Post-Market Surveillance of Six COVID-19 Point-of-Care Tests Using Pre-Omicron and Omicron SARS-CoV-2 Variants

Post-market surveillance of test performance is a critical function of public health agencies and clinical researchers that ensures diagnostics maintain performance characteristics following their regulatory approval. Changes in product quality, manufacturing processes over time, or the evolution of new variants may impact product quality. During the COVID-19 pandemic, a plethora of point-of-care tests (POCTs) were released onto the Canadian market. This study evaluated the performance characteristics of several of the most widely-distributed POCTs in Canada, including four rapid antigen tests (Abbott Panbio, BTNX Rapid Response, SD Biosensor, Quidel QuickVue) and two molecular tests (Abbott ID NOW, Lucira Check IT). All tests were challenged with 149 SARS-CoV-2 clinical positives, including multiple variants up to and including Omicron XBB.1.5, as well as 29 clinical negatives. Results were stratified based on whether the isolate was Omicron or pre-Omicron as well as by RT-qPCR Ct value. The test performance of each POCT was consistent with the manufacturers claims and showed no significant decline in clinical performance against any of the variants tested. These findings provide continued confidence in the results of these POCTs as they continue to be used to support decentralized COVID-19 testing. This work demonstrates the essential role of post-market surveillance in ensuring reliability in diagnostic tools. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was funded by the Public Health Agency of Canada. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics committee/IRB of The Public Health Agency of Canada waived ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All primary research data used to generate this manuscript are included in-text and within Supplementary Data 1.