Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B

Respirio

Status

Completed

Conditions

Influenza

Treatments

Device: Respirio Flu Test

Study type

Interventional

Funder types

Industry

Identifiers

NCT01431768

RESP11001

Details and patient eligibility

About

This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for identifying Influenza A infection Polymerase Chain Reaction (PCR).

The secondary aim is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.

Enrollment

250 estimated patients

Sex

All

Ages

7 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects aged between 7 and 80 years (inclusive);
Fever > 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;
Cough or sore throat;
Rhinorrhea or nasal congestion;
≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;
Subject (or parent/guardian) capable and willing to give informed consent;
Subject provides written assent according to his/her age, if applicable.

Exclusion criteria

Recent craniofacial abnormality or injury (last 3 months);
Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
Craniofacial abnormality, such as severe deviation of the nasal septum;
Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;
Know history of allergic reaction to plastics or adhesives;
Subject (or parent/guardian) unwilling or unable to give informed consent.