Sofia RSV FIA Field Study

Quidel Corporation2,468 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,468

Conditions

Respiratory Syncytial Virus

Interventions

In Vitro Diagnostic device to aid in diagnosisDEVICE

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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®.

Locations (17)

Best Medical Group

Phoenix, Arizona, United States

Santo Nino Medical Clinic

Panorama City, California, United States

Outcomes

Primary Outcomes

High level of sensitivity and specificity for performance vs. culture

Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.

Time frame: Culture results within 48 hours of plating

Data from ClinicalTrials.gov

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