Standardization activities in the field of thyroid function tests: a status report
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Linda M. Thienpont
Abstract
Background: Laboratory testing is an essential tool for diagnosis and management of thyroid diseases. However, the current status of standardization hampers the interchangeability of results. To improve this situation, the Working Group for Standardization of Thyroid Function Tests was established.
Methods: Method comparisons were organized for measurement of human thyroid stimulating hormone (TSH), and free and total thyroid hormone in serum from apparently healthy donors. The aim was to assess the status of standardization and the quality of the performance of current routine assays. A second objective was to investigate the effect of mathematical recalibration of the results using their relationship to the overall mean (TSH) or the reference measurement procedure values (other thyroid hormones).
Results: The need for standardization was shown to be highest for free thyroid hormone and total triiodothyronine measurements, while the majority of TSH and total thyroxine assays agreed within 10% of the reference. Most assays showed good performance. However, some could benefit from improved precision, consistency of calibration, or within- and between-run stability. Recalibration eliminated assay-specific bias. Thus, the residual spread was due to within-method effects. Not withstanding, sample-related effects remained.
Conclusions: These studies confirmed the feasibility of standardization based on method comparison with native sera, but highlighted the need to resolve issues, such as sample-related effects. In view of the fact that in this phase the project worked with samples from individuals with euthyroid status, the next method comparison shall place emphasis on challenging the performance of the assays with clinical samples and expanding the covered measurement range.
Clin Chem Lab Med 2010;48:1577–83.
©2010 by Walter de Gruyter Berlin New York
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- Congress Abstracts
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Articles in the same Issue
- Editorial
- IFCC Scientific Division
- IFCC Documents
- Nucleic acid reference materials (NARMs): definitions and issues
- An appraisal of statistical procedures used in derivation of reference intervals
- An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
- Review
- Standardizing plasma protein measurements worldwide: a challenging enterprise
- Status Reports
- Standardization activities in the field of thyroid function tests: a status report
- Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material
- Research Articles
- Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
- Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation
- Towards the development of a certified reference material for hemoglobin A2
- Short Communication
- First certified reference material for cystatin C in human serum ERM-DA471/IFCC
- General Clinical Chemistry and Laboratory Medicine
- Increased γ-glutamyltransferase and decreased total bilirubin are associated with metabolic syndrome in Korean postmenopausal women
- Effect of homeostasis model assessment computational method on the definition and associations of insulin resistance
- Association between thyroid hormones, lipids and oxidative stress biomarkers in overt hypothyroidism
- Biochemical markers of particle induced osteolysis in C57BL/6 mice
- An on-line solid phase extraction procedure for the routine quantification of urinary methylmalonic acid by liquid chromatography-tandem mass spectrometry
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- Increased integrity of circulating cell-free DNA in plasma of patients with acute leukemia
- The relationship between three heat shock protein 70 gene polymorphisms and susceptibility to lung cancer
- Real-time polymerase chain reaction quantification of free DNA in serum of patients with polyps and colorectal cancers
- Letters to the Editor
- Thyroid hormones are stable even during prolonged frozen storage
- Thyroid hormones after long-term cold storage: stable or unstable, that is the question
- Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
- Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
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- Interferences in red blood cell counting in urinalysis using evacuated tubes
- Congress Abstracts
- 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
