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

NCT03299283 | Unknown FDA Device

• 1 other identifier: 804 Pilot
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Respiratory Tract Infections; Gastrointestinal Infection

Outcome Measures

Primary Outcomes (1)

• Analyte stability (as measured by nucleic acid detection)

  Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will investigate analyte stability for the various pre-analytical steps. Analyte stability will be measured by assessing nucleic acid level using real-time PCR.

  Through completion of Phase 1 (approximartely 9 months)

Secondary Outcomes (1)

• Device performance relative to reference methods

  Through completion of Phase 2 (approximately 9 months)

Study Arms (2)

Respiratory/Pharyngitis

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

Diagnostic Test: BioFire test platform

Gastrointestinal

Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days

Diagnostic Test: BioFire test platform

Interventions

BioFire test platform DIAGNOSTIC_TEST

Analysis of analyte stability under various conditions as measured by BioFire test platforms

Gastrointestinal; Respiratory/Pharyngitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects present to ED or urgent care centers with signs/symptoms of respiratory tract or gastrointestinal infection

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

Sponsors & Collaborators

• BioFire Diagnostics, LLC: lead

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Respiratory and gastrointestinal specimens collected using medically established techniques

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Kevin Bourzac, PhD

  BioFire Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: October 3, 2017
• Study Start: October 5, 2017
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)