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.
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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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By GlobalDataSince 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.
