Standardization of the antibody to hepatitis A virus (anti-HAV) content of immunoglobulin.
A batch of standard immunoglobulin was selected as a United States Reference Hepatitis A Immunoglobulin. Subsequent to its testing in research laboratories, public health laboratories, hospitals and universities throughout North America and Europe, this immunoglobulin was provided to the World Health Organization and accepted as an International Hepatitis A Immunoglobulin Reference Preparation. This reference preparation is provided lyophilized in flame-sealed ampules which have been back-filled with argon. When the contents of one ampule are reconstituted to a volume of 1.0 ml, the reciprocal end-point dilution titer of anti-HAV in this reference preparation is approximately 1:500 by competitive-inhibition radioimmunoassay (RIA). Based on data in the literature and that obtained from testing more than 200 batches of immunoglobulin manufactured in the United States between 1967 and 1977, it appears that the level of anti-HAV in the reference preparation could be achieved in each batch of immunoglobulin. Standardization will assure the continued and consistent efficacy of immunoglobulin batches for prophylaxis against hepatitis A.
D000914:Antibodies, Viral / Q000032:analysis*; D006507:Hepatovirus / Q000276:immunology*; D006801:Humans; D007136:Immunoglobulins / Q000032:analysis*
D000914:Antibodies, Viral; D007136:Immunoglobulins