J. Hilfenhaus et al., ANALYSIS OF HUMAN PLASMA PRODUCTS - POLYMERASE CHAIN-REACTION DOES NOT DISCRIMINATE BETWEEN LIVE AND INACTIVATED VIRUSES, Transfusion, 37(9), 1997, pp. 935-940
BACKGROUND: The viral safety of human plasma products is based on the
careful selection of donors and donations and the removal and inactiva
tion of human pathogenic viruses that could potentially contaminate hu
man plasma. For the analysis of the final products for potential virus
contamination, the use of polymerase chain reaction (PCR) has been pr
oposed. To test whether this method can discriminate between infectiou
s and inactivated viruses, the following studies were performed. STUDY
DESIGN AND METHODS: Infectious and virus-inactivated preparations wer
e titrated with specific PCR, using viruses such as hepatitis B virus
(HBV), hepatitis C virus, bovine viral diarrhea virus, and poliovirus.
The inactivation method employed was pasteurization (10 hours, 60 deg
rees C) or solvent/detergent (SD) treatment; in the case of HBV, there
was consecutive treatment by both methods. RESULTS: Pasteurization of
HBV and hepatitis C virus as well as SD treatment of HBV or pasteuriz
ation of HBV followed by SD treatment did not affect the detectability
of these viruses by PCR, whereas an infectivity study in chimpanzees
demonstrated that infectious hepatitis C virus was inactivated by past
eurization. Pasteurization also had no effect on the PCR titers of sta
bilized bovine viral diarrhea virus or poliovirus preparations, but it
destroyed the infectivity of these viruses completely after only 4 ho
urs' heat treatment. CONCLUSION: Pasteurization or SD treatment destro
ys the infectivity of the viruses tested, but neither significantly af
fects their detectability by specific PCR. Therefore PCR is not a suit
able measure for testing the viral safety of finished plasma products
that have been subjected to virus inactivation.