Second hepatitis C virus transmission by blood components since introduction of mandatory NAT screening in Germany

• Published in: Transfusion (Philadelphia, Pa.) Vol. 63; no. 2; pp. 339 - 347
• Main Authors: Himmelsbach, Kiyoshi, Mueller, Susanne, Kress, Julia, Fiedler, Sarah A., Miskey, Csaba, Ivics, Zoltan, Patek, Alexander, Chudy, Michael
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.02.2023; Wiley Subscription Services, Inc
• Subjects: 5' Untranslated Regions; Amplification; Blood; Blood & organ donations; blood components; blood donor screening; Blood Donors; Dilution; Genotypes; Genotyping; Germany; Hepacivirus - genetics; Hepatitis; Hepatitis C; Hepatitis C - diagnosis; hepatitis C virus; Humans; Mass Screening; nucleic acid amplification techniques; Nucleic Acid Amplification Techniques - methods; Nucleic acids; Product safety; Ribonucleic acid; RNA; Screening; Sequence analysis; transfusion transmission; Viruses; Germany; hepatitis C virus; blood donor screening; transfusion transmission; blood components; nucleic acid amplification techniques
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1111/trf.17224

Background Viral safety of blood products in Germany has improved significantly over the last two decades. We describe the second documented transfusion‐transmitted (TT) episode for the hepatitis C virus (HCV) in Germany since mandatory nucleic acid amplification techniques (NAT) screening was introduced in 1999. Study Design and Methods When a repeat donor who had tested negative for anti‐HCV tested positive for HCV RNA by NAT in a minipool (MP) of eight, a look‐back procedure was initiated. Qualitative, quantitative and genotyping assays were used to investigate the titers of the quarantined fresh frozen plasma (FFP) from the donor and a serum sample from the recipient of the pooled platelet concentrate (PPC). Amplified products of 5'UTR and HVR1 were used for sequence comparison to characterize the HCV genomic identity of donor and recipient samples. Results All NAT tests utilized in this procedure were able to detect a low HCV RNA titer (~15 IU/ml) in the FFP from the donation. Dilution of FFP by factor 8 was performed to mimic an MP, and the detection rate correlated well with the claimed sensitivity of the tests. Analysis of donor and recipient samples revealed genotype 3a viral transmission confirmed by sequence analysis. Conclusion This TT HCV case could have been prevented by individual donation (ID) NAT. However, a low titer blood donation in the window period (WP) is very rare. Residual risk calculation for TT HCV in the WP revealed that, compared to MP‐NAT testing, ID‐NAT would improve blood safety only marginally.