Quantitative SARS-CoV-2 Antibody Tests Announced

Aesku Group has launched the first quantitative SARS-CoV-2 antibody tests. Aesku is currently the only company in the biotechnology industry, developing quantitative SARS-CoV-2 antibody tests that can certify the acquired immunity of patients or vaccinated individuals.

For the determination of an immune reaction, examining the body's immunoglobulins (Ig), so-called antibodies, has been established for years. Since protein structures on the surface of a pathogen (bacterium, virus) are specific, and the immune system forms the appropriate, specific antibody, it is possible to examine various antibodies to confirm an infection. In the case of the SARS-CoV-2 viruses, the nucleocapsid protein (N) and the spike protein (S1) and their antibodies are suitable.

Aesku's six different SARS-COV-2 immune assays:

AESKULISA® SARS-CoV-2 NP IgM/IgA/IgG

The AESKULISA® SARS-CoV-2 NP IgA, IgG, and IgM tests are qualitative and quantitative immunoassays for the detection of human IgM, IgA, and IgG antibodies in serum or plasma directed against SARS-CoV-2 in highly conserved nucleocapsid protein (NP).

The nucleocapsid protein is very reactive and stimulates a very strong response to the immune system. This strong immune response provides sensitive detection of antibodies, which allows a clear differentiation between positive and negative samples. They are, therefore, ideal for IgM, IgA, and IgG detection for screening and diagnosis. However, due to the high sensitivity and strong conservation of the nucleocapsid protein in the coronavirus family, the risk of cross-reaction with antibodies against SARS-CoV-1 is increased. Since antibodies against the nucleocapsid protein have no neutralising effect, they are not suitable for determining the immune status, the so-called antibody titre. The AESKULISA® SARS-CoV-2 NP IgA is recommended for the detection of acute infections.

The AESKULISA® SARS-CoV-2 NP IgG allows the confirmation of pathogen contact and the determination of the immune status.

The AESKULISA® SARS-CoV-2 NP IgM allows to determine the first specific reaction of the immune system.

Aesku uses immunogenic nucleocapsid proteins of SARS-CoV-2 expressed in insect cells for the sensitive detection of IgM, IgA, and IgG antibodies.

AESKULISA® SARS-CoV-2 S1 IgM/IgA/IgG

AESKULISA® SARS-CoV-2 S1 IgA, IgG, and IgM tests are qualitative and quantitative immunoassays for the detection of human IgM, IgA, and IgG antibodies of the highly specific spike protein (S1) in serum or plasma directed against SARS-CoV-2.

The spike protein has the advantage over the nucleocapsid protein that is highly specific for the SARS-CoV-2 virus. This results in a much lower risk of cross-reactions with antibodies against other members of the coronavirus family. IgG antibodies react against the receptor-binding domain (RBD) on the spike proteins and are considered neutralising, and therefore are suitable for monitoring the antibody titre of patients. In this respect, AESKU's tests are one step ahead of clinical research, as there is no scientific proof yet at which antibody level immunity is reached.

The AESKULISA® SARS-CoV-2 S1 IgA is recommended for the detection of acute infections.

The AESKULISA® SARS-CoV-2 S1 IgG allows the confirmation of pathogen contact and the determination of the immune status. It can be used to detect and monitor the antibody titre of a patient.

The AESKULISA® SARS-CoV-2 S1 IgM allows to determine the first specific reaction of the immune system.

Aesku currently produces 300,000 tests daily. To set up the production, Aesku initially used different patient samples of positive PCR tests from hospitals in Germany and abroad. ELISA antibody tests against the various antibody classes allow a precise differentiation between active but symptom-free disease and antibodies that indicate a past infection.

Pre-series tests have already been conducted in Italy and South America,

where entire towns and cities are being tested.

Aesku’s AESKULISAS® can be used everywhere and in an uncomplicated way by using common reagents. AESKULISAS® are easy and fast to use due to the possibility of automating them.

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