StrongStep® System Device for SARS-CoV-2 Antigen Rapid Test employs immunochromatography technology to detect the SARS- CoV-2 nucleocapsid antigen in human saliva. This test is single use only and intended for sei—testing. It is recommended to use this test within 7 days of symptom onset It is supported by the clinical performance assessment.
INTRODUCTION
The novel coronaviruses belong to the 0 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 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® System Device for SARS-CoV-2 Antigen Test employs immunochromatographic test, this kit collects saliva samples from the saliva adsorption stick at the front of the test card, and the saliva samples move forward under capillary action. If the sample contains a SARS-CoV-2 N protein antigen.it is identified and bound by antibodies labeled on the latex surface to form an immune complex. When the formed immune complex migrates to the nitric acid fiber membrane detection line, to identify the packed antibodies and form a fuchsia detection line (T-lins), showing SARS-Cov-2 antigen positive; if the T-line does not show color, it is a negative result. Another line on the nitric acid fiber membrane is packed with Streptavidin antibodies as a quality control line (C line),to indicate an effective testing process.