INTENDED USE The StrongStep® SARS-CoV-2 Antigen Rapid Test is a rapid immunochromatographic assay for the detection of SARS-CoV-2 virus Nucleocapsid Protein antigen in human Saliva collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. The assay is used as an aid in the diagnosis of COVID-19.INTRODUCTION The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.