Therapeutic products made from human plasma provide life‐saving relief to hundreds of thousands of patients each year. The efficient production of these derivatives requires that they be made from large pools of human plasma, often comprising as many as 60,000 donations each. This review will examine the viruses that can be transmitted by plasma and for which sensitive detection systems and virus‐removal and ‐inactivation methods are available. The exclusion of plasma units that test positive for certain viral markers ensures that almost all units entering the pool are free of viruses. Each plasma donation is screened by using sensitive immunoassays to detect the presence of hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV types 1 and 2 (HIV‐1/2). Manufacturing steps for plasma products have been shown to remove or inactivate these viruses. Nevertheless, plasma units containing these viruses can enter the pool when a donor is in the window period of the disease, which is the short period during which the virus is present in the blood before the screening tests have become positive. At present, the screening of small pools of plasma (“minipools”) by using nucleic acid amplification assays such as polymerase chain reaction (PCR)
Transfusion – Wiley
Published: Jan 12, 1999
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