Collection of Anonymized Samples

• Conditions: Respiratory Disease; Gastrointestinal Disease; Healthy

• Registration Number: NCT03319446
• Lead Sponsor: BioFire Diagnostics, LLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-09
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-23
• Last Update Submitted: 2017-10-23
• Study First Posted: 2017-10-24
• Last Update Posted: 2017-10-24
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Consenting adult

Exclusion Criteria

• Weigh less that 110 lb for blood collection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PCR Amplification Curves	10 years	PCR amplification curves will be used to confirm the presence or absence of target analytes.

Trial Locations

Locations (1)

BioFire Diagnostics; 🇺🇸 Salt Lake City, Utah, United States