An urgently needed low-cost, rapidly deployable platform for simultaneous SARS-CoV-2 viral particle and COVID-19 IgG/IgM detection and quantification

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By adapting low-cost technology developed by Nodexus prior to and during the course of the current NCI Phase I SBIR award, we hereby propose a low-cost, rapidly deployable platform for quantification of both SARS-CoV-2 viral particles and anti-SARS-CoV-2 IgG/IgM antibodies simultaneously from saliva by bead-based capture in a simple flow-through assay for low-infrastructure screening utilizing patented microfluidic Node-Pore Sensing (NPS) to urgently address the need for affordable diagnostics and asymptomatic carrier detection to protect at-risk populations including cancer patients and immunocompromised survivors. The proposed solution further enables rapid deployment to testing centers and ultimately patient/individual walk-up usability with universal web-based compatibility (including mobile device) for maximum accessibility and adoption for the general public. There is great need for an at-home diagnostic solution like the proposed Nodexus platform because the world is currently in the midst of a global pandemic caused by severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, which emerged from Wuhan, China at the end of 2019. As of May 23, 2020, there are currently over >5M cases reported worldwide, and tragically over 338,000 deaths (average mortality rate ~7%, data from ECDC daily tracker). The lack of direct viral particle diagnostic tests currently available has placed an immense burden on governments around the world to curtail economic and social activities to prevent further community spread of COVID-19. Recent studies have shown that risk of developing severe events in COVID-19 is statistically significantly higher in cancer patients. This can present enormous hurdles for engaging with their support system (e.g. family and friend visits) and also lead to fear and safety issues when attending clinical sites for checkups, monitoring, and treatment. Nodexus’ proposed platform (system and cartridge-based kit) solution would offer an affordable, at-home-deployable diagnostic test that would directly detect both the virus and antibodies against COVID-19 in a rapid manner (<20 minutes to result) using saliva samples to diagnose/monitor patients, with particular focus to assist disparately affected populations including cancer patients and immunocompromised survivors. Saliva was chosen as the optimal diagnostic sample type for a number of reasons. Firstly, saliva samples have a >93% concordance of detection for SARS-CoV-2 as compared to FDA/CDC standard diagnostic test using nasopharyngeal aspirate (NPA). Secondly, saliva is the easiest sample for patients to self-collect, without the discomfort or potential bleeding of nasopharyngeal/oropharyngeal swabs, and without the difficulty of sputum to self-collect. Finally, patient self-collecting of saliva significantly has been shown to lower risk of virus spread to healthcare workers or nearby members of the public compared to more invasive methods which may result in expectoration or sternutation. Nodexus’ proposed platform will ultimately detect viral particles and IgM/IgG antibodies with high sensitivity, specificity, and concordance with NPA qRT-PCR assays. Successful completion of the proposed Aims will significantly contribute to diagnosing COVID infection at the earliest stages (prior to hospitalization becoming needed). Nodexus is well positioned to complete the Aims within the urgent timeline based on the previously demonstrated low-cost cartridge production with high margins using standard as well as proprietary in-house processes, significant design-for-manufacturing already being performed, and because the majority of the proposed platform components have already been developed/integrated into Nodexus’ existing products by existing external partners as part of NCI Phase I SBIR award.