Collection of Anonymized Samples

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03319446

Enrollment

1500

Registered

2017-10-24

Start date

2017-10-09

Completion date

2027-10-31

Last updated

2017-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Disease, Healthy, Respiratory Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Inclusion criteria

* Consenting adult

Exclusion criteria

* Weigh less that 110 lb for blood collection

Design outcomes

Primary

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

Countries

United States

Outcome results