Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2

The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument. The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test: 1. shows sensitivity: * ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or * ≥ 90% for subjects with Ct ≤ 25. 2. show ≥ 98% specificity.