The assay is designed for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma
EUROIMMUN has secured FDA EUA for Anti-SARS-CoV-2 S1 Curve ELISA assay. (Credit: PIRO4D from Pixabay)
PerkinElmer company EUROIMMUN has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG) assay.
The assay is designed for the qualitative and semi-quantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma.
According to the company, the existence of IgG antibodies specifically illustrates recent or prior infection due to the low protein homologies within the coronavirus family.
Clinical laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) are allow to immediately start using the assay to detect antibodies of the immunoglobulin class G.
The assay, which is based on EUROIMMUN’s CE-marked Anti-SARS-CoV-2 QuantiVac ELISA (IgG), enables to measure the concentration of antibodies against the S1 domain of the spike protein including the receptor binding domain (RBD).
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.”
EUROIMMUN’s assay holds the potential to run manually, as well as using the EUROLab, Workstation ELISA, Sprinter XL and other third party ELISA platforms.
The company’s SARS-CoV-2 specific portfolio also consists of 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.
In April this year, EUROIMMUN introduced SARS-CoV-2 NeutraLISA assay to determine the neutralising capacity of anti-SARS-CoV-2 antibodies.