Report of the IFCC Working Group for Standardization of Thyroid Function Tests - Part 1: Thyroid-Stimulating Hormone

BACKGROUND: Laboratory testing of serum thyroidstimulating hormone (TSH) is an essential tool for the diagnosis and management of various thyroid disorders whose collective prevalence lies between 4% and 8%. However, between-assay discrepancies in TSH results limit the application of clinical practice guidelines. METHODS: We performed a method comparison study with 40 sera to assess the result comparability and performance attributes of 16 immunoassays. RESULTS: Thirteen of 16 assays gave mean results within 10% of the overall mean. The difference between the most extreme means was 39%. Assay-specific biases could be eliminated by recalibration to the overall mean. After recalibration of singlicate results, all assays showed results within the biological total error goal (22.8%), except for 1 result in each of 4 assays. For a sample with a TSH concentration of 0.016 mIU/L, 6 assays either did not report results or demonstrated CVs greater than 20%. Within-run and total imprecision ranged from 1.5% to 5.5% and 2.5% to 7.7%, respectively. Most assays were able to match the internal QC targets within 5%. Within-run drifts and shifts were observed. CONCLUSIONS: Harmonization of TSH measurements would be particularly beneficial for 3 of the 16 examined assays. These data demonstrate that harmonization may be accomplished by establishing calibration traceability to the overall mean values for a panel of patient samples. However, the full impact of the approach must be further explored with a wider range of samples. Although a majority of assays showed excellent quality of performance, some would benefit from improved within-run stability.

THIENPONT Linda;  VAN UYTFANGHE Katleen;  BEASTALL Graham;  FAIX James D.;  IEIRI Tamio;  MILLER W. Gregory;  NELSON Jerald C.;  RONIN Catherine;  ROSS H. Alec;  THIJSSEN Jos H;  TOUSSAINT Brigitte; 

2010-11-30

AMER ASSOC CLINICAL CHEMISTRY

JRC56156

0009-9147,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC56156,   

10.1373/clinchem.2009.140178,