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Enrolling by invitationNCT03319446Updated Oct 24, 2017

Collection of Anonymized Samples

An observational study in Healthy, Respiratory Disease and Gastrointestinal Disease, sponsored by BioFire Diagnostics, LLC. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by BioFire Diagnostics, LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
  • Respiratory Disease
  • Gastrointestinal Disease
03

In context

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 250 across 134 observational studies indexed under Respiration Disorders.

Browse Respiration Disorders studies →

Lead sponsor

BioFire Diagnostics, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Consenting adult

Exclusion criteria

Exclusion Criteria:

  • Weigh less that 110 lb for blood collection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. PCR Amplification Curves

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

    Time frame: 10 years

07

Study locations

1 site
  • BioFire Diagnostics
    Salt Lake City, Utah 84103, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Oct 2027, 120 months after the start.

Of 75 observational studies under Respiration Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's planned 120 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Oct 24, 2017
StartActual
Oct 9, 2017
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Oct 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03319446
Lead sponsor
BioFire Diagnostics, LLC
Responsible party
Sponsor
First posted
Oct 24, 2017
Start date
Oct 9, 2017
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 24, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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BioFire Diagnostics, LLC

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