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.
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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.	唐卓蕓, 張可依, 李冬冬, 等. 2001~2017年某大型綜合醫院新發HIV/AIDS患者的臨床流行病學分析. 四川大學學報(醫學版), 2019, 50(3): 367-372.
6.	江靈, 王華, 黃遠帥. 某綜合性醫院2009—2016年HIV感染流行病學調查分析. 中國輸血雜志, 2018, 31(4): 415-417.
7.	江光煚, 吳國輝, 裴迎新, 等. 中國老年人群HIV感染現況及行為學特征研究進展. 實用預防醫學, 2019, 26(4): 510-512, 封3.
8.	謝思燕, 陳學杰. 917例WB檢測HIV抗體陽性及不確定結果帶型分析. 中國艾滋病性病, 2018, 24(12): 1189-1191, 1196.
9.	張亞蘭, 衛曉麗, 鄭海潮, 等. 使用四代HIV抗原抗體試劑篩查聯合蛋白印跡或核酸補充實驗的檢測策略臨床評價. 中國艾滋病性病, 2018, 24(3): 286-288, 306.
10.	閆新麗, 王玉明, 李曉非, 等. HIV抗體初篩陽性報告檢測策略探討. 中華臨床實驗室管理電子雜志, 2019, 7(2): 89-91.
11.	宋麗娜. 兩種不同試劑進行HIV抗體復檢的效果研究. 皮膚病與性病, 2018, 40(5): 673-674.
12.	周昀, 楊新智, 周秋穎, 等. 500份HIV 1/2抗體蛋白印跡試驗陽性樣本的帶型分析. 中國艾滋病性病, 2018, 24(8): 821-823.
13.	石明巧, 黃曦悅, 張可依, 等. 綜合性醫院1054例HIV/AIDS患者WB帶型特征分析. 四川醫學, 2018, 39(5): 485-488.
14.	楊若男, 常謙, 高楠, 等. HIV抗原抗體聯檢電化學發光法反應性結果與蛋白印跡法檢測結果的相關性探討. 中國艾滋病性病, 2017, 23(11): 992-995.
15.	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.
16.	馮霞, 婁金麗, 李宇, 等. HIV抗原抗體篩查結合核酸定量補充實驗檢測策略的臨床應用評價. 中國艾滋病性病, 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. 中國疾病預防控制中心性病艾滋病預防控制中心性病控制中心. 2018年第3季度全國艾滋病性病疫情. 中國艾滋病性病, 2018, 24(11): 1075.
3. 中國疾病預防控制中心. 全國艾滋病檢測技術規范(2015年修訂版). 北京: 中國疾病預防控制中心, 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. 唐卓蕓, 張可依, 李冬冬, 等. 2001~2017年某大型綜合醫院新發HIV/AIDS患者的臨床流行病學分析. 四川大學學報(醫學版), 2019, 50(3): 367-372.
6. 江靈, 王華, 黃遠帥. 某綜合性醫院2009—2016年HIV感染流行病學調查分析. 中國輸血雜志, 2018, 31(4): 415-417.
7. 江光煚, 吳國輝, 裴迎新, 等. 中國老年人群HIV感染現況及行為學特征研究進展. 實用預防醫學, 2019, 26(4): 510-512, 封3.
8. 謝思燕, 陳學杰. 917例WB檢測HIV抗體陽性及不確定結果帶型分析. 中國艾滋病性病, 2018, 24(12): 1189-1191, 1196.
9. 張亞蘭, 衛曉麗, 鄭海潮, 等. 使用四代HIV抗原抗體試劑篩查聯合蛋白印跡或核酸補充實驗的檢測策略臨床評價. 中國艾滋病性病, 2018, 24(3): 286-288, 306.
10. 閆新麗, 王玉明, 李曉非, 等. HIV抗體初篩陽性報告檢測策略探討. 中華臨床實驗室管理電子雜志, 2019, 7(2): 89-91.
11. 宋麗娜. 兩種不同試劑進行HIV抗體復檢的效果研究. 皮膚病與性病, 2018, 40(5): 673-674.
12. 周昀, 楊新智, 周秋穎, 等. 500份HIV 1/2抗體蛋白印跡試驗陽性樣本的帶型分析. 中國艾滋病性病, 2018, 24(8): 821-823.
13. 石明巧, 黃曦悅, 張可依, 等. 綜合性醫院1054例HIV/AIDS患者WB帶型特征分析. 四川醫學, 2018, 39(5): 485-488.
14. 楊若男, 常謙, 高楠, 等. HIV抗原抗體聯檢電化學發光法反應性結果與蛋白印跡法檢測結果的相關性探討. 中國艾滋病性病, 2017, 23(11): 992-995.
15. 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.
16. 馮霞, 婁金麗, 李宇, 等. HIV抗原抗體篩查結合核酸定量補充實驗檢測策略的臨床應用評價. 中國艾滋病性病, 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

Abstract Full text Figures/Tables Video References Cited by

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