Standardization activities in the field of thyroid function tests: a status report

Thienpont, Linda M.; Uytfanghe, Katleen Van; Houcke, Sofie Van

doi:10.1515/cclm.2010.321

Cited by 27 publications

(22 citation statements)

References 23 publications

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“…pregnant females or patients with nonthyroidal illness (NTI), were purposely excluded as this would jeopardize the use of a uniform recalibration basis unless the design was adapted/optimized by the manufacturer [23,24]. As previously, the results are reported without identification of the assay/manufacturer [12,13,14,18], which was a carefully thought-out decision to protect the integrity and long-term objectives of the project (see the explanation in the online suppl. material).…”

Section: Discussionmentioning

confidence: 99%

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A Progress Report of the IFCC Committee for Standardization of Thyroid Function Tests

et al. 2014

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Background: The IFCC Committee for Standardization of Thyroid Function Tests aims at equivalence of laboratory test results for free thyroxine (FT4) and thyrotropin (TSH). Objectives: This report describes the phase III method comparison study with clinical samples representing a broad spectrum of thyroid disease. The objective was to expand the feasibility work and explore the impact of standardization/harmonization in the clinically relevant concentration range. Methods: Two sets of serum samples (74 for FT4, 94 for TSH) were obtained in a clinical setting. Eight manufacturers participated in the study (with 13 FT4 and 14 TSH assays). Targets for FT4 were set by the international conventional reference measurement procedure of the IFCC; those for TSH were based on the all-procedure trimmed mean. The manufacturers recalibrated their assays against these targets. Results: All FT4 assays were negatively biased in the mid- to high concentration range, with a maximum interassay discrepancy of approximately 30%. However, in the low range, the maximum deviation was approximately 90%. For TSH, interassay comparability was reasonable in the mid-concentration range, but worse in the pathophysiological ranges. Recalibration was able to eliminate the interassay differences, so that the remaining dispersion of the data was nearly entirely due to within-assay random error components. The impact of recalibration on the numerical results was particularly high for FT4. Conclusions: Standardization and harmonization of FT4 and TSH measurements is feasible from a technical point of view. Because of the impact on the numerical values, the implementation needs careful preparation with the stakeholders.

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Section: Discussionmentioning

confidence: 99%

“…This was done in cooperation with the in vitro diagnostic (IVD) industry and in essence used several method comparison studies with panels of single-donation sera [12,13,18]. These showed the assays were of good quality, but confirmed considerable interassay difference in results.…”

Section: Introductionmentioning

confidence: 99%

A Progress Report of the IFCC Committee for Standardization of Thyroid Function Tests

et al. 2014

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“…Deshalb sollte jeder Referenzbereich bevölkerungs-und gerätespezifisch angegeben werden. An einer Verbesserung der Vergleichbarkeit von TSHWerten zwischen verschiedenen Geräteherstellern wird bereits gearbeitet [22,23]. Die TSH-Referenzbereiche weichen in den verschiedenen Nationen allerdings stärker voneinander ab, als durch gerätebedingte Messabweichungen allein erklärt werden könnte.…”

Section: Statistische Auswertungunclassified

TSH-Referenzbereich bei süddeutschen Erwachsenen: Ergebnisse aus der bevölkerungsbasierten KORA F4-Studie

Burkhardt¹,

Ittermann

Heier³

et al. 2014

Dtsch med Wochenschr

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“…The medians of these previous studies were perfectly suited for comparison, because they were calculated from results of method comparison studies with samples from apparently healthy (euthyroid) volunteers. Note that here we again report anonymously on the peer group data -as we did in all previous reports [6,7,14,16] -simply because the current study was only exploratory and did not yet include all manufacturers/instruments test systems. Anyhow, we see the observations in Figure 2 as a first basis of evidence for the utility of the Percentiler to 16 serve the purpose implied by the FDA.…”

Section: Discussionmentioning

confidence: 99%

Monitoring the stability of the standardization status of FT4 and TSH assays by use of daily outpatient medians and flagging frequencies

Grande

Goossens

Uytfanghe

et al. 2017

Clinica Chimica Acta

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(197 words)Clinicians diagnose thyroid dysfunction based on TSH and FT4 testing. However, the current lack of comparability between assays limits the optimal use of laboratory data. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) gave a mandate to the Committee for Standardization of Thyroid Function Tests (C-STFT) to resolve this limitation by standardization. Recently, the Committee members and their partners felt ready to set the step towards the technical recalibration. However, before implementation, they were furthered by the Food and Drugs Administration (FDA) to develop a tool to assess the sustainability of the new calibration basis. C-STFT began to use 2 online applications, i.e., the "Percentiler"and "Flagger", with the intention to assess their utility for this purpose. The tools monitor the course of instrument-specific moving medians of outpatient results (Percentiler) and flagging rates (Flagger) from data of individual laboratories grouped by instrument/assay peer. They additionally document the mid-to long-term medians, hence, are quality indicators of stability of performance of both laboratories and peers/assays. Here, the first experiences built up in the pre-standardization phase are reported. They suggest the suitability of both applications to document the sustainability of the calibration basis in the post-standardization phase.4

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Standardization activities in the field of thyroid function tests: a status report

Cited by 27 publications

References 23 publications

A Progress Report of the IFCC Committee for Standardization of Thyroid Function Tests

A Progress Report of the IFCC Committee for Standardization of Thyroid Function Tests

TSH-Referenzbereich bei süddeutschen Erwachsenen: Ergebnisse aus der bevölkerungsbasierten KORA F4-Studie

Monitoring the stability of the standardization status of FT4 and TSH assays by use of daily outpatient medians and flagging frequencies

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