Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.
ERBA Mannheim is set to launch its CE Marked ErbaLisa Covid-19 antibody ELISA kits in response to the global Covid-19 pandemic.
The tests can be used manually or can be run on any open automated ELISA analyser such as the Erba Mannheim ELAN 30s.
In addition, the ready-to-use ELISA antibody kits allow the qualitative and semi-quantitative detection of the IgG and IgM antibodies to SARS-CoV-2 produced in the body in response to Covid-19.
IgM, which is produced first, can be detected during the early stage of the disease. IgG is produced later and is maintained for long-term immunity.
Erba Mannheim Immunoassay global product manager Petros Sarantos 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 an 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.”
The ErbaLisa Covid-19 assays have been designed, developed at Calbiotech Erba Mannheim’s immunoassay centre of excellence in El Cajon, California, where they will also be manufactured.
Erba Mannheim managing director Nikhil Vazirani said: “We are very proud to be contributing towards the fight against Covid-19. Having a better understanding of the immunity of Covid-19 will help society move back towards normality.”
The company is currently seeking the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) for both assays.
The kits will be distributed through its global distribution network, including in the US.