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Assessment of the Clinical Performance of the ARROW-FLU System

NCT02996136 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2016-12-19

No results posted yet for this study

Summary

The ARROW-FLU Influenza A\&B Test is an in vitro diagnostic immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture of an FDA cleared molecular device. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Conditions

  • Influenza, Human

Interventions

DEVICE

Flu Symptoms

Flu Symptoms

Sponsors & Collaborators

  • Beaufort CRO

    collaborator INDUSTRY

  • Sekisui Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Daiva Schmidt · Sekisui Diagnostics, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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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 NCT02996136 on ClinicalTrials.gov