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CompletedNCT03417869QuickVue FluUpdated Mar 20, 2018

QuickVue Influenza A + B Test Field Study

An observational study in Influenza A, Influenza B, sponsored by Quidel Corporation. Completed at 5 sites in United States. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Quidel Corporation · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,381
Sex
All
01

Study summary

Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.

Read the detailed description

The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.

02

Conditions studied

  • Influenza A, Influenza B

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03

In context

Influenza, Human

2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.

This study's enrollment of 1,381 is above the median of 388 across 332 observational studies indexed under Influenza, Human.

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Lead sponsor

Quidel Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza

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

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:

  1. Male or Female of all ages (with appropriate consent).
  2. The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.

  3. Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).

    1. Nasal congestion
    2. Rhinorrhea
    3. Sore throat
    4. Cough
    5. Headache
    6. Myalgia
    7. Malaise

Exclusion criteria

Exclusion Criteria:

    1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.

      1. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
      1. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,381 participants (actual)
Patient registry
No

Interventions

  • DeviceQuickVue Influenza A+B

    Rapid diagnostic test with IVD, QuickVue Influenza A+B

06

What researchers measure

Primary outcomes

  1. Influenza Diagnostic test result

    rapid IVD test

    Time frame: 10 minutes

07

Study locations

5 sites
  • Alliance Urgent Care
    Phoenix, Arizona 85353, United States
  • Twelve Corners Pediatrics
    Rochester, New York 14618, United States
  • Veritas, P.A.
    Belton, Texas 76513, United States
  • City Doc Urgent Care
    Dallas, Texas 75209, United States
  • Advanced Pediatrics
    Vienna, Virginia 22180, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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

Ran from Feb 2017 to primary completion in Feb 2018, 11 months.

Of 37 industry-sponsored observational studies under Influenza, Human, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 34. This study's 11 months is close to that.

Counting every sponsor, half of 133 studies reached it within 21 months; a quarter within 7 and three quarters within 59.

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

Registered
Jan 24, 2018
First posted
Jan 31, 2018
StartActual
Feb 16, 2017
Primary completionActual
Feb 1, 2018
CompletionActual
Feb 1, 2018
Last update
Mar 20, 2018
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 Mar 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03417869
Lead sponsor
Quidel Corporation
Responsible party
Sponsor
First posted
Jan 31, 2018
Start date
Feb 16, 2017
Primary completion
Feb 1, 2018
Completion
Feb 1, 2018
Last update
Mar 20, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Quidel Corporation

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