A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.

The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessment of the Clinical Performance of the ARROW-FLU System

NCT02996136

Influenza, Human

UNKNOWN NA

Immunogenicity and Reactogenicity of Fluarix™ (Influsplit SSW®) 2007/2008 in People 18 Years Old or Above

NCT00476307

Influenza

COMPLETED PHASE3

Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults

NCT06125691

Influenza, Human

COMPLETED PHASE1

Detection of Influenza A, Influenza B, and RSV Using the Liat™ Assays on the Liat™ Analyzer

NCT02067286

Influenza A Influenza B Respiratory Syncytial Virus (RSV)

COMPLETED

Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B

NCT01753531

Influenza, Human

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Tract Infection Bronchitis Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing
* The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
* The specimen is a nasopharyngeal swab

Exclusion Criteria

* The specimen is NOT a nasopharyngeal swab
* The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.

Eligible Sex

ALL

Accepts Healthy Volunteers

No