Evaluation of an individual-donation nucleic acid amplification testing algorithm for detecting hepatitis B virus infection in Chinese blood donors

被引：30

作者：

Gou, Hongna ^{[1
,2
]}

Pan, Yang ^{[3
]}

Ge, Hongwei ^{[4
]}

Zheng, Yourong ^{[5
]}

Wu, Yaling ^{[6
]}

Zeng, Jinfeng ^{[7
]}

Yang, Zhongsi ^{[8
]}

Pan, Tong ^{[9
]}

Cun, Wei ^{[10
]}

Zhou, Guoping ^{[11
]}

Fang, Gen ^{[12
]}

Zhang, Jiahong ^{[13
]}

Zhang, Kuo ^{[1
]}

Zhang, Rui ^{[1
]}

Sun, Yu ^{[1
]}

Xie, Jiehong ^{[1
]}

Li, Jinming ^{[1
]}

Wang, Lunan ^{[1
]}

机构：

[1] Chinese Acad Med Sci, Natl Ctr Clin Labs, Beijing Hosp, Beijing 100730, Peoples R China

[2] Chinese Acad Med Sci, Grad Sch, Peking Union Med Coll, Beijing 100730, Peoples R China

[3] Beijing Ctr Dis Prevent & Control CDC, Inst Infect Dis & Endem Dis Control, Beijing, Peoples R China

[4] Beijing Blood Ctr, Beijing, Peoples R China

[5] Guangzhou Blood Ctr, Guangzhou, Guangdong, Peoples R China

[6] Zhejiang Blood Ctr, Hangzhou, Zhejiang, Peoples R China

[7] Shenzhen Blood Ctr, Shenzhen, Peoples R China

[8] Qingdao Blood Ctr, Qingdao, Peoples R China

[9] Tianjin Blood Ctr, Tianjin, Peoples R China

[10] Kunming Blood Ctr, Kunming, Peoples R China

[11] Shanghai Blood Ctr, Shanghai, Peoples R China

[12] Neimenggu Blood Ctr, Neimenggu, Peoples R China

[13] Tongzhou Blood Ctr, Beijing, Peoples R China

来源：

TRANSFUSION | 2015年 / 55卷 / 09期

关键词：

OCCULT HBV INFECTION; TRANSMISSION RISK; WINDOW PERIOD; TEST OPTIONS; EPIDEMIOLOGY; SENSITIVITY; COMPONENTS; ASSAYS;

D O I：

10.1111/trf.13135

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND: This multicenter study was performed to evaluate the efficiency of a multiplex individual-donation nucleic acid amplification technology (ID-NAT) and discriminatory testing algorithm for detecting hepatitis B virus (HBV) infection in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 1,205,796 hepatitis B surface antigen (HBsAg)nonreactive donations from 10 blood centers were tested by ID-NATusing the Ultrio assay. Multiplex Ultrio-reactive donations were tested in the discriminatory tests as well as in quantitative polymerase chain reaction (qPCR) and in supplemental electrochemiluminescence immunoassays for HBsAg, hepatitis B surface antibody (anti-HBs), hepatitis B e antigen, and antibody to hepatitis B core antigen (anti-HBc). Meanwhile, a control group of 4317 Ultrio-nonreactive donations was tested for anti-HBc and anti-HBs. RESULTS: Of all donations, 2033 (0.17%) were reactive in the multiplex Ultrio assay. Among 1776 further tested samples, 548 (30.9%) were HBV discriminatory assay (dHBV)-reactive, while 1214 (68.4%) were nonreactive. Of 472 Ultrio+ and dHBV+ samples 86.2% were qPCR positive compared to 15.0% in 1046 Ultrio+ and dHBVsamples. The proportion of anti-HBc+ and anti-HBs( potentially infectious) donations was higher in 409 Ultrio+ and dHBV+ than in 1028 Ultrio+ and dHBVsamples (51.3% vs. 31.1%, p < 0.001). The yield rate of Ultrio+, dHBV+, and qPCR+ donations was estimated at 1 in 2500, but at 1 in 1100 when all supplemental tests were taken into account assuming that 44% of detected donations by Ultrio were false reactive. CONCLUSIONS: A quarter of HBsAg-negative Ultrio+ and dHBV-donations in China are likely given by potentially infectious low-viral-load occult carriers. Although this has no implication for blood safety, the testing algorithm needs to be redesigned to more efficiently discriminate between true and false NATreactivity.

引用

页码：2272 / 2281

页数：10

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