A study to evaluate a rapid influenza test in subjects presenting to doctors' clinics with influenza like symptoms

Not Applicable

Completed

• Conditions: Influenza; Infection - Other infectious diseases

• Registration Number: ACTRN12609000352202
• Lead Sponsor: Inverness Medical (IMI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

presented to clinic with 2 of the following symptoms: fever, headache, extreme tiredness, dry cough, sore throat, runny or stuffy nose, muscle aches AND/OR participant is suspected of having influenza.

Exclusion Criteria

Received a nasal vaccine within the last 5 days, or currently taking an antiviral medication for influenza within the past 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the clinical sensitivity and specificity of the Clearview Influenza A+B Test<br>Outcome will be assessed by comparison of the test result obtained in the clinic with a result tested and obtained by a central laboratory , using standard influenza testing, that will also be testing the same sample.[At time of presentation to doctors clinic]

Secondary Outcome Measures

Name	Time	Method
To demonstrate accuracy of the Clearview Influenza A+B Test in the hands of untrained users in the physician clinic.Outcome will be assessed by comparison of the test result obtained in the clinic with a result tested and obtained by a central laboratory that will also be testing the same sample.[At time of presentation to doctors clinic]