Evaluation of the Analytical Performance of the Nova
StatSensor Creatinine Meter for Blood Testing
Chayanit Srihong BSc (MT)*,
Kavinyanee Pangsapa MSc (MT)*, Kanyaorn Chuaboonmee BSc (MT)*,
Yongyuth Kotipan BSc (MT)*, Navapun Charuruks MD, FRC Path (Thailand)*
Affiliation :
* Department of Laboratory, Bumrungrad Hospital, Bangkok, Thailand
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 ≥ 200 mg/dL is not recommended.
Keywords : Analytical performance, Creatinine meter, POCT
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