Collection of Anonymized Samples

Collection of Anonymized Samples for Use in Product Development and Clinical Trials

This is a generic sample collection study for collecting blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources. Subjects will be recruited from BioFire Diagnostics employees and from the general community. Subjects may be asked about recent or ongoing illness at the time of specimen collection and these symptoms will be recorded and attached to the sample. No other identifying information will be collected and the samples will be kept anonymous.The samples may be used internally or by external sites, such as the clinical study sites, for evaluating and determining performance characteristics of in vitro diagnostic devices.

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Respiratory Disease; Gastrointestinal Disease

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • BioFire Diagnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Employees of BioFire Diagnostics, and the general community of the greater Salt Lake City area.

Description

Inclusion Criteria:

• Consenting adult

Exclusion Criteria:

• Weigh less that 110 lb for blood collection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR Amplification Curves	PCR amplification curves will be used to confirm the presence or absence of target analytes.	10 years

Collaborators and Investigators

• Sponsor: BioFire Diagnostics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Anticipated): October 1, 2027
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: DX-SDY-036556

Drug and device information, study documents

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