Q: If derived from human serum or plasma, please provide source information for the serum or plasma to ensure safety.
A: The serum/plasma is purchased from a commercial source.
Prior to pooling, the supplier tested each unit according to FDA guidelines for the detection of Hepatitis B Surface Antigen, antibodies to HIV and HCV, HIV-1 RNA, HBV DNA, HCV RNA, WNV RNA, and syphilis. Each donor was also tested for T. cruzi (Chagas disease) in accordance with FDA guidelines. All units yielded non-reactive/negative results for every test performed.
All blood was collected in the United States from human donors at FDA-licensed centers and tested using FDA-approved test kits. Please note that no test method can provide total assurance that Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, or other infectious agents are absent.