HIV testing algorithm using fourth generation reagents reduces the false positive rate of screening tests

To analyze the false-positive results of HIV screening in a women’s and children’s specialized hospital and discuss the improved effect of the testing algorithm that retesting with two fourth-generation HIV assays to reduce false-positive results. We retrospectively analyzed 380,390 samples tested w...

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Bibliographic Details
Published in:Scientific reports Vol. 15; no. 1; pp. 12310 - 6
Main Authors: Gou, Yu, Gao, Zhengxiang, Duan, Yifei, Wu, Yu, Peng, Leiwen
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 10.04.2025
Nature Publishing Group
Nature Portfolio
Subjects:
631/326/2521
692/699/255/1901
Adult
Algorithms
Elecsys® HIV DUO assay
False Positive Reactions
False-positive
Female
HIV
HIV Infections - diagnosis
HIV Infections - virology
HIV Testing - methods
Human immunodeficiency virus
Humanities and Social Sciences
Humans
Infertility
Male
Mass Screening - methods
Middle Aged
multidisciplinary
Pregnancy
Reagent Kits, Diagnostic
Reagents
Retrospective Studies
Science
Science (multidisciplinary)
Screening tests
Testing algorithm
Testing algorithm
HIV
Screening tests
HIV DUO assay
False-positive
Elecsys
Elecsys® HIV DUO assay
ISSN:2045-2322, 2045-2322
Online Access:Get full text
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Summary:To analyze the false-positive results of HIV screening in a women’s and children’s specialized hospital and discuss the improved effect of the testing algorithm that retesting with two fourth-generation HIV assays to reduce false-positive results. We retrospectively analyzed 380,390 samples tested with Roche Elecsys ® HIV combi PT assay from 2020 to 2023. The responsive samples were retested using the Determine HIV Early Detect assay (Abbott Diagnostic) and the Elecsys ® HIV DUO assay (Roche Diagnostic). Finally, the supplemental tests were used to confirm whether the sample is true positive. Of the 380,390 samples, 555 were reactive with Roche Elecsys ® HIV combi PT assay. After re-testing with the Determine HIV Early Detect assay and Elecsys ® HIV DUO assay, the reactive sample was reduced to 256 cases, and finally 122 cases were confirmed as true positive by supplementary tests. The false positive rate was reduced from 0.11 to 0.04%. The median cut-off index (COI) of false positive samples was significantly lower than that of true positive samples. Pregnancy, tumor and infertility are the top three clinical diagnoses of false positive patients (19.92%, 15.23% and 13.67%, respectively). Retested with two different fourth-generation HIV assays can significantly reduce the false positive rate and improve the positive predictive value. False-positive samples still require longer follow-up to rule out HIV infection.
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ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-025-97169-y