J Lab Med Qual Assur.
2004 Jun;26(1):197-205.
Evaluation of LabMaster Reagents for Chemistry Autoanalyzer
- Affiliations
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- 1Department of Laboratory Medicine, Asan Medical Center & Ulsan University Hospital, University of Ulsan College of Medicine, Seoul, Korea. wkmin@amc.seoul.kr
Abstract
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BACKGROUND: Although routine chemistry tests provide valuable information for the clinical practice and play an important role in clinical laboratory, most clinical laboratories in Korea preferred imported reagents to domestic ones. It may be due to the lack of reliable evaluation data for domestic chemistry reagents. We evaluated the LabMaster reagent produced by HanLab Corporation(Korea) and report the data.
METHODS
Fifteen chemistry reagents of albumin, ALP, ALT, AST, BUN, Calcium, Creatinine, GGT, Glucose, LD, Total Bilirubin, Cholesterol, Triglyceride, Protein, and Uric acid were tested for precision, linearity, interference, and correlation according to the NCCLS guidelines EP5-A, EP6-A, EP7-A, and EP9-A2 respectively in the Toshiba 200FR Neo Chemistry autoanalyzer (Toshiba Medical Systems Co., Ltd., Tokyo, Japan).
RESULTS
Coefficients of variation (CVs) of within-run and total precision were satisfactory in all the analytes and the linearity was satisfactory in measurement ranges excepts of uric acid. Coefficients of correlation are satisfactory in all analytes except for ALP and LDH. The effects of interfering factors, hemolysis, bilirubin, lipid were all reported.
CONCLUSIONS
LabMaster reagents revealed good precision, linearity, and correlation. LabMaster reagents are suitable for use in clinical laboraotry.