Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic test for SARS-CoV-2, influenza A and influenza B.
- Who it may be relevant to
- Registry conditions: SARS CoV 2 Infection, Influenza A Virus Infection, Influenza B Virus Infection. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Prospective clinical study conducted at three sites (with a simulated home environment) in Australia for the clinical validation of the NowFuture Digital Flu / COVID Test. Results from the investigational test will be compared to results from a highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2, Influenza A and Influenza B. The primary objective of this study is to evaluate the clinical performance (positive percent agreement, negative percent agreement and 95% confidence intervals for upper and lower bounds) of the NowFuture Digital Flu / COVID Test for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, Influenza A and Influenza B nucleoproteins antigens using AN swab samples collected and processed in the test by lay users.
Interventions
- Diagnostic test Diagnostic test for SARS-CoV-2, influenza A and influenza B
Participants will test themselves or another participant for SARS-CoV-2, influenza A and influenza B. Participants will observe the test result displayed on the device. Participants will be advised to not use investigational test result for diagnostics purposes.
Primary outcome measures
- Investigational Test Result [Time frame: 60 minutes]
- Comparator Test Result [Time frame: 14 days from sample collection to testing in a reference laboratory]
Eligibility criteria
Inclusion criteria
- Written informed consent obtained prior to study enrollment.
- Male or female aged 2 years of age and older.
- Participant is currently exhibiting at least one symptom (i.e. symptomatic) associated with COVID-19 or influenza (such as, but not limited to, fever, headache, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) and must present within 6 days of symptom onset (equates to 5 DPSO). Subject must still be exhibiting symptom(s) on the day of sample collection.
Exclusion criteria
- Participant or participant's legally acceptable representative (for minors) who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.
- Participant who has had a positive SARS-CoV-2, Influenza A and/or Influenza B result within the past 30 days.
- Participant has had seasonal influenza vaccine such as the FluMist/FluMist Quadrivalent live intranasal influenza vaccine and/or the SARS-CoV-2 vaccine within the past 5 days.
- Participant is not able to tolerate sample collection or is not willing to contribute the required swab samples for testing or complete the study procedures.
- Participant is currently undergoing antiviral treatment such as baloxavir marboxil (Xofluza), oseltamivir (Tamiflu®), zanamivir (Relenza®), and peramivir (Rapivab®).
- Participant currently undergoing treatment and/or has undergone treatment within the past thirty (30) days with prescription medication to treat Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.
- Participant who has had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.
- Participant who has had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Australia · 3 centers
- Paratus Western Sydney — Blacktown
- Clinical Trials Institute Torquay — Torquay
- Brecken Health — Bunbury
Identifiers
NCT: NCT07743970 · CLN-0020 · 75A50125C00003