Clinical evaluation of three chemiluminescence immunoassays for human immunodeficiency virus antigen and antibody screening_West China Medical Journal

Authors：

LUO Lan , LI Dongdong , WANG Tingting , AO Keping ,  TAO Chuanmin

Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

TAO Chuanmin, Email: taocm@scu.edu.cn

Keywords：

Human immunodeficiency virus; chemiluminescence immunoassay; clinical evaluation

DOI：

10.7507/1002-0179.202009272

Video：

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Objective To evaluate the performance of i3000 direct chemiluminescence detection of human immunodeficiency virus (HIV) antigen and antibody (Ag/Ab) screening assay (Maccura), compared with E170 electrochemiluminescence method (Roche, Elecsys® HIV Combi PT assay) and IS1200 indirect chemiluminescence method (Maccura). Methods Ten HIV seroconversion panels and 11 p24 antigen positive samples from West China Hospital of Sichuan University from April to December 2017 were used to evaluate the sensitivity of those three assays. A total of 351 samples were collected for consistency evaluation, including 350 HIV Ag/Ab test samples (200 HIV-1 positive plasma samples and 150 HIV 1+2 negative plasma samples) from West China Hospital of Sichuan University from April to December 2017, and one commercial HIV-2 sera. A total of 98 interfere samples for HIV testing were collected from West China Hospital of Sichuan University from April to December 2017. Results In the sensitivity evaluation, there were 63 samples from the 10 seroconversion panels, in which Roche E170 detected 25 samples, Maccura i3000 detected 23 samples, and Maccura IS1200 detected 22 samples; Maccura i3000 and Roche E170 assays detected all the p24 antigen positive samples (11, 100%), while Maccura IS1200 only detected 10 samples. In the consistency evaluation, Maccura i3000 had nice consistency with both Roche E170 and Maccura IS1200 (kappa>0.9, P<0.001). In the interference evaluation, there were two false positives in Maccura i3000 detection, one case of rheumatoid arthritis and one case of syphilis. Conclusion In addition to high throughput and good consistency, Maccura i3000 direct chemiluminescence reagent has high sensitivity and a short window period, which can meet clinical needs.

Citation： LUO Lan, LI Dongdong, WANG Tingting, AO Keping, TAO Chuanmin. Clinical evaluation of three chemiluminescence immunoassays for human immunodeficiency virus antigen and antibody screening. West China Medical Journal, 2022, 37(8): 1176-1180. doi: 10.7507/1002-0179.202009272 Copy

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10.	郑朝晖, 冯月清, 杨光远. 第 4 代 HIV 抗原抗体联合检测试剂在无偿献血群体筛查中的应用. 浙江预防医学, 2014, 26(9): 971-972.
11.	朱绍汶, 王庆敏, 陈妍, 等. 第 3 代和第 4 代 HIV 检测试剂在血液筛查中的应用比较. 临床检验杂志, 2010, 28(6): 482.
12.	王红春, 尹跃平, 魏万惠, 等. 第 4 代 HIV ELISA 诊断试剂在性病门诊筛查中的评价. 中国麻风皮肤病杂志, 2010, 26(6): 392-394.
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14.	夏邦世, 吴金华. Kappa 一致性检验在检验医学研究中的应用. 中华检验医学杂志, 2006, 29(1): 83-84.
15.	李璐, 邢文革. 化学发光技术在 HCV 和 HIV 检测中的应用. 中国艾滋病性病, 2011, 17(3): 382-385.
16.	周俊, 袁帆, 潘涛, 等. 直接化学发光免疫分析法作为传染四项快速检测方法的应用探讨. 临床输血与检验, 2016, 18(4): 378-381.
17.	程木好, 王业涌, 高广彬. 化学发光免疫分析法与酶联免疫法检测艾滋病抗体的对照研究. 现代医院, 2016, 16(1): 30-32.
18.	Rao C, Wang T, Chen Q, et al. Performance evaluation of a novel automated HIV Ag/Ab chemiluminescence immunoassay. Clin Chem Lab Med, 2016, 54(9): e255-e258.
19.	Cui C, Liu P, Feng Z, et al. Evaluation of the clinical effectiveness of HIV antigen/antibody screening using a chemiluminescence microparticle immunoassay. J Virol Methods, 2015, 214: 33-36.
20.	国家食品药品监督管理总局. 国家药监局关于发布体外诊断试剂临床试验技术指导原则的通告（2021 年第 72 号）. (2021-09-16)[2022-07-29]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210927152837140.html.

