PerkinElmer company Euroimmun has received the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) for Anti-SARS-CoV-2 ELISA (IgG) serology test to identify Covid-19 antibodies.
Following the EUA, clinical laboratories can now start using the test to detect antibodies of the immunoglobulin class G.
Serological tests can detect antibodies in the blood and determine who had previously been infected with Covid-19 and may have developed an immunity.
Individuals with an adaptive immune response to SARS-CoV-2 can be identified using the Anti-SARS-CoV-2 ELISA (IgG), indicating recent infection. The test has 99% specificity and 100% sensitivity after 21 days, following the onset of symptoms.
PerkinElmer president and CEO Prahlad Singh said: “Leading with science is a fundamental part of our DNA at PerkinElmer, and the Euroimmun team recognised early on that understanding the pathogenesis of Covid-19 from a cellular biology level is paramount to developing a highly accurate and reliable antibody test.
“As a result, the antigen used in the Euroimmun Anti-SARS-CoV-2 ELISA (IgG), the spike protein S1 domain, is more likely to reflect virus neutralising antibodies than antibodies to N capsid nucleoprotein.”
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Since March, Euroimmun has already started shipping Anti-SARS-CoV-2 ELISA (IgG) to laboratories worldwide and intends to ramp up production capacity to meet increasing demand.
The Anti-SARS-CoV-2 ELISA (IgG) EUA has not been cleared or approved by the FDA and has been authorised under EUA for use by authorised laboratories.
It is authorised only to detect SARS-CoV-2 antibodies and not for any other viruses or pathogens.