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

Abstract:

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-NAT using 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 dHBV- samples. The proportion of anti-HBc+ and anti-HBs- (potentially infectious) donations was higher in 409 Ultrio+ and dHBV+ than in 1028 Ultrio+ and dHBV- samples (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 NAT reactivity.

journal_name

Transfusion

journal_title

Transfusion

authors

Gou H,Pan Y,Ge H,Zheng Y,Wu Y,Zeng J,Yang Z,Pan T,Cun W,Zhou G,Fang G,Zhang J,Zhang K,Zhang R,Sun Y,Xie J,Li J,Wang L

doi

10.1111/trf.13135

subject

Has Abstract

pub_date

2015-09-01 00:00:00

pages

2272-81

issue

9

eissn

0041-1132

issn

1537-2995

journal_volume

55

pub_type

杂志文章,多中心研究
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    pub_type: 杂志文章,多中心研究,随机对照试验

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    pub_type: 杂志文章,评审

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    pub_type: 临床试验,杂志文章,随机对照试验

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    pub_type: 杂志文章

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    pub_type: 杂志文章

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    pub_type: 杂志文章

    doi:10.1046/j.1537-2995.1991.31992094673.x

    authors: Nordhagen R,Vik H,Wolthuis K,Bøhn HP,Urdahl P,Michaelsen TE

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    pub_type: 杂志文章

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