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FDA gives emergency approval for test that detects COVID-19 immunity

FDA gives emergency approval for test that detects COVID-19 immunity
A woman is pictured wearing a face shield as she walks last Thursday through New York City's famous Times Square. Photo by John Angelillo/UPI | License Photo

Nov. 25 (UPI) -- Federal regulators have given emergency authorization for a new type of antibody test that can precisely assess human levels of immunity against COVID-19, developers said Wednesday.

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.

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Kantaro officials say 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.

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"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."

Kantaro is a joint venture between New York's Mount Sinai Health System and British diagnostics company RenalytixAI.

The test kit, developed in New York City this spring, has shown a 98.8% sensitivity and 99.6% specificity for detecting neutralizing antibodies that are produced by the immune system to attack the novel coronavirus that causes COVID-19, Kantaro said.

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The two-step assay, which can be used in any laboratory and without special equipment, was approved for use in the European Union last month.

Kantaro said the test can accurately measure levels of COVID-specific antibodies, as opposed to all antibodies in the body, and can aid research of the SARS-CoV-2 virus.

The test, for instance, could determine whether people already have high levels of neutralizing antibodies due to a previous exposure. If so, they would not immediately need a vaccine, Mt. Sinai Chief Commercial Officer Erik Lium told CNBC.

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Kantaro said the test kits are being manufactured, through a partnership with Minneapolis-based Bio-Techne, with a capacity to produce as many as 10 million per month.

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