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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 Sep 4, 2026, 2:36 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
Nov 30, 2016
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update posted
Dec 18, 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 18, 2016 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02996136 live on ClinicalTrials.gov.

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