Harmonization of immunoassays to the all-procedure trimmed mean – proof of concept by use of data from the insulin standardization project

Houcke, Sofie K. Van; Aelst, Stefan Van; Uytfanghe, Katleen Van; Thienpont, Linda M.

doi:10.1515/cclm-2012-0661

Cited by 14 publications

(10 citation statements)

References 7 publications

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“…To circumvent the often encountered commutability issues in establishing calibration traceability of IVD assays, it was a premise for C-STFT that harmonization should be done from a multi-assay method comparison study with a panel of native and clinically relevant samples (19)(20)(21). We developed a robust factor analysis method for estimation of the harmonization targets and demonstrated the equivalence of the approach to standardization to a reference measurement procedure (22,23).…”

Section: Introductionmentioning

confidence: 99%

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

et al. 2017

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Section: Introductionmentioning

confidence: 99%

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

et al. 2017

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“…For free thyroxine (FT4), this led to an IFCC-approved international conventional reference measurement procedure (cRMP), based on equilibrium dialysis isotope dilution-liquid chromatography-tandem mass spectrometry (ED ID-LC/tandem MS) [ 15 ]. In the case of TSH, for which it is technically unlikely to have an RMP available in the mid- to short term, the C-STFT proposed a statistical alternative for ‘harmonization’ rather than standardization [ 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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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“…thyroid stimulating hormone, insulin, parathyroid hormone [PTH] and troponin), harmonization protocols using panels of authentic individual serum samples and commutable control materials used in EQA schemes have allowed between methods agreement to be achieved. In addition to the utilization of commutable sera, this approach is based on the development of robust statistical approaches for value assignment of the panel of individual samples and or EQA materials [53][54][55][56][57]. Serological testing and virological testing are other areas of interest in standardization and harmonization initiatives.…”

Section: Harmonization In Laboratory Medicine: Not Only Clinical Chemmentioning

confidence: 99%

Harmonization in laboratory medicine: more than clinical chemistry?

Plebani

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. "omics") rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only "good biological samples" can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the "pre-preanalytical" phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the "post-post-analytical" steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.

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Harmonization of immunoassays to the all-procedure trimmed mean – proof of concept by use of data from the insulin standardization project

Cited by 14 publications

References 7 publications

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval

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

Harmonization in laboratory medicine: more than clinical chemistry?

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