QuickVue Influenza A + B Test Field Study

Completed

• Conditions: Influenza A, Influenza B

• Registration Number: NCT03417869
• Lead Sponsor: Quidel Corporation

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-16
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1381

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

• 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.

  2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.

  3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Influenza Diagnostic test result	10 minutes	rapid IVD test

Trial Locations

Locations (5)

Alliance Urgent Care; 🇺🇸 Phoenix, Arizona, United States

Advanced Pediatrics; 🇺🇸 Vienna, Virginia, United States

City Doc Urgent Care; 🇺🇸 Dallas, Texas, United States

Veritas, P.A.; 🇺🇸 Belton, Texas, United States

Twelve Corners Pediatrics; 🇺🇸 Rochester, New York, United States