J Lab Med Qual Assur.  2013 Jun;35(1):23-28.

Peformance Evaluation of Bioporto Diagnostics' Neutrophil Gelatinase-associated Lipocalin Assay on Automated Clinical Chemistry Analyzer Hitachi 7600

• Seo Y
• Lee W
• Kwon OH

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.

Keyword

Acute kidney injury; Neutrophil gelatinase-associated lipocalin; Immunoassay; Turbidimetry

MeSH Terms

Acute Kidney Injury
Biomarkers
Chemistry, Clinical
Immunoassay
Lipocalins
Nephelometry and Turbidimetry
Neutrophils
Reference Values
Lipocalins