Diagnostics / IVD Chemistry Reagents

The NGAL Test™ Reagent Kit CE IVD*

Cat.No. ST001CA

Intended use

The NGAL Test™ is a particle-enhanced turbidimetric immunoassay for the quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine, EDTA plasma or heparin plasma on automated clinical chemistry analyzers. NGAL measurements are useful in the diagnosis of acute kidney injury which may lead to acute renal failure.

Assay specifications

Method Particle-enhanced turbidimetric immunoassay (PETIA
Sample Urine, heparin and EDTA plasma
Number of tests Approx. 100 (Can vary based on analyzer model)
Assay time Approx. 10 minutes
Measuring range 25 to 5,000 ng/mL
Shelf life 24 months from manufacturing. See expiry date on the label
Stability after opening 4 weeks at 2-8°C. On the Hitachi 917 analyzer, the manufacturer obtains satisfactory performance for up to 8 weeks.
On board stability 4 weeks at correct temperature (2-8°C) in appropriate containers. On the Hitachi 917 analyzer, the manufacturer obtains satisfactory performance for up to 8 weeks on board
Sample stability If testing after 24 hours of sampling, freeze samples at -20°C or below. For long-term storage of specimens, -70°C or below is recommended
 Application IVD - in vitro diagnostic use*

*Not available in the USA for in vitro diagnostic use. 

*For in vitro diagnostic use in the European Union, Canada, Chile, Columbia, India, Korea, Russia and Israel only. For research use only in all other markets.

Assay procedure

The assay should be carried out in accordance with the specific application note for the chemistry analyzer to be used.

Clinical application

Measuring NGAL in urine or plasma gives you information on AKI status that you need for rapid decision making e.g. in the following settings -

  • Intensive care - monitoring
  • Emergency room - triage tool
  • Cardiopulmonary bypass surgey - monitoring
  • Renal transplantation - predictive evaluation
  • Intravenous contrast agents - assessing nephrotoxicity

Method patented/patent pending in selected countries.

For further patent information please click  here