SARS-CoV-2 Antigen Rapid Test(25test)
INTENDED USE
TheStrongStep® SARS-CoV-2 Antigen Rapid Test is a rapid immunochromatographic assay for the detection of COVID-19 antigen to SARS-CoV-2 virus in human Throat/Nasopharyngeal swab. The assay is used asan 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.
PRINCIPLE
The StrongStep® SARS-CoV-2 Antigen Test employs chromatographic lateral flow test device in a cassette format. Latex conjugated antibody (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 are 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 least 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 anti- SARS-CoV-2 antigens in sample, no red line is formed in the Test Zone(T). The streptavidin conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the Biotin-BSA aggregating in a line, which indicates the validity of the test.
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