Affiliation:
1. Medical Affairs and Innovation Héma‐Québec Montréal Québec Canada
2. Medical Affairs and Innovation Héma‐Québec Québec Québec Canada
3. Epidemiology and Surveillance Canadian Blood Services Ottawa Ontario Canada
Abstract
AbstractBackground and ObjectivesNo transfusion‐associated cases of variant Creutzfeldt–Jakob disease (vCJD) have occurred in more than 20 years. Yet, many countries have maintained blood donor deferral criteria for vCJD. We developed a risk simulation model to reassess the need for vCJD‐related deferral criteria in Canada.Materials and MethodsThe model provides results separately for Héma‐Québec (HQ) and Canadian Blood Services (CBS). The model used a Monte Carlo simulation approach to estimate the risk of having a vCJD‐contaminated blood donation (‘risk of vCJD’) in a simulated cohort of 10 million donors followed for up to 85 years. The model assumed current deferral criteria for vCJD were lifted, which would allow new ‘at‐risk’ donors to give blood. The model accounted for disease prevalence, donors' travel/immigration history, PRNP genotype at codon 129, demographics and the type of labile blood product.ResultsIn the base case, the risk of vCJD was estimated at zero at both blood services. In the most pessimistic scenario, the risk of vCJD was 6.4 × 10−9 (i.e., 1 in 157 million donations) at HQ, or ≤1 in 77 million based on the upper bound of the 95% confidence interval (CI). At CBS, this risk was 4.8 × 10−8 (i.e., 1 in 21 million donations), or ≤1 in 16 million based on the upper bound of the 95% CI.ConclusionvCJD poses minimal risks to the Canadian blood supply. Current vCJD deferral criteria may, therefore, be lifted with virtually no impact on safety, while significantly expanding the donor base.
Subject
Hematology,General Medicine
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