Measurement uncertainty: Friend or foe?

Infusino, Ilenia; Panteghini, Mauro

doi:10.1016/j.clinbiochem.2018.01.025

Cited by 24 publications

(20 citation statements)

References 17 publications

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“…Very important to the scope of the present paper, the ISO Technical Specification 20914 dealing with the MU estimation also emphasizes that the magnitude of MU should be suitable for a result to be used in a medical decision [3]. Therefore, the definition of an allowable MU is essential to ascertain if estimated MU for a given laboratory result may significantly affect its interpretation [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models

Braga

Panteghini

2021

Clinical Chemistry and Laboratory Medicine (CCLM)

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Objectives Definition and fullfillment of analytical performance specifications (APS) for measurement uncertainty (MU) allow to make laboratory determinations clinically usable. The 2014 Milan Strategic Conference have proposed models to objectively derive APS based on: (a) the effect of analytical performance on clinical outcome; (b) biological variation components; and (3) the state of the art of the measurement, defined as the highest level of analytical performance technically achievable. Using these models appropriately, we present here a proposal for defining APS for standard MU for some common biochemical measurands. Methods We allocated a group of 13 measurands selected among the most commonly laboratory requested tests to each of the three Milan models on the basis of their biological and clinical characteristics. Both minimum and desirable levels of quality of APS for standard MU of clinical samples were defined by using information obtained from available studies. Results Blood total hemoglobin, plasma glucose, blood glycated hemoglobin, and serum 25-hydroxyvitamin D3 were allocated to the model 1 and the corresponding desirable APS were 2.80, 2.00, 3.00, and 10.0%, respectively. Plasma potassium, sodium, chloride, total calcium, alanine aminotransferase, creatinine, urea, and total bilirubin were allocated to the model 2 and the corresponding desirable APS were 1.96, 0.27, 0.49, 0.91, 4.65, 2.20, 7.05, and 10.5%, respectively. For C-reactive protein, allocated to the model 3, a desirable MU of 3.76% was defined. Conclusions APS for MU of clinical samples derived in this study are essential to objectively evaluate the reliability of results provided by medical laboratories.

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Section: Introductionmentioning

confidence: 99%

Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models

Braga

Panteghini

2021

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…This also relates to measurement uncertainty in paragraph 5.5.1.4., which is closely linked to traceability. Paragraph 5.5.1.4 does not intend calculation and documentation of measurement uncertainty to be a one-time exercise, but to provide data that enables the laboratory staff to judge continuously whether a measuring system meets the acceptance criteria [20].…”

Section: Iso 15189:2012 Requirements About Metrological Traceabilitymentioning

confidence: 99%

“…Quality control procedures as documented in paragraph 5.6.2 should use these performance specifications and check that performance is for the intended use as during verification/validation. The acceptable bias and imprecision define acceptable inaccuracy in a single measurement and can be expressed as measurement uncertainty [20,21]. Laboratories have procedures for internal quality control (5.6.2) and external quality assessment (5.6.3) to make sure that their measurement uncertainty does not exceed the acceptance criteria of the validation/verification [24,25].…”

Section: A Role For Risk Managementmentioning

confidence: 99%

“…The concepts of measurement uncertainty and metrological traceability are interrelated. Although the debate on how to calculate and express measurement uncertainty is -like the fundamentals of metrological traceability -outside of the scope of this paper, and depends on harmonization by itself [20,24,26] we do have to discuss its impact on ISO 15189 accreditation assessment. In ISO 17511:2003, it is clearly stated and graphically depicted that each single step of the traceability chain comes with its own uncertainty [6,7].…”

Section: Measurement Uncertaintymentioning

confidence: 99%

“…This budget of uncertainty should be distributed between the individual steps of the traceability chain involved. In such an approach the uncertainty of end user procedure is not a result that has to be accepted, but a predefined goal that should be achieved in dialogue with the higher steps of the chain [20]. Braga et al has proposed that no more than one third of the total uncertainty budget, established by appropriate analytical performance specifications, is consumed by the uncertainty of reference materials and no more than 50% of the total budget is consumed by the manufacturer's calibration and all higher steps in the chain [21,24].…”

Section: Measurement Uncertaintymentioning

confidence: 99%

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Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

Thelen

Vanstapel

Brguljan

et al. 2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer’s selected measurement procedure and the manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

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Great future or greedy venture: Precision medicine needs philosophy

Jiao

Guo

Beckmann

et al. 2021

Health Science Reports

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Introduction: Over the past decade, we have witnessed the initiation and implementation of precision medicine (PM), a discipline that promises to individualize and personalize medical management and treatment, rendering them ultimately more precise and effective. Despite of the continuing advances and numerous clinical applications, the potential of PM remains highly controversial, sparking heated debates about its future.Method: The present article reviews the philosophical issues and practical challenges that are critical to the feasibility and implementation of PM.Outcome: The explanation and argument about the relations between PM and computability, uncertainty as well as complexity, show that key foundational assumptions of PM might not be fully validated. Conclusion:The present analysis suggests that our current understanding of PM is probably oversimplified and too superficial. More efforts are needed to realize the hope that PM has elicited, rather than make the term just as a hype.

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Measurement uncertainty: Friend or foe?

Cited by 24 publications

References 17 publications

Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models

Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models

Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

Great future or greedy venture: Precision medicine needs philosophy

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