Abstract
BackgroundA substantial proportion of HIV-infected individuals in the UK are unaware of their status and late presentations continue, especially in low prevalence areas. Fourth generation antigen/antibody rapid test kits could facilitate earlier diagnosis of HIV in non-clinical settings but lack data on performance under programmatic conditions.Methods and FindingsWe evaluated the performance of Determine HIV-1/2 Ag/Ab Combo Test (Determine Combo), a rapid test with indicators for both HIV antibodies and p24 antigen, in participants recruited from community outreach and hospital-based sexual health clinics. HIV infection was confirmed using laboratory enzyme-linked immunosorbent assay (EIA), Line Immuno Assay (LIA) and quantitative polymerase chain reaction (PCR). In total, 953 people underwent HIV testing. HIV antibody (Ab) prevalence was 1.8% (17/953). Four false positive rapid tests were identified: two antibody and two p24 antigen (Ag) reactions. Of participants diagnosed as HIV Ab positive, 2/17 (12%) were recent seroconverters based on clinical history and HIV antibody avidity test results. However, none of these were detected by the p24 antigen component of the rapid test kit. There were no other true positive p24 Ag tests.ConclusionThese data lend support to an increasing body of evidence suggesting that 4th generation rapid HIV tests have little additional benefit over 3rd generation HIV kits for routine screening in low prevalence settings and have high rates of false positives. In order to optimally combine community-based case-finding among hard-to-reach groups with reliable and early diagnosis 3rd generation kits should be primarily used with laboratory testing of individuals thought to be at risk of acute HIV infection. A more reliable point of care diagnostic is required for the accurate detection of acute HIV infection under programmatic conditions.
Highlights
Fourth generation HIV antibody-antigen combination tests are increasingly used in UK laboratory settings to ensure reliable laboratory diagnosis of acute HIV infection, since the antibody may not be detected during the so-called ‘‘seroconversion window period’’ [1,2]
In order to optimally combine community-based case-finding among hard-to-reach groups with reliable and early diagnosis 3rd generation kits should be primarily used with laboratory testing of individuals thought to be at risk of acute HIV infection
A more reliable point of care diagnostic is required for the accurate detection of acute HIV infection under programmatic conditions
Summary
Fourth generation HIV antibody-antigen combination tests are increasingly used in UK laboratory settings to ensure reliable laboratory diagnosis of acute HIV infection, since the antibody may not be detected during the so-called ‘‘seroconversion window period’’ [1,2]. Kit manufacturers have developed a 4th generation point of care antigen/antibody kit (Determine HIV 1/2 Ag/Ab Combo; Alere) This has performed well in published data against known panels of seroconverters [7] with the p24 antigen detection preceding the development of antibody, by an average of 5 to 9 day [8]. It has performed less well in field evaluations in London [9] and Malawi [10] with both reporting a low sensitivity for the p24 component. Fourth generation antigen/antibody rapid test kits could facilitate earlier diagnosis of HIV in non-clinical settings but lack data on performance under programmatic conditions
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