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
1 other identifier
observational
1,642
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 31, 2016
August 1, 2016
1.2 years
February 14, 2014
August 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Eligibility Criteria
Subjects must be exhibiting symptoms characteristic of influenza or RSV
You may qualify if:
- Patients exhibiting 2 or more symptom groups characteristic of influenza and/or RSV at the time of visit or within the past 48 hours:
- fever of at least 37.8 C (100F)
- runny or stuffy nose
- coughing, wheezing or difficulty breathing
- sore throat, headache, extreme tiredness, or muscle aches
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IQuum, Inc.lead
- Roche Molecular Systems, Inccollaborator
Study Sites (8)
Pediatrics-by-the-Sea
Delray Beach, Florida, 33483, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Northpoint Pediatrics
Indianapolis, Indiana, 46256, United States
Meridian Clinical Research
Bellevue, Nebraska, 68005, United States
Cleveland Clinic
Cleveland, Ohio, United States
Accurate Clinical Research
Houston, Texas, 77034, United States
Plano Pediatrics
Plano, Texas, 75093, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
Biospecimen
Nasopharyngeal swabs
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 20, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 31, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share