J Lab Med Qual Assur.  2006 Jun;28(1):189-198.

Evaluation of HiSense(TM) Reagents for Chemistry Autoanalyzer

• Woo HY
• Kim YJ
• Park H

Abstract

BACKGROUND: As many kinds of reagents for chemistry autoanalyzer have been developed, comprehensive evaluation of the reagents is needed for proper selection. We evaluated the analytical performances of the HiSense(TM) reagents (HBI Co., Ltd, An-yang, Korea).
METHODS
Sixteen chemistry reagents of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), total protein, total bilirubin, albumin, glucose, blood urea nitrogen (BUN), creatinine, total calcium, phosphorus, lactate dehydrogenase (LDH), uric acid, total cholesterol, and triglyceride (TG) were evaluated for linearity, precision, interference, and correlation according to CLSI guidelines in the Toshiba ACCURATE chemistry autoanalyzer (Toshiba Medical Systems Co., Ltd., Tokyo, Japan).
RESULTS
The coefficients of variation (CV) of both within-run and total precision were below 2.6% for all analytes. Good linearity was observed for all analytes in measurement ranges. Coefficients of correlation were also good for all analytes. There were clinically significant effects of interfering factors, hemoglobin and lipid, in LDH and total protein, respectively.
CONCLUSIONS
HiSense reagents showed good precision, linearity, and correlation. We conclude that these reagents are appropriate for routine clinical use.

Keyword

HiSense reagents; Precision; Linearity; Correlation; Interference

MeSH Terms

Alanine Transaminase
Alkaline Phosphatase
Aspartate Aminotransferases
Bilirubin
Blood Glucose
Calcium
Chemistry*
Cholesterol
Creatinine
Indicators and Reagents*
L-Lactate Dehydrogenase
Nitrogen
Phosphorus
Transferases
Triglycerides
Urea
Uric Acid
Alanine Transaminase
Alkaline Phosphatase
Aspartate Aminotransferases
Bilirubin
Blood Glucose
Calcium
Cholesterol
Creatinine
Indicators and Reagents
L-Lactate Dehydrogenase
Nitrogen
Phosphorus
Transferases
Urea
Uric Acid