← Back to Search

In Vitro Diagnostic

Nasal Swab for Flu

N/A
Waitlist Available
Research Sponsored by Sekisui Diagnostics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject may be of any age and either gender.
Preliminary assessment of the subject by the Investigator/Designee should be suggestive of influenza virus infection. Subject should present with an influenza-like febrile respiratory illness defined as both
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 5 months
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Performance of the ARROW-FLU Influenza Test
Secondary outcome measures
Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nasopharyngeal SwabExperimental Treatment1 Intervention
Nasopharyngeal Swab
Group II: Nasal SwabExperimental Treatment1 Intervention
Nasal Swab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flu Symptoms
2012
N/A
~680

Find a Location

Who is running the clinical trial?

Beaufort CROIndustry Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Sekisui Diagnostics, LLCLead Sponsor
1 Previous Clinical Trials
677 Total Patients Enrolled
Daiva SchmidtStudy DirectorSekisui Diagnostics, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~364 spots leftby Mar 2025