On Oct. 5, 2021, PerkinElmer announced that the U.S. Food and Drug Administration had provided Emergency Use Authorization (EUA) for its Anti-SARS-CoV-2 S1 CurveTM ELISA (IgG). This assay allowed for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma. Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were able to 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 QuantiVacTM 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.

The assay can run manually or using the EUROLabTM Workstation ELISA, Sprinter XLTM and other third party ELISA platforms.

The Anti-SARS-CoV-2 S1 Curve ELISA (IgG) is one of many solutions in EUROIMMUN’s SARS-CoV-2 specific portfolio, which also includes real-time PCR tests, an antigen detection assay and multiple antibody tests, a dried blood spot solution, as well as automation systems for small, medium and high sample throughput.