Collection of Anonymized Samples

NCT03319446 | Enrolling By Invitation

• 1 other identifier: DX-SDY-036556
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Respiratory Disease; Gastrointestinal Disease

Outcome Measures

Primary Outcomes (1)

• PCR Amplification Curves

  PCR amplification curves will be used to confirm the presence or absence of target analytes.

  10 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Consenting adult

You may not qualify if:

• Weigh less that 110 lb for blood collection

Sponsors & Collaborators

• BioFire Diagnostics, LLC: lead

Study Sites (1)

BioFire Diagnostics

Salt Lake City, Utah, 84103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, rectal swabs, nasal washes, nasopharyngeal aspirates, nasopharyngeal swabs, throat swabs, nasal swabs, and urine from human sources.

MeSH Terms

Conditions

Respiration Disorders; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 24, 2017
• Study Start: October 9, 2017
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

US (1)