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KMID : 0375320000220020271
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Journal of Clinical Pathology and Quality Control
2000 Volume.22 No. 2 p.271 ~ p.275
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Evaluation of In Hwa Reagent for the Chemistry Autoanalyzer
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Lee Seong-Gyu
Kong Sun-Young
Song Sun-Mi
Lee Soo-Youn
Kim Jong-Won
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Abstract
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Background : Although the autochemistry test plays an important role in the clinical laboratory, most clinical laboratories in the Korea have used the foreign reagent for the autochemistry test. Fortunately many domestic reagents for the autochemistry test were recently developed, we evaluated In Hwa reagent (In Hwa pharmaceutical Corp., Seoul, Korea), compared with foreign reagents.
Methods : The comparison of results between In Hwa reagent and the foreign reagents was performed by the chemistry autoanalyzer, Hitachi 7070 (Hitachi, LTD., Tokyo, Japan) for 8 items (Total protein, albumin, blood urea nitrogen (BUN), creatinine, uric acid, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and cholesterol). We evaluated precision, linearity, and method comparison according to NCCLS guidelines (EP5-A, EP6-P and EP9-A). But we could not test interference in this study.
Results : Coefficient of variation (CV) of within-run and total precision is satisfactory in most analytes, compared with the foreign reagents. The linearity was good for all analytes. Comparison study showed good results in most items, except proportional bias for albumin.
Conclusions : In Hwa reagent for the autochemistry test revealed good precision, linearity, and correlation with the foreign reagents. So, we concluded that In Hwa reagent is good enough to replace the foreign reagents for the autochemisty test.
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KEYWORD
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Domestic, foreign, reagent, autochemistry test, automated chemistry analyzer
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