» 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.