Retrospective and prospective studies evaluating the performance of the SARS-Cov-2 “AQ+ COVID-19 Ag Rapid Test” from InTec on symptomatic and non-symptomatic patients

For the last two years, the SARS-CoV-2 virus spread all around the world and led to the COVID-19 pandemic. The need of methods to control the pandemic and to propose rapid and efficient diagnostic tools has emerged. In this perspective, SARS-CoV-2 rapid antigen detection tests (RADT) have been developed. We performed a retrospective study on 638 collected nasopharyngeal samples used for reference RT-qPCR diagnosis to compare the AQ+ COVID-19 Ag Rapid Test” from InTec (AQ+ InTec test) performance with other commercially available RADT. We analysed the sensitivity and specificity of the different tests and showed a better overall performance of the AQ+ InTec test, which was confirmed on the SARS-Cov-2 Omicron variant. We then conducted a prospective study on 1428 patients, to evaluate the sensitivity and specificity of the AQ+ InTec test on nasal and nasopharyngeal samples in a point of care setting. We showed that sensitivity and specificity reach acceptable criteria regarding the official recommendations of the MDCG 2021-21 in both symptomatic and asymptomatic patients. Overall, the results of these two studies confirm that the AQ+ InTec test is a valuable tool for testing in a pandemic context with a high proportion of asymptomatic patients who are potential carriers for the SARS-CoV-2 virus and is performant on the most current circulating variant Omicron. Highlights ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial IDRCB2020-A02619-30 ### Funding Statement This study was funded by the Regional Hospital of Orleans ### 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: The ethics committee of the Regional Hospital of Orleans (France) and the ethics committee of Sud Ouest and Outre Mer (France) gave 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I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the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 and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors