Standardization of Free Thyroxine Measurements Allows the Adoption of a More Uniform Reference Interval
| Autor: | Katleen Van Uytfanghe, Dries Reynders, Paul Van Crombrugge, Annick Van den Bruel, Bruno Lapauw, Linda M. Thienpont, Akira Hishinuma, James D. Faix, Barnali Das, Brigitte Velkeniers, Paul Taelman, Paul F. Williams, Brigitte Decallonne, Finlay MacKenzie, Linde A.C. De Grande |
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| Přispěvatelé: | Internal Medicine Specializations, Clinical sciences |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Validation study
Standardization Clinical Biochemistry 030209 endocrinology & metabolism Interval (mathematics) Thyroid Function Tests FUNCTION TESTS GUIDELINES DIAGNOSIS Total error SERUM 03 medical and health sciences PROPOSAL 0302 clinical medicine HARMONIZATION Limit of Detection Reference Values Tandem Mass Spectrometry Biological variation Statistics Humans LABORATORY MEDICINE Immunoassay Biochemistry medical Biochemistry (medical) Biology and Life Sciences Free thyroxine Thyroxine Chemistry Reference measurement HYPOTHYROIDISM 030220 oncology & carcinogenesis Reference values Calibration AMERICAN THYROID ASSOCIATION ENDOCRINOLOGISTS Chromatography Liquid |
| Zdroj: | CLINICAL CHEMISTRY |
| ISSN: | 0009-9147 1530-8561 |
| Popis: | BACKGROUNDThe IFCC Committee for Standardization of Thyroid Function Tests intended to standardize free thyroxine (FT4) immunoassays. We developed a Système International d'Unités traceable conventional reference measurement procedure (RMP) based on equilibrium dialysis and mass spectrometry. We describe here the latest studies intended to recalibrate against the RMP and supply a proof of concept, which should allow continued standardization efforts.METHODSWe used the RMP to target the standardization and reference interval (RI) panels, which were also measured by 13 manufacturers. We validated the suitability of the recalibrated results to meet specifications for bias (3.3%) and total error (8.0%) determined from biological variation. However, because these specifications were stringent, we expanded them to 10% and 13%, respectively. The results for the RI panel were reported as if the assays were recalibrated. We estimated all but 1 RI using parametric statistical procedures and hypothesized that the RI determined by the RMP was suitable for use by the recalibrated assays.RESULTSTwelve of 13 recalibrated assays had a bias, meeting the 10% specification with 95% confidence; for 7 assays, this applied even for the 3.3% specification. Only 1 assay met the 13% total error specification. Recalibration reduced the CV of the assay means for the standardization panel from 13% to 5%. The proof-of-concept study confirmed our hypothesis regarding the RI but within constraints.CONCLUSIONSRecalibration to the RMP significantly reduced the FT4 immunoassays' bias, so that the RI determined by the RMP was suitable for common use within a margin of 12.5%. |
| Databáze: | OpenAIRE |
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