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Not listed Not applicable Interventional

Assessment of the Clinical Performance of the ARROW-FLU System

ClinicalTrials.gov ID: NCT02996136

Public ClinicalTrials.gov record NCT02996136. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Assessment of the Clinical Performance of the ARROW-FLU System for the Detection of Influenza A and B in Symptomatic Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02996136
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Sekisui Diagnostics, LLC
Industry
Enrollment
3,000 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2016 (Type not available)
Primary completion
Apr 2017 (Estimated)
Completion
Apr 2017 (Estimated)
Last update posted
Dec 19, 2016

2016 – 2017

United States locations

U.S. sites
14
U.S. states
12
U.S. cities
14
Facility City State ZIP Site status
Applied Research Center of Arkansas Little Rock Arkansas 72212 —
Clinical Research of South Florida Coral Gables Florida 33134 —
Sunrise Medical Research Lauderdale Lakes Florida 33319 —
Sacred Heart Hospital Pensacola Florida 32504 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
University of Iowa Iowa City Iowa 52242 —
Avant Research Associates LLC Crowley Louisiana 70526 —
Tristan Medical Research Center / Regeneris Medical North Attleboro Massachusetts 02760 —
Children's Mercy Kansas City Missouri 64108 —
Accent Clinical Vegas Las Vegas Nevada 89104 —
Wake Research Associates Raleigh North Carolina 27612 —
Clinical Research Solutions LLC (Ohio) Middleburg Heights Ohio 44130 —
Clinical Research Solutions LLC (Tennessee) Smyrna Tennessee 37167 —
Marshfield Clinic Eau Claire Wisconsin 54701 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02996136, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 19, 2016 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02996136 live on ClinicalTrials.gov.

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