Accuracy And Precision - NOVA BIOMEDICAL MAX PRO CREATININE eGFR Instructions For Use Manual

Accuracy and Precision

Clinical Accuracy
Clinical accuracy was assessed within 3 Point-of-Care/Near Patient
Testing (POC/NPT) settings on normal subjects and subjects
previously diagnosed with chronic kidney disease (CKD). The
clinical study compared the creatinine and eGFR results obtained
from capillary whole blood specimens obtained by finger-stick
measured on the Nova Max Pro Creatinine and eGFR Meter with
venous, plasma creatinine and eGFR results measured on the IDMS
traceable, Seimens Healthineers Dimension RxL Chemistry System
(Seimens Healthineers, Erlangen Germany). The eGFR results re-
ported in this study were derived using the CKD-EPI eGFR equation
A sensitivity and specificity analysis were performed using the
reported eGFR to assess the ability of the Nova Max Pro Creatinine
and eGFR Meter System to correctly screen enrolled subjects for
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Appendix
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