FDA clears new Covid-19 antibody test that quantifies specific levels of antibodies

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The FDA confirmed to CNN on Wednesday that the agency had cleared the test. But it’s not the first test to estimate a patient’s antibodies from a previous coronavirus infection. The FDA had previously cleared similar tests over the summer.
“Being able to measure a patient’s relative antibody level in response to a previous SARS-CoV-2 infection may be helpful as we continue to learn more about the virus and what antibodies exist. can mean, ”Dr. Tim Stenzel, director of the Bureau of In Vitro Diagnostics and Radiologic Health at the FDA’s Center for Devices and Radiologic Health, said in a press release in July around the time the tests have been authorized.

“There are still many unknowns about what the presence of anti-SARS-CoV-2 antibodies can tell us about potential immunity,” Stenzel said at the time. “Patients should not interpret the results as telling them they are immune or have any level of immunity to the virus.”

Kantaro Biosciences – a joint venture between Mount Sinai and RenalytixAI to step up innovation and testing efforts – announced Wednesday that it has partnered with Bio-Techne Corporation to manufacture its test kits with an initial capacity of up to to 10 million tests per month.

While the newly licensed Covid-19 antibody test is similar to others in that it detects levels of Covid-19 antibodies, it goes one step further by providing a digital readout of the level detected – and not just a simple one. positive or negative result, said Dr Amesh Adalja, a senior researcher at the Johns Hopkins University Center for Health Safety, who was not involved in the Kantaro test.

“The ability to quantify antibody levels helps us understand what level of antibody correlates with protection against infection,” Adalja told CNN Wednesday.

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“Each test will have a limit of detection – meaning the test will have a limit at which they will have a certain level of antibodies that must be present for the test to be positive, and when it is below that, the test will be negative, “Adalja said.” From what I understand from this test, it actually gives you a number so you can tell that your antibody titer is X, Y or Z. “

This kind of data on antibody levels could help inform vaccine development, Adalja said.

“I also think it becomes important when we think about the vaccine, because we will often vaccinate someone and want to know the levels of antibodies generated and then follow those people over time to understand what the interval might be for them to be stimulated. . Said Adalja. “So if the antibodies drop below a certain level after three years, you can get a booster at three years.”

Studies suggest that Covid-19 antibody levels may decline over time – after a period of around five to six months – but more research is needed, said Dr Saju Mathew, an Atlanta-based primary care physician and public health specialist who did not participate in the newly licensed Kantaro test.

“So a test like this would be exciting if it is accurate,” Mathew told CNN Wednesday.

“This test suggests that it is over 98% sensitive and specific, which is good,” added Mathew, referring to Kantaro’s announcement that the test showed a sensitivity of 98.8% and a 99.6% specificity for the detection of novel coronavirus antibodies against two viral antigens.

“He’s looking at two viral antigens, including the spike protein,” Mathew said.

“The spike protein is the protein that the virus uses to get into our lungs and infect the body. That’s why I think this test is really promising,” Mathew said. “Ultimately the end game is, how accurate is this test?”

Mathew added that patients should keep in mind that this is an antibody test, which suggests a previous infection with Covid-19 – not a current infection. Mathew also pointed out that having antibodies doesn’t mean someone is immune to Covid-19 their entire life, but maybe they have some protection for weeks or months.



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