1. 中华医学会感染病学分会艾滋病丙型肝炎学组, 中国疾病预防控制中心. 中国艾滋病诊疗指南(2018 版). 新发传染病电子杂志, 2019, 4(2): 65-84.
2. 王丽艳, 秦倩倩, 葛琳, 等. 我国 50 岁及以上艾滋病病毒感染者/艾滋病患者特征分析. 中华流行病学杂志, 2016, 37(2): 222-226.
3. 赵丽娜, 郑剑, 王大勇, 等. 2017-2019 年浙江省温州市经性传播感染 HIV/AIDS 感染来源及特征分析. 实用预防医学, 2021, 28(11): 1319-1323.
4. Zhu S, Li D, An J, et al. Using Elecsys® HIV Combi PT assay to identify acute and early HIV infection in a teaching hospital of southwest China. Int J STD AIDS, 2016, 27(3): 213-218.
5. Tao CM, Cho Y, Ng KP, et al. Validation of the Elecsys® HIV combi PT assay for screening and reliable early detection of HIV-1 infection in Asia. J Clin Virol, 2013, 58(1): 221-226.
6. 马晓旭. 第四代 HIV 检测试剂与第三代 HIV 检测试剂的结果比较. 中国医药指南, 2016, 14(4): 154-155.
7. 李川, 温浩瑄, 杨红, 等. 化学发光四代试剂结合病毒载量检测在 HIV-1 感染急性期诊断中的应用分析. 医学动物防制, 2020, 36(6): 541-543.
8. 吴忠华, 吕沁风, 郑伟, 等. 3 种进口第四代人类免疫缺陷病毒检测试剂检测性能评价. 中华医院感染学杂志, 2014, 24(17): 4412-4414.
9. 常俊峰. 三种 HIV 抗原/抗体检测方法对 HIV 早期感染检测的诊断研究. 中国免疫学杂志, 2015, 31(8): 1082-1084.
10. 郑朝晖, 冯月清, 杨光远. 第 4 代 HIV 抗原抗体联合检测试剂在无偿献血群体筛查中的应用. 浙江预防医学, 2014, 26(9): 971-972.
11. 朱绍汶, 王庆敏, 陈妍, 等. 第 3 代和第 4 代 HIV 检测试剂在血液筛查中的应用比较. 临床检验杂志, 2010, 28(6): 482.
12. 王红春, 尹跃平, 魏万惠, 等. 第 4 代 HIV ELISA 诊断试剂在性病门诊筛查中的评价. 中国麻风皮肤病杂志, 2010, 26(6): 392-394.
13. Fiebig EW, Wright DJ, Rawal BD, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS, 2003, 17(13): 1871-1879.
14. 夏邦世, 吴金华. Kappa 一致性检验在检验医学研究中的应用. 中华检验医学杂志, 2006, 29(1): 83-84.
15. 李璐, 邢文革. 化学发光技术在 HCV 和 HIV 检测中的应用. 中国艾滋病性病, 2011, 17(3): 382-385.
16. 周俊, 袁帆, 潘涛, 等. 直接化学发光免疫分析法作为传染四项快速检测方法的应用探讨. 临床输血与检验, 2016, 18(4): 378-381.
17. 程木好, 王业涌, 高广彬. 化学发光免疫分析法与酶联免疫法检测艾滋病抗体的对照研究. 现代医院, 2016, 16(1): 30-32.
18. Rao C, Wang T, Chen Q, et al. Performance evaluation of a novel automated HIV Ag/Ab chemiluminescence immunoassay. Clin Chem Lab Med, 2016, 54(9): e255-e258.
19. Cui C, Liu P, Feng Z, et al. Evaluation of the clinical effectiveness of HIV antigen/antibody screening using a chemiluminescence microparticle immunoassay. J Virol Methods, 2015, 214: 33-36.
20. 国家食品药品监督管理总局. 国家药监局关于发布体外诊断试剂临床试验技术指导原则的通告（2021 年第 72 号）. (2021-09-16)[2022-07-29]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210927152837140.html.

West China Medical Journal

Clinical evaluation of three chemiluminescence immunoassays for human immunodeficiency virus antigen and antibody screening

Abstract Full text Figures/Tables Video References Cited by

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