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

Laboratory testing of serum thyroid-stimulating 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 guidelin...

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Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 2010-06, Vol.56 (6), p.902-911
Main Authors: THIENPONT, Linda M, VAN UYTFANGHE, Katleen, TOUSSAINT, Brigitte, BEASTALL, Graham, FAIX, James D, LEIRI, Tamio, MILLER, W. Greg, NELSON, Jerald C, RONIN, Catherine, ROSS, H. Alec, THIJSSEN, Jos H
Format: Article
Language:English
Subjects:
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Biological variation
Calibration
Fundamental and applied biological sciences. Psychology
Humans
Immunoassay - methods
Immunoassay - standards
Investigative techniques, diagnostic techniques (general aspects)
Mass spectrometry
Medical sciences
Molecular biophysics
Standardization
Studies
Thyroid diseases
Thyroid Function Tests - methods
Thyroid Function Tests - standards
Thyroid gland
Thyrotropin - blood
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Summary:Laboratory testing of serum thyroid-stimulating 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. We performed a method comparison study with 40 sera to assess the result comparability and performance attributes of 16 immunoassays. 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 >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. 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.
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2009.140178