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J Lab Med Qual Assur. 2007 Dec;29(2):239-245. Korean. Original Article.
Kim YS , Lee HK , Kim SY , Seo EJ , Min KO , Kwon HJ .
Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. hjkkwon@catholic.ac.kr
Department of Pathology, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Abstract

BACKGROUND: Many modern chemistry analyzers are open systems and they can use reagents other than those supplied by the manufacturer of the analyzer. There are many generic reagents for use in open systems. The objective of this study was to evaluate the analytical performance of the BD Lab reagents (BD Lab co., Korea) which were generic reagents. METHODS: Sixteen kinds of reagents of total protein, albumin, blood urea nitrogen (BUN), creatinine, glucose, uric acid, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase (ALP), lactate dehydrogenase (LD), gamma glutamyl transferase (GGT), calcium, inorganic phosphorus, total cholesterol, triglycerides were tested for precision, linearity and correlation according to the NCCLS guidelines (EP5-A, EP6-A, EP9-A2). Toshiba 200-FR Neo (Toshiba Medical Systems Co., Japan) was used in this evaluation. RESULTS: All reagents showed acceptable precision with total coefficients of variation less than 7%. Comparison of BD Lab reagents with the current reagents by regression analysis resulted in slopes ranging from 0.86 to 1.06 and correlation coefficients more than 0.975. Fifteen of sixteen reagents showed good linearity in broad range. CONCLUSIONS: BD Lab reagents showed good precision, linearity, and correlation. Therefore, we conclude that the BD Lab reagents can be an alternative of currently used reagents in chemistry analyzers.

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