Introducing…
ProNephro AKI (NGAL) Assay for Use on the cobas® c 501 module
Roche is pleased to announce the launch of the BioPorto ProNephro AKI (NGAL) assay for use on the cobas c 501
module. This is the first FDA 510(k) cleared Acute Kidney Injury (AKI) biomarker distributed by Roche.*
The ProNephro AKI (NGAL) assay is a particle-enhanced turbidimetric immunoassay for the quantitative
determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine. NGAL is an early biomarker
of kidney damage, with levels rising within 2 hours of the insult. The test is intended to be used in conjunction
with clinical evaluation in pediatric patients (≥3 months to <22 years) who are admitted to the Intensive Care Unit.
ProNephro AKI (NGAL) is intended for use in the first 24 hours of ICU admission. It aids clinicians in identifying
patients at risk for developing moderate to severe AKI (Stage 2/3) or having persistent moderate to severe AKI
(Stage 2/3) 48 to 72 hours after assessment, depending on the initial serum creatinine (SCr) level.
This assay uses an internal standard reference material to help ensure full traceability for lot-specific calibrator
and control target values; therefore, helping enhance accuracy and consistency of sample measurements across
lots and over time.
