Real-World Clinical Performance Evaluation of a Fourth-Generation HIV Antigen/Antibody Differentiation Test

Abstract

Abstract Background HIV testing is still an important component of routine sexual health screening, assessment of at-risk individuals and as part of the care of pregnant women. To prevent further transmission of infection, it is important that HIV tests are highly sensitive and that positive cases are not missed. HIV serologic antigen/antibody tests are commonly used as they are capable of detecting recent and established infection. Methods In this study we assessed the performance of the Elecsys HIV Duo assay (Elecsys assay) against the Abbott Architect assay in 10 121 samples from US and non-US adult, pediatric, and pregnant populations including low-risk, high-risk, and known positive cohorts. Congruent repeatedly reactive and/or discrepant samples followed a confirmatory algorithm consisting of an antigen/antibody differentiation assay and a nucleic acid test, as per the study protocol. Results The overall sensitivity of the Elecsys assay was 100.00% (95% CI 99.81–100.00 [1977/1977]), and the specificity was 99.84% (95% CI 99.73–99.91 [8129/8142]). The Elecsys assay detected all positive samples within the study, including all 50 antigen-only positive samples and samples from different HIV subtypes, including group O, group M subtypes, HIV-2 positives, and HIV-1 and HIV-2 dual positives. Conclusions The Elecsys HIV Duo assay was highly sensitive for diagnosis of HIV in a range of clinical samples from the United States and outside the United States and is suitable for routine use.