Evaluation of analytical performance of tests worked on the same brand devices with six sigma metrics

Abstract

INTRODUCTION: The aim of this study is that evaluate the analytical performance with six sigma metrics between the same brand devices actively working in the laboratory and answer the question of which tests will be performed on these devices according to the laboratory test working rates.
 METHODS: In the research, all tests were studied on Abbott brand, Architeck c8000, and Architeck ci4000 model devices for 6 months. Glucose (Glc), blood urea nitrogen (BUN), creatinine (CREA), aspartate aminotransferase (AST), total cholesterol (CHOL), triglycerides (Tg), sodium (Na), potassium (K), chlorine (Cl) parameters were evaluated in the sigma values were calculated according to the performance approach. The comparisons were drew between these two devices. Total allowable error (TEa) is derived from the Clinical Laboratories Improvement Amendments (CLIA) guidelines.
 RESULTS: In the comparative follow-up performed for 6 months, the determination of the parameters to be worked on which device on monthly basis varied. Since the sigma values of the glucose, urea and creatinine tests, which are the most studied in our laboratory, are lower in the Architeck ci4000 device than the Architeck c8000 device. It was decided to run these tests only on the Architeck c8000 device. All metrics have been obtained until October 2019. An increase in the sigma value was detected with the start of working of electrolytes on a single device six months later.
 DISCUSSION AND CONCLUSION: Six sigma metrics should be used monthly to monitor tests with particularly low biological variation to evaluate the method performance of same-brand devices which is used for thousands of tests.