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.
|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 Turkey only. For research use only in all other markets.
The assay should be carried out in accordance with the specific application note for the chemistry analyzer to be used.
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 -
Method patented/patent pending in selected countries.
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