Smartphone-based digital point-of-care panel assay with enzymatic catalytic reaction

Abstract

The recent pandemic improved awareness amongst the public of the need for rapid blood tests for community and home settings. In this work, we evaluated the performance of a digital, lipid panel test in microfluidic assay format which can be read using a smartphone camera. The PocDoc Lipid test is embedded within a cardiovascular screening application that utilizes the QRISK3 risk prediction algorithm to determine an individual's risk of having a cardiovascular event in the next 10 years and their healthy heart age. The test can be used to screen for individuals at risk of hyperlipidemia (e.g. high total cholesterol or triglycerides) and for individuals at high risk of cardiovascular disease at home or in community or surgery settings. The device was evaluated in a performance evaluation study, using 125 whole blood samples, following CLSI guidelines. Performance evaluation of the PocDoc device demonstrated accuracy that meets international NCEP guidelines and that is on par with other point-of-care tests. Sensitivity and specificity analysis supports the use of PocDoc to identify patients with hyperlipidemia or at high risk of cardiovascular disease. Bland-Altman analysis suggests that this point-of-care device can be used as an alternative to venous blood collection. This single-step model for cardiovascular disease risk measurement which can be done at home or in community settings may improve cardiovascular disease prevention.