The first FDA-cleared biomarker assay for pediatric AKI

US commercial availability expected in 2024

The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas® c 501 clinical chemistry analyzer.

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Indication for Use: 

Immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.

Determination of NGAL is intended to be used in conjunction with clinical evaluation in pediatric patients (≥ 3 months to < 22 years) without underlying kidney disease admitted to the intensive care unit (ICU) for the management of cardiovascular or respiratory compromise or who have had a solid organ or bone marrow transplant.

ProNephro AKI (NGAL) is intended to be used in the first 24 hours of ICU admission. In patients with low SCr levels, indicative of no acute kidney injury (AKI) or AKI Stage 1, the test can be used as an aid to identify patients at risk to develop moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. In patients with an elevated SCr level, indicative of Stage 2/3 AKI, the test can be used as an aid to identify patients at risk of having persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment.

*Now FDA-cleared in the US.

ProNephro AKI™ (NGAL)

The risk for developing or having persistent Acute Kidney Injury (AKI) has been difficult to assess early because the current standard of care relies on changes in serum creatinine and urine output, physiologic endpoints that are delayed, non-specific, and impacted by extrarenal factors such as nutrition status and muscle mass.i

ProNephro AKI (NGAL) quantifies levels of neutrophil gelatinase-associated lipocalin (NGAL) in urine. A damage biomarker that rises rapidly in response to kidney injury, NGAL precedes changes in creatinine by as much as 2 to 3 days.ii

By integrating a damage marker into their clinical evaluation, clinicians can assess AKI risk earlier to confidently take action to manage fluid levels, avoid nephrotoxic agents, and potentially prevent permanent kidney damage.iii

Clinical Study Data

The following posters were presented at ASN Kidney Week 2023 and are intended for healthcare professionals.

 

GUIDANCE: Primary results of a prospective, observational clinical study evaluating the performance of NGAL in the risk assessment of acute kidney injury (AKI) in pediatric intensive care unit patients

A prospective, observational clinical study to validate the performance of NGAL in pediatric patients at risk of developing severe to moderate AKI within 48 to 72 hours of ICU admission.

 

Determination of Urinary NGAL Reference Intervals from Specimens of Healthy Adult and Pediatric Individuals

Reference intervals for NGAL in healthy pediatric and adult patients, aged 3 months to greater than 65 years of age

 

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While each hospital has its own method for adding new lab tests into clinical practice, several steps are common and BioPorto is available to ease and expedite the process. From initial exploratory meetings and clinical education to economic justifications and lab validation, the BioPorto team has experience helping customers onboard this important assay.

 

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REFERENCES

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 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;3(10):e2019209.