Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e
Anti-Rh Blood Grouping Serums.
» Blood Grouping Serums Anti-D, Anti-C, Anti-E, Anti-c, Anti-e (Anti-Rh Group) conform to the regulations of the federal Food and Drug Administration concerning biologics (660.20 to 660.29) (see Biologics 1041). They are sterile, liquid or dried preparations derived from the blood plasma or serum of human subjects who have developed specific Rh antibodies. They are free from agglutinins for the A or B antigens and from alloantibodies other than those for which claims are made in the labeling. They contain a suitable antimicrobial preservative. Liquid serums are not artificially colored. Two varieties of Anti-Rh Blood Grouping Serums are recognized, i.e., (1) saline agglutinating complete antiserums, which specifically agglutinate human red blood cells suspended in saline TS, and (2) blocking or incomplete antiserums, which contain protein or other macromolecular substances, usually require the cells to be suspended in serum or plasma, and generally are for slide or rapid tube tests. The most commonly used of these blood grouping serums are listed in Table 1, each reacting with the antigen(s) designated by the corresponding letter(s) with the alternative nomenclature indicated parenthetically.
Each Serum meets the requirements of the test for potency in the case of serums for saline tube test in parallel with, and not less than equivalent to, the U.S. Reference Blood Grouping Serum for Anti-D, Anti-C, or Anti-E, whichever is applicable, or, in the case of Anti-c and Anti-e for saline tube test which have no reference preparations, the test for minimum agglutination reactivity at a specified dilution; and in the case of serums for slide or rapid tube test in parallel with, and not less than equivalent to, the U.S. Reference Blood Grouping Serum for Anti-D, Anti-C, Anti-E, Anti-c, or Anti-e, whichever is applicable, in agglutinating as a minimum red blood cells from the donors indicated in Table 2 (which may be from Group A, B, AB, or O).
Each serum for slide or rapid tube test meets the requirements of the tests for avidity with the cells as indicated under tests for potency above.
Each serum 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 (see Table 3), 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, except where some of these confirmatory tests cannot be done by the manufacturer, in which event such omissions are noted. Antigens having such population incidence in the United States [other than low-incidence antigens, serum proteins (e.g., Gm, Km), leukocyte factors, drugs, chemicals or polyagglutinable cells, which are not necessarily excluded] are the following: A, B, H, Lea, Leb, Lec, Led, I, K, k, Kpa, Kpb, Jsb, P1, D, C, E, c, e, Cw, M, N, S, s, U, Lua, Lub, Jka, Jkb, Fya, Fyb, Xga, Doa, Dob, Yta, Ytb, Lan, Coa, Cob, Mg, Wra, and Sda.
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 Serums is not later than 1 year and for dried Serums 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 Serums is not later than 1 year after constitution.
Labeling Label each 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 to state that it is for in vitro diagnostic use.