Imprecision Evaluation of Self-Monitoring of Blood Cholesterol (SMBC)Handheld Point of Care Testing Devices: Elemark⢠and Cardiochek PA

Abstract

The aim of this study was to determine the imprecision of two cholesterol point of care testing devices, the very established CardioChek PA and recently the Elemark™ which is a mobile blood testing device capable of testing multiple parameters for the management of hypercholesterolaemia undergoing certification. The imprecision study of the Elemark™ and CardioChek PA were performed using blood donations from 3 healthy normal lipidemic subjects. There were 10 repetitions for the within run imprecision and the number of measurement days was 6 for between day imprecision. This study showed comparable within run and between day imprecision between the CardioChek PA and the Elemark™. Based on the imprecision guidelines from the NCEP and CRMLN both devices showed reasonable within run imprecision for their total cholesterol and HDLcholesterol estimations but not the LDL-cholesterol calculations. The between day imprecision for both devices was reasonably consistent with the published within person biological variability. With more accuracy and imprecision studies being carried out in understanding these cholesterol testing point of care devices, their value, or lack of, in the lipid monitoring would become more apparent.