The story for the diagnostics industry in March and April was FDA’s Emergency Use Authorization of multiple tests to detect the novel coronavirus (COVID-19).
The conversation is now shifting to SARS-CoV-2 antibody testing. PerkinElmer’s EUROIMMUN division is the latest to add to the narrative as it has received EUA for its Anti-SARS-CoV-2 ELISA (IgG) serology test.
The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. PerkinElmer said the EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms.
“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,” Prahlad Singh, president and CEO, PerkinElmer, said in a release. “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. This is also supported by the fact that most of the COVID-19 vaccine development programs in the U.S. and worldwide have chosen the spike protein as their target.”
PerkinElmer’s announcement comes on the heels of Roche announcing it had also received EUA for an antibody test. The Basel, Switzerland-based company said it would ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark as well as the U.S.
FDA has been cracking down on fraudulent antibody tests. The agency recently revised its March 16 policy, which has served as a regulatory roadmap for COVID-19 antibody tests. The revision comes about two weeks after FDA issued a warning to healthcare providers about the limitations of such tests.