HIV Insight: Performance of Determine Combo & Other Point-of-Care HIV Tests among Seattle MSM

Highlights

Point-of-care HIV tests fail to detect many persons with early HIV infection.
Oral fluid identifies fewer persons with HIV infection compared to fingerstick.
Some differences were seen among the fingerstick point-of-care tests.
Determine Combo detected only one case of acute HIV infection.
Specificity of Combo may be a limitation to use in low prevalence settings.

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.

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By: Stekler JD1, Ure G2, O'Neal JD3, Lane A4, Swanson F5, Maenza J2, Stevens C2, Coombs RW6, Dragavon J7, Swenson PD4, Golden MR8.

1Departments of Medicine, University of Washington, Seattle, WA, United States; Departments of Epidemiology, University of Washington, Seattle, WA, United States; Public Health-Seattle & King County, Seattle, WA, United States. Electronic address: jstekler@uw.edu.
2Departments of Medicine, University of Washington, Seattle, WA, United States.
3San Francisco AIDS Foundation, San Francisco, CA, United States.
4Public Health-Seattle & King County, Seattle, WA, United States.
5Gay City Health Project, Seattle, WA, United States.
6Departments of Medicine, University of Washington, Seattle, WA, United States; Departments of Laboratory Medicine, University of Washington, Seattle, WA, United States.
7Departments of Laboratory Medicine, University of Washington, Seattle, WA, United States.
8Departments of Medicine, University of Washington, Seattle, WA, United States; Departments of Epidemiology, University of Washington, Seattle, WA, United States; Public Health-Seattle & King County, Seattle, WA, United States.
J Clin Virol. 2016 Jan 2;76:8-13. doi: 10.1016/j.jcv.2015.12.011.