Ten commercial kits compared for assay of thyrotropin in the normal and thyrotoxic range.

I developed a standard procedure for assessing sensitivity, intra-assay precision, parallelism of sample dilutions, and assay drift, using a single trial assay kit. I used this to compare the performance of 10 commercial kits with an in-house radioimmunoassay for human thyrotropin. No one kit stood out as clearly superior overall. Differences in calibration between kits were evident in a comparison of thyrotropin concentrations measured in clinical samples, and by direct comparison of standards from different kits in a single assay. However, all kits gave clinically consistent results with respect to their published normal reference interval. Moreover, the performance of human thyrotropin assay kits has improved during the 14 months of this study.