J Clin Pathol Qual Control.
2001 Jun;23(1):233-238.
Evaluation of DiaSys(R) Reagents for the Autoanalyzer
- Affiliations
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- 1Department of Clinical Pathology, Korea University College of Medicine, Seoul, Korea.
- 2Department of Clinical Pathology, Kangwon National University College of Medicine, Chunchon, Korea.
Abstract
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BACKGROUND: To establish the new method in the clinical laboratory, essential work is the choice and proper evaluation of the method to get reliable results and minimize analytical error. The aim of this study was to evaluate DiaSys(R) reagents for cholesterol, triglyceride(TG), high density lipoprotein-cholesterol(HDL-cholesterol), low density lipoprotein-cholesterol(LDL-cholesterol) and to compare the analytical performance of reagents with those being currently used reagents using Hitachi 747 autoanalyzer.
METHODS
We performed the evaluation of DiaSys(R) reagents through precision, accuracy, linearity and comparison study and compared the performance results with those of existing reagents. The specimens used were patient sera and commercial quality control materials.
RESULTS
Coefficients of analytical variance were acceptable, showing within-run precision; 0.3 to 2.1%, between-run precision; 0.7 to 2.6%, between-day precision; 1.3 to 3.2%. The recovery rates were 86.1-118.4%. Excellent linearity and correlation with the existing reagents in the range of 0.986 to 0.999 by comparison study were noted.
CONCLUSIONS
The DiaSys(R) reagents for cholesterol, TG, HDL-C and LDL-C revealed acceptable analytical precision, accuracy, linearity in the range of clinically important concentration and good correlation with the existing reagents. So we conclude that these reagents are suitable for clinical use with reliable results and as the substitute for the currently used reagents.