Trueness verification and traceability assessment of results from commercial systems for measurement of six enzyme activities in serum

Jansen, Rob; Schumann, G.; Baadenhuijsen, H.; Franck, Paul; Franzini, Carlo; Kruse, Rolf; Kuypers, Aldy; Weykamp, Cas; Panteghini, Mauro

doi:10.1016/j.cca.2005.12.033

Cited by 30 publications

(21 citation statements)

References 17 publications

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“…The development of such materials, the value assignment by reference laboratories and establishment of Category 1 EQA schemes, make it possible at present to really assess whether the metrological traceability concept is implemented in an adequate way so that test standardization/harmonization is achieved. Jansen et al [33] showed this was not the case even for serum enzymes.…”

Section: Contributors To Greater Harmonizationmentioning

confidence: 97%

“…The development of commutable EQA materials [33,42,54,55], the first 'Holy Grail' materials, made evaluation of interlaboratory differences possible. In the studies it was shown that harmonization was achievable for several analytes, at first for lipids and also for serum enzymes [42,43,54,55].…”

Section: General Chemistrymentioning

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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Section: Contributors To Greater Harmonizationmentioning

confidence: 97%

Section: General Chemistrymentioning

confidence: 99%

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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“…4,22,23 In addition, for glucose, uric acid, and enzymes, they performed more accurately. 5,21,24,25 Especially for enzymes, the measured values for CK, LDH, and amylase were significantly different from the target values for the Abbott system according to Jansen et al 5 who assessed traceability for those enzymes on various platforms. Based on our results, the measurement accuracy of the Abbott enzyme assays has greatly improved.…”

Section: Commentmentioning

confidence: 99%

“…2 However, even common clinical-chemistry analytes have been shown to demonstrate problems with comparability, exhibiting unacceptable or suboptimal bias in comparison to the true value, as determined by a reference method. [3][4][5][6] As a consequence, emphasis has increasingly been placed on the need for standardization or harmonization of laboratory tests.…”

mentioning

confidence: 99%

Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers

Lim¹,

Song²,

Song³

et al. 2016

Archives of Pathology &Amp; Laboratory Medicine

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Context.-The traceability of clinical results to internationally recognized and accepted reference materials and reference measurement procedures has become increasingly important. Therefore, the establishment of traceability has become a mandatory requirement for all in vitro diagnostics devices.Objectives.-To evaluate the traceability of the Abbott Architect c8000 system (Abbott Laboratories, Abbott Park, Illinois), consisting of calibrators and reagents, across 4 different chemistry analyzers, and to evaluate its general performance on the Toshiba 2000FR NEO (Toshiba Medical Systems Corporation, Otawara-shi, Tochigi-ken, Japan).Design.-For assessment of traceability, secondary reference materials were evaluated 5 times, and then bias was calculated. Precision, linearity, and carryover were determined according to the guidelines of the Clinical and Laboratory Standards Institute (Wayne, Pennsylvania).Results.-The biases from 4 different analyzers ranged from À2.33% to 2.70% on the Toshiba 2000FR NEO, À2.33% to 5.12% on the Roche Hitachi 7600 (Roche Diagnostics International, Basel, Switzerland), À0.93% to 2.87% on the Roche Modular, and À2.16% to 2.86% on the Abbott Architect c16000. The total coefficients of variance of all analytes were less than 5%. The coefficients of determination (R 2 ) were more than 0.9900. The carryover rate ranged from À0.54% to 0.17%.Conclusions.-Abbott clinical chemistry assays met the performance criteria based on desirable biological variation for precision, bias, and total error. They also showed excellent linearity and carryover. Therefore, these clinical chemistry assays were found to be accurate and reliable and are readily applicable on the various platforms used in this study.

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Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile

Talbot

Keisu

Ståhle

2011

Stephens' Detection and Evaluation of Adverse Drug Reactions

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Trueness verification and traceability assessment of results from commercial systems for measurement of six enzyme activities in serum

Cited by 30 publications

References 17 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

Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers

Clinical Trials—Collecting Safety Data and Establishing the Adverse Drug Reactions Profile

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