A pilot study on screening blood donors with individual-donation nucleic acid testing in China.

Jie Dong · Yaling Wu · Hong Liang Zhu · Li Gan · Mengen Lv · Daxiao Wu +3 more

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Blood donation and transfusion practices Hepatitis B Virus Studies Hepatitis C virus research

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.

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References

2011International survey on NAT testing of blood donations: expanding implementation and yield from 1999 to 2009 2000NAT of the United States and Canadian blood supply 2009Impact of individual‐donation nucleic acid testing on risk of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission by blood transfusion in South Africa 2009Relative safety of first‐time volunteer and replacement donors in West Africa 2002Assessing the accuracy of three viral risk models in predicting the outcome of implementing HIV and HCV NAT donor screening in Australia and the implications for future HBV NAT 2007Residual risk of transfusion‐transmitted viral infections in Shenzhen, China, 2001 through 2004 2008A pilot study for screening blood donors in Taiwan by nucleic acid amplification technology: detecting occult hepatitis B virus infections and closing the serologic window period for hepatitis C virus 2005Impact of nucleic acid amplification technology (NAT) in Italy in the three years following implementation (2001-2003)

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2022The impact of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus yields from a single blood center in China with 10-years review 2022Re-Entry Evaluation of Chinese Blood Donors with Unconfirmed Hepatitis B Screening Results 2019

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