Abstract
BackgroundDetermine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics.MethodsWe compared DHC performance (overall, by test component and in early infection) with conventional laboratory HIV serology (fourth generation screening immunoassay, supplementary HIV antibody, p24 antigen and Western blot tests) when testing gay and bisexual men attending four clinic sites. Early infection was defined as either acute or recent HIV infection acquired within the last six months.ResultsOf 3,190 evaluation specimens, 39 were confirmed as HIV-positive (12 with early infection) and 3,133 were HIV-negative by reference testing. DHC sensitivity was 87.2% overall and 94.4% and 0% for the antibody and antigen components, respectively. Sensitivity in early infection was 66.7% (all DHC antibody reactive) and the DHC antigen component detected none of nine HIV p24 antigen positive specimens. Median HIV RNA was higher in false negative than true positive cases (238,025 vs. 37,591 copies/ml; p = 0.022). Specificity overall was 99.4% with the antigen component contributing to 33% of false positives.ConclusionsThe DHC antibody component detected two thirds of those with early infection, while the DHC antigen component did not enhance performance during point of care HIV testing in a high risk clinic-based population.
Highlights
People with acute HIV infection contribute disproportionately to HIV transmissions due to their high viral loads [1,2]
Among men who have sex with men (MSM) surveyed in New South Wales (NSW) in 2013, 45% of men who had ever tested reported their last HIV test was at a public sexual health clinic [25]
89.9% of men reported previous HIV testing and, in the last six months, 28.4% reported more than ten male sexual partners and 35.0% unprotected anal intercourse with casual male partners
Summary
People with acute HIV infection contribute disproportionately to HIV transmissions due to their high viral loads [1,2]. If HIV antibody only rapid tests are the mainstay of testing in these settings the longer window periods of such assays may mean many acute HIV infections are missed, especially in high incidence populations [17,18]. The Determine HIV Combo (DHC) has been approved for use by regulatory authorities in Europe, Australia and the United States (US) and is the first point of care assay containing both HIV antibody and antigen components designed to increase sensitivity in patients recently infected with HIV. Determine HIV Combo (DHC) is the first point of care assay designed to increase sensitivity in early infection by detecting both HIV antibody and antigen. We conducted a large multi-centre evaluation of DHC performance in Sydney sexual health clinics
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