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

J Med Assoc Thai. 2012 Sep;95(9):1225-31.

Abstract

Background and objective: 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.

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 > or = 200 mg/dL is not recommended

Publication types

  • Evaluation Study

MeSH terms

  • Creatinine / blood*
  • Hematologic Tests / instrumentation*
  • Humans
  • Kidney Function Tests / instrumentation*

Substances

  • Creatinine