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

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.