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KMID : 0390320170270010007
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Chungbuk Medical Journal
2017 Volume.27 No. 1 p.7 ~ p.14
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Evaluation of Analytical Performance of TBA-FX8 Automatic Chemical Analyzer
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Son Bo-Ra
Shin Kyeong-Seob
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Abstract
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Purpose: In this study, we evaluated the performance of a recently developed automatic chemical analyzer, TBA-FX8 (Toshiba, Tokyo, Japan). Precision, accuracy and comparability with Hitachi 7600 (Hitachi, Tokyo, Japan) were evaluated according to the Clinical and Laboratory Standards Institute guideline (CLSI).
Materials and methods: For twenty days, the precision was measured for glucose, aspartic transaminase (AST), gamma glutamyl transferase (GGT), blood urea nitrogen (BUN), creatinine, total cholesterol, triglyceride, and high density lipoprotein (HDL)-cholesterol. The comparison study was performed with Hitachi 7600 for glucose, AST, GGT, BUN, creatinine, total cholesterol, triglyceride, and HDL-cholesterol. The analytical measurement ranges (AMR) were set up for 8 analytes.
Results: The within-run coefficients of variations (CVs) at low and high concentrations were less than 2.57% and 0.84%, respectively. The between-day CVs for each groups were less than 1.19% and 4.39%, respectively. In comparison study, coefficients of correlation exceeded 0.999 for all of eight tests. The AMR showed the sufficient range enough to trace the clinical progress. The linearities within AMR range were excellent (r2>0.99 in all of 8 tests).
Conclusion: In this study, the TBA-FX8 revealed the excellent performance and it is suggested that TBA-FX8 may be useful for clinical laboratory.
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KEYWORD
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Automatic chemical analyzer, Precision, Comparison study, Evaluation
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