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

IQuum

Status: Completed

Conditions: Influenza A; Respiratory Syncytial Virus (RSV); Influenza B

Study type: Observational

Funder types: Industry

Identifiers

NCT02067286

FR4, Rev. 3.3

Details and patient eligibility

About

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.

Enrollment: 1,642 patients

Sex: All

Volunteers: No Healthy Volunteers

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