EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA Granted FDA Emergency Use Authorization

EUROIMMUN, a PerkinElmer, Inc. (Waltham, MA; USA) company, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration has provided for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG).

The assay allows for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma. The assay can run manually or using the EUROLab Workstation ELISA, Sprinter XLTM and other third party ELISA platforms. Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.

The Anti-SARS-CoV-2 S1 Curve ELISA (IgG) - based on EUROIMMUN’s Anti-SARS-CoV-2 QuantiVac ELISA (IgG) that received CE mark in November 2020 - measures the concentration of antibodies against the S1 domain of the spike protein, including the receptor binding domain (RBD), which represents an important target antigen for virus neutralizing antibodies. Due to the low protein homologies within the coronavirus family, the existence of IgG antibodies specifically indicates recent or prior infection and is to be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. For this reason, S1 based tests play a critical role in ongoing vaccine development programs and in research efforts to examine the immunity of individuals previously infected by SARS-CoV-2.

“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,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “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.”

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