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kidney disease. Sensitivity is defined as the ability to correctly
identify patients with a disease. Specificity is defined as the ability
to correctly identify patients without a disease. The eGFR clinical
cut-off level for normal/abnormal kidney function used for this
assessment was 60 mL/min/1.73m2. Subjects with an eGFR above
60 mL/min/1.73m2 are considered to have normal kidney function.
Subjects below 60 mL/min/1.73m2 are considered to have abnor-
mal kidney function. Pooled eGFR data from all 3 clinical testing
sites is shown below.
Sensitivity = 98.8% (342/346)
Specificity = 79.2% (57/72)
TN = 57
FN = 4
FP = 15
TP = 342
Appendix
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eGFR MeterIFU Manual PRO PN64322.indd 63
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