Anti-A Blood Grouping Serum
»Anti-A Blood Grouping Serum conforms to the regulations of the federal Food and Drug Administration concerning biologics (660.20to 660.29)(see Biologics á1041ñ).It is a sterile,liquid or dried preparation containing the particular blood group antibodies derived from high-titered blood plasma or serum of human subjects,with or without stimulation by the injection of Blood Group Specific Substance A(or AB).It agglutinates human red cells containing A-antigens,i.e.,blood groups Aand AB(including subgroups A1,A2,A1B,and A2Bbut not necessarily weaker subgroups).It contains a suitable antimicrobial preservative.It meets the requirements to the test for potency,in parallel with,and not less than equivalent to,the U.S.Reference Blood Grouping Serum Anti-A,in agglutinating red blood cells from Group A1and Group A2Bdonors.It meets the requirements of the tests for specificity with Group A1,A2B,B,and Ocells and confirms the absence of contaminating antibodies reactive with Mg,Wraantigens as well as other antigens having an incidence of 1percent 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 Group A1and A2Bcells.All fresh or frozen red blood cell suspensions used for these tests are prepared under specified conditions and meet specified criteria.Anti-A Blood Grouping Serum may be artificially colored blue.
Packaging and storage—
Preserve at a temperature between 2
and 8.
and 8.
Expiration date—
The expiration date for liquid Serum is not later than 1year,and for dried Serum not later than 5years after date of issue from manufacturer's cold storage (5,1year;or 0,2years),provided that the expiration date for dried Serum is not later than 1year after constitution.
,1year;or 0,2years),provided that the expiration date for dried Serum is not later than 1year after constitution.
Labeling—
Label it to state that the source material was not reactive for hepatitis Bsurface antigen,but that no known test method offers assurance that products derived from human blood will not transmit hepatitis.Label it also to state that it is for in vitro diagnostic use.[NOTE—The labeling is in black lettering imprinted on paper that is white or is colored completely or in part to match the specified blue color standard.]
Auxiliary Information—
Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(BBP)Blood and Blood Products
USP28–NF23Page 272
Phone Number:1-301-816-8339