FDA approves first antibody test in the US to detect the coronavirus

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FDA approves first antibody test in the US to detect the coronavirus​

By Yasemin Saplakoglu - Staff Writer 8 hours ago

Antibody tests can help identify people who have already had COVID-19.

The Food and Drug Administration (FDA) has approved the first test in the U.S. designed to detect coronavirus antibodies, according to a letter of authorization. Widespread antibody testing can be useful in determining how many people in a population were infected with the virus and might now be immune.

Up until now, all of the coronavirus tests conducted in the U.S. were designed to find fragments of the virus itself. This type of test, which uses a method called PCR to find viral RNA in nasal samples, is useful for detecting people who are currently infected with the coronavirus.

But diagnostic tests won’t be useful in identifying people who have already recovered from COVID-19, as they will no longer have detectable levels of viral RNA in their body. These recovered patients will, however, have antibodies that fight off the virus circulating in their blood.

The FDA approved this test, produced by the biotech company Cellex, under “emergency use authorization,” which allows for the tests to be used prior to gaining full approval, provided there aren’t any already-approved alternatives, according to the FDA.

Cellex’s antibody test requires a blood sample that can be analyzed only in authorized labs. The test takes about 15 to 20 minutes to give results, according to the letter. The test looks for two types of antibodies: immunoglobulin M and immunoglobulin G. Immunoglobulin M is the first antibody that the body makes in response to a foreign substance and can appear a couple of days after infection.

In contrast, the body produces large quantities of immunoglobulin G later on in the infection process. Immunoglobulin G is specific to the novel coronavirus. Positive results could either mean either a person is currently infected or was recently infected by the coronavirus, according to the letter. . . .
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Maxirad said:
Can a proper, effective vaccine for COVID-19 be officially deployed sooner than mid-2021?
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I am very optimistic about this. The depth to information that was obtained on this virus - its sequence and its structure (cryo-EM) that reveal structure/function homologues - give us an enormous head start in the development of many types of vaccines. What we already know about what it is and how it works is phenomenal.


Just as with the healthcare professionals, I am grateful to the community of people who have made all of this possible.
 
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I’m not quite as optimistic about a vaccine this year. The industry have not been that successful at coming up with a coronavirus vaccine for various animals such as horses and cats that are known to contract them in the US. They’ll have to be careful too as the first round of SARS vaccines did not do well at all, but further efforts were suspended when SARS faded away. So there will likely be iterations of testing before it can be approved for mass distribution and thanks to the potential for long incubation periods for this virus, those iterations will each take awhile.

But antibodies tests are being tried out now and once the test population data have been sorted and evaluated for safety and accuracy, we should see these deployed widely so that random samples can be taken everywhere. Because we really need that denominator to determine further policy. If we’re going to destroy the economy, we’d best have solid data in favor of it, not the hodgepodge we have without that denominator.

As I’ve been reading anecdotes from people who are sure they contracted it well before the first official case was confirmed, it would be very interesting to see what penetration Covid-19 has had in California as Santa Clara County was the first location in the state to confirm a Covid-19 case.
 
Good question Maxirad.

I don’t know.

Thanks for posting your informative article though.
. . . Medical tests already can determine the presence of the three key antibodies that the immune system generates in response to the virus. But their presence alone doesn’t mean the person cannot become ill with COVID-19 and transmit it to others.

“Those [European] tests show that the person was exposed but don’t say in and of themselves if the person is immune,” Dr. Wells said. “There is no clear test for immunity at this point.”

Tests to determine exposure and infection presented their own challenges and aren’t yet 100% determinant, given that a more advanced infection that might be detected only in the lungs rather than nose or throat.
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Key words (for me): COVID19marked
 
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