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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Tract Infections; Gastrointestinal Infection
• Intervention / Treatment: Diagnostic test: BioFire test platform

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. Current BioFire FilmArray test panels will be used to assay each specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or other post-collection variables. In the second phase of the study only two specimens will be collected from each subject: one for testing with the new test (using handling procedures identified in Phase 1) and another for testing with the reference method. Up to 2,000 subjects will be enrolled across all sites in each phase (up to 4,000 subjects total). Enrollment is expected to last approximately 18 months to cover both phases of the study. All specimens and subject data will be de-identified and coded. Prior to study initiation, each participating site will have the necessary Institutional Review Board (IRB) reviews. Specimens in both phases will be tested at the study site using various BioFire test platforms and cartridges.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Analysis of analyte stability under various conditions as measured by BioFire test platforms
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; Analysis of analyte stability under various conditions as measured by BioFire test platforms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device performance relative to reference methods	Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will determine device performance relative to reference method(s) i.e. if an anlyte is detected (or not) by each method (presence or absence)	Through completion of Phase 2 (approximately 9 months)

Collaborators and Investigators

• Sponsor: BioFire Diagnostics, LLC
• Investigators: Study Director: Kevin Bourzac, PhD, BioFire Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 804 Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No