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

August 30, 2016 updated by: IQuum, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1642

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Delray Beach, Florida, United States, 33483
        • Pediatrics-by-the-Sea
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Northpoint Pediatrics
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Meridian Clinical Research
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States, 77034
        • Accurate Clinical Research
      • Plano, Texas, United States, 75093
        • Plano Pediatrics
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects must be exhibiting symptoms characteristic of influenza or RSV

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome 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
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IQuum, Inc.

Collaborators

Roche Molecular Systems, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR4, Rev. 3.3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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