A retrospective analysis of the application of the Elecsys® HIV combi PT assay in southern China

Abstract

Background: Fourth-generation HIV assays have been implemented worldwide as a screening test for many years. Understanding the performance of fourth-generation assay in low HIV prevalence region is pivotal to interpret the test result correctly. In this study, retrospective analysis was used to evaluate application of the Elecsys® HIV combi PT assay. Methods: A total of 85 043 specimens from a low prevalence setting were detected between June 2013 and October 2015. We evaluated the false-positive rate (FPR), specificity, and positive predictive value (PPV). Results: The specificity between male and female were 99.85% and 99.82%, respectively. The PPV on male (50.75%) was higher than female (17.05%) significantly, while the FPR was 0.15% and 0.18%. The gap between false-positive (median: 1.83, [IQR]: 1.30, 3.38) and confirmed-positive (median: 407.5, [IQR]: 184.2, 871.7) is enormous. The highest s/co ratio for false-positive cases was 85.45, while the lowest s/co ratio for confirmed-positive cases was 59.68. Various reasons were attributed to false-positive cases. Conclusion: Optimal cutoff value is needed to be set to reduce the false-positive cases and predict the final status of HIV infection reliably. Retrospective analysis will help us to understand more about diagnosis of HIV.