The NGAL Test™ Reagent Kit CE IVD

Cat.No. ST001CA

Numbers of tests:

92 on Hitachi 917 (Can vary based on analyzer model)

Assay time:

10 minutes

Result type:

Quantitative

Regulatory status:

For in vitro diagnostic use in the European Union, Canada, Columbia, India and Korea only.

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.

NGAL is a novel biomarker for diagnosing acute kidney injury (AKI)

Its key advantage is that it respondsearlier than other renal status markers like serum creatinine and shows a proportionate response to injury. NGAL determination thus permits the early diagnosis and prognostic stratification of patients with AKI.

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

·Renal transplantation - predictive evaluation

·Intravenous contrast agents - assessing nephrotoxicity

What is NGAL?

NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a small protein expressed in neutrophils and certain epithelia, including the renal tubules. Renal expression of NGAL is dramatically increased in kidney injury from a variety of causes, and NGAL is released into both urine and plasma. NGAL levels rise within 2 hours of the insult, making NGAL an early and sensitive biomarker of kidney injury.

Assay specifications

- MethodParticle-enhanced turbidimetric immunoassay

- Sample Urine, EDTA plasma and heparin plasma

- Sample stability If the assay cannot be performed within 24 hours or specimens are to be shipped, freeze the specimens at -20°C or below. For long-term storage of specimens, -70°C or below is recommended.

- Measuring range 25 to 5,000 ng/mL

- Assay time 10 minutes (Hitachi 917) (Can vary based on analyzer model)

- Shelf life 12 month

- Open vial stability 30 days

- On board stability 30 days (when refrigerated)

References:

For Scientific references, please download the flyer from the right-hand menu.

IFU DOWNLOAD

MSDS DOWNLOAD

APPLICATION NOTES

Abbott AEROSET

Roche Cobas c501

Roche Hitachi 917

Roche Modular P

Olympus AU640

Abbott Architect c8000

PATENT INFORMATION

Method patented/patent pending in selected countries.

For further patent information please click here

The NGAL Test™ CE IVD
The NGAL Test™ Reagent Kit CE IVD
The NGAL Test™ reagent kit CE IVD
NGAL reagent kit
NGAL Reagent Kit
The NGAL Test
NGAL Test
NGAL Test CE IVD
NGAL

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