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

ObjectiveTo evaluate the analytical performance of the Nova StatSensor creatinine meter.Design and methodsImprecision, linearity, patient correlation and interference studies were completed.ResultsTotal 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 (R2 = 0.9328) but exhibited a negative proportional bias. In vitro, high levels of creatine and urea falsely elevated creatinine measurement.ConclusionsThe creatinine meter provides reliable measurement across a clinically relevant range and has potential use in point-of-care testing.