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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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
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Abstract	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.
AbstractList	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. 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. 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.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. Abstract 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. 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.
ArticleNumber	12310
Author	Peng, Leiwen Gou, Yu Wu, Yu Duan, Yifei Gao, Zhengxiang
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Cites_doi	10.1016/j.jviromet.2017.09.005 10.1016/j.jcv.2019.04.002 10.1371/journal.pone.0239782 10.5578/mb.9838 10.1016/j.jcv.2017.10.005 10.1373/clinchem.2009.139535 10.1016/j.phrs.2018.01.005 10.1128/JCM.02264-09 10.1016/j.ajog.2018.06.008 10.1016/j.jcv.2013.08.019 10.1002/jcla.23503 10.1016/j.jcv.2018.03.014 10.1002/jcla.21743 10.1093/ajcp/aqy153 10.1128/JCM.02045-17 10.1128/JCM.03583-14 10.1186/s12981-015-0086-3
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Snippet	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... 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... Abstract 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...
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SubjectTerms	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
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Title	HIV testing algorithm using fourth generation reagents reduces the false positive rate of screening tests
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