VAXDIAX

The VAXDIAX antibody test is an in-vitro diagnostic rapid test for the qualitative detection of highly specific neutralising antibodies against SARS-CoV-2 after COVID-19 vaccination.

 

The test, developed, produced and CE-certified in Germany, is set to an analytical sensitivity of 35 BAU/ml. Depending on the titre strength, the VAXDIAX test indicates the status of protective antibodies in just 10 minutes according to the WHO International Standard for anti-SARS-COV-2-immunoglobulin.

This point-of-care test must be performed by medically trained personnel and is used as a tool to detect a sufficiently high and protective antibody titre against SARS CoV-2 in the blood. The test can be used in any laboratory setting as well as in medical facilities such as test centres, pharmacies, clinics, doctors’ offices, elderly people’s and nursing homes that meet local and regulatory requirements.
Federal Institute for Drugs and Medical Devices

Officially registered with the Federal Institute for Drugs and Medical Devices under document no. 00102288 and registration no. DE/CA08/3.1.126-04

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Application

The VAXDIAX antibody test uses a blood sample taken from the fingertip after a painless prick with a safety lancet using a pipette. To perform the test, one drop of blood and two drops of buffer are then placed in a test cassette. After 10 minutes at the latest, the test result can be read directly in the readout window via a control line and a test line. This means that the test can be used quickly, efficiently and safely at any location.

The exact procedure and the correct interpretation of the VAXDIAX antibody test are described in the instructions for use and can be seen in the illustrated short instruction. Both documents can be downloaded here.

» Instructions for Use (PDF)

» Short instruction (PDF)

VAXDIAX Short Instruction

Possible Applications

Since late 2019, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has spread globally, becoming one of the largest known pandemics. Vaccination against the virus is one of the most important tools in combating the pandemic. However, not all vacci­nated people develop robust and protective antibody titres and thus, also depending on the vaccine used or the specific endpoint in the study, protection rates between 50 % and 95 % have been reported.

 

In principle, the reaction of the immune system to a vaccination can be a cellular and a humoral response. In the case of the humoral response, it is primarily the antibodies formed that provide evidence of a corresponding reaction and possibly protection. Of particular interest are antibodies to the Receptor Binding Domain (RBD) of the virus since they correlate with the neutralising antibody titre and are thus decisively responsible for protection. The neutralising antibodies prevent the binding of the virus to the specific cell receptor and thus the penetration of the virus into the host cell.

The VAXDIAX antibody test is a rapid immunochromatographic test for the qualitative determination of antibodies to the Receptor Binding Domain (RBD) of the spike protein of SARS CoV-2 after a vaccination. Thanks to this qualitative detection, the test is suitable for checking specific antibody formation from 14 days after a complete vaccination and thus for monitoring an existing antibody titre.

Key Advantages of VAXDIAX

  1. Detection of highly specific neutralising antibodies against SARS-CoV-2 after COVID-19 vaccination
  2. Adjusted to an analytical sensitivity of 35 BAU/ml (WHO International Standard)
  3. Developed, manufactured and CE-certified in Germany
  4. From test to result in just 10 minutes
  5. Can be used at any time and any place

Partnerships

BacTrace BioTec AG works closely with a renowned and decorated Scientific Advisory Board as well as with internationally recognized universities and scientific institutions.

  • Prof. Dr. Dr. h.c. mult. Willi Jäger, Universität Heidelberg
  • Dipl.-Ing. Manfred Opel, Brigade General a.D.
  • Prof. Dr. Valentin N. Pavlov, Bashkir State Medical University
  • Priv.-Doz. Dr. med. Michael T. Pawlik, Universität Regensburg
  • Dr. med. Sören Wagner, Harvard Medical School
  • Prof. Dr. med. Dr. h.c. mult. Wolf F. Wieland, Universität Regensburg
  • Dr. med. Hans Hermann Wörl
Contact

Institutions and businesses can order the VAXDIAX Post Vaccination COVID-19 Antibody Test directly from the Online-Shop of our German distribution partner igefa. If you require further information about our product, please contact us directly.