PERFORMANCE EVALUATION OF THE BS-120 AND BS-200E CHEMISTRY ANALYZER

Ju Bin Park MS, Man Kyu Huh PhD and *Yong Lim PhD

ABSTRACT

The prevalence of chronic diseases is growing due to aging population and westernized lifestyle habits in South Korea. Primary care enables continuous management of chronic diseases and even prevention of chronic diseases in healthy individuals, for which diagnostic tests play an important role. Primary care facilities generally use small pieces of equipment that can only handle a few tests, such as the Mindray BS-120 and BS-200E used in the present experiment, to manage chronic diseases and promote people’s health. This study was conducted upon an understanding that performance assessments for small-size equipment have not been adequately performed. In this study, precision and cross-contamination rates were investigated based on the Clinical and Laboratory Standards Institute (CLSI) guidelines EP5-A3 and EP10-A3. Test categories were those included by the National Health Insurance Service (NHIS) in primary health diagnosis. In the precision assessment, the total coefficients of variation (total %CV) for BS-120 and BS-200E were within 10.0%. Cross-contamination rate was within 1.0% for all items on BS-120 except for HDL-cholesterol, LDL-cholesterol, and triglyceride and for all items on BS-200E except for ALT, HDL-cholesterol, creatinine, and glucose. Therefore, it is difficult to conclude that these two types of equipment have excellent performance, but improvements should be made to increase the reliability of the test results.

Keywords: Chronic disease, CLSI, Performance assessment, Preventive medicine, Primary care.