November 25th – The developers said Wednesday that federal regulators have given urgent permission for a new type of antibody test that can accurately assess human immune levels against COVID-19.
Kantaro Biosciences said the Food and Drug Administration has granted an emergency permit for the COVID-Sero Klir antibody test kit. The company states that it has been demonstrated to be able to detect and measure levels of coronavirus-specific neutralizing antibodies.
According to Kantaro officials, this “new generation” test has a wide range of uses.
“This is a high-performance test that quantifies antibody levels in individuals who are equally credible to healthcare professionals and policy makers,” said Sarah Barrington, Chief Commercial Officer of Cantaro, in a statement.
“A numerical understanding of antibody levels is especially powerful for patients, allowing them to manage their health and enjoy some relief during these uncertain times.”
Kantaro is a joint venture between Mount Sinai Health System in New York and Renaissance AI, a UK diagnostics company.
According to Cantaro, the test kit developed in New York City this spring has 98.8% sensitivity and 99.6% sensitivity to detect neutralizing antibodies produced by the immune system that attack the new coronavirus that causes COVID-19. It showed specificity.
The two-step assay, which can be used in any laboratory without special equipment, was approved for use in the European Union last month.
The test, in contrast to all antibodies in the body, can accurately measure levels of COVID-specific antibodies, which could be useful in the study of the SARS-CoV-2 virus, Kantarou said.
For example, this test can determine whether people already have high levels of neutralizing antibodies from previous exposures. If so, they wouldn’t need the vaccine right away, mountains.Sinai Chief Commercial Officer Eric Rium Said CNBC.
According to Cantaro, the test kits are manufactured in partnership with Minneapolis-based Bio-Techne and have a monthly production capacity of 10 million.
FDA gives urgent approval for tests to detect COVID-19 immunity
Source link FDA gives urgent approval for tests to detect COVID-19 immunity