Clinical Performance of the Diassess Influenza A and B Test

Not Applicable

Completed

• Conditions: Influenza; Flu; Influenza, Human
• Interventions: Device: Diassess Influenza A and B Test

• Registration Number: NCT03035396
• Lead Sponsor: Diassess Inc.

Brief Summary

The primary objective of this study is device feasibility of the Diassess Influenza A and B Test

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-29
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-30
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

• Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
• Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough

Exclusion Criteria

• Subject received nasal vaccine (e.g. FluMist) within the past 10 days
• Subject has been taking or took any antivirals for influenza in the past 30 days
• Subject enrolled in any drug trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diassess Influenza A and B Test	Diassess Influenza A and B Test	-

Primary Outcome Measures

Name	Time	Method
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)	One (1) patient visit which is a time frame of one (1) hour

Trial Locations

Locations (1)

University Health Care Center; 🇺🇸 Syracuse, New York, United States