Evaluation of human serum based tumor marker control.

A human serum based tumor marker control containing 13 antigen associated with tumors or cancer cell proliferation has been developed for use in quality control of various cancer diagnostic test methodologies. The menu is comprehensive including several new antigens: the Carbohydrate Antigens 125 and 19-9, Tissue Polypeptide Antigen (TPA), Beta-2-microglobulin, as well as some traditional markers; CEA, AFP and PAP. The control is bilevel; Level I representing low values and Level II showing elevated or clinically significant values, designed to control the linear range of the assays. Stability of reconstituted material is 14 days at 2-8 degrees C and 30 days at -20 degrees C. Accelerated stress testing shows that the lyophilized material is stable for 3 years when stored at 2-8 degrees C. Testing was completed using commercially available RIA and IRMA assays. The product contains no azide or other preservatives that may interfere in these immunoassays. This product is designed for use in cancer antigen testing as part of a quality assurance program. This control will effectively assist in evaluating the accuracy and precision of immunoassay methods used in cancer evaluation.