Personal smart phone-integrated virus sensors & app for rapid & accurate saliva self-screening

The latest SARS-CoV-2 pandemic is spreading so rapidly across the world that health care facilities, even in developed countries, have inadequate resources to contain it. A vaccine is still many months away and based on previous experience with the 2002-03 SARS-CoV pandemic its effectivity is yet to be determined. Universal testing has been proposed as a key element in slowing the spread, since a large fraction of carriers are asymptomatic. Unfortunately, due to the large demand, test kits are in short supply and even when available, are mostly based on PCR detection of viral RNA which requires sophisticated laboratory equipment, often takes one or two days to receive results, and it still less than 80% reliable. Hence despite recent advances, there is still an urgent, unmet need for the development of a point-of-care assay, which can be administered by the individual, transmit the data wirelessly to a cell phone, interface with an app which provides analysis, and connects to a touchscreen dashboard which gives control to the individual as to further communications. We propose here to develop a potential point-of-care (POC) diagnostic system, using a chip-based potentiometric sensor, which directly detects the presence of the entire SARS-CoV-2 virion or its associated capsid proteins, using a 3D molecular imprinting technique. The technique was previously shown to be comparable to Elisa in accuracy of CEA cancer marker detection in humans with 1/100 of the test volume. In a recent publication, we demonstrated that the technique could detect ZIKV in saliva at sub-infectious concentrations of less than 10 PFU/mL and accurately discriminate against DENV. This technique, which is sensitive to details of the morphological structure of the analyte, rather than its genetic or proteomic sequence, is based on simple potentiometric detection, which can be interfaced with Bluetooth technology and transmit data to a smartphone. Since coronaviruses are very different than ZIKV, preliminary data on chips imprinted with purified flu viruses indicated feasibility by easily obtaining sensitivity to 102 PFU/mL. Hence here we propose a plan for;
(A) Adapt this technology to SARS-COV-2 viruses via the development of optimal imprinting and assay protocols using Oc43 and 229E analogues and capsid proteins. (B) Transition to a BSL-3 facility for imprinting and testing with different strains of SARS-COV-2 virus and (C) miniaturizing the data acquisition, producing a flexible mount for the chip, and developing a user friendly, yet secure app for analyzing and communicating the results.