The NGAL Test is a quantitative particle-enhanced turbidimetric immunoassay designed to run on automated chemistry analyzers. Kit contains ready to use Buffer Solution (R1) and (R2) NGAL latex suspension.

The NGAL Test Reagent Kit

CAT NO: ST001

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Product Summary

Cat. No.

ST001

Test Method

Particle-enhanced turbidimetric immunoassay (PETIA)

Assay range

50 ng/mL to 3000 ng/mL (Can vary based on analyzer model)

Assay time

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

Content

1 x NGAL Buffer Solution (R1), 35 mL, 1 x NGAL latex suspension (R2), 7 mL

Form

Ready-to-use solution

Shelf life

24 months from manufacturing. See expiry date on the label

Storage after opening

Open vial stability 30 days, On board stability 30 days (when refrigerated)

Background

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 Calibrator Kit contains calibrator solutions for establishing the calibration curve. NGAL measurements are useful in the diagnosis of acute kidney injury which may lead to acute renal failure.

Regulatory status

CE Marked and available for in vitro diagnostic use in the European Union; for Research Use Only in the United States.

Patent status

This product is protected by one or more US, European and/or foreign patents.

Scientific References

Itenov TS, Bangert K, Christensen PH, Jensen JU, Bestle MH (2014) Serum and Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels are Not Equivalent in Patients Admitted to Intensive Care. J Clin Lab Anal. 28:163-167

Hansen YB, Damgaard A, Poulsen JH (2013) Evaluation of NGAL TestTM on Cobas 6000. Scand J Clin Lab Invest. 74:20-26

Allavena C, Bach-Ngohou K, Billaud E, Secher S, Dejoie T, Reliquet V, Fakhouri F, Raffi F (2013) Neutrophil gelatinase-associated lipocalin, a marker of tubular dysfunction, is not increased in long-term virologically controlled patients receiving a tenofovir/emtricitabine + nevirapine regimen. J Antimicrob Chemother. 68:2866-2870

Feldheiser A, Pavlova V, Bonomo T, Jones A, Fotopoulou C, Sehouli J, Wernecke KD, Spies C (2013) Balanced crystalloid compared with balanced colloid solution using a goal-directed haemodynamic algorithm. Br J Anaesth. 110:231-240

Seo Y, Lee W, Kwon OH (2013) Performance Evaluation of BioPorto Diagnostics’ Neutrophil Gelatinase-associated Lipocalin Assay on Automated Clinical Chemistry Analyzer Hitachi 7600. J Lab Med Qual Assur. 35:23-28