Clinical performance evaluation of an HIV Duo assay: From HIV screening to acute and non-acute HIV infection detection

•The Elecsys® HIV Duo assay has demonstrated a high specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a high PPV of 0.8516 (95 % CI: 0.8225, 0.8776), indicating that the assay is suitable for primary HIV screening in China.•The median (IQR) of the numeric cut-off index (COI) ratios of the HIV D...

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Veröffentlicht in:Clinica chimica acta Jg. 565; S. 119949
Hauptverfasser: Liu, Xin, Wu, Chongyang, Yuan, Yulin, Li, Dongdong, Lou, Jinli, Feng, Xia, Lu, Qiuwei, Wu, Rongcai, Chen, An-Jou, Tao, Chuanmin
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Sprache:Englisch
Veröffentlicht: Netherlands Elsevier B.V 15.01.2025
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ISSN:0009-8981, 1873-3492, 1873-3492
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Abstract •The Elecsys® HIV Duo assay has demonstrated a high specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a high PPV of 0.8516 (95 % CI: 0.8225, 0.8776), indicating that the assay is suitable for primary HIV screening in China.•The median (IQR) of the numeric cut-off index (COI) ratios of the HIV Duo antibody (Ab) and antigen (Ag) results significantly differed among the subgroups of diagnosed HIV patients: Ag + Ab-, Ag-Ab+, and Ag + Ab+ (all P<0.05).•The Elecsys® HIV Duo assay can identify acute HIV patients with Western blot (WB) −/not able to define (ND) results by providing Ag + HIV Duo result. Therefore, integrating the assay into a novel laboratory HIV testing algorithm has the potential to enable early detection of acute HIV infections and facilitating treatment initiation. Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection. This study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured. The HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups. The Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice. Abbreviations: HIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male;
AbstractList Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection.BACKGROUNDEvaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection.This study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured.METHODSThis study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured.The HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups.RESULTSThe HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups.The Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice.CONCLUSIONThe Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice.HIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male.ABBREVIATIONSHIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male.
Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection. This study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured. The HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups. The Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice. HIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male.
•The Elecsys® HIV Duo assay has demonstrated a high specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a high PPV of 0.8516 (95 % CI: 0.8225, 0.8776), indicating that the assay is suitable for primary HIV screening in China.•The median (IQR) of the numeric cut-off index (COI) ratios of the HIV Duo antibody (Ab) and antigen (Ag) results significantly differed among the subgroups of diagnosed HIV patients: Ag + Ab-, Ag-Ab+, and Ag + Ab+ (all P<0.05).•The Elecsys® HIV Duo assay can identify acute HIV patients with Western blot (WB) −/not able to define (ND) results by providing Ag + HIV Duo result. Therefore, integrating the assay into a novel laboratory HIV testing algorithm has the potential to enable early detection of acute HIV infections and facilitating treatment initiation. Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection. This study was conducted from April 2022 to April 2023 and involved two distinct populations. For the HIV screening population, three HIV Duo results [HIV Duo, HIV antigen (Ag), and HIV antibody (Ab)] in primary screening were obtained (January 2021 to June 2021). In the diagnosed HIV population, retrospective samples from November 2016 to March 2023 were measured. The HIV screening population included 111,383 samples from a real-world screening program. The assay demonstrated a specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a PPV of 0.8516 (95 % CI: 0.8225, 0.8776). Regarding the diagnosed HIV population, 836 HIV patients were enrolled, including 14 acute HIV infectious patients with only HIV Ag + and a Western Blot (WB) confirmation rate of 0 %. The median (IQR) of the numeric cut-off index (COI) ratios of HIV Duo Ab and Ag significantly differed among the Ag + Ab-, Ag-Ab+, and Ag + Ab + subgroups. The Elecsys HIV Duo assay is suitable for primary HIV screening and can be integrated into a novel laboratory HIV testing algorithm to improve acute HIV detection in Chinese clinical practice. Abbreviations: HIV, Human immunodeficiency virus; AIDS, acquired immunodeficiency syndrome; Ag, antigen; Ab, antibody; WB, Western Blot; COI, numeric cut-off index; CI, confidence interval; NAT, nucleic acid tests; EDC, electronic data capture systems; CDC, Chinese Centers for Disease Control and Prevention; IQR, interquartile range; PPV, positive predictive value; HCV, hepatitis C virus; HBV, hepatitis B virus; CI, confidence interval; ND, not able to define; F, female; M, male;
ArticleNumber 119949
Author Chen, An-Jou
Li, Dongdong
Lou, Jinli
Yuan, Yulin
Wu, Chongyang
Tao, Chuanmin
Wu, Rongcai
Liu, Xin
Feng, Xia
Lu, Qiuwei
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  organization: Beijing You’An Hospital, Capital Medical University, Beijing, China
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  givenname: Chongyang
  surname: Wu
  fullname: Wu, Chongyang
  organization: West China Hospital, Sichuan University, Chengdu, China
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  givenname: Yulin
  surname: Yuan
  fullname: Yuan, Yulin
  organization: The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, China
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  givenname: Dongdong
  surname: Li
  fullname: Li, Dongdong
  organization: West China Hospital, Sichuan University, Chengdu, China
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  givenname: Jinli
  surname: Lou
  fullname: Lou, Jinli
  organization: Beijing You’An Hospital, Capital Medical University, Beijing, China
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  fullname: Feng, Xia
  organization: Beijing You’An Hospital, Capital Medical University, Beijing, China
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  organization: The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, China
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  surname: Wu
  fullname: Wu, Rongcai
  organization: The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, China
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  surname: Chen
  fullname: Chen, An-Jou
  organization: Roche Diagnostics (Shanghai) Ltd., Shanghai, China
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  givenname: Chuanmin
  surname: Tao
  fullname: Tao, Chuanmin
  email: taocm@scu.edu.cn
  organization: West China Hospital, Sichuan University, Chengdu, China
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Keywords Diagnostic testing algorithm
P24 antigen
HIV screening
Acute HIV infection
HIV Duo
Language English
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Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.
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Snippet •The Elecsys® HIV Duo assay has demonstrated a high specificity of 99.91 % (95 % CI: 99.89 %, 99.93 %) and a high PPV of 0.8516 (95 % CI: 0.8225, 0.8776),...
Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection detection. This...
Evaluating the clinical performance of Elecsys HIV Duo assay for primary human immunodeficiency virus (HIV) screening and acute HIV infection...
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StartPage 119949
SubjectTerms Acute Disease
Acute HIV infection
Adult
Diagnostic testing algorithm
Female
HIV Antibodies - blood
HIV Antigens - blood
HIV Antigens - immunology
HIV Duo
HIV Infections - diagnosis
HIV screening
HIV Testing
Humans
Male
Mass Screening - methods
Middle Aged
P24 antigen
Retrospective Studies
Title Clinical performance evaluation of an HIV Duo assay: From HIV screening to acute and non-acute HIV infection detection
URI https://dx.doi.org/10.1016/j.cca.2024.119949
https://www.ncbi.nlm.nih.gov/pubmed/39241902
https://www.proquest.com/docview/3101793808
Volume 565
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