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CompletedNCT01431768Updated Apr 30, 2014

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

An interventional study of Respirio Flu Test in Influenza, sponsored by Respirio Pty Ltd. Completed at 2 sites in Australia. Open to participants aged 7 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-30.

Sponsored by Respirio Pty Ltd · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
7 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Influenza

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Keywords

  • Influenza
  • Human
  • Orthomyxoviridae infections
  • RNA Virus Infections
  • Virus Diseases
  • Respiratory Tract infections
  • Respiratory Tract Diseases
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 250 is close to the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

This is the only study on the registry with Respirio Pty Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Recent craniofacial abnormality or injury (last 3 months);
  2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;
  3. Craniofacial abnormality, such as severe deviation of the nasal septum;
  4. Onset of clinical Influenza - Like Illness (ILI) symptoms > 5 days;
  5. Know history of allergic reaction to plastics or adhesives;
  6. Subject (or parent/guardian) unwilling or unable to give informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (estimated)

Interventions

  • DeviceRespirio Flu Test

    The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B.

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of Influenza A

    Time frame: Day 1

Secondary outcomes

  1. Sensitivity and specificity of Influenza B

    Time frame: Day 1

07

Study locations

2 sites
  • Taringa 7 Day Medical Practice
    Brisbane, Queensland 4068, Australia
  • Capalaba Medical Centre
    Brisbane, Queensland 4157, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01431768
Lead sponsor
Respirio Pty Ltd
Responsible party
Sponsor
First posted
Sep 12, 2011
Start date
Jul 2011
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Apr 30, 2014

Study contacts

Julie Todhunter, MBBS
principal investigator · Unaffliated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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