Material and Method: 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.

Results: 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.

Conclusion: 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 ≥ 200 mg/dL is not recommended.

Keywords: Analytical performance, Creatinine meter, POCT