RecruitingNot ApplicableNCT07743970

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


Sponsor

Biocrucible Ltd

Enrollment

500 participants

Start Date

Aug 17, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Diagnostic test for SARS-CoV-2, influenza A and influenza B for people with influenza a virus infection, influenza b virus infection, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 2 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDiagnostic 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.


Locations(3)

Paratus Western Sydney

Blacktown, New South Wales, Australia

Clinical Trials Institute Torquay

Torquay, Victoria, Australia

Brecken Health

Bunbury, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT07743970


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