Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Australia / NCT07743970
Active, not recruiting Not applicable

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

NCT07743970 · tracked via the Priya Life Science Australia tracker
Sponsor
Biocrucible Ltd
Phase
Not applicable
Started
2026-08-17
Last updated
2026-10-06

Condition(s) studied

SARS CoV 2 InfectionInfluenza A Virus InfectionInfluenza B Virus Infection

Investigational drug(s) / intervention(s)

Diagnostic test for SARS-CoV-2, influenza A and influenza B

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.

Study 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

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Investigational Test Result — 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 — 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

Trial sites (3)

FacilityCityRegionStatus
Paratus Western Sydney Blacktown New South Wales
Clinical Trials Institute Torquay Torquay Victoria
Brecken Health Bunbury Western Australia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07743970 on ClinicalTrials.gov ↗ ← All trials in Australia