BioPorto Diagnostics
The purpose of this study is to evaluate the performance of the ProNephro AKI™ (NGAL) test for identifying critically ill adults at risk of developing moderate to severe acute kidney injury (KDIGO Stage 2/3) within 48 to 72 hours of ICU admission. The study will assess how accurately the test predicts acute kidney injury by evaluating its sensitivity, specificity, positive predictive value, and negative predictive value. Participants will provide blood and urine samples for testing.
Inclusion Criteria: Males and females ≥ 22 years of age. Subjects must be admitted or admission pending to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission. Subjects must have at least one of the following, leading to admission to the ICU, or occurring within 24 hours of admission to the ICU (unless otherwise specified): Vasoactive medication administration Mechanical ventilation Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula Serum Lactate greater than 2.5 mmol/L, within 6…
ProNephro AKI™ (NGAL) is an immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL) in human urine.
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