In December 2019 a novel coronavirus SARS-CoV-2 was identified in Wuhan, China and was announced as the causative agent for COVID-19 disease. The incubation period of the disease is 1-14 days. Symptoms of COVID-19 include fever, fatigue and cough, shortness of breath, muscle pain and tiredness. Most of the patients have a good prognosis, some of severe cases may have pneumonia, severe acute respiratory distress or even succumb to the disease.

The entry process of SARS-CoV-2 to the host cell is mediated by the envelope-embedded surface-located spike glycoprotein S. The protein is cleaved by host proteases into the S1 and S2 subunits, which are responsible for receptor recognition and membrane fusion, respectively. A Dutch research group has found that antibodies to this protein called S1 can neutralize the new SARS-CoV-2 coronavirus.

The Mediagnost Anti-SARS-CoV-2 ELISA is a highly specific enzyme immunoassay for the detection of IgG antibodies against the SARS-CoV-2-S1 receptor binding domain (RBD) in human blood.

The fragment of the SARS-CoV-2 S1 protein that binds to the ACE2 receptor is used in the assay. Detected antibodies in human sera, which are directed against the SARS-CoV-2 S1-RBD antigen, could have a neutralizing potential and thus have an anti-infection effect.

The assay procedure is based on the technique of the Enzyme Linked Immunoassay, the ELISA technique. Mediagnost specializes in developing such ELISA systems and producing and selling these test procedures as so-called test kits: e.g. the Growth Factor detection in the field of endocrinology, Leptin detection methods in the field of obesity. In the field of infectiology, Mediagnost has many years of experience in the production of detection methods for antibodies against Hepatitis A-Virus or Pseudomonas aeruginosa.

The Anti-SARS-CoV-2 ELISA is produced and sold by Mediagnost and is now available to diagnostic laboratories that have established the appropriate facilities to carry out the ELISA technique.

Mediagnost sees this test development as a breakthrough in combating the new threatening pandemic caused by the SARS-CoV-2 virus.

CeGaT GmbH, based in Tübingen, has been using the Mediagnost Anti-SARS-CoV-2 ELISA since May 11, 2020 in their Corona antibody tests.