|
KMID : 0985420130350020081
|
|
Laboratory Medicine and Quality Assurance
2013 Volume.35 No. 2 p.81 ~ p.86
|
|
|
Performance Evaluation of Gentian Cystatin C on the Hitachi 7600 Automatic Analyzer
|
|
Jo Yun-A
Shin Mi-Kyung
Song Won-Keun
Kim Han-Sung
Park Min-Jeong
|
|
|
Abstract
|
|
|
Background: Cystatin C, a 13-kDa protein synthesized in all nucleated cells, has been proposed as a replacement for serum creatinine in assessments of renal function. The Gentian Cystatin C immunoassay (Gentian, Norway) was recently developed using particle enhanced turbidimetric immunoassay. In this study, we evaluated the analytical performance of the Gentian Cystatin C immunoassay on the Hitachi 7600 Automatic Analyzer (Hitachi Ltd., Japan).
Methods: Cystatin C, a 13-kDa protein synthesized in all nucleated cells, has been proposed as a replacement for serum creatinine in assessments of renal function. The Gentian Cystatin C immunoassay (Gentian, Norway) was recently developed using particle enhanced turbidimetric immunoassay. In this study, we evaluated the analytical performance of the Gentian Cystatin C immunoassay on the Hitachi 7600 Automatic Analyzer (Hitachi Ltd., Japan).
Results: The coefficient of variations (CVs) for within-run imprecision at low and high levels were 1.58% and 1.06% and the CVs for total imprecision at low and high levels were 2.53% and 2.09%, respectively. In the linearity test, the coefficient of determination (R2) was 0.9997 (range, 0.23 to 7.50 mg/L), and comparison with the results obtained by Siemens reagent showed an excellent correlation coefficient of 0.9982. In the traceability test, Gentian reagent is more accurate than Siemens reagent and the total accuracy was 96.0%.
Conclusion: Gentian reagent provides good analytic performance on the Hitachi 7600 Automatic Analyzer and can be used for the diagnosis, treatment, monitoring, and risk assessment of renal function.
|
|
|
KEYWORD
|
|
|
Gentian reagent provides good analytic performance on the Hitachi 7600 Automatic Analyzer and can be used for the diagnosis, treatment, monitoring, and risk assessment of renal function
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
  
|
|