Assessment of the Clinical Performance of the ARROW-FLU System

Status unconfirmed · Not applicable

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID

NCT02996136

Run by

Sekisui Diagnostics, LLC

People needed

3000

Starts

2016-12-01

Expected to finish

2017-04-01

Last updated by the study team

2016-12-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Presentation within that last 48 hours of developing a subjective feeling of being feverish and/or a temperature recorded at the clinic within the last 48 hours of greater than or equal to 100.5 F and
• At least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore throat, headache, myalgia.
• Written informed consent must be obtained prior to study enrollment:
• A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
• The legal authorized representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the clinical site's IRB).

You may not qualify if…

• The subject underwent a nasal wash/aspirate as part of standard-of-care (SOC) testing during this study visit.
• The subject is undergoing treatment currently or within the past seven (7) days of the study visit with either
• A nasally-administered influenza vaccine (FluMist)
• Anti-viral medication, which may include but is not limited to Amantadine (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu), or Ribavirin.
• The subject is currently receiving or has received within the past thirty (30) days of the study visit anu experimental biologic, drug, or device including either treatment or therapy.

Where it is running

• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Sunrise Medical Research — Lauderdale Lakes, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Avant Research Associates LLC — Crowley, Louisiana, United States
• Tristan Medical Research Center / Regeneris Medical — North Attleboro, Massachusetts, United States
• Children's Mercy — Kansas City, Missouri, United States
• Accent Clinical Vegas — Las Vegas, Nevada, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Clinical Research Solutions LLC (Ohio) — Middleburg Heights, Ohio, United States
• Clinical Research Solutions LLC (Tennessee) — Smyrna, Tennessee, United States
• Marshfield Clinic — Eau Claire, Wisconsin, United States

Full record on ClinicalTrials.gov

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