对中国南部献血者中乙型肝炎病毒感染的综合分析，这些感

StephenW

Transfusion. 2020 May 1. doi: 10.1111/trf.15824. [Epub ahead of print]
Comprehensive analysis of hepatitis B virus infections in blood donors in southern China that are surface antigen positive but nucleic acid testing negative.
Ye X1, Li T1, Zhang R1, Liu H1, Zeng J1, Hong W1, Lu L1, Zhu W1, Li S2, Xu M2, Wu S2, Chen L2,3.
Author information

1
    Shenzhen Blood Center, Shenzhen, Guangdong, China.
2
    Provincial Key Laboratory for Transfusion-transmitted Infectious Diseases, Institute of Blood Transfusion, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Chengdu, Sichuan, China.
3
    Toronto General Research Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada.

Abstract
BACKGROUND:

Hepatitis B virus (HBV) infection is one of the major concerns for the safety of blood transfusion in high-prevalent countries such as in China. Prior studies outside of China have shown hepatitis B surface antigen (HBsAg) false-reactive rate of 0.02% to 0.04%. Similarly, false-negative HBsAg and HBV DNA results may occur in infected donors. Our study analyzed HBsAg enzyme-linked immunosorbent assay (ELISA)-reactive but NAT-negative donations in Shenzhen Blood Center, China.
STUDY DESIGN AND METHODS:

HBsAg ELISA-positive/NAT-negative plasma samples identified from screening 101,025 donations during 2017-2018 were analyzed by molecular and serologic tests including neutralization, chemiluminescence immunoassays, and various HBV DNA amplification assays. Molecular characterizations of HBsAg-positive/NAT-negative samples were determined by quantitative polymerase chain reaction (qPCR) and nested PCR amplification of the basic core and precore promotor regions (295 base pairs) and HBsAg (S) region (496 base pairs).
RESULTS:

Screening of 101,025 eligible blood donations identified 157 (0.16%, 95% confidence interval, 0.13%-0.18%) HBsAg ELISA-positive/NAT-negative plasma samples; of those, 71 (45.2%) were HBsAg confirmed positive by further HBsAg testing and DNA positive by molecular tests with increased sensitivity. Of the 71, all but one was antibody to hepatitis B core antigen reactive without antibody to hepatitis B surface antigen, yielding one recent (window-period) HBV infection. Of the remaining donations, 80 (51%) were not considered as HBV-infected donors, and 6 (3.8%) were interpreted as indeterminate since HBsAg results were discordant with unconfirmed HBV DNA results. In the 71 confirmed positives, HBsAg levels ranged from 0.05 to 400 IU/mL and HBV DNA from 6 to 2654 IU/mL; however, the correlation between the two was weak (R2 = 0.24).
CONCLUSION:

Fewer than half of HBsAg ELISA-positive/NAT-negative samples were confirmed as HBsAg positive. Our study demonstrates that in highly HBV-endemic countries, assays with high sensitivity and specificity may be required.

© 2020 AABB.

PMID:
    32358842
DOI:
    10.1111/trf.15824

StephenW

输血。 2020年5月1日。doi：10.1111 / trf.15824。 [Epub提前发行]
对中国南部献血者中乙型肝炎病毒感染的综合分析，这些感染的表面抗原阳性，而核酸检测阴性。
叶X1，李T1，张R1，刘H1，曾J1，洪W1，陆L1，朱W1，李S2，徐M2，吴S2，陈L2,3。
作者信息

1个
    中国广东省深圳市深圳市血液中心
2
    中国医学科学院（CAMS）和北京协和医学院（PUMC）输血研究所输血传播传染病省重点实验室，四川成都。
3
    多伦多大学综合研究所，大学卫生网络，多伦多大学，加拿大安大略省多伦多市。

抽象
背景：

乙型肝炎病毒（HBV）感染是中国等高流行国家对输血安全性的主要关注之一。在中国以外的先前研究表明，乙型肝炎表面抗原（HBsAg）的假反应率为0.02％至0.04％。同样，在感染的供体中可能出现假阴性的HBsAg和HBV DNA结果。我们的研究分析了中国深圳血液中心的HBsAg酶联免疫吸附测定（ELISA）反应性但NAT阴性。
研究设计和方法：

通过分子和血清学测试（包括中和，化学发光免疫测定和各种HBV DNA扩增测定）对从2017-2018年筛查的101,025例捐赠中鉴定出的HBsAg ELISA阳性/ NAT阴性血浆样品进行了分析。通过定量聚合酶链反应（qPCR）和巢式PCR扩增基本核心和前核心启动子区域（295个碱基对）和HBsAg（S）区域（496个碱基对）来确定HBsAg阳性/ NAT阴性样品的分子特征。
结果：

筛选101,025份合格献血者，确定157（0.16％，95％置信区间，0.13％-0.18％）HBsAg ELISA阳性/ NAT阴性血浆样品；其中71例（45.2％）通过进一步的HBsAg检测确认为HBsAg阳性，而通过分子检测以更高的敏感性确认DNA阳性。在这71种病毒中，除一种病毒外，其余所有病毒都是抗乙型肝炎核心抗原的抗体，而没有抗乙型肝炎表面抗原的抗体，从而产生了一种最近的（窗期）HBV感染。在剩余的捐赠中，80（51％）被认为不是HBV感染的捐赠者，6（3.8％）被认为是不确定的，因为HBsAg结果与未经证实的HBV DNA结果不一致。在71例确诊阳性中，HBsAg水平为0.05至400 IU / mL，HBV DNA为6至2654 IU / mL；然而，两者之间的相关性较弱（R2 = 0.24）。
结论：

少于一半的HBsAg ELISA阳性/ NAT阴性样品被确认为HBsAg阳性。我们的研究表明，在高度HBV流行的国家中，可能需要具有高灵敏度和特异性的检测方法。

©2020 AABB。

PMID：
    32358842
DOI：
    10.1111 / trf.15824