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. 2016 Mar:76:8-13.
doi: 10.1016/j.jcv.2015.12.011. Epub 2016 Jan 2.

Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM

Joanne D Stekler  1 , George Ure  2 , Joshua D O'Neal  3 , Aric Lane  4 , Fred Swanson  5 , Janine Maenza  2 , Claire Stevens  2 , Robert W Coombs  6 , Joan Dragavon  7 , Paul D Swenson  4 , Matthew R Golden  8
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Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM

Joanne D Stekler et al. J Clin Virol. 2016 Mar.

Abstract

Background and objective: The rapid test study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection.

Study design: Men and transgender persons reporting sex with men in the prior year were recruited at the Public Health-Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected.

Results: Between February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component (p=.008) and Combo overall (p=.004), and there was a trend when compared to INSTI (p=.06). The Determine Combo specificity was 98.99%.

Conclusions: As reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence.

Keywords: Background; HIV testing; Oral fluids; Rapid HIV test.

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Conflict of interest statement

Conflict of interest

None.

Figures

Figure 1
Figure 1. Study-specific and standard HIV testing, by study site
Figure 1 shows the HIV tests that occurred at each of the three participating study sites and the changes that occurred over the duration of the study. EIA: enzyme immunoassay, CMIA: chemiluminescent microparticle immunoassay, NAAT: nucleic acid amplification testing
See this image and copyright information in PMC

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