# New test for the diagnosis of acute respiratory infection that detects viruses and evaluates host gene expression in a nasal sample

> **NIH NIH R21** · WASHINGTON UNIVERSITY · 2020 · $196,823

## Abstract

Project Summary / Abstract
Dramatic worldwide increases in antibiotic resistance raise the specter of a return to the pre-
antibiotic era. Overuse of antibiotics is the main driver of this process. One of the main areas of
clinical medicine where unnecessary antibiotic use occurs is in the management of patients with
acute respiratory infections, which are often caused by viruses. The long-term goal of our work
is to develop better diagnostic tests that will help physicians avoid using antibiotics to treat viral
infections. Highly sensitive molecular assays are now available to detect respiratory viruses.
However, their high sensitivity leads to detection of viruses in cases in which they are not the
cause of the patient’s illness. We have proposed using host response, including host gene
expression, to provide more accurate diagnostic information. Most previous work evaluating
host response to respiratory infections was done using blood samples but we have recently
shown that human gene expression can be measured in nasal samples, and the ability to
recognize and discriminate between symptomatic infection, asymptomatic infection, and no
infection is at least as good for nasal samples as for blood. The work proposed here represents
an academic-industry partnership between Washington University and BioFire Diagnostics that
will develop a new diagnostic test performed on a nasal sample that combines virus detection
with human gene expression. Our intention is to move the test towards regulatory approval so
that it can be used to help patients and physicians. BioFire will prepare a prototype test device
using their FilmArray system, which is already widely used for multiplex pathogen detection. The
viral component is based on assays that BioFire has developed, and the gene expression
component will use genes selected by the Washington University team based on our recent with
informed consent/assent. A nasal swab from each subject will be tested using the prototype test
device and a blood sample will be obtained for procalcitonin measurement to help determine the
cause of the patient’s illness. The results of the prototype test device will be compared to
classification by a panel of expert clinicians who will use the patient’s clinical information
including the procalcitonin result to determine whether the patient had a viral infection, bacterial
infection, both, or neither. We will also analyze the potential impact of using the test results on
antibiotic utilization. In a second phase of the study, samples that are discrepant between virus
detection and host response will be analyzed using RNA-seq and quantitative virology to
understand why results were discrepant. If this project is successful, it will lead directly to a
clinical trial designed to establish clinical efficacy, used to support an application for FDA
approval.

## Key facts

- **NIH application ID:** 9955184
- **Project number:** 5R21AI146999-02
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Gregory A. Storch
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $196,823
- **Award type:** 5
- **Project period:** 2019-06-17 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9955184

## Citation

> US National Institutes of Health, RePORTER application 9955184, New test for the diagnosis of acute respiratory infection that detects viruses and evaluates host gene expression in a nasal sample (5R21AI146999-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9955184. Licensed CC0.

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