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October 6, 2021

US FDA grants EUA for Euroimmun Anti-SARS-CoV-2 S1 Curve ELISA assay

The Anti-SARS-CoV-2 S1 Curve ELISA assay measures the IgG antibodies against the S1 domain of the spike protein.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Euroimmun Anti-SARS-CoV-2 S1 Curve ELISA (IgG) assay.

The new assay is developed based on the company’s Anti-SARS-CoV-2 QuantiVac ELISA (IgG) test, which received the CE mark in November last year.

It enables qualitative and semi-quantitative detection in human serum and plasma of IgG antibodies that are formed against the SARS-CoV-2 S1 antigen.

The Anti-SARS-CoV-2 S1 Curve ELISA test also enables the measurement of antibodies against the S1 domain of the spike protein, including the receptor-binding domain.

The assay can be operated manually or with Euroimmun’s EuroLab Workstation ELISA, Sprinter XL, and other third-party ELISA platforms.

Additionally, it can be used by clinical laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) immediately to detect antibodies of the immunoglobulin class G.

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Euroimmun CEO Dr Wolfgang Schlumberger said: “Assays that enable the detection of IgG antibodies are an important tool in the arsenals of scientists and researchers working to understand the nature of SARS-CoV-2 and prevent the spread of other highly infectious viruses like it in the future.

“With this latest EUA of our semi-quantitative antibody test, more laboratories will have the ability to generate in-depth insights on immunity that advance future antibody therapies and vaccines for Covid-19.”

The company noted that the new test is one of several solutions that are available in its SARS-CoV-2 specific portfolio.

Dried blood spot solution, an antigen detection assay and multiple antibody tests, real-time PCR tests and automation systems for small, medium and high sample output are also part of the portfolio.

In May, Euroimmun launched the EUROPattern Microscope Live (EPML) compact immunofluorescence microscope with EUROLabOffice 4.0 (ELO 4.0) software for modern diagnostics.

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