Performance of the Determine HIV-1/2 Combo rapid test for detection of acute/early HIV-1 infection
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Abstract
Background: New guideline from CDC for HIV testing recommended the 4th generation assay as the primary screening test to avoid late diagnosis and to shorten the window period. The first point-of-care HIV assay named Determine HIV Combo was used in high prevalence setting. The capacity of this assay detects HIV infection more rapid than IgM/IgG laboratory-based assays. Sensitivity of HIV-1 p24 antigen (Ag) detection was lower than those of laboratory-based 4th generation assays. However, the capacity to detect acute/early HIV-1 infection in high risk subjects is needed to evaluate.
Objectives: To evaluate the performance of Determine HIV Combo in seroconversion plasma specimens of acute/early HIV-1 patient.
Materials and methods: Twelve seroconversion plasma specimens from 5 acute/early patients were diagnosed by Elecsys HIV Ag, 4th generation ECLIA (Elecsys HIV Combi PT) and supplemented by NAAT (viral load) to evaluate the performance of Determine HIV Combo sensitivity. McNemar’s exact test was applied to compare the difference in reactivity during acute/early infection between tests. Specificity was evaluated with 96 HIV-1 negative plasma specimens.
Results: Seroconversion sensitivity of Determine HIV Combo was 91.67% (11/12, p=0.32) compared to 4th generation ECLIA and Elecsys HIV Ag results. There were 3 discordant results with 3rd generation HIV POCT (p=0.14). The reactivity of HIV p24 Ag detection which compared to Elecsys HIV Ag, were 41.67% (5/12, p=0.0021). Determine HIV Combo had 8.33% (1/12) false negative result and 100% specificity. The first positive HIV p24 Ag and antibody results from Determine HIV Combo were found on 14 days and 21 days, respectively.
Conclusion: Determine HIV Combo provides poorer antigen sensitivity compared to HIV Ag and viral load performance, p24 Ag. However, Determine HIV Combo can detect acute/early HIV-1 infection at more than 13 days after sexual exposure. It can improve HIV rapid test to decrease the window period, expand access to HIV testing and prevent HIV transmission.
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