The Rapid Antigen Test for Novel Coronavirus (SARS-Cov-2) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens in nasopharyngeal swabs swabs using the rapid immunochromatographic method. Identification is based on the monoclonal antibodies specific for the novel coronavirus antigen. This product is intended for professional use in the laboratory and at the point of care. Available at www.Rutronik24.com
• High clinical sensitivity (92.00%) and specificity (99.26%)
• Rapid and reliable test results in 15 minutes
• Can be performed with nasal samples
• All test components are included
• Tested by Paul-Ehrlich-Institute
• Officially listed by the federal institute for pharmaceuticals and medical products
The current test card is based on the specific antibody-antigen reaction and immunoanalysis technology. The test card contains colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad, matched SARS-CoV-2 N protein monoclonal antibody immobilized on the Test area and corresponding antibody in the quality control area. During testing, the N protein in the sample combines with the colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad. The conjugates migrate upward under capillary effect, and subsequently captured by the N protein monoclonal antibody immobilized in the Test area. The higher the contents of N protein in the sample, the more the conjugates captures and the darker the color in the test area is. If there is no virus in the sample or the virus content is lower than the detection limit, then there is no color demonstrated in the test area. Regardless of the presence or absence of the virus in the sample, a purple stripe will appear in the quality control area. The purple stripe in the quality control area is a criterion for the judgment of whether or not there is enough sample and whether or not the chromatography procedure is normal.