Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies

Braga, Federica; Panteghini, Mauro

doi:10.1016/j.cca.2013.11.022

Cited by 73 publications

(65 citation statements)

References 23 publications

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“…Measurement uncertainty should in principle be within limits based on medical relevance making the results clinically acceptable and reliable for clinical decision-making and patient management [1]. If PS are not objectively defined and fulfilled, there is a risk of letting the variation in laboratory result overwhelm the clinical information supplied, even causing negative effects on patients' outcomes [2,3]. What degree of quality is needed to guarantee patient safety should therefore be precisely defined and specified for each analyte.…”

Section: Introductionmentioning

confidence: 99%

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Panteghini

Ceriotti

Jones

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:Measurements in clinical laboratories produce results needed in the diagnosis and monitoring of patients. These results are always characterized by some uncertainty. What quality is needed and what measurement errors can be tolerated without jeopardizing patient safety should therefore be defined and specified for each analyte having clinical use. When these specifications are defined, the total examination process will be "fit for purpose" and the laboratory professionals should then set up rules to control the measuring systems to ensure they perform within specifications. The laboratory community has used different models to set performance specifications (PS). Recently, it was felt that there was a need to revisit different models and, at the same time, to emphasize the presuppositions for using the different models. Therefore, in 2014 the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) organized a Strategic Conference in Milan. It was felt that there was a need for more detailed discussions on, for instance, PS for EQAS, which measurands should use which models to set PS and how to set PS for the extra-analytical phases. There was also a need to critically evaluate the quality of data on biological variation studies and further discussing the use of the total error (TE) concept. Consequently, EFLM established five Task Finish Groups (TFGs) to address each of these topics. The TFGs are finishing their activity on 2017 and the content of this paper includes deliverables from these groups.

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Section: Introductionmentioning

confidence: 99%

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Panteghini

Ceriotti

Jones

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…According to the definition of a Category 1 EQA scheme [18] the SKML scheme uses commutable native sera with value assignment by reference methods and allows for verification of trueness and precision of IVD tests based on predefined tolerance limits of measurement errors to evaluate whether medical tests are fit-for-purpose [19]. It incorporates the following: 1.…”

Section: Toolboxmentioning

confidence: 99%

The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability

Jansen

Cobbaert

Weykamp

et al. 2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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Calibration 2.000 was initiated 20 years ago for standardization and harmonization of medical tests. The program also intended to evaluate adequate implementation of the In Vitro Diagnostics (IVD) 98/79/EC directive, in order to ensure that medical tests are fit-for-clinical purpose. The Calibration 2.000 initiative led to ongoing verification of test standardization and harmonization in the Netherlands using commutable external quality assessment (EQA)-tools and a type 1 EQA-design, where feasible. National support was guaranteed by involving all laboratory professionals as well as laboratory technicians responsible for EQA and quality officers. A category 1 EQA-system for general chemistry analytes, harmonizers for specific analytes like hGH and IGF-1, and commutable materials for other EQA-sections have been developed and structurally introduced in the EQA-schemes. The type 1 EQA-design facilitates the dialogue between individual specialists in laboratory medicine and the IVD-industry to reduce lot-to-lot variation and to improve standardization. In such a way, Calibration 2.000 sheds light on the metrological traceability challenges that we are facing and helps the laboratory community to get the issues on the table and resolved. The need for commutable trueness verifiers and/or harmonizers for other medical tests is now seen as paramount. Much knowledge is present in the Netherlands and for general chemistry, humoral immunology and protein chemistry, a few endocrinology tests, and various therapeutic drug monitoring (TDM) tests, commutable materials are available. Also the multi sample evaluation scoring system (MUSE) and the category 1 EQA-design offer many possibilities for permanent education of laboratory professionals to further improve the between and within laboratory variation and the test equivalence.

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“…Two papers published in this issue of Clinical Chemistry and Laboratory Medicine further discuss the subject [2,3], which was revitalized by the organization of the 1st EFLM Strategic Conference in Milan on the analytical performance specifications at the end of 2014 [4]. The organizers considered it timely to address the topic of performance specifications both because it was 15 years since it was previously addressed and because performance specifications are more and more central for the clinical application of test measurements [5,6].…”

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confidence: 99%

“…If we agree that TE may still be useful, for example, in evaluating single EQAS results, there is also a need that all stakeholders working in the field of Laboratory Medicine look carefully to the measurement uncertainty as this help very much in the identification of important sources of bias [6,13,14]. Saying that medical laboratories should take care of TE and IVD manufacturers of measurement uncertainty is a simplification that includes the risk to separate responsibilities that should be conversely strongly integrated [6].…”

mentioning

confidence: 99%

Total error vs. measurement uncertainty: the match continues

Panteghini

Sandberg

2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies

Cited by 73 publications

References 23 publications

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference

The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability

Total error vs. measurement uncertainty: the match continues

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