A comparative analysis of Sigma metrics using conventional and alternative formulas.

Background And Aim: The Six Sigma approach, employing Sigma Metrics (SM), is commonly used to evaluate analytical performance in clinical laboratories. However, there is ongoing debate regarding the suitability of the conventional SM formula, which incorporates total allowable error (TEa) and bias. To address this, an alternative formula based on within-subject biological variation (CV) as the tolerance range (TR) has been proposed. The study aimed to calculate and compare SM values using both formulas.

Material And Methods: Twenty clinical chemistry parameters were evaluated, and SM values were calculated using conventional formula with two TEa goals and the alternative formula. Intermediate precision (CV%) values were obtained from internal quality control data, while bias values were derived from external quality assessment reports.

Results: The results showed that using the conventional formula, 11 SM values based on CLIA TEa goals and 21 SM values based on BV TEa goals were deemed unacceptable (SM < 3). Additionally, 22 SM values calculated using the alternative formula were below 3.

Conclusion: The choice of TR had a substantial impact on the assessed analytical performance. Laboratories should carefully consider the appropriateness of each approach based on their specific quality objectives, analyte characteristics, and laboratory operations.