ANALYSIS OF HUMAN PLASMA PRODUCTS - POLYMERASE CHAIN-REACTION DOES NOT DISCRIMINATE BETWEEN LIVE AND INACTIVATED VIRUSES

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.