Internal quality control of radioimmunoassays: monitoring of error.

A cumulative sum technique has been specially designed to monitor the error between replicate determinations made on quality control plasma for consecutive batches of assays. This procedure has played a vital role in assessing assay performance. Special consideration has been given to small sample sizes (n = 2 or 3) which is generally the rule rather than the exception in many situations. This technique has been applied to numerous steroid radioimmunoassays and has ensured that both the mean value and the standard error of hormone levels of a quality control pool were under control. Data from routine assays of oestriol and testosterone in plasma from women are presented. Since this technique provides a sensitive measure of monitoring error, it assists the endocrinologist in elucidating statistical inferences which are a manifestation of assay performance.