The neutralising antibodies have been noticed in a laboratory setting to reduce SARS-CoV-2 viral infection of cells
GenScript USA has secured FDA EUA status for cPass SARS-CoV-2 neutralisation antibody detection kit. (Credit: visuals3Dde from Pixabay)
GenScript USA has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its serology test to detect neutralising antibodies from recent or prior SARS-CoV-2 infection.
The EUA status has been granted to the cPass SARS-CoV-2 neutralisation antibody detection kit to specifically identify this type of antibody.
The neutralising antibodies, which bind to a specific part of a pathogen, were noticed in a laboratory setting to reduce SARS-CoV-2 viral infection of cells.
According to FDA, the regulator has earlier issued EUAs to over 50 antibody (serology) tests that can only identify the presence of binding antibodies.
The FDA has also stated that the effect of neutralising antibodies for SARS-CoV-2 in humans is under assessment.
The FDA’s Center for Devices and Radiological Health and in vitro diagnostics director Dr Tim Stenzel said: “The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against Covid-19.
“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus.”
Separately, Quansys Biosciences has secured FDA EUA status for its SARS-CoV-2 IgG antibody test.
The laboratory-based IgG Q-Plex SARS-CoV-2 Human IgG (4-Plex) assay has been developed to simultaneously identify human IgG antibodies, which recognise the S1 and S2 subunits of the SARS-CoV-2 spike protein from the same sample.