Clinical Performance of the Diassess Influenza A and B Test

February 2, 2018 updated by: Diassess Inc.
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

567

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13202
        • University Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diassess Influenza A and B Test
Device: Diassess Influenza A and B Test

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diassess Inc.

Investigators

  • Study Director: Carol Chen, PhD, Diassess Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 29, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIA 01A-CLI-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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