Prospective Clinical Evaluation of Anterior Nasal Swab Specimens for Use with the BIOFIRE SPOTFIRE Respiratory Panel Mini in a Near-Patient Setting Rev 02
TED
Thomas E. Davis
Principal Investigator
Status: Enrolling By Invitation
Ages: 18 Years - 100 Years
Gender: All Genders
Phase: N/A
2 Locations
Brief Description
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
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
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.
- 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.
Interested in participating?
Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.