Multi-Center Study of In Vitro Diagnostic Devices for the Detection of Influenza A, Influenza B, and RSV

IQuum, Inc.7 sites in 1 country1,642 target enrollmentJanuary 2014

ConditionsInfluenza A Influenza B Respiratory Syncytial Virus (RSV)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Influenza A
Sponsor: IQuum, Inc.
Enrollment: 1642
Locations: 7
Primary Endpoint: 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
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

April 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

IQuum, Inc.

Responsible Party

Sponsor

Eligibility 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:
•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

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

Outcomes

Primary Outcomes

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