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

Completed

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

• Registration Number: NCT02067286
• Lead Sponsor: IQuum, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1642

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Pediatrics-by-the-Sea; 🇺🇸 Delray Beach, Florida, United States

Meridian Clinical Research; 🇺🇸 Bellevue, Nebraska, United States

Plano Pediatrics; 🇺🇸 Plano, Texas, United States

Accurate Clinical Research; 🇺🇸 Houston, Texas, United States

Advanced Pediatrics; 🇺🇸 Vienna, Virginia, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Northpoint Pediatrics; 🇺🇸 Indianapolis, Indiana, United States