Influenza A, Influenza B, Respiratory Syncytial Virus (RSV)
Conditions
Brief summary
The objective of this study is to evaluate the clinical sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay when used on the Liat Analyzer to detect the presence or absence of Influenza A, Influenza B, and RSV in a nasopharyngeal swab specimen as compared to an FDA approved NAAT and culture.
Interventions
None listed
Sponsors
Roche Molecular Systems, Inc
IQuum, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours: 1. fever of at least 37.8 C (100F) 2. runny or stuffy nose 3. coughing, wheezing or difficulty breathing 4. sore throat, headache, extreme tiredness, or muscle aches 5. infants: decreased activity, irritability, poor feeding * Subject who are able to understand and consent to participation; for minors under the age of 18, this includes a parent or legal guardian
Exclusion criteria
* Patients who are under-going anti-viral medication now or within the last 7 days. * Patients who received Nasal Spray Flu Vaccine within the last 6 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to an FDA-cleared nucleic acid amplification test | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the sensitivity and specificity of the Liat™ Influenza A/B & RSV Assay and the Liat™ Influenza A/B Assay as compared to culture | 1 day |
Countries
United States
Outcome results
None listed