Table 1 Unmet clinical needs and desirable biomarker characteristics and clinical performance specifications
From: Rational selection of a biomarker panel targeting unmet clinical needs in kidney injury
Unmet clinical need | Target population | Key clinical endpoints | Desirable biomarker kinetics | Test purpose and test role | Desirable clinical performance specifications |
|---|---|---|---|---|---|
Early diagnosis of in-hospital AKI after a medical insult and in critically ill patients | Critically ill patients At ICU admission After cardiothoracic surgery | AKI RRT ICU stay | Early rise and protracted fall kinetics | Prognostic marker Add-on testing | Improve detection rate kidney injury Sensitivity outweighs specificity NPV > 80–95% |
Risk stratification for kidney injury prior to a scheduled intervention | Overall hospital population/at admission Patients with stable eGFR | AKI RRT CKD ICU stay hospital stay | Altered at baseline level | Prognostic marker Triage testing | Specificity outweighs sensitivity PPV > 80–95% |
Patient monitoring for kidney injury and progression | Patients receiving nephrotoxic medication Kidney transplantation recipients | RRT CKD ESRD Allograft function/rejection | Relation between biomarker levels and damage | Monitoring marker Add-on testing | Specificity outweighs sensitivity PPV > 80–90% Increase before kidney function decline |
Differentiation between prerenal AKI and structural kidney damage | Patients with suspected structural kidney injury Patients with established AKI | RRT duration CKD ATN, AIN ESRD | Kidney-topography specific biomarker release patterns | Diagnostic marker Add-on/replacement testing | Ruling out prerenal AKI and reduce unnecessary treatment in patients with prerenal AKI Acceptable sensitivity High specificity (> 85%) |