{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T03:30:28Z","timestamp":1789097428595,"version":"build-2803163510"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,5,22]],"date-time":"2025-05-22T00:00:00Z","timestamp":1747872000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"},{"start":{"date-parts":[[2025,5,22]],"date-time":"2025-05-22T00:00:00Z","timestamp":1747872000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"funder":[{"name":"Shandong Provincial Medical and Health Science and Technology Project","award":["202011000934"],"award-info":[{"award-number":["202011000934"]}]},{"name":"Shandong Province Humanities and Social Science Project","award":["2021-ZXJK-24"],"award-info":[{"award-number":["2021-ZXJK-24"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"DOI":"10.1038\/s41598-025-03077-6","type":"journal-article","created":{"date-parts":[[2025,5,22]],"date-time":"2025-05-22T13:05:56Z","timestamp":1747919156000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Analytical and clinical performance evaluation of the Wantai chemiluminescence microparticle immunoassay on the Wan200 +\u2009analyzer for diagnosing HIV"],"prefix":"10.1038","volume":"15","author":[{"given":"Jianfeng","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liyue","family":"Jiang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ran","family":"Ju","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yitong","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengtian","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,22]]},"reference":[{"key":"3077_CR1","unstructured":"Sheet, G. H. A. s. F. Global HIV & AIDS statistics \u2014 Fact sheet. (2023)."},{"key":"3077_CR2","doi-asserted-by":"publisher","first-page":"28","DOI":"10.13303\/j.cjbt.issn.1004-549x.1990.01.013","volume":"8","author":"J Yang","year":"1990","unstructured":"Yang, J. et al. HIV antibody testing report for blood donors and blood products in ten cities and counties in Sichuan Province. Chin. J. Blood Transf. 8, 28\u201329. https:\/\/doi.org\/10.13303\/j.cjbt.issn.1004-549x.1990.01.013 (1990).","journal-title":"Chin. J. Blood Transf."},{"key":"3077_CR3","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1258\/0956462971919480","volume":"8","author":"Z Xiang","year":"1997","unstructured":"Xiang, Z. et al. Analysis of the Test Situation of the Blood Donors HIV Antibody from1993to 1995in Kunming Area. Chin. J. AIDS STD 8, 7\u20138 (1997).","journal-title":"Chin. J. AIDS STD"},{"key":"3077_CR4","doi-asserted-by":"publisher","first-page":"316","DOI":"10.1186\/s12879-015-1073-y","volume":"15","author":"S Chen","year":"2015","unstructured":"Chen, S. et al. Eighteen-year follow-up report of the surveillance and prevention of an HIV\/AIDS outbreak amongst plasma donors in Hebei Province,\u00a0China. BMC Infect. Dis. 15, 316. https:\/\/doi.org\/10.1186\/s12879-015-1073-y (2015).","journal-title":"BMC Infect. Dis."},{"key":"3077_CR5","doi-asserted-by":"publisher","first-page":"1244","DOI":"10.13303\/j.cjbt.issn.1004-549x.2012.12.032","volume":"25","author":"S Wenqian","year":"2012","unstructured":"Wenqian, S., Li, Z., Yong, G., Xiaohua, L. & Wanxin, A. Survey of HIV detection rates in blood donors tested by 357 provincial and municipal blood collection agencies nationwide. Chin. J. Transf. Med. 25, 1244\u20131246. https:\/\/doi.org\/10.13303\/j.cjbt.issn.1004-549x.2012.12.032 (2012).","journal-title":"Chin. J. Transf. Med."},{"key":"3077_CR6","doi-asserted-by":"publisher","first-page":"722","DOI":"10.13303\/j.cjbt.issn.1004-549x.2013.08.044","volume":"26","author":"Z Yongbao","year":"2013","unstructured":"Yongbao, Z. et al. Analysis of nucleic acid test results in unpaid blood donors in the Jinan Region from 2010 to 2012. Chin. J. Transf. Med. 26, 722\u2013724. https:\/\/doi.org\/10.13303\/j.cjbt.issn.1004-549x.2013.08.044 (2013).","journal-title":"Chin. J. Transf. Med."},{"key":"3077_CR7","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1016\/j.jviromet.2014.07.026","volume":"214","author":"C Cui","year":"2015","unstructured":"Cui, C. et al. Evaluation of the clinical effectiveness of HIV antigen\/antibody screening using a chemiluminescence microparticle immunoassay. J. Virol. Methods 214, 33\u201336. https:\/\/doi.org\/10.1016\/j.jviromet.2014.07.026 (2015).","journal-title":"J. Virol. Methods"},{"key":"3077_CR8","doi-asserted-by":"crossref","unstructured":"Arcot, P. et al. Comparative evaluation of ADVIA Centaur\u00ae XP chemiluminescence system for screening of HBV, HCV, HIV and syphilis in Indian blood donors. Transf. Apheresis Sci.