Comparative Analysis of Multi-system Nucleic Acid-amplification Testing for Hepatitis B Virus Nucleic Acid Reactive Specimens in Blood Screening

doi:10.3969/j.issn.1671-2587.2026.02.012

JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE ›› 2026, Vol. 28 ›› Issue (2): 227-230.DOI: 10.3969/j.issn.1671-2587.2026.02.012

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Comparative Analysis of Multi-system Nucleic Acid-amplification Testing for Hepatitis B Virus Nucleic Acid Reactive Specimens in Blood Screening

MA Limin, GAO Zhijun, TANG Qingjun, LI Jianjun, CAI Yin, ZHOU Guoping, ZHENG Lan, WANG Xun

Shanghai Blood Center, Shanghai 200051

Received:2025-07-16 Accepted:2025-09-09 Online:2026-04-20 Published:2026-04-22

Abstract

Abstract: Objective To evaluate the consistency of results among three hepatitis B virus (HBV) nucleic acid-amplification testing (NAT) for blood donor screening and identify the influencing factors. Methods A total of 241 527 voluntary blood donation specimens negative for HBV by enzyme-linked immunosorbent assay (ELISA) were subjected to NAT. One hundred and twenty-five NAT-reactive specimens were selected for retesting using the three NAT systems, and hepatitis B core antibody (anti-HBc) detection was performed. The reactive detection rate of each system, cross-reactive detection rate across multiple systems, Cohen's Kappa coefficient analysis, and anti-HBc results were analyzed to evaluate differences in HBV detection. Results The reactive detection rates of systems A, B, and C were 96.78%, 48.24%, and 44.44% respectively. The Kappa coefficients ranged from 0.58 to 0.65, indicating moderate to substantial consistency. Among specimens reactive to system A, the reactive detection rate in system B was higher than that in system C. The positive rate of anti-HBc detection was 73.6% (92/125). Among transient NAT-reactive specimens, the positive rate of anti-HBc was 58%. Conclusion NAT can effectively reduce the risk of HBV transmission via blood transfusion, but no single NAT can completely eliminate this infection risk. Particularly in the screening of transient NAT-reactive specimens, combining multi-system NAT with anti-HBc testing can further reduce the risk of transfusion-transmitted HBV infection.

Key words: Hepatitis B virus, Nucleic acid testing, Transfusion safety

CLC Number:

R457.1R512.6+2

MA Limin, GAO Zhijun, TANG Qingjun, LI Jianjun, CAI Yin, ZHOU Guoping, ZHENG Lan, WANG Xun. Comparative Analysis of Multi-system Nucleic Acid-amplification Testing for Hepatitis B Virus Nucleic Acid Reactive Specimens in Blood Screening[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2026, 28(2): 227-230.

References

[1] 郭瑞,侯云,苏常山,等. 采用发病率-窗口期模型分析2018—2022年国内21家采供血机构输血传播HBV检测残余风险[J]. 临床输血与检验,2024,26(6):781-787.
[2] 周怡,史恩溢,曹谊,等. HBsAg阴性献血者隐匿性HBV感染的血清学特征及其与病毒载量的关系[J]. 临床输血与检验,2017,19(6):570-573.
[3] 易萌,樊斌,段晓琼,等. 隐匿性乙肝感染对输血安全的影响及应对策略[J]. 临床输血与检验,2025,27(2):254-260.
[4] 符鑫,刘悦,彭鑫,等. 采用高敏检测技术检测血清HBV DNA载量筛选低病毒血症的无偿献血人群隐匿性乙型肝炎病毒感染研究[J]. 实用肝脏病杂志,2023,26(2):169-172.
[5] Li H L,Song W J,Li H Y,et al.Advances in isothermal nucleic acid amplification methods for hepatitis B virus detection[J]. Analyst,2023,148(16):3708-3718.
[6] 张毓,张丽,王学刚,等. 京津冀血站实验室核酸混样模式单阳性率分析[J]. 中国输血杂志,2020,33(4):295-299.
[7] 刘淼,潘彤,王霞. 不同血液筛查核酸检测模式检测结果的分析[J]. 检验医学与临床,2023,20(16):2375-2377.
[8] Jayalakshmi V T,Bernal W.Update on the management of acute liver failure[J]. Curr Opin Crit Care,2020,26(2): 163-170.
[9] 王素玲,韩卫,葛红卫,等. 京津冀血站实验室核酸单检模式鉴别阳性率分析[J]. 中国输血杂志,2022,35(1):57-60.
[10] 胡一钦,黄纪红,王敏,等. 乙肝酶免无反应而核酸未鉴别反应性结果分析[J]. 中华实验和临床病毒学杂志,2023, 37(4):422-428.
[11] Lelie N,Bruhn R,Busch M,et al.Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing[J]. Transfusion, 2017, 57(1):24-35.
[12] 程卫芳,周学勇,崔伟娅,等. 单项HBV核酸反应性献血者两次追踪结果分析[J]. 临床输血与检验,2020,22(5):514-517.
[13] 国家卫生健康委员会. 血站技术操作规程(2019年版)[S]. 2019.
[14] 何智纯,伍晓菲,贾尧,等. 血液筛查核酸检测室间质评结果分析[J]. 中国输血杂志,2021,34(11):1225-1227.
[15] Raimondo G,Locarnini S,Pollicino T,et al.Update of the statements on biology and clinical impact of occult hepatitis B virus infection[J]. J Hepatol,2019,71(2): 397-408.
[16] 赵晶. 化学发光免疫分析法检测乙肝病毒血清学标志物的应用价值分析[J]. 现代诊断与治疗,2023,34(22):3405-3407.
[17] Ramachandran S,Groves J A,Xia G L,et al.Recent and occult hepatitis B virus infections among blood donors in the United States[J]. Transfusion,2019,59(2):601-611.

Comparative Analysis of Multi-system Nucleic Acid-amplification Testing for Hepatitis B Virus Nucleic Acid Reactive Specimens in Blood Screening

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