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

> **NIH NIH R43** · NODEXUS, INC. · 2020 · $248,790

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10172022
- **Project number:** 3R43CA243815-01S2
- **Recipient organization:** NODEXUS, INC.
- **Principal Investigator:** Karthik Ratna Balakrishnan
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $248,790
- **Award type:** 3
- **Project period:** 2019-09-20 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10172022

## Citation

> US National Institutes of Health, RePORTER application 10172022, An urgently needed low-cost, rapidly deployable platform for simultaneous SARS-CoV-2 viral particle and COVID-19 IgG/IgM detection and quantification (3R43CA243815-01S2). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10172022. Licensed CC0.

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