\u00a061, 103318, doi: 10.1016\/j.transci.2021.103318 (2022).","DOI":"10.1016\/j.transci.2021.103318"},{"key":"3077_CR9","doi-asserted-by":"crossref","unstructured":"Schmidt, M. et al. Head-to-head comparison between two screening systems for HBsAG, anti-HBc, anti-HCV and HIV combination immunoassays in an international, multicentre evaluation study. Vox sanguinis 109, 114\u2013121. doi: 10.1111\/vox.12259 (2015).","DOI":"10.1111\/vox.12259"},{"key":"3077_CR10","unstructured":"China, N. H. C. o. (April 2019)."},{"key":"3077_CR11","doi-asserted-by":"publisher","first-page":"580","DOI":"10.1046\/j.1537-2995.2000.40050580.x","volume":"40","author":"P Kiely","year":"2000","unstructured":"Kiely, P. & Wilson, D. Results of HCV screening of volunteer blood donors with a chemiluminescent immunoassay and a second- or third-generation EIA: overlap of false-positive reactivity and its impact on donor management. Transfusion 40, 580\u2013584. https:\/\/doi.org\/10.1046\/j.1537-2995.2000.40050580.x (2000).","journal-title":"Transfusion"},{"key":"3077_CR12","doi-asserted-by":"publisher","first-page":"660","DOI":"10.3109\/00365548.2014.926564","volume":"46","author":"L Sommese","year":"2014","unstructured":"Sommese, L. et al. Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: evaluation of two chemiluminescent immunoassay systems. Scand. J. Infect. Dis. 46, 660\u2013664. https:\/\/doi.org\/10.3109\/00365548.2014.926564 (2014).","journal-title":"Scand. J. Infect. Dis."},{"key":"3077_CR13","doi-asserted-by":"publisher","first-page":"2688","DOI":"10.1111\/trf.16559","volume":"61","author":"M Vermeulen","year":"2021","unstructured":"Vermeulen, M., Swanevelder, R., Van Zyl, G., Lelie, N. & Murphy, E. An assessment of hepatitis B virus prevalence in South African young blood donors born after the implementation of the infant hepatitis B virus immunization program: Implications for transfusion safety. Transfusion 61, 2688\u20132700. https:\/\/doi.org\/10.1111\/trf.16559 (2021).","journal-title":"Transfusion"},{"key":"3077_CR14","doi-asserted-by":"publisher","first-page":"1393","DOI":"10.1111\/j.1537-2995.2012.03909.x","volume":"53","author":"R Taira","year":"2013","unstructured":"Taira, R. et al. Residual risk of transfusion-transmitted hepatitis B virus (HBV) infection caused by blood components derived from donors with occult HBV infection in Japan. Transfusion 53, 1393\u20131404. https:\/\/doi.org\/10.1111\/j.1537-2995.2012.03909.x (2013).","journal-title":"Transfusion"},{"key":"3077_CR15","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1093\/ajcp\/aqy153","volume":"151","author":"D Uettwiller-Geiger","year":"2019","unstructured":"Uettwiller-Geiger, D. et al. Analytical and clinical performance evaluation of the elecsys HIV combi PT assay on the cobas e 602 analyzer for the diagnosis of human immunodeficiency virus. Am. J. Clin. Pathol. 151, 377\u2013385. https:\/\/doi.org\/10.1093\/ajcp\/aqy153 (2019).","journal-title":"Am. J. Clin. Pathol."},{"key":"3077_CR16","unstructured":"Administration, N. M. P. Notice from the National Medical Products Administration regarding the release of the Technical Guidelines for clinical experiments of In Vitro Diagnostic Reagents (Announcement No. 72, 2021). (September 16, 2021)."},{"key":"3077_CR17","unstructured":"Regulation, S. A. f. M. Drug Registration Management Measures. (January 22, 2020)."},{"key":"3077_CR18","doi-asserted-by":"crossref","unstructured":"Chang, L. et al. Comparative Evaluation and measure of accuracy of ELISAs, CLIAs, and ECLIAs for the detection of HIV infection among blood donors in China. Can. J. Infect. Dis. Med. Microbiol.\u20092020, 2164685, doi: 10.1155\/2020\/2164685 (2020).","DOI":"10.1155\/2020\/2164685"},{"key":"3077_CR19","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.mimet.2019.105742","volume":"166","author":"H Ji","year":"2019","unstructured":"Ji, H. et al. Evaluation of ELISA and CLIA for Treponema pallidum specific antibody detection in China: A multicenter study. J. Microbiol. Methods 166, 377 (2019).","journal-title":"J. Microbiol. Methods"},{"key":"3077_CR20","doi-asserted-by":"publisher","first-page":"260","DOI":"10.7534\/j.issn.1009-2137.2019.01.042","volume":"27","author":"J Chen","year":"2019","unstructured":"Chen, J. et al. Performance evaluation of the CLIA and ECLIA for anti-tp screening in blood donors. Zhongguo shi yan xue ye xue za zhi 27, 260\u2013265. https:\/\/doi.org\/10.7534\/j.issn.1009-2137.2019.01.042 (2019).","journal-title":"Zhongguo shi yan xue ye xue za zhi"},{"key":"3077_CR21","doi-asserted-by":"crossref","unstructured":"Tao, C. et al. Validation of the Elecsys\u00ae HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia. J. Clin. Virol. 