Antibody

F.D.A. Orders Companies to Submit Antibody Test Data

The Food and Drug Administration announced on Monday that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market.

The antibody tests are an effort to detect whether a person had been infected with the coronavirus, but results have been widely varied. Since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate.

The agency has also been under fire from several members of Congress, with numerous lawmakers raising

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Can Antibody Tests Help End the Coronavirus Pandemic?

A survey of New Yorkers last week found that one in five city residents carried antibodies to the new coronavirus — and in that, Gov. Andrew M. Cuomo saw good news.

If so many had been infected and survived, he reasoned, the virus may be far less deadly than previously thought. But many scientists took a darker view, seeing instead a vast pool of people who are still very vulnerable to infection.

Like the leaders of many states, Mr. Cuomo has been hoping that the results of large-scale antibody testing may guide decisions about when and how to reopen the economy and reintegrate society.

Few scientists ever imagined that these tests would become an instrument of public policy — and many are uncomfortable with the idea. Antibody tests, which show who has been infected, are often inaccurate, recent research suggests, and it is not clear whether a positive result actually

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Coronavirus Antibody Tests: Can You Trust the Results?

The researchers worked around the clock, in shifts of three to five hours, hoping to stave off weariness and keep their minds sharp for the delicate task.

They set up lines of laboratory volunteers: medical residents, postdoctoral students, even experienced veterans of science, each handling a specific task. They checked and rechecked their data, as if the world were depending on it. Because in some ways, it is.

For the past few weeks, more than 50 scientists have been working diligently to do something that the Food and Drug Administration mostly has not: Verifying that 14 coronavirus antibody tests now on the market actually deliver accurate results.

These tests are crucial to reopening the economy, but public health experts have raised urgent concerns about their quality. The new research, completed just days ago and posted online Friday, confirmed some of those fears: Of the 14 tests, only three delivered consistently

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Will a Coronavirus Antibody Test Allow Us to Go Back to School or Work?

The first type of antibody to appear is called immunoglobulin M or IgM, and its levels spike within a few days of infection. But IgM is a generic fighter. To target and destroy a specific virus, the body refines it into a second type of antibody, called immunoglobulin G, or IgG, that can recognize that virus.

As IgG levels rise, IgM levels drop; IgG levels peak around 28 days after the onset of infection.

There is a third type of antibody, called IgA, that is present in mucosal tissues — like the inner lining of the lung. IgA is known to be important for fighting respiratory infections such as influenza, and is likely to be central in coronavirus infection, too.

Many of the tests being developed look for levels of all three antibodies; some look for just IgM and IgG, and still others test for only one type.

What can

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