Intended use and principle:
Spartacus-Biomed presents the COVID-19 ANTIGEN RAPID TEST for a rapid detection of the virus as a diagnostic aid for the COVID-19. This device is based on the rapid immunochromatography technique for the detection of the virus in nasal swab and nasal aspirate samples. This lateral flow device can reliably detect the new SARS-CoV-2 virus in 10 minutes. The test device is composed of a sample pad, a reagent pad and a reaction membrane. The assembled strip is fixed inside a plastic cassette. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against SARS-CoV-2; the reaction membrane contains the secondary antibodies for SARS-CoV-2 and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane. In 2019, a new coronavirus disease COVID-19 was reported in Wuhan, China. This disease subsequently affected a majority of countries in the world causing significant lung damage and respiratory failure. The pathogen has been identified as a coronavirus similar to that of SARS and MERS. He was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 Antigen Rapid Test is used for the in vitro qualitative detection of the virus in the throat swabs, sputum samples of suspected pneumonia infected patients or suspected clustering cases. When the sample is added into the sample well, conjugates (previously dried on the reagent pad) are dissolved and migrate along with the sample. If SARS-CoV-2 is present in the sample, a complex formed between the anti- SARS-CoV-2 conjugate and the virus will be caught by the specific anti- SARS-CoV-2 monoclonal coated on the T region. Results appear in 10 minutes in the form of a pink line.