A nanomonitor compared to ELISA for C-reactive protein detection in patient blood

Abstract

The nanomonitors are multi scale “point-of care” devices comprised of high density nanopores formed from the integration of nanoporous alumina membranes onto metallic microscale platforms. The nanomonitors have approximately 250,000 nanowells per sensing site and use antibody binding reactions for detection of proteins. The antigen explored was C-reactive protein (CRP), an inflammatory biomarker associated with cardiovascular disease. Protein detection on the nanomonitor was achieved through electrical impedance spectroscopy. We performed a prospective cohort study of patients undergoing vascular surgery and compared the nanomonitor results to the industry standard ELISA (enzyme-linked immuno-sorbant assay) for the measurement of CRP in patient blood using Bland-Altman and mixed effects model statistical techniques. No statistical difference was found between the nanomonitor, ELISA, and CRP results, p = 0.994. In addition, the mean inter-assay coefficient of variation (CV) for the nanomonitor was 1.3%, and mean intra-assay CV 1.8%. The mean inter-assay CV for ELISA was 6.1%, and mean intra-assay CV was 5.2%. The nanomonitor time-to-result was 15 minutes and the ELISA was 3 hours, a critical time saving for patient care. In conclusion, we validated the use of the nanomonitor in clinical patient blood samples for the detection of CRP.