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Comparison of Fluid Rapid Influenza and BinaxNOW Influenza A & B

NCT00828100 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2009-03-06

No results posted yet for this study

Summary

The primary objective of this study is to compare the performance of the investigational fluid Rapid Influenza Test and the BinaxNOW® Influenza A \& B Test in detecting influenza type A and influenza type B.

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) setting.

DEVICE

BinaxNOW® Influenza A & B

The BinaxNOW Influenza A \& B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.

Sponsors & Collaborators

  • Nanogen, Inc.

    lead INDUSTRY

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
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00828100 on ClinicalTrials.gov