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

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.

Instrument-free single-step direct estimation of the plasma glucose level from one drop of blood using smartphone-interfaced analytics on a paper strip.

We demonstrated an instrument-free miniaturized adaptation of the laboratory gold standard methodology for the direct estimation of plasma glucose from a drop of whole blood using a low-cost single-user-step paper-strip sensor interfaced with a smartphone. Unlike a majority of the existing glucose meters that use whole blood-based indirect sensing technologies, our direct adaptation of the gold-standard laboratory benchmark could eliminate the possibilities of cross interference with other analytes present in the whole blood by facilitating an in situ plasma separation, capillary flow and colorimetric reaction occurring concomitantly, without incurring additional device complexity or embodiment. The test reagents were dispensed in lyophilized form, and the resulting paper strips were found to be stable over three months stored in a normal freezer, rendering easy adaptability commensurate with the constrained supply chains in extreme resource-poor settings. Quantitative results could be arrived at via a completely-automated mobile-app-based image analytics interface developed using dynamic machine learning, obviating manual interpretation. The tests were demonstrated to be of high efficacy, even when executed by minimally trained frontline personnel having no special skill of drawing precise volume of blood, on deployment at under-resourced community centres having no in-built or accessible healthcare infrastructure. Clinical validation using 220 numbers of human blood samples in a double-blinded manner evidenced sensitivity and specificity of 98.11% and 96.7%, respectively, as compared to the results obtained from a laboratory-benchmarked biochemistry analyser, establishing its efficacy for public health and community disease management in resource-limited settings without any quality compromise of the test outcome.

PSA detection using label free graphene FET with coplanar electrodes based microfluidic point of care diagnostic device.

Affordable point-of-care (PoC) diagnostic devices enable detection of prostate specific antigen (PSA) in resource limited settings. Despite the advancements in PoC systems, most of the reported methods for PSA detection have unsatisfactory detection limits and are based on labelled assays, requiring multiple reagent flow steps which increases both expenses and inconvenience. Circumventing these constraints, we report here the development and validation of a label free, affordable dielectrophoresis (DEP) based graphene field effect transistor (FET) sensor implemented using coplanar electrodes and integrated uniquely with a compact disc based microfluidic platform along with electronics readout for the estimation of PSA at the point of care. Design of coplanar gate electrode which has not been explored earlier is not a straightforward approach. In fact, it has been observed that there is a non-monotonic dependence of the capture of PSA molecules in the channel region of the FET with varying widths and spacings of the gate electrode. The graphene FET based PoC device with optimized coplanar gate electrode is the only label free analytical system for PSA detection requiring simple operation and achieving a detection limit of 1 pg/ml in serum with a wide dynamic range upto 4 ng/ml and appreciable selectivity against potential interferents like bovine serum albumin (BSA) and human immunoglobulin G (IgG). Further, it has been validated satisfactorily with commercially available existing systems using human serum samples. Moreover, the proposed sensing system lowers the detection limit by three orders of magnitude compared to a recent study on label free PoC device on other cancer biomarkers.