NCT03035396CompletedNot Applicable
Clinical Performance of the Diassess Influenza A and B Test
Diassess Inc.2 sites in 1 country567 target enrollmentStarted: December 29, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 567
- Locations
- 2
- Primary Endpoint
- Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
Study Overview
Brief Summary
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diassess Influenza A and B Test
Experimental
Intervention: Diassess Influenza A and B Test (Device)
Outcomes
Primary Outcomes
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
Time Frame: One (1) patient visit which is a time frame of one (1) hour
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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