EuGeni COVID-19 (SARS-CoV-2) Antigen Rapid Diagnostic Test Clinical Performance Study in Victoria

Prospective nasal and throat swabs will be collected from consenting participants who have COVID-19 infection and also from participants who are likely to be healthy (will test negative) for COVID-19 infection. Swabs will be tested on the trial IVD device to detect COVID-19 infection (SAR-CoV-2 antigen). Results from the trial device will be compared against standard of care reference PCR results. The study design is as follows: This study is a prospective clinical study using an in vitro diagnostic (IVD) rapid test called EuGeni SARS-CoV-2 Ag RDT and EuGeni Reader. The intervention required for this trial is the randomised collection of bilateral nasal anterior in arm A and a bilateral combined mid-turbinate and throat swab in arm B and standard of care mid-turbinate and throat swabs, which are then compared against a previously collected standard of care mid-turbinate and throat swabs (taken as part of local standard of care COVID-19 testing). Participants will be asked to provide consent, prior to the conduct of any study procedures. Participant samples with a collection date and the number of days since onset of symptoms, if any, will be recorded. Participants that have received a COVID-19 positive result by RT-PCR or rapid antigen test (RAT), will be re-tested with EuGeni SARS-CoV-2 Ag RDT and EuGeni Reader, as well as RT-PCR. Both asymptomatic and symptomatic positive patients will be included. If symptomatic, the RDT test will be done within 7 days post onset of symptoms. Participants that have received a COVID-19 negative result by RT-PCR or RAT will be re-tested with the RDT and RT-PCR. For the trial component, two separate swab collections will be collected per participant, as follows: Pilot: Around 15 known positives and 10 negative participant anterior nasal for IVD testing and a combined nose and throat samples (for a second confirmatory PCR test) will be recruited and tested in a pilot arm of the study. This will assist in determining the feasibility of the study design. Upon successful completion of the pilot, Arm A will run, followed by Arm B. Arm A: All participants will provide two swabs as follows. The first swab, for bilateral anterior anterior nasal sampling, will be tested by healthcare professionals using swabs provided in the EuGeni SARS-CoV-2 Ag RDT kit, as per the instructional product information. The second swab will be taken from the bilateral mid-turbinate and throat, using a swab supplied by the Sponsor, placed into viral transport media (VTM) and then transported to the specified laboratory for RT-PCR testing, as per standard laboratory procedures. Target number of trial-derived swab collections are: a) 50100 RT-PCR confirmed COVID-19 positive nasal (nasal anterior anterior) swabs. b) at least 50200 RT-PCR confirmed COVID-19 negative nasal (nasal anterior anterior) swabs. Arm B: All participants will provide two swabs as follows. The first swab, for combined bilateral mid-turbinate and throat nasal sampling will be tested by healthcare professionals using swabs provided in the EuGeni SARS-CoV-2 Ag RDT kit, as per the instructional product information. The second swab will be taken from the bilateral mid-turbinate and throat, using a swab supplied by the Sponsor, placed into viral transport media (VTM) and then transported to the specified laboratory for RT-PCR testing, as per standard laboratory procedures. Target number of trial-derived swab collections are: a) 50 RT-PCR confirmed COVID-19 positive nasal (combined bilateral mid-turbinate and throat) swabs. b) at least 50 RT-PCR confirmed COVID-19 negative nasal (nasal anterior) swabs. The above results will be validated by comparing captured research data against accredited COVID-19 RT-PCR standard of care data, which is obtained from electronic medical records, from the consenting participants. Participants within the relevant arms will be educated on how to self-collect the respective samples of either bilateral anterior nasal, combined bilateral mid-turbinate and throat mid-turbinate and nasopharyngeal nose and throat standard of care PCR samples, under supervision by a research study team member. Participant demographics and COVID-19 medical history will be collected as follows: o Gender. o Age at the time of intervention and year of birth. o Race. o COVID-19 vaccination, including name of the vaccine and number of doses. o Any previous anti-viral medications.