Prospective Evaluation of the Fluid Rapid Influenza Test

NCT00826709 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2009-04-15

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the fluID Rapid Influenza Test's ability in detecting influenza A and influenza B from individuals presenting with signs and symptoms of influenza-like illness (ILI).

Conditions

Interventions

DEVICE

fluID Rapid Influenza Test

The fluID™ Rapid Influenza Test is an in vitro diagnostic assay designed to be used with a reader for the qualitative detection of influenza type A and type B nucleoprotein antigens, and the differentiation of influenza type A subtypes A/H1 and A/H3 antigens associated with the seasonal influenza H1N1 and H3N2, in nasal swabs, nasopharyngeal swabs and nasal wash/aspirate specimens. The test is intended as an aid in the rapid, qualitative diagnosis of influenza type A and type B viral infections in patients symptomatic with influenza-like illness. The fluID™ Rapid Influenza Test is intended for use by a healthcare professional in a laboratory or Point-of-Care (POC).

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31

Countries

  • United States
  • Hong Kong

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826709 on ClinicalTrials.gov