US RIVM approves EUROIMMUN IgG antibody test

Press Release May 5, 2020 WALTHAM, Mass.

PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovation for a healthier world, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for use EUROIMMUN's (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test. Clinical laboratories certified to perform these complex tests can immediately begin using this ELISA test for the detection of immunoglobulin class G antibodies.

Serological tests detect antibodies in the blood when an immune response to the pathogen has already occurred. These tests can determine who was previously infected with COVID-19 (2-4 weeks or longer prior to testing) and may have developed immunity. How long antibodies last and whether they are protective are under active investigation. The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) is intended to assist in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or previous infection. The EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) has a specificity of 99% and a sensitivity of 100% after 21 days from the onset of symptoms.

The EUROIMMUN team recognized early research from a cell biology level is critical 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) is more likely to be the most specific for COVID-19, i.e. the spike protein. This is also supported by the fact that most COVID-19 vaccine development programs have chosen the spike protein as their target. "

"It is possible that 50 percent* or more of those infected with COVID-19 may not show symptoms, making it difficult to identify those who have previously contracted COVID-19," Prahlad Singh said. "That's why serological testing, which uses an antigen that is highly specific for SARS-CoV-2, is such an important tool for understanding how this virus is spread."

EUROIMMUN has the capacity to produce millions of assays per month. Since March, it has already started shipping its Anti-SARS-CoV-2 ELISA (IgG) to leading laboratories around the world. EUROIMMUN plans to further build its production capacity to meet the increased demand.

More information about this test and how to order it can be found here

The link to the full press release can be found here



Here you can see that after the virus you tested with the PCR throat nose test is gone, the IgG antibodies come up. So you are no longer contagious if your IgG antibodies are present.