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

Overview

Journal Viruses

Publisher MDPI

Specialty Microbiology

Date 2022 Nov 24

PMID 36423154

Authors

Xuelian Deng

Liang Zang

Daniel Candotti

Affiliations

Soon will be listed here.

Abstract

The hepatitis B virus (HBV) remains a high priority for Chinese blood banks due to the high prevalence of infection. HBV blood safety has been significantly improved by the implementation of highly sensitive and specific serological and molecular HBV screening assays. The multiplication of viral markers tested and the ever-increasing analytical sensitivity of the tests can make the interpretation of the results difficult. False-positive or indeterminate results may lead to permanent donor deferrals and conflicts between donors and blood banks. To avoid blood shortages, blood services aim to limit unnecessary donor losses by developing procedures for the re-entry of donors temporarily deferred due to an unconfirmed HBV reactivity. The development of such procedures based on donor follow-up and HBV confirmation remains limited. A review of the scarce data available revealed considerable heterogeneity in testing methods and re-entry algorithms, limited validation studies, and a lack of accurate assessment of the residual infectious risk potentially associated with donor re-entry. In conclusion, systematic and widely validated confirmatory testing and prolonged follow-up are essential for safe re-entry of temporary deferred donors. Standardization of HBV testing methods and the establishment of dedicated expert laboratories are needed because of the complexity of HBV infection in blood donors.

Citing Articles

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.

Viruses Special Issue "Transfusion-Transmitted Viral Infections".

Candotti D Viruses. 2023; 15(1).

PMID: 36680126 PMC: 9862417. DOI: 10.3390/v15010086.

References

Cui F, Shen L, Li L, Wang H, Wang F, Bi S . Prevention of Chronic Hepatitis B after 3 Decades of Escalating Vaccination Policy, China. Emerg Infect Dis. 2017; 23(5):765-772. PMC: 5403029. DOI: 10.3201/eid2305.161477. View

Candotti D, Tagny-Tayou C, Laperche S . Challenges in transfusion-transmitted infection screening in Sub-Saharan Africa. Transfus Clin Biol. 2021; 28(2):163-170. DOI: 10.1016/j.tracli.2021.01.007. View

Candotti D, Assennato S, Laperche S, Allain J, Levicnik-Stezinar S . Multiple HBV transfusion transmissions from undetected occult infections: revising the minimal infectious dose. Gut. 2018; 68(2):313-321. DOI: 10.1136/gutjnl-2018-316490. View

Hu W, Jiang N, Zhu S, Lin H . [Study on Reentry Evaluation Mode for Blood Donors Used to be HBV Reactive in Jiangsu Province]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2022; 30(1):264-269. DOI: 10.19746/j.cnki.issn.1009-2137.2022.01.044. View

Kiely P, Stewart Y, Castro L . Analysis of voluntary blood donors with biologic false reactivity on chemiluminescent immunoassays and implications for donor management. Transfusion. 2003; 43(5):584-90. DOI: 10.1046/j.1537-2995.2003.00386.x. View

Moore M, Howell D, Barbara J . Donors whose blood reacts falsely positive in transfusion microbiology screening assays need not be lost to transfusion. Transfus Med. 2007; 17(1):55-9. DOI: 10.1111/j.1365-3148.2006.00700.x. View

Levicnik-Stezinar S, Rahne-Potokar U, Candotti D, Lelie N, Allain J . Anti-HBs positive occult hepatitis B virus carrier blood infectious in two transfusion recipients. J Hepatol. 2008; 48(6):1022-5. DOI: 10.1016/j.jhep.2008.02.016. View

Dong J, Wu Y, Zhu H, Li G, Lv M, Wu D . A pilot study on screening blood donors with individual-donation nucleic acid testing in China. Blood Transfus. 2013; 12(2):172-9. PMC: 4039698. DOI: 10.2450/2013.0095-13. View

Zhang L, Chang L, Laperche S, Ji H, Zhao J, Jiang X . Occult HBV infection in Chinese blood donors: role of N-glycosylation mutations and amino acid substitutions in S protein transmembrane domains. Emerg Microbes Infect. 2019; 8(1):1337-1346. PMC: 6758628. DOI: 10.1080/22221751.2019.1663130. View

10.

Seed C, Maloney R, Kiely P, Bell B, Keller A, Pink J . Infectivity of blood components from donors with occult hepatitis B infection - results from an Australian lookback programme. Vox Sang. 2014; 108(2):113-22. DOI: 10.1111/vox.12198. View

11.

Gao D, Li H, Wang K . The development of a legal framework for blood donation and blood safety in China over 24 years. BMC Health Serv Res. 2020; 20(1):1099. PMC: 7702669. DOI: 10.1186/s12913-020-05944-6. View

12.

Yugi H, Mizui M, Tanaka J, Yoshizawa H . Hepatitis B virus (HBV) screening strategy to ensure the safety of blood for transfusion through a combination of immunological testing and nucleic acid amplification testing - Japanese experience. J Clin Virol. 2006; 36 Suppl 1:S56-64. DOI: 10.1016/s1386-6532(06)80010-7. View

13.

Taira R, Satake M, Momose S, Hino S, Suzuki Y, Murokawa H . Residual risk of transfusion-transmitted hepatitis B virus (HBV) infection caused by blood components derived from donors with occult HBV infection in Japan. Transfusion. 2012; 53(7):1393-404. DOI: 10.1111/j.1537-2995.2012.03909.x. View

14.

Zou S, Musavi F, Notari E, Rios J, Trouern-Trend J, Fang C . Donor deferral and resulting donor loss at the American Red Cross Blood Services, 2001 through 2006. Transfusion. 2008; 48(12):2531-9. DOI: 10.1111/j.1537-2995.2008.01903.x. View

15.

Allain J, Mihaljevic I, Gonzalez-Fraile M, Gubbe K, Holm-Harritshoj L, Garcia J . Infectivity of blood products from donors with occult hepatitis B virus infection. Transfusion. 2013; 53(7):1405-15. DOI: 10.1111/trf.12096. View

16.

Kiely P, Hoad V, Wood E . False positive viral marker results in blood donors and their unintended consequences. Vox Sang. 2018; . DOI: 10.1111/vox.12675. View

17.

Stramer S, Krysztof D, Brodsky J, Fickett T, Reynolds B, Dodd R . Comparative analysis of triplex nucleic acid test assays in United States blood donors. Transfusion. 2013; 53(10 Pt 2):2525-37. DOI: 10.1111/trf.12178. View

18.

Candotti D, Laperche S . Hepatitis B Virus Blood Screening: Need for Reappraisal of Blood Safety Measures?. Front Med (Lausanne). 2018; 5:29. PMC: 5826332. DOI: 10.3389/fmed.2018.00029. View

19.

Tynell E, Norda R, Ekermo B, Sanner M, Andersson S, Bjorkman A . False-reactive microbiologic screening test results in Swedish blood donors-how big is the problem? A survey among blood centers and deferred donors. Transfusion. 2007; 47(1):80-9. DOI: 10.1111/j.1537-2995.2007.01067.x. View

20.

Enjalbert F, Krysztof D, Candotti D, Allain J, Stramer S . Comparison of seven hepatitis B virus (HBV) nucleic acid testing assays in selected samples with discrepant HBV marker results from United States blood donors. Transfusion. 2014; 54(10):2485-95. DOI: 10.1111/trf.12653. View