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NCT03035396 Clinical Trial

Clinical Performance of the Diassess Influenza A and B Test

Influenza Clinical Trial

Official title:
Clinical Performance of the Diassess Influenza A and B Test

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03035396
Other study ID # DIA 01A-CLI-002
Secondary ID
Status Completed
Phase N/A
First received January 20, 2017
Last updated February 2, 2018
Start date December 29, 2016
Est. completion date May 2017

Study information
Verified date February 2018
Source Diassess Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 567
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Diassess Influenza A and B Test

Locations
Country Name City State
United States University Health Care Center Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
Diassess Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diassess test measurement agreement with Polymerase Chain Reaction (PCR) One (1) patient visit which is a time frame of one (1) hour
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