Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay
ObjectivesThe 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 a clin...
Saved in:
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-01-01
|
| Series: | Frontiers in Cellular and Infection Microbiology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcimb.2025.1474127/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832576336003072000 |
|---|---|
| author | Yijun Li Fangfang Jin Yunhui Li Yan Li Yajie Wang Ximing Yang |
| author_facet | Yijun Li Fangfang Jin Yunhui Li Yan Li Yajie Wang Ximing Yang |
| author_sort | Yijun Li |
| collection | DOAJ |
| description | ObjectivesThe 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 a clinical setting.MethodsWe used banked samples and national reference controls to identify the ability to detect HIV Ag/Ab and different viral subtypes. Thirteen seroconversion panels were tested to evaluate early detection of HIV. A total of 21,042 patient samples were collected to compare the diagnostic performance of LiCA® with Architect®. Screening-reactive results were confirmed by Western blotting and nucleic acid testing.ResultsTotal 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.ConclusionLiCA® 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 the early detection of HIV. |
| format | Article |
| id | doaj-art-52e7b49543cb4041b5ca101e0e13aa34 |
| institution | Kabale University |
| issn | 2235-2988 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cellular and Infection Microbiology |
| spelling | doaj-art-52e7b49543cb4041b5ca101e0e13aa342025-01-31T06:41:05ZengFrontiers Media S.A.Frontiers in Cellular and Infection Microbiology2235-29882025-01-011510.3389/fcimb.2025.14741271474127Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assayYijun Li0Fangfang Jin1Yunhui Li2Yan Li3Yajie Wang4Ximing Yang5Clinical Laboratory, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaClinical Laboratory, Beijing Ditan Hospital, Capital Medical University, Beijing, ChinaClinical Laboratory, Beijing Ditan Hospital, Capital Medical University, Beijing, ChinaClinical Laboratory, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaClinical Laboratory, Beijing Ditan Hospital, Capital Medical University, Beijing, ChinaClinical Laboratory, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaObjectivesThe 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 a clinical setting.MethodsWe used banked samples and national reference controls to identify the ability to detect HIV Ag/Ab and different viral subtypes. Thirteen seroconversion panels were tested to evaluate early detection of HIV. A total of 21,042 patient samples were collected to compare the diagnostic performance of LiCA® with Architect®. Screening-reactive results were confirmed by Western blotting and nucleic acid testing.ResultsTotal 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.ConclusionLiCA® 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 the early detection of HIV.https://www.frontiersin.org/articles/10.3389/fcimb.2025.1474127/fullhuman immunodeficiency viruslight-initiated chemiluminescent assayhomogeneous immunoassayperformance evaluationLiCA® |
| spellingShingle | Yijun Li Fangfang Jin Yunhui Li Yan Li Yajie Wang Ximing Yang Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay Frontiers in Cellular and Infection Microbiology human immunodeficiency virus light-initiated chemiluminescent assay homogeneous immunoassay performance evaluation LiCA® |
| title | Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay |
| title_full | Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay |
| title_fullStr | Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay |
| title_full_unstemmed | Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay |
| title_short | Evaluation of a new human immunodeficiency virus antigen and antibody test using light-initiated chemiluminescent assay |
| title_sort | evaluation of a new human immunodeficiency virus antigen and antibody test using light initiated chemiluminescent assay |
| topic | human immunodeficiency virus light-initiated chemiluminescent assay homogeneous immunoassay performance evaluation LiCA® |
| url | https://www.frontiersin.org/articles/10.3389/fcimb.2025.1474127/full |
| work_keys_str_mv | AT yijunli evaluationofanewhumanimmunodeficiencyvirusantigenandantibodytestusinglightinitiatedchemiluminescentassay AT fangfangjin evaluationofanewhumanimmunodeficiencyvirusantigenandantibodytestusinglightinitiatedchemiluminescentassay AT yunhuili evaluationofanewhumanimmunodeficiencyvirusantigenandantibodytestusinglightinitiatedchemiluminescentassay AT yanli evaluationofanewhumanimmunodeficiencyvirusantigenandantibodytestusinglightinitiatedchemiluminescentassay AT yajiewang evaluationofanewhumanimmunodeficiencyvirusantigenandantibodytestusinglightinitiatedchemiluminescentassay AT ximingyang evaluationofanewhumanimmunodeficiencyvirusantigenandantibodytestusinglightinitiatedchemiluminescentassay |