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Erba Mannheim Garners CE Mark for SARS-CoV-2 Antibody Test

NEW YORK – Erba Mannheim announced Monday its ErbaLisa COVID-19 ELISA kits for the detection of IgG and IgM antibodies were granted CE certification. 

The tests have been designed to be used manually or with any open automated ELISA analyzer, including Erba Mannheim's ELAN 30s. IgM antibodies are produced first and are detectable during the onset of COVID-19, the company said. "Our IgM test could be used to identify people recently infected by the virus, including those who may not have displayed symptoms," Petros Sarantos, the company's global product manager for immunoassay, said in a statement.

IgG antibodies are for long-term immunity, and Erba Mannheim's test can measure how many people have been infected and developed immunity, the company said. Both tests allow qualitative and semi-quantitative detection of IgG and IgM antibodies and were designed and developed at Calbiotech in El Cajon, California.

The Mannheim, Germany-based company has also submitted both tests for Emergency Use Authorization with the US Food and Drug Administration.