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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 and 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 to have persistent moderate to severe AKI (Stage 2/3) 48 to 72 hours after the assessment. The particle-enhanced turbidimetric immunoassay is intended for use on the Roche cobas c 501 clinical chemistry analyzer.

The ProNephro AKI™ (NGAL) Reagent Kit contains Reaction Buffer Reagent (R1) and Immunoparticle Suspension Reagent (R2). The R1 reagent is a ready-to-use tris-buffer solution containing murine protein and preservative. The R2 reagent is a ready-to-use suspension of polystyrene microparticles coated with mouse monoclonal antibodies to NGAL that also contains preservative. The ProNephro AKI Reagent Kit provides enough reagents for 100 tests on the Roche cobas c 501 clinical chemistry analyzer. The finished kit will also include a labeled Roche cassette and two funnels for transferring the reagent into the Roche cassette. The reagents must be transferred to a Roche cassette prior to the cobas c 501. This is done by pouring the R1 reagent into Position B of the cassette and R2 reagent into Position C. The operator will load the cassette onto the instrument and run the ProNephro AKI™ (NGAL) test per the instructions for use. The ProNephro AKI® (NGAL) Calibrator Kit consists of five (5) individual ready-to-use calibrator solutions (1 mL each) comprised of different concentrations (50-3000 ng/mL) of recombinant human NGAL in a HEPES buffer and a preservative. The ProNephro AKI™ (NGAL) Control Kit contains ready-to-use High (500 ng/mL target concentration) and Low (200 ng/mL target concentration) Controls comprised of recombinant human NGAL in HEPES buffer and a preservative. There are three (3) 1 mL bottles of each level included with the kit.