Sofia RSV FIA Field Study

Quidel

Status: Completed

Conditions: Respiratory Syncytial Virus

Treatments: Device: In Vitro Diagnostic device to aid in diagnosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01734668

CS-0143-01

Details and patient eligibility

About

The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.

Enrollment: 2,468 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female

2. Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).

3. Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.

4. Subjects must present with one or more of the following to be eligible for enrollment:

   • Fever, ≥ 37.8º C (100º F) at present or within past 24 hours
   • Moderate to severe runny nose*
   • Moderate to severe congestion*
   • Decreased appetite
   • Coughing
   • Sneezing*
   • Wheezing
   • Irritability
   • Decreased activity
   • Labored breathing

Exclusion criteria

1. Subjects nineteen years of age or older.
2. The parent or legal guardian is unable to understand and consent to participation.
3. Current or prior treatment during this infection with anti-RSV Synagis®.