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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
500
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.
Paratus Western Sydney
Blacktown, New South Wales, Australia
RECRUITINGClinical Trials Institute Torquay
Torquay, Victoria, Australia
RECRUITINGBrecken Health
Bunbury, Western Australia, Australia
RECRUITINGInvestigational Test Result
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
Time frame: 60 minutes
Comparator Test Result
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
Time frame: 14 days from sample collection to testing in a reference laboratory
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