Vivaciiz SARS-COV-2 / FLOW B AG具有FIA测试Covid19 /影响B抗原FIA测试

VivaDiag^TM SARS-CoV-2/Flu A/Flu B Ag FIA Test is for the rapid,qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen, the influenza A and influenza B viral antigens in human nasal swab or throat 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^TM SARS-CoV-2/Flu A/Flu B Ag FIA Test is based on fluorescence immunochromatography technology. Each test device has one line of anti-SARS coronavirus monoclonal antibody on the detection line (SARS-CoV-2line), one line of anti-influenza A monoclonal antibody on the detection line(A line), one line of anti-influenza B monoclonal antibody on the detectionline (B 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 coronavirus monoclonal antibody, anti-influenza A monoclonal antibody and anti-influenza B monoclonal antibody on the detection line. If the specimen contains SARS-CoV-2, influenza A or influenza B antigen,the fluorescence complex flows through the membrane, are captured by the SARS-CoV-2, influenza A or influenza B antibody, signal intensity of fluorescence reflects amount of the influenza A, influenza B or SARS-CoV-2 captured and is detected by VivaDiagTM POCT Analyzer to show positive result.Otherwise, the test result will be negative.