Influence of specimen carryover on sensitive thyrotropin (TSH) assays: is there a problem?

Abstract

Abstract A relatively slow transition has occurred from so-called 1st-generation thyrotropin (TSH) assays (e.g., RIAs) through 2nd-generation assays (e.g., IRMAs) to 3rd-generation assays (e.g., immunochemiluminometric assays). Analysis of data from a modified internal quality-control design, followed up by a computer simulation, showed that specimen carryover has minimal effect on 2nd-generation TSH assays. However, extension of the simulation to a 3rd-generation assay showed the possibility of substantial effects in the subnormal region. Carryover of 1:1250 (0.08%), for example, may reduce the theoretical 10-fold precision improvement claimed for 3rd-generation assays to nearer fourfold. Simulation results suggest maximum allowable specimen carryover of approximately 1:10,000 (approximately 0.01%) for 3rd-generation TSH assays. We suggest that when automated specimen handling is used in a TSH assay, a well-designed carryover experiment should become a routine part of reports that claim 3rd-generation (or better) performance characteristics.