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

Steven Baveewo,Judith A Hahn,Moses R Kamya,David R Bangsberg,Thomas Coates,Robin Fatch,Rhoda K Wanyenze,Harriet Mayanja-Kizza

doi:10.1186/1756-0500-5-154

Abstract

BackgroundRapid 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.ResultsOf 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.ConclusionAlthough 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.

Highlights

Rapid HIV tests provide same-day results and are widely used in HIV testing programs in areas with limited personnel and laboratory infrastructure
Study procedures The study was conducted as part of the HIV VCT and Linkage to Care study in Mulago hospital [10]; a research collaboration between Makerere University, University of California Los Angeles (UCLA) and University of California San Francisco (UCSF)
Subjects that tested positive on Determine, negative on STAT-PAK and negative on UniGold were reported as negative

Summary

Introduction

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. Rapid HIV tests provide quick results [1], usually in less than 30 minutes, can be performed by any adequately trained health worker, do not require sophisticated equipment and can be stored at room temperature (20°C30°C); [2]. Their diagnostic accuracy has been found to be comparable to that of Enzyme Linked Immunosorbent Assay (ELISA) [1,3]. Despite the high sensitivity and specificity, rapid diagnostic tests have a rare potential for false negative and false positive test results [8]

Methods

Results

Discussion

Conclusion