PerkinElmer Joins the COVID-19 Antibody Test Conversation with EUA

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...
Source: MDDI - Category: Medical Devices Tags: COVID-19 IVD Source Type: news