A Pilot Study on Screening Blood Donors with Individual-donation Nucleic Acid Testing in China

Overview

Journal Blood Transfus

Specialty Hematology

Date 2013 Dec 17

PMID 24333061

Citations 9

Authors

Jie Dong

Yaling Wu

Hong Zhu

Gan Li

Mengen Lv

Daxiao Wu

Xiaotao Li

Faming Zhu

HangJun Lv

Affiliations

Soon will be listed here.

Abstract

Background: Nucleic acid amplification testing (NAT) is not yet obligatory in China for blood donor screening and the risk of enzyme immunoassay (EIA)-negative, NAT-reactive donations in Chinese blood donors has rarely been reported. The aim of this study was to screen a population of Chinese blood donors using a triplex individual-donation (ID)-NAT assay and assess the safety benefits of implementing NAT.

Materials And Methods: Between 1st August, 2010 and 31st December, 2011 all donations at a Chinese blood centre were screened individually using the Procleix® Ultrio® assay, a multiplex NAT assay for the detection of hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) RNA and human immunodeficiency virus-1 (HIV-1) RNA. All donations were also screened for HBsAg, anti-HIV and anti-HCV using two different EIA for each marker. Samples with discordant results between NAT and EIA were further tested with an alternative NAT assay (Cobas® TaqMan®). Potential yield cases (serologically negative/NAT-reactive donors) were further evaluated when possible.

Results: During the study period a total of 178,447 donations were screened by NAT and EIA, among which 169 HBV NAT yield cases (0.095%) were detected. No N AT yield cases were found for HIV-1 or HCV. For the HBV NAT yield cases, follow-up results showed that 11 (6.51%) were probable or confirmed HBV window period infections, 5 (2.96%) were chronic HBV carriers and 153 (90.53%) were probable or confirmed occult HBV infections. There was a statistically significant difference between the NAT-positive rates for first-time vs repeat donations (0.472% vs 0.146%, respectively; P<0.001).

Discussion: Our data demonstrate that the potential HBV yield rate was 1:1,056 for blood donations in the Zhejiang province of China. Implementation of NAT will provide a significant increment in safety relative to serological screening alone.

Citing Articles

Nucleic Acid Amplification Testing for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus in Blood Donors at a Tertiary Care Hospital Blood Bank.

Kouser S, Qadir H, Ahmad M, Tahir H, Sajjad M, Khan F Cureus. 2025; 17(1):e77571.

PMID: 39958131 PMC: 11830125. DOI: 10.7759/cureus.77571.

Establishing a screening strategy for non-discriminatory reactive blood donors by constructing a predictive model of hepatitis B virus infection status from a single blood center in China.

Wu D, Hu Y, Wang M, Wu Y, Dong J, Liu J Front Public Health. 2024; 12:1366431.

PMID: 38601498 PMC: 11004229. DOI: 10.3389/fpubh.2024.1366431.

Comparison of Two Different Serological Viral Marker Testing Assays for Screening of Apheresis Donors: Which Assay Provides Optimum Safety for Transfusion?.

Tiwari A, Setya D, Dara R, Arora D, Mehta S, Aggarwal G Indian J Hematol Blood Transfus. 2023; 39(2):300-307.

PMID: 37006975 PMC: 10064355. DOI: 10.1007/s12288-022-01553-x.

Re-Entry Evaluation of Chinese Blood Donors with Unconfirmed Hepatitis B Screening Results.

Deng X, Zang L, Candotti D Viruses. 2022; 14(11).

PMID: 36423154 PMC: 9698129. DOI: 10.3390/v14112545.

Anti-HBc-nonreactive occult hepatitis B infections with HBV genotypes B and C in vaccinated immunocompetent adults.

Deng X, Guo X, Gu H, Wang D, Laperche S, Allain J J Viral Hepat. 2022; 29(11):958-967.

PMID: 35876456 PMC: 9804389. DOI: 10.1111/jvh.13733.

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