Application of Sigma metrics in assessing the clinical performance of verified versus non-verified reagents for routine biochemical analytes

Biochemia Medica
Shuang Cao, Xiaosong Qin

Abstract

Sigma metrics analysis is considered an objective method to evaluate the performance of a new measurement system. This study was designed to assess the analytical performance of verified versus non-verified reagents for routine biochemical analytes in terms of Sigma metrics. The coefficient of variation (CV) was calculated according to the mean and standard deviation (SD) derived from the internal quality control for 20 consecutive days. The data were measured on an Architect c16000 analyser with reagents from four manufacturers. Commercial reference materials were used to estimate the bias. Total allowable error (TEa) was based on the CLIA 1988 guidelines. Sigma metrics were calculated in terms of CV, percent bias and TEa. Normalized method decisions charts were built by plotting the normalized bias (biasa: bias%/TEa) on the Y-axis and the normalized imprecision (CVa: mean CV%/TEa) on the X-axis. The reagents were compared between different manufacturers in terms of the Sigma metrics for relevant analytes. Abbott and Leadman's verified reagents provided better Sigma metrics for the alanine aminotransferase assay than non-verified reagents (Mindray and Zybio). All reagents performed well for the aspartate aminotransferase and u...Continue Reading

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Citations

Sep 21, 2020·Journal of Clinical Laboratory Analysis·Yanming LiuWencan Cai
Jul 20, 2018·Biochemia Medica·Sten WestgardJames O Westgard
Dec 15, 2020·Journal of Clinical Laboratory Analysis·Yong XiaLing Ji
Oct 5, 2021·Journal of Clinical Laboratory Analysis·Yanfen LuoSongbang Ou

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Software Mentioned

Sigma
SPSS

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