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KMID : 0985420100320020197
Laboratory Medicine and Quality Assurance
2010 Volume.32 No. 2 p.197 ~ p.204
Evaluation of Cheongmeak DCS(TM) Reagents for Chemistry Analyzers
Shin Kyeong-Seob

Jeong Taek-Eun
Son Bo-Ra
Abstract
Background: The evaluation of newly developed reagents for chemical analyzer is essential for an accurate testing of various samples. We evaluated the analytical performance of the DCS(TM) reagents (Cheongmeak, Korea).

Methods: Fifteen chemistry reagents of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin, total protein, albumin, blood urea nitrogen (BUN), creatinine, glucose, calcium, inorganic phosphorus, total cholesterol, triglyceride and HDL-cholesterol were tested for precision, linearity and correlation according to CLSI guidelines in the Hitachi 7180 chemistry analyzer (Hitachi High-Technologies Co., Japan).

Results: The coefficients of variation (CV) of both within-run and total precision were below 3.98% for all analytes, which fully meets of CLIA 88 decision ranges. Good linearity was shown for all analytes in measurement ranges. Coefficients of correlation were also good for all analytes.

Conclusions: DCS(TM) reagents showed good precision, linearity and correlation. Therefore, the DCS(TM) reagents could be acceptable for use in routine chemistry analyzers.
KEYWORD
DCS(TM) reagents, Precision, Linearity, Correlation, Evaluation
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