Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data.

Introduction: The interest in quality management tools/methodologies is gradually increasing to ensure quality and accurate results in line with international standards in clinical laboratories. Six Sigma stands apart from other methodologies with its total quality management system approach. However, the lack of standardization in tolerance limits restricts the advantages for the process. Our study aimed both to evaluate the applicability of analytical quality goals with Roche Cobas c 702 analyser and to determine achievable goals specific to the analyser used.

Materials and methods: The study examined under two main headings as Sigma_laboratory and Sigma_analyser. Sigma_laboratory was calculated using internal and external quality control data by using Roche Cobas c 702 analyser for 21 routine biochemistry parameters and, Sigma_analyser calculation was based on the manufacturer data presented in the package inserts of the reagents used in our laboratory during the study. Sigma values were calculated with the six sigma formula.

Results: Considering the total number of targets achieved, Sigma_analyser performed best by meeting all CLIA goals, while Sigma_laboratory showed the lowest performance relative to biological variation (BV) desirable goals.

Conclusions: The balance between the applicability and analytical assurance of "goal-setting models" should be well established. Even if the package insert data provided by the manufacturer were used in our study, it was observed that almost a quarter of the evaluated analytes failed to achieve even "acceptable" level performance according to BV-based goals. Therefore, "state-of-the-art" goals for the Six Sigma methodology are considered to be more reasonable, achievable, and compatible with today's technologies.