Clinical Performance of the Diassess Influenza A and B Test

Diassess

Status: Completed

Conditions: Influenza, Human; Influenza; Flu

Treatments: Device: Diassess Influenza A and B Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03035396

DIA 01A-CLI-002

Details and patient eligibility

About

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

Enrollment: 567 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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567 participants in 1 patient group

Diassess Influenza A and B Test

Experimental group

Treatment:

Device: Diassess Influenza A and B Test