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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%)