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Testing patients visiting a general practice suspected of having Influenza using an in-home test for influenza vs. PCR gold-standard test

Testing the flu@home test (QuickVue lateral flow test for influenza and RDT application) for patients with an influenza-like illness visiting a general practitioner vs. PCR gold-standard test for influenza.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001087145
Enrollment
364
Registered
2019-08-06
Start date
2019-07-18
Completion date
2020-07-24
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

The overall aim of the Australian arm of the Seattle Flu Study is to evaluate the accuracy of the flu@home self-test for influenza by recruiting patients who present with an influenza-like illness to a GP or nurse practitioner who is a member of ASPREN for national influenza surveillance activities. Flu@home test results will be compared to PCR test results, which is considered to be the gold-standard for detection of influenza.

Interventions

Adults who present to a general practitioner with an influenza-like illness and are swabbed for surveillance purposes are given the opportunity the participate in this study if they have an Android or iOS smartphone or tablet. The patient will take the self-test home. The test consists of the QuickVue test for influenza A and B, and the flu@home app. The QuickVue test is a lateral flow test. It requires the patient to take a nasal swab and elute the swab into the test tube with the reagents

Adults who present to a general practitioner with an influenza-like illness and are swabbed for surveillance purposes are given the opportunity the participate in this study if they have an Android or iOS smartphone or tablet. The patient will take the self-test home. The test consists of the QuickVue test for influenza A and B, and the flu@home app. The QuickVue test is a lateral flow test. It requires the patient to take a nasal swab and elute the swab into the test tube with the reagents provided, and put a test strip into the test tube. If positive, a pink line will appear on the test strip. All instructions for performing the test are guided by the app. The app will also ask the patient to answer questions about symptom history and risk factors, and also ask the patient to take a photo of the test strip once completed. This, combined with the QuickVue test, will give them an accurate result in approximately 20 minutes, via the app. This result will be compared to the gold-standard PCR result (from surveillance data), the results of which are provided to their GP within 24 hours of receipt of the sample at the lab. The app data are matched up to the PCR data via a unique barcode identification number. For the first 4 weeks of the study these data are continually analysed by the flu@home team and used to develop an optimal algorithm which incorporates the PCR data, photograph, and patient survey data to provide the patient with a highly accurate result.

Sponsors

The University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Must be swabbed for surveillance purposes (ie. present to an ASPREN GP or nurse practitioner with an influenza-like illness i.e. fever, cough and fatigue). Must have an Android or iOS smartphone or tablet. Must be 18 year or older.

Exclusion criteria

Children. People without an influenza-like illness who aren't swabbed for surveillance purposes. People without an Android or iOS smartphone or tablet.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026