Piriou E, Pearce N, Ariti C, Masiga J, Muluneh L, Wazome J, Ritmeijer K, Klarkowski D
- Issue date: 2015 May 14