After the Anti-SARS-CoV-2 ELISAs for immunoglobulin classes A and G and the RT-PCR test EURORealTime SARS-CoV-2 from EUROIMMUN, a PerkinElmer, Inc. company (NYSE:PKI), already received the CE mark in March, the Anti-SARS-CoV-2 ELISA (IgG) was now approved for use in authorised laboratories by the US-American food and drug administration FDA within the framework of an emergency use authorization (EUA). The results of a new independent validation effort by the U.S. Government provided the scientific evidence used to support the authorization.Official press release on FDA EUA of the Anti-SARS-CoV-2-ELISA IgG
“In order to meet the worldwide demand for our test systems, EUROIMMUN AG has substantially expanded the production capacity within shortest time.”,
says EUROIMMUN’s CEO, Dr. Wolfgang Schlumberger.
Serological tests, on the other hand, like the ELISA, detect antibodies in the blood. This means they are applied when an immune reaction to the pathogen has already taken place.
“Moreover, the test systems for detection of IgG antibodies are suitable for collection of epidemiological data.”
explains Katja Steinhagen, Head of EUROIMMUN’s Business Division Immunobiochemistry Infectious Serology.
RT-PCR technology plays a role especially in the early stage of a viral infection, in which the virus reproduces quickly.
“The EURORealTime SARS-CoV-2 was developed for specific detection of the novel coronavirus. Because the test detects two genetic sequences of the virus simultaneously, it is very sensitive”,
explains Dr. Ulf Steller, Head of EUROIMUN’s Business Division Molecular Genetic Diagnostics.
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EUROIMMUN develops and produces test systems for doctors and laboratories that cannot be performed by private individuals.