A category 1 EQA scheme for comparison of laboratory performance and method performance: An international pilot study in the framework of the Calibration 2000 project

Jansen, Rob; Jassam, Nuthar; Thomas, Annette; Perich, Carmen; Fernández–Calle, Pilar; Faria, Ana Paula; Correia, Helena; Barth, Julian H.; Weykamp, Cas; Cobbaert, Christa; Thelen, Marc; Ricós, Carmen

doi:10.1016/j.cca.2013.11.003

Cited by 36 publications

(29 citation statements)

References 19 publications

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“…Although for ALT results were relatively good, major drawbacks were shown for AST, CK, γGT, LDH, and AMY. More recently, the same group reassessed the traceability of enzyme measurements in four European countries [31]. Authors concluded that CK is now satisfactorily standardized and a substantial improvement in performance of marketed GGT assays is evident.…”

Section: Fulfilling Expectations Traceability Implementation By Industrymentioning

confidence: 99%

Progress and impact of enzyme measurement standardization

Infusino

Frusciante

Braga

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established reference measurement procedures (RMPs) for the most popular enzymes. Manufacturers should assign values to commercial calibrators traceable to these RMPs to achieve equivalent results in clinical samples, independent of reagent kits, instruments, and laboratory where the measurement is carried out. The situation is, however, far from acceptable. Some manufacturers continue to market assays giving results that are not traceable to internationally accepted RMPs. Meanwhile, end-users often do not abandon assays with demonstrated insufficient quality. Of the enzyme measurements, creatine kinase (CK) is satisfactorily standardized and a substantial improvement in performance of marketed γ-glutamyltranspeptidase (GGT) assays has been demonstrated. Conversely, aminotransferase measurements often exceed the desirable analytical performance because of the lack of pyridoxal-5-phosphate addition in the commercial reagents. Measurements of lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and α-amylase (AMY) still show major disagreement, suggesting the need for improvement in implementing traceability to higher-order references. This is mainly the result of using assays with different analytical selectivities for these enzymes. The definition by laboratory professionals of the clinically acceptable measurement uncertainty for each enzyme together with the adoption by EQAS of commutable materials and use of an evaluation approach based on trueness represent the way forward for reaching standardization in clinical enzymology.

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Section: Fulfilling Expectations Traceability Implementation By Industrymentioning

confidence: 99%

Progress and impact of enzyme measurement standardization

Infusino

Frusciante

Braga

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Figure 3 shows serum creatinine results obtained by 23 Spanish laboratories participating in a SKML pilot study using commutable controls with values assigned by reference methods. The samples are targeted with reference methods, undertaken in either the Joint Committee for Traceability in Laboratory Medicine (JCTLM) listed reference laboratories or in International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) network laboratories [37]. All laboratories using the alkaline picrate kinetic (Alk picr k) (method gave unacceptably high results at the clinical decision level, while various laboratories using the compensated method produced dispersed results.…”

Section: Use Of Databases In Laboratory Medicinementioning

confidence: 99%

Rationale for using data on biological variation

Ricós¹,

Álvarez²,

Perich³

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The aims of this study are: 1) to use the data included in the biological variation (BV) database to address the usability of BV estimates; and 2) to use different examples from the authors' laboratories to illustrate the use and the usefulness of BV data in laboratory medicine. The BV database is an essential tool for laboratory management. Examples of application of data derived from BV are given in this paper, such as analytical performance specifications that have been included in various quality control software designed to optimize operative rules; also they have been incorporated as acceptability limits in external quality assurance reports. BV data from pathological status are of utmost interest for monitoring patients and differences between the intra-individual coefficients of variation (CV I ) estimated from healthy and patients are shown. However, for a number of analytes there are limited data available and for many there are no data, consequently new studies should be encouraged at an international level. In addition, developing international criteria to evaluate publications dealing with the estimation of BV components would be of the utmost interest. We are ready and willing to collaborate with such worthy initiatives. The first EFLM strategic conference on analytical performance specifications is an excellent opportunity for debating these ideas.

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“…With the above described approach and toolbox for standardization/harmonization of measurands, the Dutch EQA scheme organization SKML established a Category 1 EQA system [8,16], according to the criteria described in the 'Roadmap to Harmonization' paper [17,18]. 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].…”

Section: Toolboxmentioning

confidence: 99%

“…In Calibration 2.000 a Category 1 EQA scheme was developed using commutable samples that were value assigned with reference methods and covering the concentration range of interest, and using biological variation based trueness and imprecision tolerance limits including Six Sigma metric [8,16]. The development of commutable samples made it possible to perform national and international studies on standardization and harmonization.…”

Section: Contributors To Greater Harmonizationmentioning

confidence: 99%

“…The introduction of biological variation based tolerance limits made objective judgment of the performance of laboratories and methods possible. Wide variation with both acceptable and unacceptable performance was shown in international studies for lipids, enzymes, creatinine, electrolytes and other analytes [16,33,45,56]. The joint project by the national EQA organizers in Italy, the Netherlands, Portugal, UK and Spain (INPUtS) [45] showed that the analytical performance of 11 of 17 general chemistry analytes measured in European medical laboratories met the minimum performance specifications.…”

Section: General Chemistrymentioning

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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A category 1 EQA scheme for comparison of laboratory performance and method performance: An international pilot study in the framework of the Calibration 2000 project

Cited by 36 publications

References 19 publications

Progress and impact of enzyme measurement standardization

Progress and impact of enzyme measurement standardization

Rationale for using data on biological variation

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

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