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.
Subject(s)
HIV Infections , HIV-1 , Adult , Child , Female , HIV Infections/diagnosis , HIV-1/genetics , Humans , Mass Screening , Pregnancy , Sensitivity and Specificity , Serologic Tests , United StatesABSTRACT
We evaluated the analytical performance of the Elecsys® Epstein-Barr virus (EBV) immunoassay panel for the in vitro detection of EBV immunoglobulin M (IgM), EBV viral capsid antigen immunoglobulin G (VCA IgG), and EBV nuclear antigen immunoglobulin G (EBNA IgG). Relative sensitivity/specificity were assessed using 1,734 human blood samples (1,068 residual samples from routine EBV testing; 467 presumed acute infection; 199 presumed seronegative) tested with the Elecsys EBV and 2 comparator panels (ARCHITECT EBV; Liaison EBV). EBV infection status was defined by majority approach. The three panels demonstrated comparable relative sensitivities/specificities, ranging between values (%) of 98.3-99.5 / 96.9-97.4 (EBV IgM); 96.3-98.4 / 98.4-98.7 (EBV VCA IgG); and 98.1-99.5 / 99.1-99.5 (EBV EBNA IgG). The Elecsys EBV IgM assay demonstrated superior analytical specificity in samples containing potential interferents. Utilizing the Elecsys EBV panel for the EBNA-first approach showed 97.5% overall agreement versus the majority approach in samples with clear EBV status.
