EUROIMMUN qualitative and semi-quantitative IgG test receives FDA EUA

Oct. 7, 2021

EUROIMMUN, a PerkinElmer company, announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the company's Anti-SARS-CoV-2 S1 CurveTM 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 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.

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

Visit PerkinElmer for more news