The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for PerkinElmer company Euroimmun’s Anti-SARS-CoV-2 ELISA (IgG) serology test.
The EUA status enables certified clinical laboratories under Clinical Laboratory Improvement Amendments (CLIA) to use Euroimmun’s serology test to detect antibodies of the immunoglobulin class G.
Serological tests will facilitate the detection of antibodies in the blood
Serological tests enable to identify antibodies in the blood, as well as determine who had earlier been infected with Covid-19.
The Anti-SARS-CoV-2 ELISA (IgG) serology test will help detect individuals with an adaptive immune response to SARS-CoV-2, specifying recent or prior infection.
The Anti-SARS-CoV-2 ELISA (IgG) test has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms, said the company.
Euroimmun, which has the capacity to produce millions of assays per month, has already commenced supplying its Anti-SARS-CoV-2 ELISA (IgG) test to major laboratories across the laboratory.
PerkinElmer president and CEO Prahlad Singh said: “Leading with science is a fundamental part of our DNA at PerkinElmer, and the EUROIMMUN team recognized 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 neutralizing antibodies than antibodies to N capsid nucleoprotein.”
In December 2019, PerkinElmer secured approval from the FDA for its GSP Neonatal Creatine Kinase –MM (CK-MM) kit.
The new FDA-approved assay kit is claimed to be the first commercially available assay for screening newborns affected by Duchenne muscular dystrophy (DMD).
