Immediately following donation, the plasma is deep-frozen and subjected to a series of tests to determine if the donor has been exposed to potential pathogens.¹

Rigorous virus clearance testing verifies safety throughout the manufacturing operation. The manufacturing process for Talecris Biotherapeutics Albumin Products has been shown to provide a high level of clearance of both enveloped and non-enveloped viruses.²

PCR Testing
In addition to standard antigen and antibody testing, Talecris Biotherapeutics uses state-of-the-art nucleic acid testing (NAT) technology to test the plasma units for HIV, HBV, HCV, and parvovirus B19 genetic material. These polymerase chain reaction (PCR)-based tests help reduce the "window period" during which infection is present, but detectable levels of virus antigens or antibodies have not yet developed.⁴

Screening Method Prion Clearance Talecris Research

All of the products below are made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. The physician should discuss the risks and benefits of these products with the patient, before prescribing or administering to the patient.

References