B L O O D C O M P O N E N T T E S T I N G
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
Michael K. Hourfar, Christine Jork, Volkmar Schottstedt, Marijke Weber-Schehl, Veronika Brixner,*
Michael P. Busch,* Geert Geusendam,* Knut Gubbe,* Christina Mahnhardt,* Uschi Mayr-Wohlfart,*
Lutz Pichl,* W. Kurt Roth,* Michael Schmidt,* Erhard Seifried,* and David J. Wright*
for the German Red Cross NAT Study Group
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, predomi-
nantly with pool sizes of 96 donations. These donations
cover approximately 80 percent of all the blood col-
lected 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 trans-
fused 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 HB