ArticlesFeasibility and efficacy of routine PCR screening of blood donations for hepatitis C virus, hepatitis B virus, and HIV-1 in a blood-bank setting
Introduction
Virus safety of cellular blood components mainly relies on donor selection and donor screening for transfusionassociated viruses by antibody/antigen testing. The introduction of highly sensitive and specific secondgeneration and third-generation screening assays for hepatitis C virus (HCV) and HIV-1 antibodies and hepatitis B virus (HBV) antigens significantly reduced transmission risk.1, 2, 3, 4 However, transmission of these viruses by blood transfusion still occurs.1, 4 This is mostly due to the diagnostic window during which an acutely infected blood donor may harbour large amounts of highly infectious viruses without developing symptoms or detectable antigen and antibody concentrations.1, 3, 4, 5
Testing nucleic acids by highly sensitive amplification methods is a promising approach to shorten the preseroconversion window and reduce virus transmission. As calculated by Schreiber and colleagues,1 PCR testing for HCV, HBV, and HIV-1 of blood donors would reduce this window by 59 days, 25 days, and 11 days, respectively. Virus-prevalence data for people who have donated blood many times (multiple-time donors) in the USA suggest that the residual risk of transmitting one of these viruses can be reduced by 72%, 42%, and 50%, respectively, with PCR. Based on these data and estimates of incidence of HCV, HBV, and HIV-1 infections in Germany6, 7 we decided to establish a PCRscreening procedure at our blood bank. The system should be suitable to test up to 3000 donations per day for HCV, HBV, and HIV-1.
We present the feasibility of PCR routine screening in a blood-bank setting and the results of testing 373 423 donations.
Section snippets
Routine donor screening by antigen/antibody ELISA
Routine donor screening for HCV, HBV, and HIV-1 was done with the Abbott Prism and Abbott AxSYM test systems (Abbott GmbH, Wiesbaden, Germany). Initially reactive samples were confirmed with the Abbott Matrix 1·0 and 2·0 (since January 1998) for HCV, Abbott HBsAg confirmatory test for HBV, and Sanofi Pasteur western blot for HIV-1.
Plasma-sample pooling
For PCR testing, 7 mL of blood was collected from each donor into an edetic-acid tube. Plasma was separated from cells within 12 h. Pooling was done overnight on two
Performance data
Using mini pools of 96 samples we had a maximum capacity of testing 3000 samples per day for HCV, HBV, and HIV-1 by PCR. Testing was completed in 7–8 h, enabling release of packed red cells and random platelet concentrates without delay. Identification of positive samples was achieved 1 or 2 days later and the retained negative-testing units of the pool were released.
Test results proved to be reliable and sensitive. The detection limits for HCV, HBV, and HIV-1 PCRs are shown in table 1. The
Discussion
We have established a sensitive and reliable routine HCV, HBV, and HIV-1 PCR for a blood-bank setting enabling testing of up to 3000 samples per day in 7–8 h.
Our efforts to establish a PCR for donor screening were mainly driven by the demands of producers of plasma products who wanted to use PCR-tested plasma from the beginning of 1997. Moreover, it became apparent that the Paul Ehrlich Institute, the governmental authority for the regulation of blood and blood products affairs of Germany,
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