The StrongStep® SARS-CoV-2 Antigen Rapid Test is is a rapid immunochromatographic assay assayfor the detection of SARS-CoV-2 virus Nucleocapsid Protein antigen in human Nasalv collected fromindividuals who are Asymptomatic or, Symptomatic of being infected with COVID-19 within the first fivedays of the onset of symptoms. The assay is used as an aid in the diagnosis of COVID-19. It is designedto be used for infection screening and auxiliary diagnosis in Symptomatic and Asymptomatic people.
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 ina few cases.
PRINCIPLE
The StrongStep® SARS-CoV-2 Antigen Test employs immunochromatographic test. Latex conjugated antibodies (Latex-Ab) corresponding to SARS-CoV-2 are dry-immobilized at the end of nitrocellulose membrane strip. SARS-CoV-2 antibodies are bond at the Test Zone (T) and Biotin-BSA is bond at the Control Zone (C).When the sample is added, it migrates by capillary diffusion rehydrating the latex conjugate. If present in sample, SARS-CoV-2 antigens will bind with the conjugated antibodies forming particles.