Clinical Trial

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

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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.
Trial Details
NCT Number NCT07743970
Lead Sponsor Biocrucible Ltd
Conditions SARS CoV 2 Infection, Influenza A Virus Infection, Influenza B Virus Infection
Enrollment 500 participants
Start Date 2026-08
Primary Completion 2026-10 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-05