Image credit: Roche Holding
The FDA has awarded Emergency Use Authorization to Roche’s COVID-19 test to allow users in the US to analyse the level of antibodies for the virus in their blood.
The Elecsys anti-SARS-CoV-2 S antibody test targets antibodies engineered against the novel coronavirus’ spike protein, the same target of many of the leading vaccines, including those from Pfizer and Moderna. According to Roche, the test provides a qualitative result in addition quantifying the concentration of antibodies in a numerical readout from 0.40-250 U/mL.
This means that while it could be used to test the immunity of an individual following exposure to the virus, it could also be used to quantify immune response following inoculation with a vaccine, according to the company.
“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” remarked Thomas Schinecker, CEO of Roche Diagnostics. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response”.
This latest authorisation follows approval of the test in the European Union in all markets accepting the CE mark.
Matt Fellows
This is a syndicated feed from Pharmafile
