The Waltham, Mass.-based company’s Anti-SARS-CoV-2 ELISA serology test for detecting the IgG antibody in COVID-19 patients is now available for immediate use in clinical laboratories.
PerkinElmer and EuroImmun designed the ELISA test to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, the virus causing coronavirus, indicating recent or prior infection. According to a news release, the test has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms.
EuroImmun has the capacity to produce millions of assays per month and started shipping its ELISA to laboratories around the world in March. The PerkinElmer subsidiary also intends to increase its production capacity further.
“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,” PerkinElmer president & CEO Prahlad Singh said in the 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.”