COVID-19 rapid test StrongStep®

for antigensviruscoronavirus

StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette employs immunochromatography technology to detect the SARS- CoV-2 nucleocapsid antigen in human anterior nasal swab specimen. This testis single use only and intended for self-testing. It is recommanded to use this test within 5 days of symptom onset. It is supported by the clinical performance assessment. INTRODUCTION The novel coronaviruses belong totiie p genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel cxjronavinis are the main source of infection; asymptomatic infected people can also be an infectious source. Based on 1he 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. 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. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by SARS-CoV-2 antibodies generating a visible red line. If there are no SARS-CoV-2 antigens in sample, no red line is formed in the Test Zone (T).