A new approach to the quality control of steroid receptor assays.

Lyophilized cytosols prepared from calf uterus and human breast tumor tissue are commonly used to assess the reliability of routine steroid receptor assays. However, preanalytical error (sample preparation, storage, homogenization) cannot be detected in this way. Participating laboratories were asked to mail us all their receptor results obtained over a four-month interval, and to include some information about the patients involved (age, menopausal status, nodal status). After verifying the homogeneity of the populations investigated, we computed consensus means for the percentages of positive samples and for their absolute value. Despite the homogeneity of the characteristics of the populations studied, results from some laboratories systematically differed from the consensus mean. This approach to the quality control of steroid receptors allows evaluation of the whole procedure, from sample preparation to analysis, and thus may be helpful as an addition to the usual practice of distribution of cytosols and tissue powders for assay.