Federal regulators in the United States have given emergency authorization for a new type of antibody test that can precisely assess human levels of immunity against the coronavirus disease 2019 (Covid-19).
Kantaro Biosciences said the Food and Drug Administration has granted emergency use authorization for its Covid-SeroKlir antibody test kit. The company says it’s demonstrated it can detect and measure levels of coronavirus-specific neutralizing antibodies.
The test kit, developed in New York City this spring, has shown a 98.8-percent sensitivity and 99.6-percent specificity for detecting neutralizing antibodies that are produced by the immune system to attack the novel coronavirus that causes Covid-19, Kantaro said.
Kantaro officials said this “new generation” of testing has a broad range of applications.
“It is a high-performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust,” Kantaro Chief Commercial Officer Sara Barrington said in a statement.
“Having a numerical understanding of antibody levels can be especially powerful for patients, enabling them to take control of their health and enjoy some peace of mind during these uncertain times,” she added.Kantaro is a joint venture between New York’s Mount Sinai Health System and British diagnostics company RenalytixAI. SOVEREIGNPH