(CNN) – The United States Food and Drug Administration (FDA) has issued emergency use authorizations for new tests for antibodies to the coronavirus.
The FDA recently issued an emergency use authorization for a new coronavirus antibody test developed in a Mount Sinai laboratory.
With this new test, there are now four tests for coronavirus antibodies that have been granted agency emergency use authorizations, and further tests are expected to be conducted through an authorization, the commissioner of the FDA, Dr. Stephen Hahn, during a live video interview with The Washington Post Thursday.
Tests can detect past infections after people have recovered. But it is not yet clear whether having antibodies means that a person has long-term immunity against the virus.
The FDA determined that the benefits of using rapid design tests during a pandemic outweigh the risks, such as false negatives or false positives.
The tests, which use blood samples instead of a swab, are limited to use in licensed laboratories. Instead of looking for traces of the virus, they look for the body’s response to the virus: the antibodies.
But the FDA cautions that the tests could lead to false negatives because the antibodies may not be detectable early in infection.
“A negative result can occur if you are tested early in your disease and your body has not had time to make antibodies against the infection,” the FDA said in a fact sheet.
Still, experts say antibody tests can be helpful in understanding how widespread coronavirus really is, as they should be able to detect past infections, even if someone had few or no symptoms.
The newly authorized tests come from Chembio Diagnostic Systems and Ortho Clinical Diagnostics. They add to a test authorized in early April by the Cellex company.
Also on Wednesday, Abbott Laboratories announced that it will launch a new antibody test, although it does not have the explicit authorization of the FDA.
Abbott is legally authorized to distribute it under regulatory flexibilities issued by the FDA.
Abbott said he will send a million tests to customers immediately and plans to produce and ship up to 20 million tests by the end of June.
Abbott said his coronavirus blood test identifies IgG antibodies, which are proteins that the body produces in the later stages of infection. Those antibodies can remain for months, or possibly years, after a person has recovered.
That contrasts with the other tests that have been cleared by the FDA. These tests can detect another class of antibodies called IgM antibodies, which are present earlier in infection.
Abbott’s IgG antibody test will initially be available on its ARCHITECT i1000SR and i2000SR laboratory instruments, which can run up to 100-200 tests per hour, the company said. More than 2,000 of these instruments are in use in laboratories in the United States.
Abbott is making the tests available as part of an FDA process that allows companies to run and sell tests without receiving an emergency use authorization, although Abbott plans to file one.
But the company says it plans to apply for an emergency use authorization from the FDA.
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