# Point-of-care antigen detection assay for early diagnosis of Ebola virus disease (EVD)

> **NIH NIH R41** · INBIOS INTERNATIONAL, INC. · 2020 · $299,112

## Abstract

Project Summary
Ebolavirus spp. cause a severe hemorrhagic fever known as Ebola virus disease (EVD). EVD is
a serious public health concern, both as an emerging infectious disease and a potential
biothreat. The 2013-2016 Ebola pandemic in West Africa brought global attention to the
challenges associated with controlling an Ebola. The ongoing outbreak in the Democratic
Republic of Congo, which recently reached over 1000 cases with no signs of slowing, has only
confirmed the need for improved Ebola medical countermeasures. To better control Ebola
outbreaks, it is imperative for healthcare workers to be able to diagnosis and isolate infected
patients at the point-of-care in a timely manner. As such, the World Health Organization and
other healthcare agencies have called for development of Ebola rapid diagnostic tests (RDTs).
The proposed joint effort, for development a point-of-care antigen detection assay for early
diagnosis of EVD, stems from a history of successful collaborations between the academic
laboratory of Dr. David AuCoin at the University of Nevada, Reno (UNR) and commercial
partner, InBios International, Inc. The two organizations have valuable expertise in RDT
development and navigating the FDA approval process. The effort is further bolstered by
assistance from collaborators at the United States Army Medical Research Institute of Infectious
Diseases (USAMRIID) who will perform all high containment level (BSL4) studies.
Preliminary studies for this proposal have resulted in an Ebola RDT prototype that shows a
substantial improvement in sensitivity for Zaire ebolavirus. Our goal is to further improve assay
sensitivity and expand detection to all EVD causing Ebolavirus spp. A comprehensive approach
with clearly defined strategies will be used to support successful development of a pan-Ebola
RDT with high sensitivity. Key aspects and milestones include: i) high throughput monoclonal
antibody (mAb) production using multiple immunization strategies, ii) mAb characterization and
RDT-based mAb screening, iii) commercial optimization and development of multiple assay
prototypes, iv) determination of analytical sensitivity and specificity and v) assay validation with
samples from Ebola-infected non-human primates.

## Key facts

- **NIH application ID:** 9910131
- **Project number:** 1R41AI149940-01
- **Recipient organization:** INBIOS INTERNATIONAL, INC.
- **Principal Investigator:** David P AuCoin
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,112
- **Award type:** 1
- **Project period:** 2020-03-10 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9910131

## Citation

> US National Institutes of Health, RePORTER application 9910131, Point-of-care antigen detection assay for early diagnosis of Ebola virus disease (EVD) (1R41AI149940-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9910131. Licensed CC0.

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