Comparison of Sigma metrics computed by three bias estimation approaches for 33 chemistry and 26 immunoassay analytes

Objectives: Sigma metric can be calculated using a simple equation. However, there are multiple sources for the elements in the equation that may produce different Sigma values. This study aimed to investigate the importance of different bias estimation approaches for Sigma metric calculation. Methods: Sigma metrics were computed for 33 chemistry and 26 immunoassay analytes on the Roche Cobas 6000 analyzer. Bias was estimated by three approaches: (1) averaging the monthly bias values obtained from the external quality assurance (EQA) studies; (2) calculating the bias values from the regression equation derived from the EQA data; and (3) averaging the monthly bias values from the internal quality control (IQC) events. Sigma metrics were separately calculated for the two levels of the IQC samples using three bias estimation approaches. The resulting Sigma values were classified into five categories considering Westgard Sigma Rules as ≥6, <6 and ≥5, <5 and ≥4, <4 and ≥3, and <3. Results: When classifying Sigma metrics estimated by three bias estimation approaches for each assay, 16 chemistry assays at the IQC level 1 and 2 were observed to fall into different Sigma categories under at least one bias estimation approach. Similarly, for 12 immunoassays at the IQC level 1 and 2, Sigma category was different depending on bias estimation approach. Conclusions: Sigma metrics may differ depending on bias estimation approaches. This should be considered when using Six Sigma for assessing analytical performance or scheduling the IQC events.

Standort
Deutsche Nationalbibliothek Frankfurt am Main
Umfang
Online-Ressource
Sprache
Englisch

Erschienen in
Comparison of Sigma metrics computed by three bias estimation approaches for 33 chemistry and 26 immunoassay analytes ; volume:4 ; number:3 ; year:2023 ; pages:236-245 ; extent:10
Advances in laboratory medicine ; 4, Heft 3 (2023), 236-245 (gesamt 10)

Urheber
Ercan, Şerif

DOI
10.1515/almed-2022-0095
URN
urn:nbn:de:101:1-2023100514121360038504
Rechteinformation
Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.
Letzte Aktualisierung
14.08.2025, 10:55 MESZ

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Beteiligte

  • Ercan, Şerif

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