Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map.

Abstract:

:Reliable procedures are needed to quantify the performance of instruments and methods in order to increase the quality in clinical laboratories. The Sigma metrics serves that purpose, and in the present study, the current methods for the calculation of the Sigma metrics are critically evaluated. Although the conventional model based on permissible (or allowable) total error is widely used, it has been shown to be flawed. An alternative method is proposed based on the within-subject biological variation. This model is conceptually similar to the model used in industry to quantify measurement performance, based on the concept of the number of distinct categories and consistent with the Six Sigma methodology. The quality of data produced in clinical laboratories is expected, however, to be higher than the quality of industrial products. It is concluded that this model is consistent with Six Sigma theory, original Sigma metrics equation and with the nature of patients' samples. Therefore, it can be used easily to calculate the performance of measurement methods and instruments used in clinical laboratories.

journal_name

Biochem Med (Zagreb)

journal_title

Biochemia medica

authors

Oosterhuis WP,Coskun A

doi

10.11613/BM.2018.020503

subject

Has Abstract

pub_date

2018-06-15 00:00:00

pages

020503

issue

2

eissn

1330-0962

issn

1846-7482

pii

bm-28-2-020503

journal_volume

28

pub_type

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