PerkinElmer Secures FDA Emergency Use Authorization for EUROIMMUN’s Anti-SARS-CoV-2 ELISA Serology Test

PerkinElmer, Inc. (Waltham, MA; USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for EUROIMMUN’s (a PerkinElmer company) 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. It has 99% specificity and 100% sensitivity after 21 days following the onset of symptoms. Clinical laboratories certified to perform high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this ELISA for the detection of antibodies of the immunoglobulin class G.

EUROIMMUN has the capacity to manufacture millions of assays per month. Since March, it has already started shipping its Anti-SARS-CoV-2 ELISA (IgG) to leading laboratories across the globe. EUROIMMUN intends to further build production capacity to meet heightened demand.

“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,” said Prahlad Singh, president and chief executive officer, PerkinElmer. “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 US and worldwide have chosen the spike protein as their target.”

“It is possible that 50% or more of people who have been infected with COVID-19 might not display symptoms, making it difficult to identify those who have previously contracted COVID-19,” added Prahlad Singh. “That’s why serological testing that utilizes an antigen highly specific to SARS-CoV-2 is such an important tool in understanding how pervasive this virus is.”