Diagnostics / IVD Control Kit

The NGAL Test™ Control Kit CE IVD*

Cat.No. ST003CA

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. The NGAL Test™ Control Kit contains control solutions to validate the calibration curve. NGAL measurements are useful in the diagnosis of acute kidney injury which may lead to acute renal failure.

Specifications

Content Control Low, 3 x 1 mL and Control High, 3 x 1 mL
Preparation Ready-to-use solution
Storage Store at 2-8°C. Do not freeze
Shelf life 24 months from manufacturing. See expiry date on the label
Stability after opening  4 weeks at 2-8°C, capped. On the Hitachi 917 analyzer, the manufacturer obtains satisfactory performance for up to 8 weeks.
Regulatory status IVD - in vitro diagnosic 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.

Instructions

Measurements should be carried out in accordance with the specific application note for the automated chemistry analyzer used. Please see the Instructions for Use for The NGAL Test™ Reagent Kit ST001CA, which also give details of test principle and performance characteristics of The NGAL Test™.

Method patented/patent pending in selected countries.

For further patent information please click here