FDA Issues Emergency Use Authorization for Assay Detecting Anti-SARS-CoV-2 Immunoglobulin G Antibodies

Officials with the FDA have issued an emergency use authorization for the Anti-SARS-CoV-2 S1 Curve ELISA (IgG), an assay for the qualitative and semi-quantitative detection of immunoglobulin G antibodies formed against the SARS-CoV-2 antigen in human serum and plasma.

According to a press release, clinical laboratories can immediately begin using the assay for the detection of immunoglobulin G antibodies. The test is based on an assay approved in November 2020, which measures the concentration of antibodies against the S1 domain of the spike protein, including the receptor-binding domain, which is an important target antigen for virus neutralizing antibodies.

Because the coronavirus family has low protein homologies, the existence of immunoglobulin G antibodies specifically indicates recent or prior infection and can help identify individuals with an adaptive immune response to SARS-CoV-2. Therefore, S1-based tests are vital in ongoing vaccine development programs and in research efforts to examine the immunity of individuals with previous SARS-CoV-2 infections.

“Assays that enable the detection of [immunoglobulin G] 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 Wolfgang Schlumberger, MD, CEO of EUROIMMUN, in the press release. “With this latest [emergency use authorization] 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.”

REFERENCE

EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA Receives FDA Emergency Use Authorization. Business Wire; October 5, 2021. Accessed October 6, 2021. https://www.businesswire.com/news/home/20211005006175/en