Use of a control serum containing a low level of HBsAg for monitoring proficiency in screening for HBsAg.
Aliquots of a serum preparation called "run control" containing low levels (1.4 ng/ml) of hepatitis B surface antigen (HBsAg) were tested by four American Red Cross Blood Services regions using a commercial test based on enzyme-linked immunosorbent assay (EIA). The run control was tested a total of 424 and 892 times by procedures A and C, respectively, as recommended by the manufacturer (Abbott Laboratories, North Chicago, IL) of the EIA test kit. Results of all the tests were analyzed and showed that the run control was stable and reliable under field conditions. Illustrative examples of different approaches for the use of the run control in monitoring quality control of HBsAg testing are discussed.
D001771:Blood Banks; D004797:Enzyme-Linked Immunosorbent Assay; D006509:Hepatitis B / Q000517:prevention & control*; D006514:Hepatitis B Surface Antigens / Q000032:analysis*; D006801:Humans; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012015:Reference Standards
D006514:Hepatitis B Surface Antigens; D011933:Reagent Kits, Diagnostic