VivaChek Biotech (Hangzhou) Co., Ltd.

Product Introduction：

VivaDiag™ SARS-CoV-2 Ag FIA Test is for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab, oropharyngeal swab or nasopharyngeal swab specimen. The test is for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professional use only for point-of-care testing. Not for at-home testing.

VivaDiag™ SARS-CoV-2 Ag FIA Test is based on fluorescence immunochromatography technology. Each test device has one line of anti-SARS-CoV-2 monoclonal antibody on the detection line (T line) and one line of anti-mouse IgG polyclonal antibody on the quality control line (C line). When extracted specimen is added to the specimen well, it will react with the fluorescence labeled antibody to form a complex, the mixture then migrates through the membrane by capillary action and interacts with the coated anti-SARS-CoV-2 monoclonal antibody on the detection line. If the specimen contains SARS-CoV-2 antigen, the fluorescence complex flows through the membrane, are captured by the SARS-CoV-2 antibody, signal intensity of fluorescence reflects amount of the SARS-CoV-2 captured and is detected by VivaDiag^TM POCT Analyzer VIM1000 to show positive result. Otherwise, the test result will be negative.