Humasis COVID-19 Ag Test

General information: Severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is the name given to the new coronavirus that originated in 2019 and is the causative agent of COVID-19 (the disease caused by the SARS-CoV-2 virus). The virus was originally known as the 2019-nCoV nomenclature. SARS-CoV-2 is a new coronavirus strain that has not been previously identified in humans. The genome of these viruses consists of single-stranded RNA protected by two protein coatings - nucleocapsid and capsid. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. Intended use: Humasis COVID-19 test is a one step in vitro diagnostic test based on immunochromatographic assay. It is designed for qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimen of suspected patients. Fast results within 15 mins Easy to use - in 3 rapid steps Specimen - nasal or nasopharyngeal swab All necessary reagents provided (individually packed) Highest accuracy - Sensitivity and Specificity Principle of the test: Humasis COVID-19 Ag Test uses monoclonal antibodies specific to COVID-19 antigens to detect COVID-19 specific antigens in human nasopharyngeal swab specimens. A nitrocellulose membrane strip in the device has a test line and a control line. The test line is pre-coated with anti-mouse monoclonal antibody to SARS-CoV-2 nucleocapsid and RBD for detection of SARS-CoV-2 antigens and the control line is coated with goat anti-mouse IgG. When the extracted swab specimen is added to the sample well, it migrates to the conjugate pad, which contains antibodies against the SARS-CoV-2 antigen conjugated with colloidal gold. If the sample contains SARS-CoV-2 antigens, an antigen-antibody conjugate complex is formed. The complex continues to migrate across the membrane until it reaches the detection area (test line) where the complex binds to immobilized antibodies and forms a visible colored band in the test line. The sample continues to move along the membrane until it reaches the control line, where excess conjugate binds and forms a second visible line. This control line indicates that the sample migrated along the membrane as intended and that the test was performed properly. Reagents and materials included: Test devices individually packed in aluminum bags (25 tests / box) Disposable test tubes with extraction buffer (25 pieces / box ) Filter cap (25 pieces / box ) Sterilized swabs for sampling (25 pieces / box ) Instructions for use (1 St.) Performance characteristics : Sensitivity 95.5% Specificity 100% CE-IVD certificated