Hepatitis E and blood donation: Status quo after 3 years of mandatory testing

Background

The testing of blood and stem cell donations for the hepatitis E virus (HEV) was introduced as mandatory for Germany on 01.01.2020. Since then, numerous donations have been found to be HEV-positive and have not been marketed. The positive test result was associated with a traceability procedure as defined in Votum 48 of the Working Group on Blood. We report on our experience with testing in the period from 01.01.2020 to 31.12.2022.

Methods

Sample material from each donation was tested for the presence of HEV genome using NAT. Routine HEV nucleic acid test (NAT) donor screening of minipools ≤ 96 was performed on the fully automated cobas 8800 system using the cobas HEV test kit (Roche Diagnostics). Minipools and subpools for pool resolution are generated by MicroLab Star IVD liquid handler (Hamilton) using 100 µl aliquots EDTA-anticoagulated plasma of each donor sample. Initially reactive minipool resolution has been performed by "chessboard subpooling" testing, finally confirming putative HEV positive sample(s) by individual NAT.

Results

1734 donations were identified as HEV-positive, 1613 from repeat donors and 121 from first-time donors. In the look-back procedure, the pre-donations of 25 donors were identified as HEV genome positive. All donors were clinically healthy at the time of donation.

Conclusion

Donors cannot be identified as possibly infected with HEV on the basis of the donor questionnaire because the infection is usually not a sexually transmitted disease. The infestation of our donor population is high compared to other pathogens tested. In contrast to the other mandatory donor tests, a significantly higher group of repeat donors is affected for HEV because, unlike other test parameters, the prevalence of the infection is always reflected in the group of multiple donors.

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