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

NCT03299283 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2019-01-15

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

BioFire test platform

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

Sponsors & Collaborators

  • BioFire Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Kevin Bourzac, PhD · BioFire Diagnostics

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2019-10-30
Completion
2019-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299283 on ClinicalTrials.gov