Phase I: mentioned that test is validated but no validation data availablePhase II overlap healthy—AKI risk—AKIPhase III—Se & Spbest cut off value S NGAL 95.2 ng/mL with Se 0.54, Sp 0.93, PPV 0.60, NPV 0.92; best cut off value U NGAL 33.1 ng/mL with Se 0.64, Sp 0.71, PPV 0.30, NPV 0.90More effective detecting negative than positive results. The gene discussed is LCN2; the disease is acute kidney injury.