58, 221\u2013226, doi:10.1016\/j.jcv.2013.05.012 (2013).","DOI":"10.1016\/j.jcv.2013.05.012"},{"key":"3077_CR22","doi-asserted-by":"publisher","first-page":"1884","DOI":"10.1002\/jmv.23423","volume":"84","author":"E Song","year":"2012","unstructured":"Song, E. et al. Performances of four fourth-generation human immunodeficiency virus-1 screening assays. J. Med. Virol. 84, 1884\u20131888. https:\/\/doi.org\/10.1002\/jmv.23423 (2012).","journal-title":"J. Med. Virol."},{"key":"3077_CR23","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1007\/s00430-012-0250-5","volume":"202","author":"A M\u00fchlbacher","year":"2013","unstructured":"M\u00fchlbacher, A. et al. Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay. Med. Microbiol. Immunol. 202, 77\u201386. https:\/\/doi.org\/10.1007\/s00430-012-0250-5 (2013).","journal-title":"Med. Microbiol. Immunol."},{"key":"3077_CR24","doi-asserted-by":"publisher","first-page":"846","DOI":"10.13303\/j.cjbt.issn.1004-549x.2018.08.009","volume":"31","author":"C Jianfeng","year":"2018","unstructured":"Jianfeng, C. et al. Evaluation of two CLIA reagents for blood screening HIV. Chin. J. Transf. Med. 31, 846\u2013850. https:\/\/doi.org\/10.13303\/j.cjbt.issn.1004-549x.2018.08.009 (2018).","journal-title":"Chin. J. Transf. Med."},{"key":"3077_CR25","first-page":"463","volume":"52","author":"B Weber","year":"2006","unstructured":"Weber, B. et al. Multicenter evaluation of a new 4th generation HIV screening assay Elecsys HIV combi. Clin. Lab. 52, 463\u2013473 (2006).","journal-title":"Clin. Lab."}],"container-title":["Scientific Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-03077-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-03077-6","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-03077-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,22]],"date-time":"2025-05-22T13:06:10Z","timestamp":1747919170000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-03077-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,22]]},"references-count":25,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["3077"],"URL":"https:\/\/doi.org\/10.1038\/s41598-025-03077-6","relation":{},"ISSN":["2045-2322"],"issn-type":[{"value":"2045-2322","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,22]]},"assertion":[{"value":"16 January 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 May 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 May 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The National Center for Clinical Laboratories (NCCL), established in 1982 under the National Health Commission of China, oversees clinical laboratory quality management nationwide. It conducts external quality assessment (EQA) programs, develops reference measurement procedures, and produces standard materials to ensure test accuracy and traceability. NCCL supports over 140 EQA programs with participation from more than 9,000 institutions and adheres to international standards such as ISO\/IEC 17043 and ISO 15195. Currently, it has developed more than 100 national primary or secondary reference materials for routine laboratory tests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"NCCL"}},{"value":"This study was conducted in full accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of the Shandong Blood Center prior to the enrollment of any participants (IRB approval number: \u201cLXB Ethics [2020] No. 4\u201d). The study was subsequently registered and approved in the National Health Insurance Platform\u2019s Medical Research Registration and Record Information System (registration number: MR-37-23-026261). Written informed consent was obtained from all participants involved in the study, and their consent forms are archived in accordance with institutional requirements.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Generative AI-assisted technologies were not used in the writing process of this manuscript.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Generative AI and AI-assisted technologies in the writing process"}},{"value":"None are declared.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declaration of competing interest"}},{"value":"J.C. contributed to the experimental design, conducted laboratory testing, performed data analysis, drafted the initial manuscript, and participated in its review and revision. F.W. oversaw the experiments, supervised laboratory testing, validated the data, and contributed to the manuscript\u2019s review and revision. L.J., R.J., and Y.L. assisted with data analysis, data curation, and drafting sections of the manuscript. All authors critically reviewed and revised the manuscript, approved the final version, and take full responsibility for the integrity of the data and the accuracy of the data analysis.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contribution statement"}}],"article-number":"17821"}}