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

By adapting low-cost technology developed by Nodexus prior to and during the course of the currentNCI Phase I SBIR award, we hereby propose a low-cost, rapidly deployable platform for quantification ofboth SARS-CoV-2 viral particles and anti-SARS-CoV-2 IgG/IgM antibodies simultaneously from saliva bybead-based capture in a simple flow-through assay for low-infrastructure screening utilizing patentedmicrofluidic Node-Pore Sensing (NPS) to urgently address the need for affordable diagnostics andasymptomatic carrier detection to protect at-risk populations including cancer patients andimmunocompromised survivors. The proposed solution further enables rapid deployment to testingcenters 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 iscurrently in the midst of a global pandemic caused by severe acute respiratory syndrome coronavirus 2, orSARS-CoV-2, which emerged from Wuhan, China at the end of 2019. As of May 23, 2020, there are currentlyover >5M cases reported worldwide, and tragically over 338,000 deaths (average mortality rate ~7%, data fromECDC daily tracker). The lack of direct viral particle diagnostic tests currently available has placed an immenseburden on governments around the world to curtail economic and social activities to prevent further communityspread of COVID-19. Recent studies have shown that risk of developing severe events in COVID-19 isstatistically significantly higher in cancer patients. This can present enormous hurdles for engaging with theirsupport system (e.g. family and friend visits) and also lead to fear and safety issues when attending clinical sitesfor checkups, monitoring, and treatment. Nodexus' proposed platform (system and cartridge-based kit) solutionwould offer an affordable, at-home-deployable diagnostic test that would directly detect both the virusand antibodies against COVID-19 in a rapid manner (<20 minutes to result) using saliva samples todiagnose/monitor patients, with particular focus to assist disparately affected populations includingcancer patients and immunocompromised survivors.Saliva was chosen as the optimal diagnostic sample type for a number of reasons. Firstly, saliva samples havea >93% concordance of detection for SARS-CoV-2 as compared to FDA/CDC standard diagnostic test usingnasopharyngeal aspirate (NPA). Secondly, saliva is the easiest sample for patients to self-collect, without thediscomfort or potential bleeding of nasopharyngeal/oropharyngeal swabs, and without the difficulty of sputum toself-collect. Finally, patient self-collecting of saliva significantly has been shown to lower risk of virus spread tohealthcare workers or nearby members of the public compared to more invasive methods which may result inexpectoration or sternutation. Nodexus' proposed platform will ultimately detect viral particles and IgM/IgGantibodies 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 theearliest stages (prior to hospitalization becoming needed). Nodexus is well positioned to complete the Aimswithin the urgent timeline based on the previously demonstrated low-cost cartridge production with high marginsusing standard as well as proprietary in-house processes, significant design-for-manufacturing already beingperformed, and because the majority of the proposed platform components have already beendeveloped/integrated into Nodexus' existing products by existing external partners as part of NCI Phase I SBIRaward.