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

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.

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Key information

Conditions

Influenza A Influenza B Respiratory Syncytial Virus (RSV)

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatrics-by-the-Sea, Delray Beach, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

IQuum, Inc.

Industry

Collaborators

Roche Molecular Systems, Inc

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 20, 2014
Registry last updated: Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed