External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe

Perich, Carmen; Ricós, Carmen; Álvarez, Virtudes; Biosca, Carmen; Boned, Beatriz; Cava, Fernando; Doménech, Mariví; Fernández–Calle, Pilar; Fernández-Fernández, Pilar; García-Lario, José-Vicente; Minchinela, Joana; Simón, Margarita; Jansen, Rob

doi:10.1016/j.cca.2013.11.005

Cited by 21 publications

(11 citation statements)

References 17 publications

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“…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. Only the enzymatic method gave all results within the limits derived from BV for total error [38]. It has to be emphasized that this can be firmly stated because this EQA uses commutable samples that are targeted with reference methods.…”

Section: Use Of Databases In Laboratory Medicinementioning

confidence: 57%

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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Section: Use Of Databases In Laboratory Medicinementioning

confidence: 57%

Rationale for using data on biological variation

Ricós¹,

Álvarez²,

Perich³

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…Therefore, several researchers recommend using the reference method instead of reference materials to assign values of the routine calibrators. [ 15 ] For most manufacturers, the detailed information of the procedure to assign the values of routine calibrators is not provided; therefore, the laboratories cannot know if the traceability chain has been maintained. The traceability standards in the in vitro diagnostic instruments directive (Directive 98/79/EC) as well as ISO17511 and ISO18153[ 16 ] are all relevant to diagnostic equipment manufacturers.…”

Section: Discussionmentioning

confidence: 99%

Inductively Coupled Plasma Mass Spectrometry as a Reference Method to Evaluate Serum Calcium Measurement Bias and the Commutability of Processed Materials during Routine Measurements

Zhao

Yin

et al. 2018

Chinese Medical Journal

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Background:Measuring total serum calcium is important for the diagnosis of diseases. Currently, results from commercial kits for calcium measurement are variable. Generally, the performance of serum calcium measurements is monitored by external quality assessment (EQA) or proficiency testing schemes. However, the commutability of the EQA samples and calibrators is often unknown, which limits the effectiveness of EQA schemes. The aim of this study was to evaluate the bias of serum calcium measurements and the commutability of processed materials.Methods:Inductively coupled plasma mass spectrometry was applied as a comparative method, and 14 routine methods were chosen as test methods. Forty-eight serum samples from individual patients and 25 processed materials were quantified. A scatter plot was generated from patient samples, and 95% prediction intervals were calculated to evaluate the commutability of the processed materials and measurement bias at three concentration levels was used to determine the accuracy of routine assays.Results:All assays showed high precision (total coefficient of variation [CV] <2.26%) and correlation coefficients (r > 0.99). For all assays, the mean bias for the 48 patient samples ranged from −0.13 mmol/L to 0.00 mmol/L (−5.61–0.01%), and the ranges for the three concentrations were −0.10–0.04 mmol/L (−5.71–2.35%), −0.14–−0.01 mmol/L (−5.80–−0.30%), and −0.19–0.04 mmol/L (−6.24–1.22%). The EQA samples, calibrators, and animal sera exhibited matrix effects in some assays; human serum pools were commutable in all assays; certificate reference materials were commutable in most assays, and only GBW09152 exhibited a matrix effect in one assay; and aqueous reference materials exhibited matrix effects in most assays.Conclusions:Biases for most assays were within the acceptable range, although the accuracy of some assays needs improvement. Human serum pools prepared from patient samples were commutable, and the other tested materials exhibited a matrix effect.

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“…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%

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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External quality assurance programs as a tool for verifying standardization of measurement procedures: Pilot collaboration in Europe

Cited by 21 publications

References 17 publications

Rationale for using data on biological variation

Rationale for using data on biological variation

Inductively Coupled Plasma Mass Spectrometry as a Reference Method to Evaluate Serum Calcium Measurement Bias and the Commutability of Processed Materials during Routine Measurements

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

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