基于HBV感染的确认探讨核酸检测反应性献血者的归队策略*

doi:10.3969/j.issn.1671-2587.2024.05.015

临床输血与检验 ›› 2024, Vol. 26 ›› Issue (5): 667-674.DOI: 10.3969/j.issn.1671-2587.2024.05.015

基于HBV感染的确认探讨核酸检测反应性献血者的归队策略^*

邓雪莲¹, 臧亮¹, 刘笑春¹, 孙鹏¹, 王颖颖¹, Daniel Candotti², 周俊³

¹大连市血液中心,辽宁省大连市 116001;
²Department of Virology,Henri Mondor Hospital,AP-HP,and University of Paris-East,INSERM U955,IMRB;
³圣湘生物科技股份有限公司,湖南省长沙市

收稿日期:2024-07-09 出版日期:2024-10-20 发布日期:2024-09-20
通讯作者: 邓雪莲,主要从事输血相关病毒及风险评估,（E-mail）dxl_dl@sina.com。周俊,主要从事病原体检测试剂研发,（E-mail）junz@sansure.com.cn。
作者简介:邓雪莲,主要从事输血相关病毒及风险评估,（E-mail）dxl_dl@sina.com。
基金资助:
*本课题受中国输血协会圣湘输血医学发展基金项目（No.CSBT-SX-2021-02）资助

Re-entry Strategy of Nucleic Acid Testing Reactive Blood Donors Based on HBV Infection Confirmation

DENG Xuelian, ZANG Liang, LIU Xiaochun, SUN Peng, WANG Yingying, CANDOTTI Daniel, ZHOU Jun

Dalian Blood Center, Dalian, 116001

Received:2024-07-09 Online:2024-10-20 Published:2024-09-20

摘要/Abstract

摘要： 目的基于血液筛查核酸检测反应性献血者的HBV感染的确认,探讨核酸检测反应性献血者的归队策略。方法联合应用自建的高灵敏度核酸检测体系、血液核酸筛查等多种核酸检测（NAT）方法,并结合血清学检测、献血者随访,对核酸检测反应性（NAT-yield）献血者中的HBV感染进行确认和感染状态识别。依据确认的HBV感染血浆样本,比较不同确认方法、确认指标或指标组合对HBV感染确认的效果。结果 2010年11月—2021年2月,在血液筛查检出的876位NAT-yield献血者中共确认HBV感染者511人（OBI 451人,急性早期HBV感染者27人,不能确认感染者33人,无感染者30人,不能确认HBV感染者335人)。采用单检系统对混检系统检出的HBV感染血浆进行复测的检出率为96.6%,明显高于混检系统对单检系统检出的HBV DNA反应性（HBV DNA R）组和鉴别试验无反应性（NDR）组的复测检出率（76.4%和55.7%）（P<0.05）。NDR样本在模式2（ID×5+鉴别×2）下复测检出率（65.2%）高于模式1（ID×2+鉴别×1）（39.2%）（P<0.05）;2种单检复测模式下的HBV DNA R样本复测检出率无明显差异（P>0.05）,但均明显高于NDR样本（P<0.05）。回溯OBI献血者既往NAT数据,有46%经历多次NAT检测而未能检出。有59.1% OBI献血者随访检不出HBV DNA。OBI献血者中抗-HBc+占比为90.2%,单独抗-HBc+为49.2%,远高于不能确认感染组（P<0.05）;HBeAg、抗-HBe和抗-HBc IgM在OBI和不能确认感染组中的比例极低且无差异（P>0.05）。结论近60%的NAT-yield献血者可以确认HBV感染。为保证献血者归队的安全性,需要更高灵敏度的HBV DNA确证技术提高HBV感染的确认率。抗-HBc是NAT-yield献血者OBI风险排查和归队评估最重要的血清学指标。

关键词: 核酸检测, 献血者归队, HBV感染, 确证, 随访

Abstract: Objective To study on the re-entry strategy of nucleic acid testing reactive blood donors based on HBV infection confirmation. Methods Multiple highly sensitive in-house nucleic acid testing (NAT) methods and routine blood NAT screening platforms were combined with serological testing and blood donor follow-up to confirm HBV infection to identify infection status in NAT-yield blood donors. The efficiency of different NAT methods, HBV markers and marker combinations were compared in detection and confirmation of HBV infections. Results From November 2010 to February 2021, 511 in 876 NAT-yield blood donors were confirmed to be infected with HBV (451 OBIs, 27 acute early HBV infections, 33 infected with HBV but infection status unidentified, 30 without infection, and 335 HBV infection unconfirmed). The detection rate of HBV DNA in HBV-infected plasma yielded by minipool NAT (MP-NAT) was 96.6% when individual NAT (ID-NAT) was used, which was significantly higher than those of HBV DNA reactive samples (HBV DNA R) and non-discriminatory reactive samples (NDR) yielded by ID-NAT (76.4% and 55.7%, respectively) (P<0.05). The detection rate (65.2%) of NDR samples under retesting mode 2 (ID×5+ Discrimination×2) was higher than that (39.2%) under retesting mode 1 (ID×2+Discrimination ×1) (P<0.05). The detection rate of HBV DNA R samples under the two retesting modes had no significant difference (P>0.05), but was clearly higher than that of NDR samples (P<0.05). Reviewing the previous NAT data of OBI blood donors, 46% had experienced multiple NAT without detection. And HBV DNA was not detected in 59.1% of OBI blood donors during follow-up. The proportion of anti-HBc+ in OBIs was 90.2%, while that of anti-HBc+ alone was 49.2%, which was much higher than that in HBV infection unconfirmed group (P<0.05). The proportions of HBeAg, anti-HBe and anti-HBc IgM in OBI were very low, similar with that of infection unconfirmed groups (P>0.05). Conclusion HBV infections were confirmed in nearly 60% of NAT-yield blood donors. HBV DNA confirmation technology with higher sensitivity is needed to improve the confirmation rate of HBV infection, which ensured the safety of re-entry blood donors. Anti-HBc was the most important serological marker in excluding the risk of OBI and assessment of NAT-yield donor's re-entry.

Key words: Nucleic acid testing, Blood donor re-entry, Hepatitis B virus infection, Confirmation, Follow up

中图分类号:

R457

邓雪莲, 臧亮, 刘笑春, 孙鹏, 王颖颖, Daniel Candotti, 周俊. 基于HBV感染的确认探讨核酸检测反应性献血者的归队策略^*[J]. 临床输血与检验, 2024, 26(5): 667-674.

DENG Xuelian, ZANG Liang, LIU Xiaochun, SUN Peng, WANG Yingying, CANDOTTI Daniel, ZHOU Jun. Re-entry Strategy of Nucleic Acid Testing Reactive Blood Donors Based on HBV Infection Confirmation[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2024, 26(5): 667-674.

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基于HBV感染的确认探讨核酸检测反应性献血者的归队策略^*

Re-entry Strategy of Nucleic Acid Testing Reactive Blood Donors Based on HBV Infection Confirmation

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