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Open Access Highly Accessed Research article

Potential for false positive HIV test results with the serial rapid HIV testing algorithm

Steven Baveewo1*, Moses R Kamya1, Harriet Mayanja-Kizza1, Robin Fatch3, David R Bangsberg4, Thomas Coates5, Judith A Hahn3 and Rhoda K Wanyenze2

Author Affiliations

1 Department of Medicine, Makerere University School of Medicine, Kampala, Uganda

2 Department of Disease Control and Environmental Health, Makerere University School of Public Health, Kampala, Uganda

3 Department of Medicine San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA

4 Massachusetts General Hospital Center for Global Health and Harvard Medical School, Boston, Massachusetts, USA

5 Division of Infectious Diseases, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA

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BMC Research Notes 2012, 5:154  doi:10.1186/1756-0500-5-154

Published: 19 March 2012

Abstract

Background

Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure. The Uganda Ministry of Health currently recommends the serial rapid testing algorithm with Determine, STAT-PAK, and Uni-Gold for diagnosis of HIV infection. Using this algorithm, individuals who test positive on Determine, negative to STAT-PAK and positive to Uni-Gold are reported as HIV positive. We conducted further testing on this subgroup of samples using qualitative DNA PCR to assess the potential for false positive tests in this situation.

Results

Of the 3388 individuals who were tested, 984 were HIV positive on two consecutive tests, and 29 were considered positive by a tiebreaker (positive on Determine, negative on STAT-PAK, and positive on Uni-Gold). However, when the 29 samples were further tested using qualitative DNA PCR, 14 (48.2%) were HIV negative.

Conclusion

Although this study was not primarily designed to assess the validity of rapid HIV tests and thus only a subset of the samples were retested, the findings show a potential for false positive HIV results in the subset of individuals who test positive when a tiebreaker test is used in serial testing. These findings highlight a need for confirmatory testing for this category of individuals.

Keywords:
False positive; HIV testing algorithm; Rapid diagnostic tests; Qualitative PCR testing