Status:
UNKNOWN
Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing
Lead Sponsor:
BioFire Diagnostics, LLC
Conditions:
Respiratory Tract Infections
Gastrointestinal Infection
Eligibility:
All Genders
Brief Summary
The purpose of this study is two-fold. In the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and stool (raw stool...
Detailed Description
This evaluation will be initiated at several sites in the US. In the first phase of the study, multiple specimens will be collected from each subject and tested using various pre-analytical techniques...
Eligibility Criteria
Inclusion
- Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue. OR Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days
- If age 18 or over, subject provides written informed consent
- If under the age of 18, parental permission and assent (as appropriate) is obtained
- Subject is willing and able to provide at least two (up to three) specimens: any combination of NS, NPS, or TS OR rectal swab or stool
Exclusion
- Subject is unable to provide consent or parental permission and assent (as appropriate) cannot be obtained
- Subject is unable or unwilling to provide two specimens
- Subject's health care provider determines that specimen collection represents an unacceptable risk
Key Trial Info
Start Date :
October 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT03299283
Start Date
October 5 2017
End Date
December 30 2019
Last Update
January 15 2019
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110