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Hepatitis was a major focus of the Bureau of Biologics’ blood regulatory program early on, from checking the proficiency of blood banks to conduct hepatitis tests, to collaborative research on the virus using animal models with National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC), to further study of donor selection criteria.
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Linda Smallwood of the FDA Bureau of Biologics checks a kit used by blood banks and other facilities to test blood for hepatitis (from FDA Consumer November 1977). |
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FDA licensed two tests in 1990 to detect Hepatitis C. Previously, researchers from CDC and industry constructed a non-A, non-B viral protein from a single stranded ribonucleic acid isolated from an animal model infected with non-A, non-B hepatitis. Recombinant DNA manipulation of this protein produced enough quantity to enable development of a commercial assay to detect antibodies to this viral protein. Clinical trials assessed the ability of this assay to detect antibodies formed against this viral protein, now designated c100-3, in donor blood. The trials showed that eliminating units that tested positive for antibodies to the c100-3 protein could eliminate non-A, non-B hepatitis, and that there was one major non-A, non-B virus, subsequently designated Hepatitis C. The first anti-HCV antibody test was licensed in May, and the second two months later.
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FDA announced in 1990 the first screening test for Hepatitis C (from the Hartford Courant, Friday, May 4, 1990). |
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