PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, announced today that EUROIMMUN, a PerkinElmer company, has launched the Anti-SARS-CoV-2 QuantiVacTM ELISA (IgG) to quantify IgG antibodies against the SARS-CoV-2 S1 antigen. The assay is available for countries accepting the CE mark, and the Company plans to file a request for this product with the U.S. Food and Drug Administration for Emergency Use Authorization (EUA).
This quantitative test kit applies a recombinant S1 subunit of the SARS-CoV-2 spike protein, enabling detection of IgG antibodies. These antibodies have been the focus of vaccine development programs as well as discussions about possible immunity in previously infected individuals. With this new ELISA assay, EUROIMMUN is providing a product to support careful evaluation of an important antibody subgroup enabling standard curve-based quantification of the anti-S1 IgG antibody concentration.
“The global research and medical community is focused on having an effective SARS-CoV-2 vaccine available as soon as possible, but to do so, it’s clear that the quantitative measurement of antibodies in clinical studies will play a huge part,“ said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The EUROIMMUN assays, especially the S1-based tests, are important tools for pharmaceutical laboratories conducting clinical trials. Our assays can help to identify individuals who have been exposed to SARS-CoV-2 and may play a critical role in accurate evaluation of antibody status before and after infection, in antibody therapies or in vaccination programs.”
The QuantiVac ELISA assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is based on the CE-marked and FDA EUA-approved semi quantitative/qualitative Anti-SARS-CoV-2 ELISA (IgG).
EUROIMMUN has increased its ELISA production for COVID-19 diagnostics to more than three million tests per week and can supply large numbers of dried blood spot collection sets for upcoming seroprevalence and vaccination development studies. Large international reference laboratories have implemented EUROIMMUN SARS-CoV-2 assays, and the tests are being applied in an increasing number of epidemiological studies worldwide.
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.