Ultrasensitive PCR system for HBV DNA detection: Risk stratification for occult hepatitis B virus infection in English blood donors

Michael X. Fu, Peter Simmonds, Julien Andreani, Hatice Baklan, Mhairi Webster, Romisa Asadi, Tanya Golubchik, Judith Breuer, Samreen Ijaz, Ines Ushiro-Lumb, Su Brailsford, William L. Irving, Monique Andersson, Heli Harvala*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    2 Citations (Scopus)


    Occult hepatitis B (HBV) infection (OBI), characterized by low viral loads, accounts for much of the risk of HBV transfusion-transmitted infection. With anticore antibodies (anti-HBc) screening introduced in England, the imperative to identify OBI donors has increased. We aimed to develop an ultra-sensitive PCR system and investigate risk factors for HBV DNA presence in blood donations. Seven extraction methods and three PCR assays were compared. The optimal system was sought to determine HBV DNA presence in anti-HBc-positive donations. Predictors of DNA positivity were subsequently investigated. Extraction from 5 mL of plasma increased sample representation and resulted in HBV DNA detection in low viral load samples (~0.5 IU/mL). Screening of 487 763 donations in 2022 identified two OBI donors and 2042 anti-HBc-positive donors, 412 of the latter with anti-HBs < 100 mIU/mL. Testing of 134 anti-HBc-positive donations utilizing the 5 mL extraction method identified two further HBV DNA-positive donations. Higher anti-HBc titer and anti-HBs negativity were significant predictors of DNA detectability in anti-HBc-positive donations. An ultrasensitive PCR assay identified potentially infectious donations increasing HBV DNA detection in anti-HBc-positive donors from 0.5% to 1.9%. Anti-HBc titers may further complement the risk stratification for DNA positivity in anti-HBc screening and minimize unnecessary donor deferral.

    Original languageEnglish
    Article numbere29144
    JournalJournal of Medical Virology
    Issue number10
    Publication statusPublished - Oct 2023

    Bibliographical note

    Publisher Copyright:
    © 2023 The Authors. Journal of Medical Virology published by Wiley Periodicals LLC.


    • HBV-ID-NAT
    • anti-HBc screening
    • hepatitis B virus
    • occult HBV infection
    • predictive markers


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