Evaluation of Routine Chemistry Reagents, SHINYANG(R)

Hur, Mina; Cho, Sung Suck; Song, Junghan; Kim, Jin Q

Abstract

BACKGROUND: As routine chemical tests are one of the most fundamental and informative laboratory tests in the clinical management, it is essential to choose and evaluate optimal reagents to get reliable results. The purpose of this investigation was to compare the newly developed reagents, SHINYANG(R) (Shinyang Chermical Co., Ltd., Kyongkido, Korea) with those being currently used in Seoul National University Hospital.
METHODS
We evaluated within-run, between-run, between-day an total precision according to the guideline of NCCLS EPS-T2. Correlation analysis was performed in comparison with the reagents currently used in Seoul National University Hospital with the evaluation of linearity and recovery rate for 14 items (Calcium, total protein, albumin, uric acid, alkaline phosphatase, gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatinine, glucose, cholesterol, and triglyceride) of SHINYANG reagents. Serum samples from 550 patients were tested for the correlation analysis.
RESULTS
Coefficient of variation (CV) of within-run, between-day, between-run and total precision was less than 3-5% in all items except lactate dehydrogenase, and was comparable to the currently used reagents. The linearities were good in all items, and the recovery rates showed acceptable results. Correlation analysis revealed good results in most items except calcium, showing the coefficient of 0.8271.
CONCLUSIONS
SHINYANG reagents for routine chemical tests showed good precision, linearity, and correlation in comparison with the currently used reagents. We conclude that these reagents are suitable as the substitute for the currently used reagents, but further reevaluation may be required for some items.

Evaluation of Routine Chemistry Reagents, SHINYANG(R)

Abstract

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