Erba Mannheim 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.
"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," Petros Sarantos, Global Product Manager for Immunoassay, said.
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The ErbaLisa® COVID-19 assays have been designed, developed, and will be manufactured at Calbiotech Inc., Erba Mannheim's immunoassay center of excellence in El Cajon, California. The ready-to-use ELISA kits will allow qualitative as well as 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.