Lipidest: a lipid profile screening test under extreme point of care settings using a portable spinning disc and an office scanner

Abstract

The demand for lipid profile (the cholesterol and triglyceride elements in the blood) testing outside resourced diagnostic centers is continuously increasing for personalized and community-based healthcare to ensure timely disease screening and management; however, it is inevitably challenged by several bottlenecks in the existing point of care technologies. These deficits include delicate sample pre-processing steps and device complexity, which give rise to unfavourable cost propositions to safeguard against compromised test accuracy. To circumvent these bottlenecks, herein, we introduce a new diagnostic technology, ‘Lipidest’, that integrates a portable spinning disc, a spin box, and an office scanner to reliably quantify the complete lipid panel from finger-prick blood. Our design facilitates the direct miniature adaptation of the established gold standard procedures as against any indirect sensing technologies that are otherwise common in point-of-care applications introduced commercially. The test procedure harmoniously connects all the elements of sample-to-answer integration in a single device, traversing the entire pipeline of the physical separation of plasma from the cellular components of the whole blood, the automated mixing with the test reagents on the same platform in situ, and office-scanner-adapted quantitative colorimetric analytics that eliminate any undesirable artefacts on account of variabilities in the background illumination and camera specifications. The exclusive value of eliminating sample preparation steps, including the rotationally actuated segregation of the specific blood constituents without any cross-interference between them, their automated homogeneous mixing with the respective test reagents, and the simultaneous, yet independent, quantitative readout without specialized instrumentation, render the test user-friendly and deployable in resource-constrained settings with a reasonably wide detection window. The extreme simplicity and modular nature of the device further make it amenable to mass manufacturing without incurring unfavourable costs. Extensive validation with laboratory-benchmark gold standards provide acceptable accuracy and indicates the value of the first-of-its-kind ultra-low-cost extreme-point-of-care test with a scientific foundation akin to highly accurate laboratory-centric technologies for cardiovascular health monitoring and beyond.