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

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.

Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

“…The entire process of POC diagnostics, from the pre-analytic through the analytic and post-analytic phases, has hidden reliability risks, which include false-positive and false-negative test results, which can lead to gross medical errors [20]. POC diagnostics, such as the oral-based OraQuick ADVANCE Rapid HIV-1/2, have been shown to identify fewer persons with HIV infection compared to fingerstick, such as the Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo and INSTI HIV-1 Rapid Antibody [21]. Therefore, POC diagnostics’ quality assurance through implementation of all appropriate components of quality systems is one of the main aspects required to ensure efficacy and sustainability [22].…”

Repeated False-Positive HIV Test Results in a Patient Taking HIV Pre-Exposure Prophylaxis

“…False-positive results occur with all HIV screening tests and should be expected. Furthermore, the Determine test has been observed to have lower specificity than other POC devices, and thus more false-positive test results may be seen with this test [10]. It is important that all positive screening test results be confirmed by using additional tests according to established test algorithms [5].…”

“…Although the POC tests used in that study were reported to detect only HIV antibody [9], the exact tests used and the timing, sequence, and resolution of false-positive results have not yet been described. Although both POC and laboratory-based tests that detect the HIV-1 p24 antigen may have lower specificity than antibody-only assays [10], the POC test presents an additional complication because providers and patients receive a preliminary result before laboratory testing can confirm that result [12]. …”

Development of an Agent-Based Model to Investigate the Impact of HIV Self-Testing Programs on Men Who Have Sex With Men in Atlanta and Seattle (Preprint)

“…In the replacement testing scenarios, we will estimate the proportion of HIV infections averted when HIV self-tests replace clinicbased opportunistic tests, regular tests, and risk-based tests, respectively and simultaneously. We will examine the impact of replacing 25% and 50% of clinic-based tests with HIV self-tests, assuming a 90-day window period (the time between when a person may have been exposed to HIV and when a test can give an accurate result) for self-tests [42].…”