PerkinElmer announced that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for EUROIMMUN’s (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. 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.
Serological tests detect antibodies in the blood and are detected when an immune reaction to the pathogen has already taken place. These tests can determine who had previously been infected with COVID-19 (two to four weeks or more prior to testing) and may have developed immunity. How long antibodies last and whether they are protective is being actively studied. 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. The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) has 99 percent specificity and 100 percent sensitivity after 21 days following the onset of symptoms.
Prahlad Singh, president and chief executive officer at PerkinElmer said, “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.”
“It is possible that 50 percent 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,” said 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.”
