Why Commutability Matters

Miller, W. Greg; Myers, Gary L.; Rej, Robert

doi:10.1373/clinchem.2005.063511

Cited by 144 publications

(88 citation statements)

References 10 publications

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“…Commutability describes the similarity or equivalence of analytical response obtained for reference materials to the response obtained from routine samples [28,29]. Freezedrying and associated processes in the production of CRM-FDMT1 resulted in a significant transformation of the matrix.…”

Section: Commutabilitymentioning

confidence: 99%

A mussel tissue certified reference material for multiple phycotoxins. Part 4: certification

et al. 2016

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Vous avez des questions? Nous pouvons vous aider. Pour communiquer directement avec un auteur, consultez la première page de la revue dans laquelle son article a été publié afin de trouver ses coordonnées. Si vous n'arrivez pas à les repérer, communiquez avec nous à PublicationsArchive-ArchivesPublications@nrc-cnrc.gc.ca. Questions? Contact the NRC Publications Archive team atPublicationsArchive-ArchivesPublications@nrc-cnrc.gc.ca. If you wish to email the authors directly, please see the first page of the publication for their contact information. NRC Publications Archive Archives des publications du CNRCThis publication could be one of several versions: author's original, accepted manuscript or the publisher's version. / La version de cette publication peut être l'une des suivantes : la version prépublication de l'auteur, la version acceptée du manuscrit ou la version de l'éditeur. NRC Publications Record / Notice d'Archives des publications de CNRC:http://nparc.cisti-icist.nrc-cnrc.gc.ca/eng/view/object/?id=2d72a8c8-d862-4bae-ae12-3ba2bf19d83e http://nparc.cisti-icist.nrc-cnrc.gc.ca/fra/voir/objet/?id=2d72a8c8-d862-4bae-ae12-3ba2bf19d83e Abstract A freeze-dried mussel tissue (Mytilus edulis)reference material (CRM-FDMT1) was produced containing multiple groups of shellfish toxins. Homogeneity and stability testing showed the material to be fit for purpose. The next phase of work was to assign certified values and uncertainties to 10 analytes from six different toxin groups. Efforts involved optimizing extraction procedures for the various toxin groups and performing measurements using liquid chromatographybased analytical methods. A key aspect of the work was compensating for matrix effects associated with liquid chromatography-mass spectrometry through standard addition, dilution, or matrix-matched calibration. Certified mass fraction values are reported as mg/kg of CRM-FDMT1 powder as bottled for azaspiracid-1, -2, and -3 (4.10 ± 0.40; 1.13 ± 0.10; 0.96 ± 0.10, respectively), okadaic acid, dinophysistoxin-1 and -2 (1.59 ± 0.18; 0.68 ± 0.07; 3.57 ± 0.33, respectively), yessotoxin (2.49 ± 0.28), pectenotoxin-2 (0.66 ± 0.06), 13-desmethylspirolide-C (2.70 ± 0.26), and domoic acid (126 ± 10). Combined uncertainties for the certified values include contributions from homogeneity, stability, and characterization experiments. The commutability of CRM-FDMT1 was assessed by examining the extractability and matrix effects for the freeze-dried material in comparison with its equivalent wet tissue homogenate. CRM-FDMT1 is the first shellfish matrix CRM with certified values for yessotoxins, pectenotoxins or spirolides, and is the first CRM certified for multiple toxin groups. CRM-FDMT1 is a valuable tool for quality assurance of phycotoxin monitoring programs and for analytical method development and validation.

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Section: Commutabilitymentioning

confidence: 99%

A mussel tissue certified reference material for multiple phycotoxins. Part 4: certification

et al. 2016

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“…Moreover, not only is the number of measurands included in the list continuously updated, particularly for the development of new biomarkers, innovative techniques such as "omics", but the list also includes measurands of significant clinical value. Second, many matrix-based CRMs have not been validated as commutable with patient samples, and in many cases it has been clearly demonstrated that they are not commutable and therefore not suitable for use in an ISO 17511 compliant calibration traceability hierarchy [44]. A body of evidence demonstrates that tracing calibration to a non-commutable CRM causes differences in results for clinical samples among different measurement procedures, which, in turn, may translate in errors in diagnostic and therapeutic decisions.…”

Section: Harmonization In Laboratory Medicine: Not Only Clinical Chemmentioning

confidence: 99%

Harmonization in laboratory medicine: more than clinical chemistry?

Plebani

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Abstract:The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. "omics") rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only "good biological samples" can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the "pre-preanalytical" phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the "post-post-analytical" steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.

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“…The EQA material ought therefore to be commutable and it is important for the EQA organizer to assign values for the measurands in the material as close as possible to true values [58,59]. The ultimate way to assign values is by using reference measurement procedures.…”

Section: How To Best Use Your Iqc and Eqa Datamentioning

confidence: 99%

How to assess the quality of your analytical method?

Topić¹,

Nikolac²,

Panteghini³

et al. 2015

Clinical Chemistry and Laboratory Medicine (CCLM)

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Laboratory medicine is amongst the fastest growing fields in medicine, crucial in diagnosis, support of prevention and in the monitoring of disease for individual patients and for the evaluation of treatment for populations of patients. Therefore, high quality and safety in laboratory testing has a prominent role in high-quality healthcare. Applied knowledge and competencies of professionals in laboratory medicine increases the clinical value of laboratory results by decreasing laboratory errors, increasing appropriate utilization of tests, and increasing cost effectiveness. This collective paper provides insights into how to validate the laboratory assays and assess the quality of methods. It is a synopsis of the lectures at the 15th European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Continuing Postgraduate Course in Clinical Chemistry and Laboratory Medicine entitled "How to assess the quality of your method?" (Zagreb, Croatia, 24-25 October 2015). The leading topics to be discussed include who, what and when to do in validation/verification of methods, verification of imprecision and bias, verification of reference intervals, verification of qualitative test procedures, verification of blood collection systems, comparability of results among methods and analytical systems, limit of detection, limit of quantification and limit of decision, how to assess the measurement uncertainty, the optimal use of Internal Quality Control and External Quality Assessment data, Six Sigma metrics, performance specifications, as well as biological variation. This article, which continues the annual tradition of collective papers from the EFLM continuing postgraduate courses in clinical chemistry and laboratory medicine, aims to provide further contributions by discussing the quality of laboratory methods and measurements and, at the same time, to offer continuing professional development to the attendees.

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Why Commutability Matters

Cited by 144 publications

References 10 publications

A mussel tissue certified reference material for multiple phycotoxins. Part 4: certification

A mussel tissue certified reference material for multiple phycotoxins. Part 4: certification

Harmonization in laboratory medicine: more than clinical chemistry?

How to assess the quality of your analytical method?

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