# Effective, Reagent-free Detection of the Odor Signature of Covid-19 Infection Using a Nano-Enabled Sensor Array

> **NIH NIH U18** · UNIVERSITY OF PENNSYLVANIA · 2021 · $999,830

## Abstract

PROJECT SUMMARY
COVID-19 presents a public health emergency: There is a critical need for rapid, not reagent intensive, non-
invasive testing technologies. This program will lead to the production of a prototype system to diagnose
COVID-19 infection using the body odor signature of the disease. Our goal is to maximize societal impact
by creating a validated prototype that can be used in a community or workplace setting by minimally
trained personnel for low-cost, on-the-spot diagnosis within minutes. The system will be developed in a
manner that puts it on a pathway for rapid FDA approval. The Research Aims are:
Aim 1. Optimization, assembly, and integration of a prototype system with the ability to odor signature
of COVID-19 in samples of body odor. The system will be simple to use, pose essentially zero risk to the
operator and the test subject, and report a result within minutes. The production cost at scale will be
approximately $9,000 for the complete measurement system, with a per test cost of approximately $0.50. The
design and construction of the prototype will be conducted by Novo Engineering, a leading firm with extensive
experience in medical device development.
Aim 2. Software development. Software for the system from VOC sampling to final diagnostic result will be
developed to ensure error-free operation of the device. Our preliminary results suggest that simple linear
discriminant analysis (LDA) does an excellent job of classifying VOCs from human body odor as COVID-19
positive or negative (92% sensitivity and 87% specificity). Optimization of the sensor array (Aim 1) and use of
richer feature sets in our classifier models will lead to further performance improvements in the prototype system.
Aim 3. System Benchmarking and Validation. We will benchmark the full prototype system against a number
of VOC mixtures, with and without in vitro skin models. The system will undergo extensive testing against body
odor samples from individuals with pathological conditions other than COVID-19 and other sources of potentially
confounding VOCs. The prototype will be validated against 1000 samples drawn from the COVID-SAFE program
at Penn. The screening will include all members of the Penn community, and represents incredible racial and
ethnic diversity as well as a wide variance in age, sex, and gender.
Aim 4. Regulatory Approval Plan The plan will be developed under the direction of Sr/Key personnel John
Fuson, JD, an attorney at Crowell & Moring LLP and a former Associate Chief Counsel at FDA. Novo Engineering
has extensive experience in guiding prototype design in alignment with the requirements for FDA approval. The
proposed COVID-19 VOC-based testing device will be regulated by the FDA, likely as a Class I or II medical
device. Because there is no clear predicate device to reference in this case, we intend to submit a direct de novo
petition to FDA asking the agency to categorize and clear the proposed COVID-19 testing device as Class I or
C...

## Key facts

- **NIH application ID:** 10266403
- **Project number:** 1U18TR003775-01
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Alan T Johnson
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $999,830
- **Award type:** 1
- **Project period:** 2020-12-21 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10266403

## Citation

> US National Institutes of Health, RePORTER application 10266403, Effective, Reagent-free Detection of the Odor Signature of Covid-19 Infection Using a Nano-Enabled Sensor Array (1U18TR003775-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10266403. Licensed CC0.

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