# Multi-parametric Integrated Molecular Detection of SARS-CoV-2 from Biofluids by Adapting Single Extracellular Vesicle Characterization Technologies

> **NIH NIH U18** · OHIO STATE UNIVERSITY · 2022 · $878,950

## Abstract

Abstract
The World Health Organization has recognized a global pandemic of novel coronavirus pneumonia (COVID-19)
from exposure to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronaviruses (CoVs)
are membrane-enveloped positive-sense, single-stranded RNA viruses decorated with membrane proteins. The
spike (S) glycoprotein is implicated in the viral attachment and fusion to host cells via the human angiotensin-
converting enzyme 2 (hACE2). There are different assays to test for COVID-19, including nucleic acid, antigen,
and serological tests that can be used in hospitals, point-of-care, and large-scale population testing. Nucleic acid
testing is the standard method for the detection of SARS-CoV-2, which consists of the amplification of viral RNA
from nasopharyngeal swabs (NPS) by quantitative reverse-transcription polymerase chain reaction (qRT-PCR).
Furthermore, given the invasive nature of NPS, saliva is being considered an alternative for detection. Methods
that bypass RNA extraction, as well as isothermal amplification such as loop-mediated isothermal amplification
(LAMP), have been developed to improve the speed of viral RNA detection. However, viral protein expression
cannot be detected by qRT-PCR. Serological tests, on the other hand, are based on host antibodies against the
virus (IgG/IgM). Although fast, these tests suffer from significant false negative/positive. Besides, they do not
detect a current infection. Therefore, to relieve the current healthcare crisis, new technologies capable of
simultaneous viral RNA/protein detection at the single virus level and host antibody response detection from a
body fluid in an integrated device would be highly valuable for enhanced COVID-19 diagnosis.
Recently, our group, as part of Phase 2 of the Extracellular RNA Communication Consortium (ERCC2), has
successfully developed a microfluidics technology capable of capturing individual exosomes from biofluids and
then simultaneously quantify both exosomal surface proteins and RNA cargo. Given the resemblance in size
and other characteristics between exosomes and coronaviruses, our technology can be adapted for COVID-19
diagnosis. Therefore, we propose to develop and validate a safe-to-use version of our microfluidics system for
direct detection of SARS-CoV-2. The integrated system is capable of multi-parametric detection for enhanced
COVID-19 diagnosis. The platform will be engineered to simultaneously quantify both viral protein, viral RNA,
and host antibodies (IgG/IgM) in the same sample, enabling diagnosis, disease status, and prognostic
assessment. Model systems, including host IgG/IgM from patient serum, standard synthetic vesicles (SVs), and
heat-inactivated SARS-CoV-2 viral particles (SVVs), will be designed and spiked in biofluids to validate and
calibrate the system. To demonstrate the clinical utility, our biochip technology will be deployed and tested using
different biofluids from COVID-19 patients at two independent ...

## Key facts

- **NIH application ID:** 10320988
- **Project number:** 4U18TR003807-02
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** Inyoul Lee
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $878,950
- **Award type:** 4N
- **Project period:** 2020-12-21 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10320988

## Citation

> US National Institutes of Health, RePORTER application 10320988, Multi-parametric Integrated Molecular Detection of SARS-CoV-2 from Biofluids by Adapting Single Extracellular Vesicle Characterization Technologies (4U18TR003807-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10320988. Licensed CC0.

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