Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine

Sandberg, Sverre; Fraser, Callum G.; Horvath, Andrea R.; Jansen, Rob; Jones, Graham; Oosterhuis, Wytze P.; Petersen, Per Hyltoft; Schimmel, Heinz; Sikaris, Ken; Panteghini, Mauro

doi:10.1515/cclm-2015-0067

Cited by 389 publications

(218 citation statements)

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“…All items are covered by Calibration 2.000. Milan hierarchy from [7]; MUSE scoring system from [8]. EQA, external quality assessment; JCTLM, Joint Committee on Traceability in Laboratory Medicine; MUSE, multi sample evaluation; TEa, total error allowable.…”

Section: Pre-requisites For Calibration 2000mentioning

confidence: 99%

“…Definition of preset analytical performance criteria for the needed level of equivalence were obtained at first from the Stockholm conference on strategies to set global quality specifications in laboratory medicine [13], and more recently from the 1st Strategic Conference of the EFLM on defining analytical performance specifications [7]. The Milan conference criteria based on clinical outcome studies (Model 1) and biological variation (Model 2) were the preferred models.…”

Section: Pre-requisites For Calibration 2000mentioning

confidence: 99%

“…The Stockholm conference and later on the Milan conference contributed much to awareness and agreement on the way forward. Clinical outcome studies and particularly biological variation based estimations of allowable error are widely accepted [1,7,13,[27][28][29].…”

Section: Contributors To Greater Harmonizationmentioning

confidence: 99%

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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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Section: Pre-requisites For Calibration 2000mentioning

confidence: 99%

Section: Pre-requisites For Calibration 2000mentioning

confidence: 99%

See 1 more Smart Citation

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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“…Although many of the ideas established in 1999 were supported, in the Milan conference the models for PS were based on three completely different theoretical frameworks (Table 1) [8]. Accordingly, the recommended approaches for defining PS should preferentially be based on the effect of measurement performance on clinical outcome or on the biological variation of the measurand.…”

Section: The Milan Strategic Conferencementioning

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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“…The Milan conference on quality specifications resulted in a "consensus statement" published in 2015 [3], derived from the previous Stockholm consensus for performance specifications [4]. Recent developments contributing to the incentives for organizing the conference included the requirement of ISO 17025 and 15189 accreditation standards that laboratories routinely provide the measurement uncertainty (MU) of the results, the harmonization of the evaluation of proficiency testing procedures and recent challenges to the TE theory including the calculation of allowable total error (ATE) [5].…”

Section: Introductionmentioning

confidence: 99%

The use of error and uncertainty methods in the medical laboratory

Oosterhuis

Bayat²,

Armbruster

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Error methods -compared with uncertainty methods -offer simpler, more intuitive and practical procedures for calculating measurement uncertainty and conducting quality assurance in laboratory medicine. However, uncertainty methods are preferred in other fields of science as reflected by the guide to the expression of uncertainty in measurement. When laboratory results are used for supporting medical diagnoses, the total uncertainty consists only partially of analytical variation. Biological variation, pre-and postanalytical variation all need to be included. Furthermore, all components of the measuring procedure need to be taken into account. Performance specifications for diagnostic tests should include the diagnostic uncertainty of the entire testing process. Uncertainty methods may be particularly useful for this purpose but have yet to show their strength in laboratory medicine. The purpose of this paper is to elucidate the pros and cons of error and uncertainty methods as groundwork for future consensus on their use in practical performance specifications. Error and uncertainty methods are complementary when evaluating measurement data.

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Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine

Cited by 389 publications

References 0 publications

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

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

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

The use of error and uncertainty methods in the medical laboratory

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