Evaluation of the analytical performance of the nova StatSensor creatinine meter for blood testing

For reliability of laboratory results, all methods, instruments, and reagents should be evaluated The Nova StatSensor creatinine meter is a hand-held device for determination of creatinine concentration in the whole blood Therefore, the device has to be validated or verified before performing.

Observational analysis method with cross sectional design was used in this evaluation. The commercial reagents and coded samples were prepared for linearity, precision, accuracy, and interference studies.

The linear measurement range of 1.3 to 9.5 mg/dL was verified with the recovery results between 91.6 to 105.0%. Total imprecision demonstrated by coefficient of variation (CV) was 6.4 to 8.9 CV%. Linear regression was y = 0.946x + 0.103, r = 0.992, r2 = 0.984. The bias was calculated from our data using regression equation. Our results demonstrated the accuracy was acceptable. Glucose level of 200 mg/dL and 400 mg/dL created the high difference between baseline creatinine (1.2 mg/dL and 2.8 mg/dL) and creatinine measured in the presence of interference was 25.0%, 16.7%, 14.3%, and 19.7% respectively.

Our results demonstrated that the device provides reliable creatinine measurement and could be used in point-of-care testing. Use of this device in diabetic patients with high glucose level of > or = 200 mg/dL is not recommended