Evaluation of the analytical performance of the Nova StatSensor creatinine meter and reagent strip technology for whole blood testing

Abstract

Objective To evaluate the analytical performance of the Nova StatSensor creatinine meter. Design and methods Imprecision, linearity, patient correlation and interference studies were completed. Results Total imprecision was 4.5–9.1%CV and a linear measurement range of 93–863 µmol/L (1.05–9.76 mg/dL) was verified. Whole blood creatinine results correlated well with laboratory plasma measurements ( R 2 = 0.9328) but exhibited a negative proportional bias. In vitro, high levels of creatine and urea falsely elevated creatinine measurement. Conclusions The creatinine meter provides reliable measurement across a clinically relevant range and has potential use in point-of-care testing.