Literature DB >> 28182577

Expressing analytical performance from multi-sample evaluation in laboratory EQA.

Marc H M Thelen1, Rob T P Jansen1, Cas W Weykamp1, Herman Steigstra1, Ron Meijer1, Christa M Cobbaert1.   

Abstract

BACKGROUND: To provide its participants with an external quality assessment system (EQAS) that can be used to check trueness, the Dutch EQAS organizer, Organization for Quality Assessment of Laboratory Diagnostics (SKML), has innovated its general chemistry scheme over the last decade by introducing fresh frozen commutable samples whose values were assigned by Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference laboratories using reference methods where possible. Here we present some important innovations in our feedback reports that allow participants to judge whether their trueness and imprecision meet predefined analytical performance specifications.
METHODS: Sigma metrics are used to calculate performance indicators named 'sigma values'. Tolerance intervals are based on both Total Error allowable (TEa) according to biological variation data and state of the art (SA) in line with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Milan consensus.
RESULTS: The existing SKML feedback reports that express trueness as the agreement between the regression line through the results of the last 12 months and the values obtained from reference laboratories and calculate imprecision from the residuals of the regression line are now enriched with sigma values calculated from the degree to which the combination of trueness and imprecision are within tolerance limits. The information and its conclusion to a simple two-point scoring system are also graphically represented in addition to the existing difference plot.
CONCLUSIONS: By adding sigma metrics-based performance evaluation in relation to both TEa and SA tolerance intervals to its EQAS schemes, SKML provides its participants with a powerful and actionable check on accuracy.

Entities:  

Keywords:  analytical performance specifications; bias; external quality assessment; imprecision

Mesh:

Year:  2017        PMID: 28182577     DOI: 10.1515/cclm-2016-0970

Source DB:  PubMed          Journal:  Clin Chem Lab Med        ISSN: 1434-6621            Impact factor:   3.694


  6 in total

1.  Indirect determination of biochemistry reference intervals using outpatient data.

Authors:  Luisa Martinez-Sanchez; Christa M Cobbaert; Raymond Noordam; Nannette Brouwer; Albert Blanco-Grau; Yolanda Villena-Ortiz; Marc Thelen; Roser Ferrer-Costa; Ernesto Casis; Francisco Rodríguez-Frias; Wendy P J den Elzen
Journal:  PLoS One       Date:  2022-05-19       Impact factor: 3.752

2.  Comparison between Sigma metrics in four accredited Egyptian medical laboratories in some biochemical tests: an initiative towards sigma calculation harmonization.

Authors:  Rania El Sharkawy; Sten Westgard; Ahmed M Awad; AbdelKarem Omneya I Ahmed; El Hadidi Iman; Ahmed Gaballah; Eman Shaheen
Journal:  Biochem Med (Zagreb)       Date:  2018-06-15       Impact factor: 2.313

3.  Association of apolipoproteins C-I, C-II, C-III and E with coagulation markers and venous thromboembolism risk.

Authors:  Fernanda A Orsi; Willem M Lijfering; Arnoud Van der Laarse; L Renee Ruhaak; Frits R Rosendaal; Suzanne C Cannegieter; Christa Cobbaert
Journal:  Clin Epidemiol       Date:  2019-07-22       Impact factor: 4.790

4.  Using Sigma metrics to establish analytical product performance requirements and optimize analytical performance of an in vitro diagnostic assay using a theoretical total PSA assay as an example.

Authors:  Victoria Petrides; Sharon Schneider
Journal:  Biochem Med (Zagreb)       Date:  2018-06-15       Impact factor: 2.313

5.  Comparative analysis of calculating sigma metrics by a trueness verification proficiency testing-based approach and an internal quality control data inter-laboratory comparison-based approach.

Authors:  Runqing Li; Tengjiao Wang; Lijun Gong; Peng Peng; Song Yang; Haibin Zhao; Pan Xiong
Journal:  J Clin Lab Anal       Date:  2019-08-06       Impact factor: 2.352

6.  Utility of process capability indices in assessment of quality control processes at a clinical laboratory chain.

Authors:  Ping Dong; Yong-Bo Wang; De-Zhi Peng; Jia-Jia Wang; Ya-Ting Cheng; Xiao-Yan Deng; Biao Zheng; Ran Tao
Journal:  J Clin Lab Anal       Date:  2021-06-24       Impact factor: 2.352

  6 in total

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