Prospective Clinical Evaluation of Anterior Nasal Swab Specimens for use With the BIOFIRE SPOTFIRE Respiratory Panel Mini in a Near-Patient Setting Rev 02

Study on Nose Swab Testing for Colds and Flu

T
Thomas E. Davis

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
1 participants needed
2 Locations

Brief description of study

The objective of this study is to demonstrate the clinical performance of the assays comprising the SPOTFIRE R Panel Mini when used to test ANS specimens obtained from individuals presenting with signs/symptoms of an upper respiratory tract infection. 

The study is being conducted by Thomas Davis, MD and his research staff from the Pathology Department at the Indiana University School of Medicine.  It is funded by BioFire Diagnostics, LLC, the manufacturer of the test being studied.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential study participants who present with upper respiratory symptoms and are are undergoing swabbing will be approached by study staff as they present to the clinic for their regularly scheduled clinic visit. Operator cohort will be IU Pathology research team employees assigned as operators by department manager.

Detailed description of study

 

There is a participant cohort and an operator (IU Pathology staff) cohort.

  • This study involves the collection of two swabs from the nose: one anterior nasal swabs (ANS) and a nasopharyngeal swab (NPS).
  • Both the ANS and NPS specimens will be collected by subject's health care provider.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Upper Respiratory Tract Infection
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:
- Subject presents with signs/symptoms of a respiratory tract infection including
but not limited to fever, cough, sore throat, runny nose, myalgia, headache,
chills, or fatigue.
- If age 18 or over, subject provides written informed consent.
- Subject is willing and able to provide one ANS specimen (both nares
swabbed) and one NPS specimen.

Exclusion Criteria:
- Subject’s health care provider determines that specimen collection represents
an unacceptable health risk.

This study investigates the use of nasal swabs to test for upper respiratory infections. The purpose of this study is to check how well a specific test works using samples from people's noses, especially those showing signs of a cold or flu, like a fever or cough.

Participants will have two types of swabs collected from their nose. One is an anterior nasal swab, which is taken from the front part of the nose, and the other is a nasopharyngeal swab, which is taken from deeper inside the nose. These samples are collected by healthcare providers.

  • Who can participate: Adults aged 18 and over who have symptoms of a respiratory infection, such as fever or cough, and are able to provide nasal swab samples can participate. Written informed consent is required.
  • Study details: These samples will be used to assess the test's performance.
Updated on 27 Jan 2026. Study ID: PATH-BIOFIRE-DX-SDY-129584, 21646
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only