Tools for evaluating the performance of HbA1c analyzer: Sigma Metric and Quality Goal Index Ratio

Abstract

INTRODUCTION: Sigma metric model is one of the most popular quality management system tools used for Six Sigma process improvement. This model provides three features that improve the results: low inaccuracy, less deviation, and correct performance of the analytical method. Internal quality control and external quality assessment programs are routinely carried out in all clinical laboratories to evaluate and continually improve the analytical quality. The Six Sigma model is a global quality management system that can also be applied in the determination of glycated hemoglobin (HbA1c). In recent years, this model has been supported by Quality Goal Index (QGI). In this study, we aimed to evaluate the analytical performances of Arkray HA8180V HbA1c analyzer according to internal and external quality Sigma metrics and QGI. METHODS: The data have been evaluated according to two internal control materials (Bio-DPC and KBUDEK External Quality Program) to calculate Sigma levels [Sigma=(TEa%-bias%)/CV%] and quality target indexes (QGI=bias/1.5×CV), where TEa is the total analytical error and CV is the coefficient of variation. QGI is a metric that can distinguish between techniques to deal with sensitivity and accuracy issues as well as calibrator lot changes. RESULTS: The mean Sigma levels for low and high quality control materials were found to be 5.17 and 2.51, respectively. QGI was found to be 0.8 1.2 for both levels. DISCUSSION AND CONCLUSION: The performance of HA8180V HbA1c analyzers was found to be acceptable compared to Sigma metrics. The values of OGI between 0.8 and 1.2 indicate inaccurate and inconsistent result. However, when evaluated as a whole with Sigma values, the results of the devices were found reliable.

Keywords

• hemoglobin a1c
• quality control
• quality goal index
• sigma metric