Clinical Trials Logo

Clinical Trial 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.

Clinical Trial Description

This multicenter prospective study will include nasal and nasopharyngeal swabs collected from patients who present with flu-like symptoms and have undergone routine testing for influenza virus strain types A or B. The ARROW-FLU Influenza A&B Test System qualitative results will be compared to a reference method for identification of Influenza A or B to determine the clinical sensitivity and specificity of the device.

The ARROW-FLU Influenza A&B Test system will be performed at CLIA-waived and non-CLIA waived clinical sites. Device operators at CLIA-waived sites will be untrained intended users (e.g. nurses, physician assistants, medical assistants, etc).

A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. After standard of care sampling, two (2) nasal or nasopharyngeal swabs will be obtained from each subject enrolled in the study. The swabs will be collected from the same nostril and alternated in their order of designation for testing (i.e. one for ARROW-FLU Influenza System testing and the other for reference testing. Any swab specimens required for standard of care testing will be collected prior to the specimens for this investigation. Investigational device operators will be blinded to standard of care testing results. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

NCT number NCT02996136
Study type Interventional
Source Sekisui Diagnostics, LLC
Contact Steven Grossman
Phone 781-652-7828
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date December 2016
Completion date April 2017

See also
  Status Clinical Trial Phase
Recruiting NCT03442582 - Afluria Pregnancy Registry
Completed NCT03275389 - A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years Phase 1
Completed NCT02914275 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. Phase 3
Completed NCT04590066 - Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy N/A
Recruiting NCT03778203 - Development of Childhood Anti-influenza Immunity Phase 4
Enrolling by invitation NCT04527614 - Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection N/A
Completed NCT03658629 - Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults Phase 2
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Completed NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02998996 - Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU Phase 1/Phase 2
Completed NCT02867358 - A Clinical Trial of KT07 Capsule in the U.S.A Phase 2
Completed NCT02545543 - A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age Phase 3
Completed NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
Completed NCT02621164 - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents Phase 3
Completed NCT02212106 - A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years Phase 4
Completed NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3
Completed NCT01674205 - Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines Phase 1
Completed NCT01390025 - Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza Phase 1
Completed NCT01381029 - Immune Response to Seasonal Influenza Vaccine in HIV Infected Individuals N/A
Completed NCT04565353 - Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates N/A