FDA Authorizes Most Accurate Antibody Test Yet

On November 25, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for a quantitative antibody test that can detect and measure levels of COVID-specific neutralizing antibodies. 



The test kit, developed by Kantaro Biosciences, is thought to be game-changing in the race to learn more about the virus and what the presence of antibodies may mean when it comes to immunity. 

The kit was developed in New York City this past spring and was approved for use in the European Union last month. Unlike other antibody tests, Kantaro’s test measures COVID-specific antibodies rather than all antibodies in the body. 

Experts have suggested using the Kantaro test as a benchmark for determining whether individuals require a vaccine, which may be available for distribution as soon as next month in the US. For example, if someone is found to have high levels of neutralizing antibodies, they may not immediately need a vaccine. 

Kantaro Biosciences—itself a joint venture between Mount Sinai and RenalytixAI, formed in the hope of rapid innovation—recently announced a partnership with Bio-Techne Corporation with the goal of manufacturing up to 10 million tests per month. 

The body’s immune system produces antibodies to defend against viruses and other foreign pathogens that invade it. But when it comes to COVID-19, the link between antibodies and immunity is not so clear. 

Scientists still don’t know how much protection neutralizing antibodies can offer against a COVID-19 infection, how long this potential protection lasts, or how it differs between demographics. A quantitative antibody test may play a critical role in finding the answers. 

While the FDA has previously authorized multiple antibody tests, Kantaro’s test kit is the first to offer a number readout regarding a patient’s relative level of antibodies in response to a previous COVID-19 infection. 

Because there are still so many unknowns regarding a potential relationship between SARS-CoV-2 antibodies and immunity, experts have warned patients against interpreting results as an indicator of any level of protection against the virus. 

The Kantaro test can also provide insight as to whether a vaccine provokes a robust immune response. For example, measuring antibody levels in immunized individuals can help evaluate the effectiveness of a vaccine. 

Staying ahead of COVID-19 response efforts demands an updated skill set. Get your teams up to speed with professional training and certification courses from the Center for Professional Innovation and Education (CfPIE). 

Are you interested in keeping your organization COVID-ready? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].