QuickVue Influenza A + B Test Field Study

Influenza A, Influenza B Clinical Trial

— QuickVue Flu  

Official title:

QuickVue Influenza A + B Test Field Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417869
• Other study ID #: CS-0103-02
• Status: Completed
• First received: January 24, 2018
• Last updated: March 16, 2018
• Start date: February 16, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1381
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza A, Influenza B
• Influenza, Human

Intervention

Device:
• QuickVue Influenza A+B
Rapid diagnostic test with IVD, QuickVue Influenza A+B

Locations

Country	Name	City	State
United States	Veritas, P.A.	Belton	Texas
United States	City Doc Urgent Care	Dallas	Texas
United States	Alliance Urgent Care	Phoenix	Arizona
United States	Twelve Corners Pediatrics	Rochester	New York
United States	Advanced Pediatrics	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza Diagnostic test result	rapid IVD test	10 minutes