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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3.	趙麗娜, 鄭劍, 王大勇, 等. 2017-2019 年浙江省溫州市經性傳播感染 HIV/AIDS 感染來源及特征分析. 實用預防醫學, 2021, 28(11): 1319-1323.
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8.	吳忠華, 呂沁風, 鄭偉, 等. 3 種進口第四代人類免疫缺陷病毒檢測試劑檢測性能評價. 中華醫院感染學雜志, 2014, 24(17): 4412-4414.
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10.	鄭朝暉, 馮月清, 楊光遠. 第 4 代 HIV 抗原抗體聯合檢測試劑在無償獻血群體篩查中的應用. 浙江預防醫學, 2014, 26(9): 971-972.
11.	朱紹汶, 王慶敏, 陳妍, 等. 第 3 代和第 4 代 HIV 檢測試劑在血液篩查中的應用比較. 臨床檢驗雜志, 2010, 28(6): 482.
12.	王紅春, 尹躍平, 魏萬惠, 等. 第 4 代 HIV ELISA 診斷試劑在性病門診篩查中的評價. 中國麻風皮膚病雜志, 2010, 26(6): 392-394.
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14.	夏邦世, 吳金華. Kappa 一致性檢驗在檢驗醫學研究中的應用. 中華檢驗醫學雜志, 2006, 29(1): 83-84.
15.	李璐, 邢文革. 化學發光技術在 HCV 和 HIV 檢測中的應用. 中國艾滋病性病, 2011, 17(3): 382-385.
16.	周俊, 袁帆, 潘濤, 等. 直接化學發光免疫分析法作為傳染四項快速檢測方法的應用探討. 臨床輸血與檢驗, 2016, 18(4): 378-381.
17.	程木好, 王業涌, 高廣彬. 化學發光免疫分析法與酶聯免疫法檢測艾滋病抗體的對照研究. 現代醫院, 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.	國家食品藥品監督管理總局. 國家藥監局關于發布體外診斷試劑臨床試驗技術指導原則的通告（2021 年第 72 號）. (2021-09-16)[2022-07-29]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210927152837140.html.

1. 中華醫學會感染病學分會艾滋病丙型肝炎學組, 中國疾病預防控制中心. 中國艾滋病診療指南(2018 版). 新發傳染病電子雜志, 2019, 4(2): 65-84.
2. 王麗艷, 秦倩倩, 葛琳, 等. 我國 50 歲及以上艾滋病病毒感染者/艾滋病患者特征分析. 中華流行病學雜志, 2016, 37(2): 222-226.
3. 趙麗娜, 鄭劍, 王大勇, 等. 2017-2019 年浙江省溫州市經性傳播感染 HIV/AIDS 感染來源及特征分析. 實用預防醫學, 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. 馬曉旭. 第四代 HIV 檢測試劑與第三代 HIV 檢測試劑的結果比較. 中國醫藥指南, 2016, 14(4): 154-155.
7. 李川, 溫浩瑄, 楊紅, 等. 化學發光四代試劑結合病毒載量檢測在 HIV-1 感染急性期診斷中的應用分析. 醫學動物防制, 2020, 36(6): 541-543.
8. 吳忠華, 呂沁風, 鄭偉, 等. 3 種進口第四代人類免疫缺陷病毒檢測試劑檢測性能評價. 中華醫院感染學雜志, 2014, 24(17): 4412-4414.
9. 常俊峰. 三種 HIV 抗原/抗體檢測方法對 HIV 早期感染檢測的診斷研究. 中國免疫學雜志, 2015, 31(8): 1082-1084.
10. 鄭朝暉, 馮月清, 楊光遠. 第 4 代 HIV 抗原抗體聯合檢測試劑在無償獻血群體篩查中的應用. 浙江預防醫學, 2014, 26(9): 971-972.
11. 朱紹汶, 王慶敏, 陳妍, 等. 第 3 代和第 4 代 HIV 檢測試劑在血液篩查中的應用比較. 臨床檢驗雜志, 2010, 28(6): 482.
12. 王紅春, 尹躍平, 魏萬惠, 等. 第 4 代 HIV ELISA 診斷試劑在性病門診篩查中的評價. 中國麻風皮膚病雜志, 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, 吳金華. Kappa 一致性檢驗在檢驗醫學研究中的應用. 中華檢驗醫學雜志, 2006, 29(1): 83-84.
15. 李璐, 邢文革. 化學發光技術在 HCV 和 HIV 檢測中的應用. 中國艾滋病性病, 2011, 17(3): 382-385.
16. 周俊, 袁帆, 潘濤, 等. 直接化學發光免疫分析法作為傳染四項快速檢測方法的應用探討. 臨床輸血與檢驗, 2016, 18(4): 378-381.
17. 程木好, 王業涌, 高廣彬. 化學發光免疫分析法與酶聯免疫法檢測艾滋病抗體的對照研究. 現代醫院, 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. 國家食品藥品監督管理總局. 國家藥監局關于發布體外診斷試劑臨床試驗技術指導原則的通告（2021 年第 72 號）. (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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