emmi^® VivaDiag SARS-CoV-2 Antigen Rapid Test

TEST PRINCIPLE AND INTENDED USE:

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 VivaDiagTM 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 labelled 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.

Information:

• listed at the Federal Institute for Drugs and Medical Devices. Search for the product name VivaDiag under the following link: BFARM
• Visit our Dropbox - HERE you will find all the necessary certificates and the package leaflet.
• Weitere Informationen zur Probengewinnung, Handhabung, Testdurchführung beziehungsweise Warnungen, Vorsichtsmassnahmen und Einschränkungen bitten wir der beigefügten Packungsbeilage zu entnehmen.

COMPOSITION:

Each test kit contains test cards, sealed capsules (filled with 300 μL extraction solution), extraction tubes, extraction tube tips, tube racks, sterile swabs and a package insert. Material required but not supplied: Timer.

STORAGE AND HANDLING:

• Keep the test kit in a cool, dry place between 2 and 30 °C.

• Protect from light. Exposure to temperature and/or humidity outside the specified conditions may cause inaccuracies.

• Do not freeze! Use the tests at temperatures between 15 and 30 °C.

• Use the tests at a humidity between 10 and 90 %.

• Do not use the tests after the expiry date (printed on the foil and box). Note: All expiry dates are printed in year-month-day format. 2022-06-18 means 18 June 2022

VivaDiag SARS-CoV-2 Antigen Rapid Test