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All plasma units used in the manufacture of Privigen (immune globulin intravenous) are tested using FDA-licensed serological assays for hepatitis B surface antigen and antibodies to HCV and HIV- as well as FDA-licensed Nucleic Acid Testing (NAT) for HCV and HIV-1 and found to be nonreactive (negative). For HBV, an investigational NAT procedure is used and the plasma units found to be negative; however, the significance of a negative result has not been established.
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