Quality management and international standardization programs for protein immunoassays.

The huge number of new immunoassays for the measurement of specific proteins/tumor markers commercially available at present has made necessary comprehensive measures for the quality management of such laboratory tests. Very important for the comparability of test results are international standardization programs for the establishment of consensus/reference methods as well as for the development of suitable reference materials. Such programs are presently conducted by various international organizations and professional societies. Important characteristics of such reference materials are molecular composition, purity, matrix, additives, storage conditions, stability. Internationally accepted reference materials which have been prepared, calibrated and certified will contribute to the harmonization of results with different test systems, improving their quality and clinical use.