Clinical application of combining human immunodeficiency virus antigen/antibody assay screening and Western blot or human immunodeficiency virus nucleic acid_West China Medical Journal

Authors：

CHEN Li ^1,2 , TANG Zhuoyun ¹ , ZHANG Keyi ¹ , LI Dongdong ¹ , LUO Lan ¹ , AO Keping ¹ ,  TAO Chuanmin ¹

1. Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
2. Department of Laboratory Medicine, Wenjiang Zhongyi Hospital, Chengdu, Sichuan 611130, P. R. China;

Corresponding author：

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

Keywords：

Human immunodeficiency virus; The fourth generation antigen/antibody assay; The third generation antibody assay; Western blot; Nucleic acid detection

DOI：

10.7507/1002-0179.202007035

Video：

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Objective To evaluate the clinical significance of human immunodeficiency virus (HIV) testing algorithm combining antigen/antibody assay screening with Western Blot (WB) or HIV nucleic acid.Methods Data of HIV antigen and antibody screening samples in West China Hospital of Sichuan University in 2018 were retrospectively analyzed. The 4th generation antigen and antibody reagents were used for initial screening, and the 3rd generation antibody reagents were used for reexamination. WB or HIV nucleic acid detection was performed as supplementary test.Results A total of 217 803 samples were initially screened, 718 samples were positive in initial screening (0.33%) and 513 samples were confirmed positive (0.24%). The 718 initial positive samples were confirmed by WB, among them, 513 (71.45%) were positive, 163 (22.70%) were negative, and 42 (5.85%) were indeterminate. Fifteen samples which were negative or indeterminate were detected by HIV RNA, as a result, 6 were positive. Two of four patients turned into positive during follow-up. Among the 536 samples which were positive in both the 4th and 3rd generation assay, there were 513 (95.71%) positive, 6 (1.12%) negative, and 17 (3.17%) indeterminate confirmed by WB; among the 182 samples which were positive in the 4th generation assay but negative in the 3rd generation assay, there were none (0.00%) positive, 157 (86.26%) negative, and 25 (13.74%) indeterminate confirmed by WB. The positive rate of confirmation test of samples positive in the 4th and 3rd generation assay (95.71%, 513/536) was significantly higher than that of samples positive in the 4th generation assay but negative in the 3rd generation assay (0%, 0/182), and the difference was statistically significant (χ²=610.091, P<0.001). WB band types for positive samples were dominated by the whole bands and sub-bands, accounting for 82.26%. The cut off index in ≥5 bands group was higher than that in < 4 bands group (P<0.001).Conclusions Samples with both the 4th and 3rd generation assay positive have a high positive rate of confirmation test, and a supplementary test is needed to be done as soon as possible to confirm the diagnosis. Samples with only the 4th generation assay positive have a low positive rate of confirmation test. But for patients with a high-risk history, HIV nucleic acid should be done as soon as possible for early diagnosis.

Citation： CHEN Li, TANG Zhuoyun, ZHANG Keyi, LI Dongdong, LUO Lan, AO Keping, TAO Chuanmin. Clinical application of combining human immunodeficiency virus antigen/antibody assay screening and Western blot or human immunodeficiency virus nucleic acid. West China Medical Journal, 2020, 35(8): 930-935. doi: 10.7507/1002-0179.202007035 Copy

