T. Weimer et al., VALIDATION OF A PCR ASSAY SYSTEM TO SCREEN PLASMA FOR HBV, HCV, AND HIV-1, Infusionstherapie und Transfusionsmedizin, 25(2-3), 1998, pp. 139-146
We describe a PCR system for the screening of plasma for fractionation
, which detects nucleic acids of hepatitis B and C viruses (HBV and HC
V) and of human immunodeficiency virus type 1 (HIV-1). Pilot pools of
different sizes (12, 120 and 1,200 donations) are generated, and a cas
cade testing is employed in order to identify PCR-positive samples. A
virus concentration step is included in the initial screening of the l
arge pools. The comprehensive efforts in validating the PCR methodolog
y as well as the whole system are described; the data demonstrate that
the system is well-suited for high throughput testing and that the me
thod is sensitive, robust and reproducible. Donations with virus loads
greater than or equal to 1.2 x 10(3) genome equivalents/ml (GE/ml) fo
r HBV, greater than or equal to 8.4 x 10(3) GE/ml for HCV, and greater
than or equal to 4.9 x 10(4) GE/ml for HIV-1 are eliminated with 95%
confidence. Therefore, this system will contribute to the virus safety
net for the final plasma product.