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PerkinElmer's Euroimmun Gets CE Mark SARS-CoV-2 Antibody Test

NEW YORK – Euroimmun said on Thursday it has received the CE mark for its SARS-CoV-2 Neutralisa assay.

The surrogate neutralization test is for detecting neutralizing antibodies against SARS-CoV-2. Euroimmun, a PerkinElmer subsidiary, said that antibodies that target the viral receptor binding domain (RBD) in the S1 domain of SARS-CoV-2 have been shown to have a virus-neutralizing ability, predominantly in the form of IgG antibodies.

The virus enters human host cells by interacting with the RBDs of the host cell ACE2 receptor, but if the RBD is blocked by antibodies formed during the immune response, SARS-CoV-2 cannot continue infecting and proliferating within the body. Vaccines, the Lubeck, Sweden-based firm said, are based on this protein domain, and the Euroimmun SARS-CoV-2 Neutralisa test "imitates this natural process by determining the inhibitory effect of antibodies capable of hampering interaction between biochemically produced RBD and ACE2," the firm said in a statement.

Unlike other neutralization tests, which can be labor intensive and exposes the test taker to the live SARS-CoV-2 virus in a high-safety lab, the Euroimmun SARS-CoV-2 Neutralisa test leverages ELISA technology and uses viral proteins that are not pathogenic, enabling the assay to be used in common lab settings either manually or automatically, Euroimmun said.