Peformance Evaluation of Bioporto Diagnostics' Neutrophil Gelatinase-associated Lipocalin Assay on Automated Clinical Chemistry Analyzer Hitachi 7600.
- Author:
Youkyung SEO
1
;
Woonhyoung LEE
;
Oh Hun KWON
Author Information
1. Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea. lukerubi@yuhs.ac
- Publication Type:Original Article
- Keywords:
Acute kidney injury;
Neutrophil gelatinase-associated lipocalin;
Immunoassay;
Turbidimetry
- MeSH:
Acute Kidney Injury;
Biomarkers;
Chemistry, Clinical;
Immunoassay;
Lipocalins;
Nephelometry and Turbidimetry;
Neutrophils;
Reference Values
- From:Journal of Laboratory Medicine and Quality Assurance
2013;35(1):23-28
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND: Neutrophil gelatinase-associated lipocalin (NGAL) is known to be one of the ideal biomarkers for acute kidney injury providing early information on damage to the kidney. METHODS: We evaluated the performance for precision and the reportable range of the automated NGAL Test (Bioporto Diagnostics, Denmark) assay and compared the values of these tests with widely used point of care test. The reference interval of NGAL was established in Korean adults. RESULTS: Within run percent coefficient of variation (%CV) and total precision %CV for 2 levels were all within 5%. The reportable range was found to be acceptable for the range of 57.0 - 3182.0 ng/mL (r=0.999). The method comparison was made between Biosite's assay and Bioporto Diagnostics' (Passing and Bablok fit, y=1.94x - 5.29; x, Biosite; y, Bioporto; n=31; y range, 250 to 1,308 ng/mL; r2=0.959). The correlation was linear within the limit of 1,500 ng/mL, but not beyond this limit. The 2.5 and 97.5 percentile of the reference range for the samples were 43.2 ng/mL and 124.8 ng/mL, respectively. CONCLUSIONS: Since NGAL Test can be used in automated chemical analyzer, it can not only reduce the man power and time consumed in but also displayed excellent precision and linearity.
