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ORIGINAL RESEARCH article

Front. Cell. Infect. Microbiol.
Sec. Clinical Infectious Diseases
Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1474127

Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay

Provisionally accepted
Ximing Yang Ximing Yang 1*Yajie Wang Yajie Wang 2*Yijun Li Yijun Li 1Fangfang Jin Fangfang Jin 2Yunhui Li Yunhui Li 2Yan Li Yan Li 1
  • 1 Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
  • 2 Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

The final, formatted version of the article will be published soon.

    The goal of this study is to evaluate the analytical and clinical performance of a new human immunodeficiency virus antigen and antibody (HIV Ag/Ab) test using light-initiated chemiluminescent assay (LiCA ® ), and compare it with the well-established Architect ® HIV Ag/Ab combo assay in clinical setting.We used banked samples and national reference controls to identify the ability to detect HIV Ag/Ab and different viral subtypes. 13 seroconversion panels were tested to evaluate early detection of HIV. 21,042 patient samples were collected to compare diagnostic performance of LiCA ® with Architect ® . Screening-reactive results were confirmed by western blotting and nucleic acid testing.Results: Total imprecision was within 2.49~6.56%. The C5~C95 interval was within -10.20~7.67% away from C50. The limit of detection for p24 antigen was <1.00 IU/mL. Using national reference panels and banked sample pools, LiCA ® successfully detected all negative and positive controls in line with the criteria, and all HIV-positive specimens containing different viral subtypes. In 13 seroconversion panels, LiCA® detected reactive results on average 5.73 days (95% CI: 3.42-8.04) after the initial RNA test results were confirmed positive, which was 1.27 days earlier (-3.75 to 1.21) compared to Architect® . Paired-comparisons in 21,042 clinical patient samples demonstrated that LiCA ® detected HIV Ag/Ab with a slightly better performance in sensitivity (100.00% vs. 99.65%), specificity (99.85% vs. 99.81%), negative predictive value (NPV, 100.00% vs. 99.99%), and positive predictive value (PPV, 89.84% vs. 87.85%) than Architect ® . Total agreement between two assays was 99.67% with a kappa value of 0.89.LiCA ® HIV Ag/Ab is a precise and highly sensitive assay for measuring HIV-1 p24 antigen and HIV-1/2 antibodies with differentiated S/Co values of Ag/Ab. The assay is appropriate for use in the clinical routine test for early detection of HIV.

    Keywords: human immunodeficiency virus, light-initiated chemiluminescent assay, Homogeneous immunoassay, performance evaluation, LiCA ®

    Received: 01 Aug 2024; Accepted: 06 Jan 2025.

    Copyright: © 2025 Yang, Wang, Li, Jin, Li and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Ximing Yang, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
    Yajie Wang, Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.