NGAL Biomarker

Early risk assessment of acute kidney injury.


ProNephro AKI  The NGAL Test  ELISA Kits

Detected 2-3 days before creatinine rises

Until now, assessing risk of AKI in critically ill patients has relied on changes in serum creatinine and urine output, physiologic endpoints that are delayed, non-specific, and impacted by extrarenal factors such as nutritional status and muscle mass.

The NGAL biomarker rises rapidly in response to kidney injury, preceding changes in creatinine by as much as 2 to 3 days.i

By identifying patients at risk of AKI early, clinicians can take more appropriate action to manage fluid levels, avoid nephrotoxic agents, and potentially prevent permanent kidney damage.i



NGAL Characteristics


NGAL responds just 2 hours after kidney injuryii and 2-3 days before serum creatinine rises.i


NGAL+ identifies subclinical AKI when serum creatinine alone failed to identify 43% of AKI.iii


Identifies patients at risk of developing moderate to severe AKI.iv



Improved management of AKI can reduce LOS, minimize unnecessary interventions, and inform treatment choices.


The NGAL biomarker has been studied in over 16,500 patients in numerous settings including post-cardiac surgery, in critical illness, and post kidney transplantation. In each setting, “NGAL significantly improved the prediction of AKI risk over the clinical model alone.” v

ProNephro AKI  The NGAL Test

AKI Assessment Using Functional and Damage Biomarkers

In 2020, the Acute Disease Quality Initiative (ADQI) workgroup recommended that “a combination of damage and functional biomarkers, along with clinical information, be used to improve the diagnostic accuracy of AKI, to recognize the different pathophysiological processes, to discriminate AKI etiology, and to assess AKI severity.” vi


The NGAL biomarker has been shown to offer early clinical decision support to guide patient management.


Adapted from: Murray PT, Mehta RL, Shaw A, et al. Potential use of biomarkers in acute kidney injury report and summary of recommendations from the 10th Acute Dialysis Quality Initiative consensus conference. Kidney Int. 2014.85(3):513-521 and Stanski N, Menon S, Goldstein SL, Basu RJ. Integration of urinary neutrophil gelatinase-associated lipocalin with serum creatinine delineates acute kidney injury phenotypes in critically ill children. Journal Critical Care. 2019.53:1-7.


Early clinical decision support to guide patient care

Used in conjunction with clinical evaluation, an NGAL result can provide data to identify AKI earlier and confidently manage the patient’s care plan.


Adapted from and Ostermann M,  JAMA Netw Open. 2020



  • Over 2,500 publications on PubMed in both human and animal studies.
  • A CDER-qualified kidney tubular injury urinary biomarker for use in Phase 1 trials.
  • FDA and EMA support the use of NGAL as a safety biomarker for early identification of renal toxicity.


NGAL ELISA kits available in six species – the bridge from pre-clinical research to clinical trials.




i Devarajan P. Neutrophil gelatinase-associated lipocalin: a promising biomarker for human acute kidney injury. Biomark Med. 2010;4(2):265–280.

ii Krawczeski CD, Goldstein SL, Woo JG, et al. Temporal relationship and predictive value of urinary acute kidney injury biomarkers after pediatric cardiopulmonary bypass. J Am Coll Cardiol. 2011;58(22):2301–2309.

iii Haase M, Devarajan P, Haase-Fielitz A, et al. The outcome of neutrophil gelatinase-associated lipocalin-positive subclinical acute kidney injury: a multicenter pooled analysis of prospective studies. J Am Coll Cardiol. 2011;57(17):1752–1761.

iv Zappitelli M, Washburn KK, Arikan AA, et al. Urine neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in critically ill children: a prospective cohort study. Crit Care. 2007;11(4):R84.

v Haase-Fielitz A, Haase M, Devarajan P. Neutrophil gelatinase-associated lipocalin as a biomarker of acute kidney injury: a critical evaluation of current status. Ann Clin Biochem. 2014;51(Pt 3):335–351.

vi Ostermann M, Zarbock A, Goldstein S, et. al. Recommendations on Acute Kidney Injury Biomarkers From the Acute Disease Quality Initiative Consensus Conference: A Consensus Statement. JAMA Netw Open. 2020.