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.
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5.	唐卓芸, 张可依, 李冬冬, 等. 2001~2017年某大型综合医院新发HIV/AIDS患者的临床流行病学分析. 四川大学学报(医学版), 2019, 50(3): 367-372.
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9.	张亚兰, 卫晓丽, 郑海潮, 等. 使用四代HIV抗原抗体试剂筛查联合蛋白印迹或核酸补充实验的检测策略临床评价. 中国艾滋病性病, 2018, 24(3): 286-288, 306.
10.	闫新丽, 王玉明, 李晓非, 等. HIV抗体初筛阳性报告检测策略探讨. 中华临床实验室管理电子杂志, 2019, 7(2): 89-91.
11.	宋丽娜. 两种不同试剂进行HIV抗体复检的效果研究. 皮肤病与性病, 2018, 40(5): 673-674.
12.	周昀, 杨新智, 周秋颖, 等. 500份HIV 1/2抗体蛋白印迹试验阳性样本的带型分析. 中国艾滋病性病, 2018, 24(8): 821-823.
13.	石明巧, 黄曦悦, 张可依, 等. 综合性医院1054例HIV/AIDS患者WB带型特征分析. 四川医学, 2018, 39(5): 485-488.
14.	杨若男, 常谦, 高楠, 等. HIV抗原抗体联检电化学发光法反应性结果与蛋白印迹法检测结果的相关性探讨. 中国艾滋病性病, 2017, 23(11): 992-995.
15.	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.
16.	冯霞, 娄金丽, 李宇, 等. HIV抗原抗体筛查结合核酸定量补充实验检测策略的临床应用评价. 中国艾滋病性病, 2018, 24(1): 15-18.
17.	Mühlbacher A, Schennach H, van Helden J, <italic>et al</italic>. Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay. Med Microbiol Immunol, 2013, 202(1): 77-86.
18.	Nasi M, Pinti M, De Biasi S, <italic>et al</italic>. Aging with HIV infection: a journey to the center of inflammAIDS, immunosenescence and neuroHIV. Immunol Lett, 2014, 162(1 Pt B): 329-333.

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. 中国疾病预防控制中心性病艾滋病预防控制中心性病控制中心. 2018年第3季度全国艾滋病性病疫情. 中国艾滋病性病, 2018, 24(11): 1075.
3. 中国疾病预防控制中心. 全国艾滋病检测技术规范(2015年修订版). 北京: 中国疾病预防控制中心, 2015: 1-70.
4. Fiebig EW, Wright DJ, Rawal BD, <italic>et al</italic>. 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.
5. 唐卓芸, 张可依, 李冬冬, 等. 2001~2017年某大型综合医院新发HIV/AIDS患者的临床流行病学分析. 四川大学学报(医学版), 2019, 50(3): 367-372.
6. 江灵, 王华, 黄远帅. 某综合性医院2009—2016年HIV感染流行病学调查分析. 中国输血杂志, 2018, 31(4): 415-417.
7. 江光煚, 吴国辉, 裴迎新, 等. 中国老年人群HIV感染现况及行为学特征研究进展. 实用预防医学, 2019, 26(4): 510-512, 封3.
8. 谢思燕, 陈学杰. 917例WB检测HIV抗体阳性及不确定结果带型分析. 中国艾滋病性病, 2018, 24(12): 1189-1191, 1196.
9. 张亚兰, 卫晓丽, 郑海潮, 等. 使用四代HIV抗原抗体试剂筛查联合蛋白印迹或核酸补充实验的检测策略临床评价. 中国艾滋病性病, 2018, 24(3): 286-288, 306.
10. 闫新丽, 王玉明, 李晓非, 等. HIV抗体初筛阳性报告检测策略探讨. 中华临床实验室管理电子杂志, 2019, 7(2): 89-91.
11. 宋丽娜. 两种不同试剂进行HIV抗体复检的效果研究. 皮肤病与性病, 2018, 40(5): 673-674.
12. 周昀, 杨新智, 周秋颖, 等. 500份HIV 1/2抗体蛋白印迹试验阳性样本的带型分析. 中国艾滋病性病, 2018, 24(8): 821-823.
13. 石明巧, 黄曦悦, 张可依, 等. 综合性医院1054例HIV/AIDS患者WB带型特征分析. 四川医学, 2018, 39(5): 485-488.
14. 杨若男, 常谦, 高楠, 等. HIV抗原抗体联检电化学发光法反应性结果与蛋白印迹法检测结果的相关性探讨. 中国艾滋病性病, 2017, 23(11): 992-995.
15. 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.
16. 冯霞, 娄金丽, 李宇, 等. HIV抗原抗体筛查结合核酸定量补充实验检测策略的临床应用评价. 中国艾滋病性病, 2018, 24(1): 15-18.
17. Mühlbacher A, Schennach H, van Helden J, <italic>et al</italic>. Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay. Med Microbiol Immunol, 2013, 202(1): 77-86.
18. Nasi M, Pinti M, De Biasi S, <italic>et al</italic>. Aging with HIV infection: a journey to the center of inflammAIDS, immunosenescence and neuroHIV. Immunol Lett, 2014, 162(1 Pt B): 329-333.

West China Medical Journal

Clinical application of combining human immunodeficiency virus antigen/antibody assay screening and Western blot or human immunodeficiency virus nucleic acid

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