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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1642 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Influenza A Influenza B Respiratory Syncytial Virus (RSV)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No