核酸检测反应性献血者归队方案探讨*

doi:10.3969/j.issn.1671-2587.2021.05.019

临床输血与检验 ›› 2021, Vol. 23 ›› Issue (5): 639-643.DOI: 10.3969/j.issn.1671-2587.2021.05.019

核酸检测反应性献血者归队方案探讨^*

任亚娜, 周国平

200051 上海市血液中心

收稿日期:2020-10-27 发布日期:2021-10-20
作者简介:任亚娜（1982-）,女,河南开封人,副主任技师,硕士,主要从事输血技术方面研究,（E-mail）renyana@sbc.org.cn。
基金资助:
*本课题受上海市卫生和健康委员会科研课题（面上项目）（No.201740097）资助

A Reentry Program for NAT Reactive Blood Donors

REN Ya-na, ZHOU Guo-ping

Shanghai Blood Center, Shanghai 200051

Received:2020-10-27 Published:2021-10-20

摘要/Abstract

摘要： 目的为减少血液报废,探讨可行的核酸检测反应性献血者归队方案。方法筛选2012年~2017年上海市血液中心无偿献血者中核酸反应性且其他血液筛查标志物无反应性的献血者,召回42人进入归队流程。通过血清学检测方法（酶联免疫吸附试验和化学发光免疫分析法）和核酸检测方法进行归队检测标志物（HBV、HCV、HIV和TP）的检测,设计核酸反应性献血者归队流程。结果第一轮归队检测为酶联免疫吸附试验无反应性核酸检测反应性的15人;两者均为无反应性的27人。此27例再使用化学发光免疫分析法检测,其中9例为Anti-HBc、Anti-HBe两项都是反应性,14例为Anti-HBc反应性。第一轮检测Anti-HBc、Anti-HBe一项或两项反应性的献血者,第二轮检测仍为反应性,建议在第一轮永久屏蔽。4位献血者召回检测的所有项目均无反应性,建议可以回归献血者队伍。结论探讨了核酸检测反应性献血者归队方案的可行性,初步确定核酸反应性献血者归队判断规则。

关键词: 核酸反应性, 献血者归队, 归队方案

Abstract: Objective To study the methods for reentry of NAT reactive blood donors to reduce blood scrapping. Methods Blood donors with NAT reactivity and other blood screening non-reactive were selected between 2012 and 2017 in Shanghai Blood Center, and 42 blood donors were recalled to the reentry program. Serological detection methods (ELISA, CLIA) and NAT methods were used to detect the markers (HBV, HCV, HIV and TP). Methods for reentry of ELISA-/NAT+ blood donors were designed. Results In the first reentry, 15 cases were ELISA non-reactive and NAT reactive; 27 cases were ELISA non-reactive and NAT non-reactive. Among 27 cases, 9 cases were anti-HBc/anti-HBe reactive and 14 cases were anti-HBc reactive. Anti-HBc and / or anti-HBe reactive blood donors in the first reentry were still reactive in the second reentry, which suggested those were all deferred permanently in the first reentry. Four reentry cases that were non-reactive to all tests may be eligible for reentry. Conclusion We studied the feasibility of reentry of NAT reactive blood donors and preliminarily determined the reentry rule.

Key words: NAT reactive, Reentry of blood donors, Reentry program

中图分类号:

R330.44

任亚娜, 周国平. 核酸检测反应性献血者归队方案探讨^*[J]. 临床输血与检验, 2021, 23(5): 639-643.

REN Ya-na, ZHOU Guo-ping. A Reentry Program for NAT Reactive Blood Donors[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2021, 23(5): 639-643.

参考文献

[1] 张红,周龙,许晓绚,等.Ultrio和Ultrio plus 2种核酸试剂对献血者HCV RNA筛查的一致性分析[J].中国输血杂志,2018,31(12):1341-1344.
[2] CANDIDO A,CHIONNE P,MILAZZO L,et al.Nucleic acid testing (NAT) for HCV RNA in Italian transfusion centres:an external quality assessment[J].J Clin Virol,2008,41(4):277-282.
[3] 孙海英,范恩勇,许守广,等.31例乙型肝炎病毒核酸检测阳性献血者跟踪调查[J].临床输血与检验,2017,19(1):53-55.
[4] European Committee on Blood Transfusion.Guide to the Preparation, use and quality assurance of blood components(20th Ed)[M/OL].https://www.edqm.eu/en/blood-guide.
[5] National Blood Service. Guidelines for the Blood Transfusion Services in the United Kingdom(8th Ed)[M/OL].(2013-03-11).https://www.tsoshop.co.uk/product/9780117081673/Guidelines-for-the-Blood-Transfusion-Services-in-the-United-Kingdom-Paperback/.
[6] FDA. Guidance for Industry. Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)[EB/OL].(2010-05).https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requalification-method-reentry-blood-donors-deferred-because-reactive-test-results-antibody.
[7] FDA. Guidance for Industry.Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus[EB/OL].(2012-11-15) .https://www.federalregister.gov/documents/2012/11/15/2012-27783/guidance-for-industry-use-of-nucleic-acid-tests-on-pooled-and-individual-samples-from-donors-of.
[8] FDA.Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components,including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus[EB/OL].(2012-11).https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-nucleic-acid-tests-pooled-and-individual-samples-donors-whole-blood-and-blood-components.
[9] 中国输血协会.血液筛查反应性献血者归队指南[S].2019.4.
[10] 蒋昵真,朱绍汶,汤心怡,等.256例ELISA筛查无反应性/核酸检测反应性标本的确认分析[J].中国输血杂志,2016,29(10):1126-1129.
[11] 释艳华,饶艳华,姚丽.襄阳市HBV DNA核酸检测反应性献血者血源屏蔽与归队策略[J].临床血液学杂志(输血与检验),2017,30(2):142-143.
[12] 王丽梅,林授,何小兰,等.核酸检测单反应性献血者归队情况分析[J].福建医药杂志,2019,41(4):12-16.
[13] 郑欣,许晓绚,曾劲峰,等.深圳地区HBV、HCV反应性献血者归队检测结果分析与策略探讨[J].中国输血杂志,2019,32(10):1024-1027.
[14] 安万新,邓雪莲,梁晓华,等.大连市血液中心HBsAg阴性献血者HBV感染的确认与HBV核酸检出效率的评估[J].中国输血杂志,2014,27(3):268-273.
[15] 杨爱莲,曾劲峰,邬旭群,等.献血者HBV DNA存在的确认与S蛋白变异特征分析[J].中国输血杂志,2015,28(4):379-383.

核酸检测反应性献血者归队方案探讨^*

A Reentry Program for NAT Reactive Blood Donors

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