Respiratory Syncytial Virus
Conditions
Brief summary
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.
Interventions
DEVICEIn Vitro Diagnostic device to aid in diagnosis
Sponsors
Quidel Corporation
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High level of sensitivity and specificity for performance vs. culture | Culture results within 48 hours of plating | Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture. |
Countries
United States
Outcome results
None listed