NEW YORK – PerkinElmer announced on Monday its Euroimmun business has received the CE mark for its Anti-SARS-CoV-2 QuantiVac ELISA test to quantify IgG antibodies against the coronavirus.
The test has been launched in countries that recognize the designation. Waltham, Massachusetts-based PerkinElmer said that it plans to seek US Food and Drug Administration Emergency Use Authorization for the test, which detects IgG antibodies against the SARS-CoV-2 S1 antigen. The quantitative kit applies a recombinant S1 subunit of the coronavirus spike protein to detect IgG antibodies, which have been targeted for the development of vaccines for SARS-CoV-2 and have drawn interest for their role in possibly conferring immunity against the virus in previously infected individuals.
"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," Euroimmun CEO Wolfgang Schlumberger said in a statement. "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."