Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing

Status unconfirmed

Conditions studied: Respiratory Tract Infections, Gastrointestinal Infection

In brief

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 and rectal swab) specimens collected using various standard, medically established procedures with and without transport media and tested at various time points and under different temperature conditions, and also to look at variation between repeat sampling events. The intention is for these data to support decisions made by BioFire regarding the appropriate specimen type and handling guidelines for future tests. In the second phase of the study, collection and transport conditions identified in Phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test.

Key facts

Study ID

NCT03299283

Run by

BioFire Diagnostics, LLC

People needed

4000

Starts

2017-10-05

Expected to finish

2019-12-30

Last updated by the study team

2019-01-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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