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Background and objectives: Based on the Council of Europe directive which dictates regulatory requirements in Australia, blood donors are currently deferred from donating for 4 months after an endoscopic procedure if either polyps were removed or a biopsy sample was taken. We aimed to assess the incidence of blood‐borne viruses (BBVs) (HIV, hepatitis B and C) in blood donors who donated after an endoscopic procedure and evaluate the risk to blood safety through risk modelling. Materials and methods: Donors from 1/1/2013 to 31/12/2017 with an endoscopy deferral on their blood donor file with pre‐ and post‐BBV testing were analysed to determine an incidence of BBVs using standard methods. The standard blood donor cohort was used as a comparator group. Using the incidence of endoscopies and BBV risk, the total residual risk estimate of allowing donors to return postendoscopy without restriction was calculated. Results: The incidence of a BBV postendoscopy in this large cohort of 16,283 where testing has been confirmed postendoscopy was zero (95% CI 0–0·000105). The upper confidence interval of the zero events is 10·5 per 100 000 donations. Total positive donations from 2017 repeat donors were 1·87 per 100 000 (95% CI 0·0000117–0·0000277). Sensitivity analysis demonstrated that the residual risk remained negligible under realistic worst‐case scenarios. Conclusion: A BBV endoscopy deferral is not required for blood safety in Australia. The presented data has enabled us to submit a request for an exemption to our regulator, which has been approved and the policy change subsequently implemented by Lifeblood on 4/4/2020. [ABSTRACT FROM AUTHOR]

Background We present an analysis of the first 2 years of hepatitis B virus ( HBV) nucleic acid testing ( NAT) of the Australian donor population. Study Design and Methods Between July 5, 2010, and July 4, 2012, all blood donations were screened for HBV DNA and hepatitis B surface antigen ( HBsAg). Donors who tested HBsAg negative but HBV NAT positive were assessed as occult hepatitis B infections ( OBI) if reactive for antibodies to HBV core antigen (anti- HBc). Donors who were anti- HBc reactive but with nonrepeatable or nondiscriminated NAT results were assessed as HBV inconclusive pending follow-up testing. Results During the study period a total of 2,673,521 donations were screened for HBV. Forty-two chronic OBI infections (5.55/100,000 donors) were identified compared to eight acute serologic window period infections (1.06/100,000 donors). Of the 42 OBI cases, 23 (54.8%) were detected the first time they were screened for HBV DNA while 19 (45.2%) gave one or more HBV NAT-nonreactive results before detection. Of 68 donors initially assessed as HBV inconclusive and available for follow-up, 10 later confirmed as OBI cases while 51 were NAT nonreactive but remained anti- HBc reactive and OBI could not be excluded. Conclusion This study demonstrated a substantially higher prevalence of OBI compared to acute serologic window period HBV infections in Australian blood donors. Follow-up testing of OBI cases indicates that HBV DNA is often only intermittently detectable in OBI, highlighting the importance of including anti- HBc to optimize the HBV testing algorithm. [ABSTRACT FROM AUTHOR]

Country" [Transfus Med Hemother. Hepatitis B virus nucleic acid amplification testing of Australian blood donors highlights the complexity of confirming occult hepatitis B virus infection. Efficacy of individual nucleic acid amplification testing in reducing the risk of transfusion-transmitted hepatitis B virus infection in Switzerland, a low-endemic region. [Extracted from the article]