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Assessment of a point-of-care device for measuring creatinine in a community screening program for chronic kidney disease

Brooke Ann Spaeth, Anne K Shephard, Mark DS Shephard, Timothy H Mathew

Abstract


ABSTRACT

 

Background: Chronic kidney disease (CKD) is a major contemporary global health problem. Creatinine measurement for the calculation of estimated glomerular filtration rate is an important component of assessing CKD risk. A point-of-care test for creatinine using capillary sampling is required as part of a screening assessment.

 

Objectives: Evaluate the analytical performance of a modified point-of-care testing method for whole blood creatinine (Nova Biomedical StatSensor whole blood creatinine analyser) relative to a laboratory method.

 

Design and methods: Conduct a patient comparison study between the point-of-care testing and laboratory methods in a rural community setting. Calculate measures of imprecision and assess the ability of the POCT method to determine staging of CKD compared to the laboratory.

 

Results: Between-device imprecision averaged 8.8%. The StatSensor devices showed a positive bias of approximately 14% for whole blood creatinine measurement compared to the laboratory method, leading to more than 40% of community patients being staged differently for CKD risk with approximately 25% more abnormal results.

 

Conclusions: The StatSensor whole blood creatinine point-of-care device remains analytically unsound for use as a screening device for CKD.


Keywords


chronic kidney disease; point-of-care testing; creatinine; estimated glomerular filtration rate

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References


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DOI: http://dx.doi.org/10.18103/mra.v0i3.132

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