# Development of Antigen-based Vertical Flow Assay for the Rapid Detection of SARS-CoV-2, Influenza A/B, and RSV

> **NIH ALLCDC R43** · AI BIOSCIENCES, INC. · 2021 · $243,000

## Abstract

Project Summary
The goal of this Phase I SBIR proposal is to develop a rapid, low-cost, multiplex immunoassay for the detection
of common respiratory tract pathogens, including influenza A (Flu A), influenza B (Flu B), respiratory syncytial
virus (RSV), and severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in less than 15 minutes. The
development of this antigen-based test will accelerate the rapid diagnosis of SARS-CoV-2 infection, along with
influenza A / influenza B and RSV. Influenza A / influenza B and RSV are the other common causative agents of respiratory tract infections other
than the ongoing SARS-CoV-2 pandemic. Analyses from the CDC have suggested that there could be 10 times
more Coronavirus disease 2019 (COVID-19) positive cases than reported cases. 2 This is primarily due to the
slow screening process as it mainly depends on the RT-PCR based testing systems. The rapid identification of
SARS-CoV-2 is critical to stop the spread of the infection as it is highly contagious. Apart from SARS-CoV-2, influenza A / influenza B and RSV cause a considerable amount of infections and severe illness. Moreover, influenza A / influenza B and RSV
infections show similar symptoms to that of SARS-CoV-2 infection. Differentiating SARS-CoV-2 infections with
Flu or RSV is also much needed as Flu and RSV infections have better treatment options if they are diagnosed
early. Rapid tests would provide a better opportunity to choose the right treatment strategy and stop the spread
of the illness. We propose to develop a rapid, multiplex test for the detection of influenza A / influenza B, RSV, and SARS-CoV-2
without any complex instrumentation. Our rapid test uses immobilized antibodies on the membrane for the
capturing and simultaneous qualitative detection of specific antigens for four common respiratory tract
pathogens. We will use our innovatively designed sequential injection syringe (SIS) to pre-fill the reagents and
disperse them sequentially into the flow-through assay cassette. The components such as the 2nd antibody
conjugated with biotin, wash buffers, neutravidin-HRP, and tetramethylbenzidine (TMB) with stable hydrogen
peroxide will be sequentially dispersed into the assay cassette. After completing the assay, the colored spots
that develop can be viewed without any special instrumentation and can be interpreted easily. If needed, a reader
can be used to further increase the sensitivity and ability to record and send test result to the physicians. This
multiplex assay can be performed in less than 15 minutes in various point-of-care (POC) and low resource
settings without any special training. We will demonstrate that our test can deliver rapid results with the same
level of performance as singleplex tests for each pathogen using clinical specimens. We will also validate our
assay method at our collaborator's lab at the Medical College of Wisconsin. We plan to achieve 100% specificity
and higher sensitivity than current lateral flow a...

## Key facts

- **NIH application ID:** 10258549
- **Project number:** 1R43IP001166-01
- **Recipient organization:** AI BIOSCIENCES, INC.
- **Principal Investigator:** Arunkumar Arumugam
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2021
- **Award amount:** $243,000
- **Award type:** 1
- **Project period:** 2021-09-30 → 2022-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10258549

## Citation

> US National Institutes of Health, RePORTER application 10258549, Development of Antigen-based Vertical Flow Assay for the Rapid Detection of SARS-CoV-2, Influenza A/B, and RSV (1R43IP001166-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10258549. Licensed CC0.

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