ERBA Mannheim Launches CE Marked COVID-19 Antibody ELISA Kits - FDA EUA Following Soon

LONDON, April 27, 2020 /PRNewswire/ -- In response to the global COVID-19 pandemic, Erba Mannheim today announced the development and imminent launch of its ErbaLisa® COVID-19 ELISA kits for detection of IgG and IgM antibodies to SARS-CoV-2. The assays have been designed for use either manually or with any open automated ELISA analyzer, such as the Erba Mannheim ELAN 30s.

SARS-CoV-2 viral antigens stimulate the body's immune system to produce antibodies that can be detected with IgM and IgG antibody tests. IgM is produced first and is detectable during early onset of the disease. IgG is produced later and is maintained for long-term immunity.

Petros Sarantos, Global Product Manager for Immunoassay, said: "Our IgM test could be used to identify people recently infected by the virus, including those who may not have displayed symptoms. The IgG test will provide an accurate measure of how many people have been infected and may have developed immunity. Once identified, immune individuals could safely return to work and help relieve stressed healthcare systems or other frontline functions. Such people could also donate their blood to potentially save other patients with severe COVID-19."

Nikhil Vazirani, MD of Erba Mannheim, said: "We are very proud to be contributing towards the fight against COVID-19. Having a better understanding about the immunity of COVID-19 will help society move back towards normality."

The ErbaLisa® COVID-19 assays have been designed, developed, and will be manufactured at Calbiotech Inc., Erba Mannheim's immunoassay centre of excellence in El Cajon, California. The ready-to-use ELISA kits will allow not only qualitative, but also semi-quantitative detection of the IgG and IgM antibodies.

Erba Mannheim has filed applications for both assays with the FDA's Emergency Use Notification process, and CE certification has already been granted. Kits are available through Erba's global distribution network, including in the USA.

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About Erba Mannheim
Erba Mannheim is a global company focused on creating a social impact in the developing nations of the world by delivering innovative, affordable and sustainable healthcare solutions. Operating and providing clinical diagnostic products in over 100 countries, Erba Mannheim utilizes a combination of cutting edge European and American R&D with efficient low cost manufacturing to craft innovative technologies that are made accessible to people in all resource settings.

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