Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes

Thienpont, Linda M.; Houcke, Sofie K. Van

doi:10.1016/j.cca.2010.09.001

Cited by 15 publications

(12 citation statements)

References 15 publications

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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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Section: Introductionmentioning

confidence: 99%

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

et al. 2014

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“…There needs to be agreement on what is actually being measured which will dictate the system calibrators, quality control materials or reference materials (Table ). Traceability to the International System of Units, Système international d'unités by certified reference materials is the ultimate goal …”

Section: Quantity Measurement and Reportingmentioning

confidence: 99%

“…Traceability to the International System of Units, Système international d'unités 53 by certified reference materials is the ultimate goal. 54 Total allergen protein concentrations for suggested clinically relevant reference materials are available 36,37 and can be used to derive concentrations (action levels) for any desired consumption amount. For example, the VITAL reference dose for peanut of 0.2 mg peanut protein suggests a clinically relevant concentration of 2 mg/kg peanut protein for a 100 g serving.…”

Section: Quantit Y Me a Surement And Rep Ortingmentioning

confidence: 99%

Evidence‐based approaches to the application of precautionary allergen labelling: Report from two iFAAM workshops

Galvin

Roberts

Schnadt³

et al. 2019

Clin Experimental Allergy

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Food allergy is a major public health concern with avoidance of the trigger food(s) being central to management by the patient. Food information legislation mandates the declaration of allergenic ingredients; however, the labelling of the unintentional presence of allergens is less defined. Precautionary allergen labelling (PAL) was introduced by the food industry to help manage and communicate the risk of reaction from the unintended presence of allergens in foods. In its current form, PAL is counterproductive for consumers with food allergies as there is no standardized approach to applying PAL. Foods with a PAL often do not contain the identified food allergen while some products without a PAL contain quantities of common food allergens that are capable of inducing an allergic reaction. Integrated Approaches to Food Allergen and Allergy Risk Management (iFAAM) was an EU‐funded project that aimed to improve the management of food allergens by the food industry for the benefit of people with food allergies. Within iFAAM, a clinically validated tiered risk assessment approach for food allergens was developed. Two cross‐stakeholder iFAAM workshops were held on 13‐14 December 2016 and 19‐20 April 2018. One of the objectives of these workshops was to develop a proposal to make PAL effective for consumers. This paper describes the outcomes from these workshops. This provides the basis for the development of more informative and transparent labelling that will ultimately improve management and well‐being in consumers with food allergy.

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“…Harmonization may require modification of existing CLMPs, or development of new CLMPs to improve specificity for the molecular form(s) of greatest clinical importance. Potential approaches for addressing measurement of complex protein mixtures have been suggested (16,17 ) and must be considered when developing a technical plan for harmonization of such measurands. It should be recognized that harmonization may not be possible for some measurands until technical advances enable more specific measurement procedures.…”

Section: Analytical Specificity For the Measurandmentioning

confidence: 99%

“…The concentrations of these samples should cover a clinically relevant range and focus on clinically significant decision points. Because there are no RMPs for category 4 and 5 measurands, the target values may be established as the all-procedure trimmed mean (12,16 ). Acceptance criteria based on the dispersion of results is another option, with reduced dispersion over time being the goal, thereby indicating improved harmonization.…”

Section: Sustaining Harmonizationmentioning

confidence: 99%

Roadmap for Harmonization of Clinical Laboratory Measurement Procedures

Myers²,

et al. 2011

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Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand, inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems, an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.

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Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes

Cited by 15 publications

References 15 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

Evidence‐based approaches to the application of precautionary allergen labelling: Report from two iFAAM workshops

Roadmap for Harmonization of Clinical Laboratory Measurement Procedures

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