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%) |