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08.05.2020
With immediate effect: 3 million proven serological tests for SARS-CoV-2. Further 17 million tests available.
With immediate effect: 3 million proven serological tests for SARS-CoV-2. Further 17 million tests available.

The antibody test gives vital information on previously undetected cases as well as epidemiology and immunity
Based on a blood sample, the serological test for antibody detection is the ideal downstream supplement to direct detection of the virus by PCR. This test is crucial for answering epidemiological questions. The results of antibody studies, for example, are significant in achieving more accurate assessment of the progression and severity of the pandemic.
The antibody test uses a blood sample to detect specific antibodies that have been produced in response to SARS-CoV-2 by the immune system. These antibodies are measured in the form of immunoglobulin levels. A positive result for immunoglobulin M (IgM) indicates an early-phase infection (from about 3 days) and a positive result for immunoglobulin G (IgG) indicates a later phase of the infection (from about 5 to 7 days). In contrast to other serological test procedures, the CLIA test procedure now offered by medac measures IgM and IgG levels separately.
   
By using medac's antibody test, it is therefore possible to do more than just determine whether someone has been infected with the virus and is therefore immune. Medac's test uses IgM measurement to provide additional valuable information as to whether a person is infected at the time of testing. Subsequent PCR testing to confirm the acute infection thereby allows for detection of patients without typical symptoms who would not otherwise have been diagnosed as COVID-19 cases. This is of great importance in the fight against the SARS-CoV-2 pandemic, helping to prevent the unchecked spread of undetected cases.
   
The existence of immunity to SARS-CoV-2 depends on neutralising antibodies, which can render the virus harmless. Neutralising antibodies bind to two specific structures of the SARS-CoV-2 virus. These structural proteins are called antigens (S and N antigens). Neutralising antibodies – against the N antigen in particular – have already been detected. Both antigens are used in the test offered by medac.
   
Rapid processing: initial results available after only 35 minutes
The antibody testing is fully automated. Medac provides high-performance systems for testing, enabling the analysis of large sample quantities in a very short period. In addition to the SARS-CoV-2 antibody tests, these laboratory workstations can process up to 100 other laboratory markers in parallel. These include inflammation markers such as CRP, PCT, interleukin 6 or cardiological markers which play a role in SARS-CoV-2 diagnostics, with up to 280 results per hour being processed on the Maglumi systems. Medac uses state-of-the-art technology that enables stable, rapid and sensitive detection of SARS-CoV-2 infection using chemiluminescence analyses (CLIA).
   
In its work, medac is cooperating with established global firm Snibe-Diagnostic, which has been specialising in clinical laboratory instruments and in-vitro diagnostic reagents for many decades.
   
Reliability and testing in the daily routine
The antibody test offered by medac was awarded ist European IVD CE marking on 19 February 2020, the first test to be so certified worldwide . Since then, it has been tested in independent studies, including in the epicentre of Italy and in prominent German laboratories, and has proven ist reliability. The test is already being used routinely in Spain and Italy and is now also available for Germany, Austria and Switzerland.
   
Guaranteed long-term reliability for delivery of both tests from a single source
medac is the exclusive distribution partner for the antibody tests in Germany, Austria and Switzerland and is already partnering with over 20 laboratories. Other countries are in the pipeline. The multiplex PCR tests are being offered by medac exclusively in Germany and Austria.
   
In order to ensure security in planning and optimal management of the current pandemic, full and comprehensive availability in the supply of both antibody and PCR tests is guaranteed. 17 million more antibody tests are available. The availability of the multiplex-PCR tests is unlimited.

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