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The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results

OBJECTIVE: To analyze the results of different cut‐off index (COI) values of Elecsys(®) HIV combi PT assay and to assess the role of COI in reducing the frequency of false‐positive results. METHODS: We conducted a retrospective study of samples analyzed by Elecsys(®) HIV combi PT assay, a 4th‐genera...

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Autores principales: Tang, Zhuoyun, Gou, Yu, Zhang, Keyi, Zhao, Zhongyi, Wei, Yinhao, Li, Dongdong, Chen, Li, Tao, Chuanmin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676207/
https://www.ncbi.nlm.nih.gov/pubmed/32841422
http://dx.doi.org/10.1002/jcla.23503
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author Tang, Zhuoyun
Gou, Yu
Zhang, Keyi
Zhao, Zhongyi
Wei, Yinhao
Li, Dongdong
Chen, Li
Tao, Chuanmin
author_facet Tang, Zhuoyun
Gou, Yu
Zhang, Keyi
Zhao, Zhongyi
Wei, Yinhao
Li, Dongdong
Chen, Li
Tao, Chuanmin
author_sort Tang, Zhuoyun
collection PubMed
description OBJECTIVE: To analyze the results of different cut‐off index (COI) values of Elecsys(®) HIV combi PT assay and to assess the role of COI in reducing the frequency of false‐positive results. METHODS: We conducted a retrospective study of samples analyzed by Elecsys(®) HIV combi PT assay, a 4th‐generation ECLIA, between 2016 and 2017. A total amount of 379 122 samples were collected for HIV (Human Immunodeficiency Virus) screening. RESULTS: A total of 379 122 samples were analyzed. 2528 (0.67%) were positive by Elecsys(®) HIV combi PT. Of these, 468 were false‐positive results, and most of them (94.87%) were in samples with 1 < COI < 15. The false‐positive rate was 0.12%. Patients with false‐positive samples were more distributed in elder (P < .001) and female (P < .001) than true‐positive specimens. The median COI in true‐positive specimens was (385.20), which is significantly higher than false‐positive specimens (2.08). The consistency between Elecsys(®) HIV combi PT assay and 3rd‐generation and positive predictive value (PPV) increased with higher COI values. Cancer, infection, and neurological diseases were considered the potential confounding factors of HIV false‐positive results (19.44%, 11.11%, and 6.62%, respectively). CONCLUSION: Samples with low COI values, especially those contain confounding factors, need to be further scrutinized to determine whether the confounding factors may cause false‐positive problem. In addition, the hypothesis that low COI values may predict false‐positive results is valid.
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spelling pubmed-76762072020-11-24 The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results Tang, Zhuoyun Gou, Yu Zhang, Keyi Zhao, Zhongyi Wei, Yinhao Li, Dongdong Chen, Li Tao, Chuanmin J Clin Lab Anal Research Articles OBJECTIVE: To analyze the results of different cut‐off index (COI) values of Elecsys(®) HIV combi PT assay and to assess the role of COI in reducing the frequency of false‐positive results. METHODS: We conducted a retrospective study of samples analyzed by Elecsys(®) HIV combi PT assay, a 4th‐generation ECLIA, between 2016 and 2017. A total amount of 379 122 samples were collected for HIV (Human Immunodeficiency Virus) screening. RESULTS: A total of 379 122 samples were analyzed. 2528 (0.67%) were positive by Elecsys(®) HIV combi PT. Of these, 468 were false‐positive results, and most of them (94.87%) were in samples with 1 < COI < 15. The false‐positive rate was 0.12%. Patients with false‐positive samples were more distributed in elder (P < .001) and female (P < .001) than true‐positive specimens. The median COI in true‐positive specimens was (385.20), which is significantly higher than false‐positive specimens (2.08). The consistency between Elecsys(®) HIV combi PT assay and 3rd‐generation and positive predictive value (PPV) increased with higher COI values. Cancer, infection, and neurological diseases were considered the potential confounding factors of HIV false‐positive results (19.44%, 11.11%, and 6.62%, respectively). CONCLUSION: Samples with low COI values, especially those contain confounding factors, need to be further scrutinized to determine whether the confounding factors may cause false‐positive problem. In addition, the hypothesis that low COI values may predict false‐positive results is valid. John Wiley and Sons Inc. 2020-08-25 /pmc/articles/PMC7676207/ /pubmed/32841422 http://dx.doi.org/10.1002/jcla.23503 Text en © 2020 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Articles
Tang, Zhuoyun
Gou, Yu
Zhang, Keyi
Zhao, Zhongyi
Wei, Yinhao
Li, Dongdong
Chen, Li
Tao, Chuanmin
The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results
title The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results
title_full The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results
title_fullStr The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results
title_full_unstemmed The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results
title_short The evaluation of low cut‐off index values of Elecsys(®) HIV combi PT assay in predicting false‐positive results
title_sort evaluation of low cut‐off index values of elecsys(®) hiv combi pt assay in predicting false‐positive results
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676207/
https://www.ncbi.nlm.nih.gov/pubmed/32841422
http://dx.doi.org/10.1002/jcla.23503
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