To optimise and undertake clinical validation of a new point-of-care diagnostic test for COVID-19 (CoOp study).

This is a prospective observational cohort study seeking the recruitment of up to 150 SARS-CoV-2-positive individuals within the Alfred Hospital care pathway. Study participants will have a clinical encounter across two time points, the first time point occurring within 5 days after testing positive for COVID-19 (acute phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase). Study participants will provide two swabs at the acute-phase encounter and two swabs at the convalescent-phase encounter. Each swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample (i.e., combined throat and nasal swab). Samples will be self-collected. Sample self-collection instructions including sample techniques and procedures are provided, along with video instruction on nasal/throat sample collections. Sample collection: Once consented the Research Coordinator (RC) will go over the study sampling techniques and procedures provide access to video instructions on nasal/throat sample collections and arrange a suitable time to drop off their study kit. Given the initial study, the visit will occur when the participant is COVID-19 positive, a member of the research team will deliver the study pack to their place of residence while isolating. This pack will contain the two swabs for the throat and bilateral mid-turbinate nasal sample collection, self-collection instructions, an additional bag for storage of collected samples, and research team contact details. The RC will contact the participant either via telehealth or phone to instruct them on sample collection and answer any questions they may have. For the second study visit, participants will have the option for the visit to occur at their place of residence or to attend to The Alfred Hospital. The swabs, once collected, will be placed into labelled biohazard bags. These are then placed in the storage bag and kept in the fridge or esky provided until collected by the RC. The RC will collect the samples within 3 days and transport them back to The Alfred. Sample testing: The one swab will be used for optimisation and clinical validation of the ZiP-CoVx-P2 point-of-care test platform, to detect the presence of SARS-CoV-2 virus RNA, including estimates of test sensitivity and specificity. The ZiP-CoVx-P2 is an integrated cartridge-instrument platform that uses novel, low-cost nucleic acid amplification test (NAATs) technology. This test platform uses respiratory swabs and provides a test result within 30 minutes of sample collection.