Evaluation of Dimension(R) RxL Automated Chemistry Analyzer / 임상검사와정도관리

ABSTRACT

BACKGROUND: The Dimension(R) RxL (Dade Behring Inc., Illinois) is a newly developed, high-throughput and versatile automated chemistry analyzer with continuous and random-access features for routine chemistry tests, enzymes, electrolytes, therapeutic drug monitoring, cardiac markers, and hormones. We evaluated the usefulness of Dimension(R) RxL in the aspect of precision, linearity, and comparison. METHODS: We evaluated the analytical performance of the Dimension(R) RxL for aspartate aminotransferase, alanine aminotransferase, high density lipoprotein cholesterol, blood urea nitrogen, creatinine, glucose, total bilirubin, total iron binding capacity, sodium, potassium, chloride, total CO2, digoxin, phenytoin, valporic acid, CK-MB, myoglobin and cardiac troponin-I. We used control materials for linearity and precision evaluation and random patients sera for comparison study with Hitachi 747 (Hitachi LTD., Tokyo, Japan), TDxFLx(TM) (Abbott Diagnotistics, Chicago) and ACS Centaur(TM) (Bayer Diagnotistics, New York) according to NCCLS guidelines. RESULTS: In the precision study, within-run and total CVs of most items were below 5% except CK-MB and cardiac troponin-I. The linearities were maintained well in the range of medically significant levels and were statistically acceptable (P<0.001). The comparison study indicated good correlation with the central laboratory analyzer and correlation coefficients were above 0.975 (P<0.01). CONCLUSIONS: Dimension(R) RxL showed satisfactory precision, linearity, and good correlation compared with other analyzers. Because it has features of one system with many capabilities, we recommend that Dimension(R) RxL would be used for the routine chemistry setting or stat test settings at medium- to large-sized hospitals.