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Trial record 2 of 2 for:    iquum

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

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ClinicalTrials.gov Identifier: NCT02067286
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
Roche Molecular Systems, Inc
Information provided by (Responsible Party):
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.

Condition or disease
Influenza A Influenza B Respiratory Syncytial Virus (RSV)

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Study Type : Observational
Actual Enrollment : 1642 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot




Primary Outcome Measures :
  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 [ Time Frame: 1 day ]

Secondary Outcome Measures :
  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 [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
Nasopharyngeal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects must be exhibiting symptoms characteristic of influenza or RSV
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067286


Locations
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United States, Florida
Pediatrics-by-the-Sea
Delray Beach, Florida, United States, 33483
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Indiana
Northpoint Pediatrics
Indianapolis, Indiana, United States, 46256
United States, Nebraska
Meridian Clinical Research
Bellevue, Nebraska, United States, 68005
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States
United States, Texas
Accurate Clinical Research
Houston, Texas, United States, 77034
Plano Pediatrics
Plano, Texas, United States, 75093
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
IQuum, Inc.
Roche Molecular Systems, Inc

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Responsible Party: IQuum, Inc.
ClinicalTrials.gov Identifier: NCT02067286     History of Changes
Other Study ID Numbers: FR4, Rev. 3.3
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases