Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV

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.

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