Blood Grouping Serums
» note—This monograph deals with those Blood Grouping Serums for which there are no individual monographs and which are not routinely used or required for the testing of blood or blood products for transfusion.
Blood Grouping Serums conform to the regulations of the federal Food and Drug Administration concerning biologics (660.20 to 660.29) (see Biologics 1041). Each is a sterile, liquid or dried preparation containing one or more of the particular blood group antibodies derived from high-titered blood plasma or serum of human subjects, with or without stimulation by the injection of red cells or other substances, or of animals after stimulation by substances that cause such antibody production. It causes either directly, or indirectly by the antiglobulin test, the visible agglutination of human red cells containing the particular antigen(s) for which it is specific. It contains a suitable antimicrobial preservative. It meets the requirements of the test for potency, (1) in the case of tube test reagents, when tested by the specified method, of agglutinating red blood cells containing the specified antigens with the specified degree of reactivity, as defined, as follows: not less than a 1+ reaction (i.e., agglutinated cells dislodged into finely granular, but definite, small clumps) with a 1:8 dilution of Serum for Anti-K, Anti-k, Anti-Jka, Anti-Fya, Anti-Cw; not less than a 1+ reaction with a 1:4 dilution of Serum for Anti-S, Anti-s, Anti-P1, Anti-M, Anti-I, Anti-e (saline), Anti-c (saline) and Anti-A1; and not less than a 2+ reaction (i.e., agglutinated cells dislodged into many small clumps of equal size) with undiluted Serum for Anti-U, Anti-Kpa, Anti-Kpb, Anti-Jsa, Anti-Fyb, Anti-N, Anti-Lea, Anti-Leb, Anti-Dia, Anti-Mg, Anti-Jkb, and Anti-Xga; and (2) in the case of reagents recommended for slide test methods, of agglutinating red blood cells, with the specified degree of reactivity, as defined, with both undiluted Serum and with a 1:2 dilution of Serum, when tested by the manufacturer's recommended method(s) using cells heterozygous for the corresponding antigen(s). It meets the requirements of the tests for specificity by the most sensitive method recommended by the manufacturer, in which not less than 4 positive and 4 negative phenotypes are included, and confirms the absence of contaminating antibodies reactive with Mg, Wra antigens as well as other antigens having an incidence of 1 percent or greater in the general population (see under Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e). It meets the requirements of the tests for avidity with the manufacturer's recommended method, red blood cells heterozygous for the corresponding antigen(s) being used. All fresh or frozen red blood cell suspensions used for these tests are prepared under specified conditions and meet specified criteria.
Packaging and storage— Preserve at a temperature between 2 and 8.
Expiration date— The expiration date for liquid Serum is not later than 1 year and for dried Serum not later than 5 years after date of issue from manufacturer's cold storage (5, 1 year; or 0, 2 years), provided that the expiration date for dried Serum is not later than 1 year after constitution.
Labeling— Label each to state the source of the product if other than human and, if of human origin, to state that the source material was not reactive for hepatitis B surface antigen, but that no known test method offers assurance that products derived from human blood will not transmit hepatitis. Label each also to state that it is for in vitro diagnostic use.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Anita Y. Szajek, Ph.D.
Senior Scientist
(BBBBP05) Biologics and Biotechnology - Blood and Blood Products
USP32–NF27 Page 1695