The Immupass VivaDiag ™ SARS-CoV-2 Ag Rapid Test is for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in a nasal or throat swab specimen. The test is for in vitro diagnostic use only. For professional use only.
Principle and intended use
The Immupass VivaDiag ™ SARS-CoV-2 Ag Rapid Test is intended for clinical laboratory and healthcare professional use for point of care testing only. Not for home testing. The Immupass VivaDiag ™ SARS-CoV-2 Ag Rapid Test is based on immunoassay technology. Each test device has an anti-SARS coronavirus monoclonal antibody line on the detection line (T line) and a polyclonal anti-mouse IgG line on the quality control line (Cline).
When the extracted sample is added to the sample well, it will react with the 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 on the detection line. . If the sample contains SARS-CoV-2 antigen, the detection line will appear purplish red, indicating that the SARS-CoV-2 antigen is positive. Otherwise, the test result will be negative. The test device also contains a quality control line C which should appear purplish red for all valid tests. If the QC line C does not appear, the test result will be invalid even if the detection line appears.
Each test kit contains 25 test devices, 25 extraction tubes (pre-filled with 300 μL extraction solution/tube), filtered mouthpieces, 1 tube holder, 25 sterile swabs, and 1 insert.
Test principle: Colloidal gold
Sample type: nasal swab, oropharyngeal swab, or nasopharyngeal swab
Sample volume: 60 μL
Test time: 15 min
Operating temperature: 15-30 ℃
Storage temperature: 2-30 ℃
Shelf Life (unopened): 24 months