Implementing reference systems for thyroid function tests - A collaborative effort.

Measurements of thyroid stimulating hormone (TSH) and free thyroxine (fT4) are critical for the early detection of thyroid diseases and for monitoring treatment. The IFCC Committee for Standardization of Thyroid Function Tests (C-STFT) established reference systems for TSH harmonization and FT4 standardization, and is now working national partners on implementing these reference systems. These implementation activities include the maintenance of the reference systems, their use to standardize and harmonize assays, and educational activities to inform stakeholders about anticipated changes in measurement values as a result of standardization and harmonization. The IFCC C-STFT formed a network of reference laboratories for FT4 and is creating a new harmonization panel for TSH. The U.S. Centers for Disease Control and Prevention is a member of the reference laboratory network and is launching a formal standardization program for FT4. In Japan, national organizations successfully implemented TSH harmonization and established harmonized reference intervals for TSH. The C-STFT made available on its website research findings about potential concerns, communication needs and benefits of FT4 standardization and is assisting local organizations with communicating changes related to these standardization and harmonization efforts. Implementation of fT4 standardization and TSH harmonization is a complex, continuous task that requires collaboration with IVD manufacturers, laboratories, physicians and health care providers. C-STFT is working successfully with national organizations and local groups on improving FT4 and TSH measurements.

Validation of 5 routine assays for serum free testosterone with a candidate reference measurement procedure based on ultrafiltration and isotope dilution-gas chromatography-mass spectrometry.

BACKGROUND/METHOD: The analytical validity of free testosterone (FTe) analog immunoassays is subject to much controversy. We revisited the validation of 4 analog assays and 1 FTe calculation procedure with a metrologically traceable reference measurement procedure (RMP) based on ultrafiltration and isotope dilution-mass spectrometry for direct measurement of Te in the ultrafiltrate. To this end, we performed split-sample measurements of 40 male sera. RESULTS: Deming regression showed that 3 of the immunoassays had moderate to good correlation (0.8474 < or = r < or = 0.9241) with the RMP; however, the slope was markedly below 1. The FTe calculation procedure was in good agreement with this result. The Sy/x values for all assays were higher than the combined imprecision values, which indicate their susceptibility to matrix-related effects. CONCLUSIONS: The study demonstrated substantial differences in analytical quality of FTe assays; however, the results suggested that after extending the validation with a larger variety of samples, recalibration of some analog assays might be worth further investigation.