Clinical Performance of the Diassess Influenza A and B Test

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03035396

Enrollment

567

Registered

2017-01-30

Start date

2016-12-29

Completion date

2017-05-31

Last updated

2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flu, Influenza, Influenza, Human

Brief summary

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

Interventions

DEVICEDiassess Influenza A and B Test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026