Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 6
- Primary Endpoint
- Investigational Test Result
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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-
- •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.
Arms & Interventions
Study participants
Participants self-collecting and testing the device themselves or collecting a sample and performing the testing on another participant
Intervention: Diagnostic test for SARS-CoV-2, influenza A and influenza B (Diagnostic Test)
Outcomes
Primary Outcomes
Investigational Test Result
Time Frame: 60 minutes
Investigational Test Result determined by the participant using the NowFuture Digital Flu / COVID Test under the test session. Participant will perform test to completion, and determine result as either of the following: * Negative * Positive to SARS-CoV-2 and/or influenza A and/or influenza B * Invalid * Test error
Comparator Test Result
Time Frame: 14 days from sample collection to testing in a reference laboratory
Study staff will collect anterior nasal swab sample from participant. Sample will be stored and transported to a reference laboratory for testing using the an RT-PCR test method. The test will record one of the following results, to be compared to the investigational test result: * Negative * Positive to SARS-CoV-2 and/or influenza A and/or influenza B * Invalid
Secondary Outcomes
No secondary outcomes reported