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.
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).


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.


CONCLUSIONS
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.
Hourfar
Michael K
MK
Institute of Transfusion and Immunohematology, German Red Cross Baden-Württemberg-Hessen, Johann Wolfgang Goethe University, Frankfurt, Germany. k.hourfar@blutspende.de
Jork
Christine
C
Schottstedt
Volkmar
V
Weber-Schehl
Marijke
M
Brixner
Veronika
V
Busch
Michael P
MP
Geusendam
Geert
G
Gubbe
Knut
K
Mahnhardt
Christina
C
Mayr-Wohlfart
Uschi
U
Pichl
Lutz
L
Roth
W Kurt
WK
Schmidt
Michael
M
Seifried
Erhard
E
Wright
David J
DJ
D001782:Blood Donors / Q000706:statistics & numerical data*; D004279:DNA, Viral / Q000097:blood; D005858:Germany / Q000453:epidemiology; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology / Q000635:transmission; D015497:HIV-1; D006509:Hepatitis B / Q000175:diagnosis / Q000453:epidemiology / Q000635:transmission; D006526:Hepatitis C / Q000175:diagnosis / Q000453:epidemiology / Q000635:transmission; D006801:Humans; D015994:Incidence; D008403:Mass Screening / Q000379:methods* / Q000706:statistics & numerical data*; D015233:Models, Statistical; D012011:Red Cross; D018570:Risk Assessment; D012307:Risk Factors; D014777:Virus Diseases / Q000175:diagnosis* / Q000453:epidemiology* / Q000635:transmission
D004279:DNA, Viral