A summary report on the 30th quality control survey for immunoassays in Japan, 2008

The results of 30th nationwide control survey for immunoassay were reported. Thirty five analytes for hormones, tumor markers and pharmaceutical drugs were investigated in participated 108 facilities. Five kinds of commercial control sera were used for the materials in this survey, and simultaneously pooled human sera were also investigated for comparing with results using the control sera in selected 20 facilities. Intra-kit and inter-kit variation were allowed. However, intra-kit variation which showed less than 10% of coefficient of variation (CV) was achieved to 88% of analytes. In using the pooled human sera, variation was slightly improved in some analytes. These results indicate that the conventional survey results using the commercial control sera might need to be reevaluated at least in some analytes. (author)