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Experience of German Red Cross blood donor services with nucleic acid testing: results of screening more than 30 million blood donations for human immunodeficiency virus‐1, hepatitis C virus, and hepatitis B virus
Author(s) -
Hourfar Michael K.,
Jork Christine,
Schottstedt Volkmar,
WeberSchehl Marijke,
Brixner Veronika,
Busch Michael P.,
Geusendam Geert,
Gubbe Knut,
Mahnhardt Christina,
MayrWohlfart Uschi,
Pichl Lutz,
Roth W. Kurt,
Schmidt Michael,
Seifried Erhard,
Wright David J.
Publication year - 2008
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2008.01718.x
Subject(s) - medicine , window period , hepatitis b virus , residual risk , virology , hepatitis c virus , population , nat , blood transfusion , hepatitis b , hepatitis c , immunology , virus , environmental health , antibody , serology , computer network , computer science
BACKGROUND: The risk of transfusion‐transmitted human immunodeficiency virus‐1 (HIV‐1), hepatitis C virus (HCV), and hepatitis B virus (HBV) infections is predominantly attributable to donations given during the early stage of infection when diagnostic tests may fail. In 1997, nucleic acid amplification technique (NAT)‐testing was introduced at the German Red Cross (GRC) blood donor services to reduce this diagnostic window period (WP). STUDY DESIGN AND METHODS: A total of 31,524,571 blood donations collected from 1997 through 2005 were screened by minipool NAT, predominantly with pool sizes of 96 donations. These donations cover approximately 80 percent of all the blood collected in Germany during that period. Based on these data, the WP risk in the GRC blood donor population was estimated by using a state‐of‐the‐art mathematic model. RESULTS: During the observation period, 23 HCV, 7 HIV‐1, and 43 HBV NAT‐only–positive donations were detected. On the basis of these data and estimated pre‐NAT infectious WPs, the residual risk per unit transfused was estimated at 1 in 10.88 million for HCV (95% confidence interval [CI], 7.51‐19.72 million), 1 in 4.30 million for HIV‐1 (95% CI, 2.39‐21.37 million), and 1 in 360,000 for HBV (95% CI, 0.19‐3.36 million). Based on observed cases of breakthrough infections, the risk of transfusion‐related infections may be even lower. CONCLUSION: The risk of a blood recipient becoming infected with HCV, HIV‐1, or HBV has reached an extremely low level. Introduction of individual donation testing for HCV and HIV‐1 would have a marginal effect on interception of WP donations.