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J Clin Pathol Qual Control. 2002 Jun;24(1):151-161. Korean. Original Article.
Bae SY , Kim SS , Park YN , Kim YK .
Department of Clinical Pathology, Korea University College of Medicine, Seoul, Korea. kyoungk@korea.ac.kr
YeongDong Pharmaceutical Corp., Seoul, Korea.
Abstract

BACKGROUND: To establish the new reagent for chemistry autoanalyzer, it is essential to evaluate and choose optimal reagents to get reliable results before utilization. The purpose of this study was to compare the newly developed liquid form reagents from YeongDong Pharmaceutical company with those being currently used in Korea University Hospital. METHODS: We evaluated the YeongDong reagents through precision, accuracy, linearity and comparision with the reagents currently used in Korea University Hospital. Nineteen kinds of items (total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (G-GT), total bilirubin, direct bilirubin, glucose, blood urea nitrogen (BUN), creatinine, uric acid, calcium, magnesium, inorganic phosphorus (Pi), cholesterol, triglyceride, lactate dehydrogenase (LD), and creatine kinase (CK)) were evaluated. We also tested interference with hemoglobin, ascorbic acid, and bilirubin in this study. The specimens used were commercial quality control materials and patient sera. RESULTS: Coefficient of variation (CV) of within-run, between run, and between day precision were satisfactory in most analytes except BUN and creatinine, and were comparable to the currently used reagents. The recovery rate were 94.5%~107.0%. Excellent linearity and correlation (r = 0.9702~0.9991) with the current reagents were disclosed for all analytes. Interference with bilirubin was negligible. Although hemoglobin and ascorbic acid showed significant effect on some analytes but, insignificant difference between YeongDong and current reagents. CONCLUSIONS: The newly developed YeongDong's ninteen liquid form chemistry reagents revealed acceptable analytical precision, accuracy and good correlation with the current reagents. So we conclude that the reagents can be an alternative of currently used reagents in autoanalyzer.

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