VivaDiag™ SARS-CoV-2 Ag Rapid Test.
– Listed by the German Federal Institute for Drugs and Medical Devices (BfArM) –
The VivaDiagTM SARS-CoV-2 Ag Rapid Test is for the rapid, qualitative detection of SARS-CoV 2 nucleocapsid protein antigen in human nasal, oropharyngeal, or nasopharyngeal swab specimens. The test is intended for in vitro diagnostic use only. For professional use only. It is intended for clinical laboratories and healthcare professionals as a point-of-care test. Not for self-testing.
The VivaDiag™ SARS-CoV-2 Ag Rapid Test is based on immunoassay technology. Each test card has anti-SARS-CoV-2 monoclonal antibodies on the detection line (T line) and anti-mouse IgG polyclonal antibodies on the control line (C line). When the extracted sample is added to the sample well, it reacts with the labeled antibody to form a complex, the mixture then migrates across the membrane by capillary action and interacts with the coated anti-SARS-CoV-2 monoclonal antibody on the T-line. If the sample contains SARS-CoV-2 Ag, the T-line will appear purple, indicating that the SARS-CoV-2 Ag is positive. Otherwise, the test result is negative. The test card also contains a control line C, which should appear purple for all valid tests. If the C line does not appear, the test result is invalid, even if the T line is displayed.
Features of the test:
- Easy to use
- Diagnostic sensitivity (SARS-CoV-2): 90.90 percent.
- Diagnostic specificity (SARS-CoV-2): 100 percent.
- Storage at room temperature (2-30℃)
- Quick result in only 15 minutes.
- Application also possible by untrained persons.
Clinical sensitivity /Clinical specificity
A total of 497 specimens were tested with the VivaDiagTM SARS-CoV-2 Ag rapid test. These samples consisted of nasopharyngeal swabs from symptomatic patients. The performance of the VivaDiagTM SARS-CoV-2 Ag rapid test was compared to a commercial molecular assay.