QuickVue Influenza A + B Test Field Study (QuickVue Flu)

Quidel

Status: Completed

Conditions: Influenza A, Influenza B

Treatments: Device: QuickVue Influenza A+B

Study type: Observational

Funder types: Industry

Identifiers

NCT03417869

CS-0103-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,381 patients

Sex: All

Volunteers: No Healthy Volunteers

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.