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NCT07743970

Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia

Sponsor: Biocrucible Ltd

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-08

Completion Date

2027-04

Last Updated

2026-08-05

Healthy Volunteers

Yes

Conditions

SARS CoV 2 Infection Influenza A Virus Infection Influenza B Virus Infection

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.

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.

Locations (3)

Paratus Western Sydney

Blacktown, New South Wales, Australia

Clinical Trials Institute Torquay

Torquay, Victoria, Australia

Brecken Health

Bunbury, Western Australia, Australia