FDA issues emergency test for first coronavirus blood test that can detect when people have become immune to the infection, hoping they can get back to work and ‘get the economy off to a flying start’
- The FDA has issued an emergency authorization for the initial coronavirus antibody test
- The test, developed by the medical equipment company Cellex Inc, requires blood sampling and is analyzed in a certified laboratory
- Scientists can use the tests to understand how widespread the virus is and how long patients remain immune after recovery
- It comes after another company falsely claimed that the FDA had approved its two-minute antibody test
- In the US, there are more than 236,000 confirmed cases of the virus and more than 5,000 deaths
The U.S. Food and Drug Administration (FDA) has approved the first blood test that would determine whether or not someone is infected with coronavirus.
This type of test, known as a serology test, looks for antibodies in the blood.
Cellex Inc., a medical device company in North Carolina, says the test can help scientists understand how widespread the virus is and how long patients remain immune after they recover.
This is important because it could allow immunists to leave their homes and return to work to jump-start the economy and help health professionals determine whether they are immune.
The FDA has issued an emergency authorization for the initial coronavirus antibody test. Pictured: A medical worker conducts a coronavirus test at a drive-thru testing site for children age 22 and younger at Trinity University in Washington, DC on April 2
The test, developed by the medical equipment company Cellex Inc, requires blood sampling and is analyzed in a certified laboratory. Pictured: A person is taken to an ambulance outside a New York City hospital on April 2
Scientists can use the tests to understand how widespread the virus is and how long patients remain immune after recovery. Pictured: A patient suspected of having coronavirus is driven to Mount Sinai Hospital in New York City on April 1
The FDA had previously advised against using antibody tests to diagnose the coronavirus, because antibodies take a while to develop.
But by issuing an emergency use authorization, the agency indicates that it believes the benefits outweigh the risks.
“Based on the total amount of scientific evidence available to the FDA, it is reasonable to assume that your product may be effective in diagnosing COVID-19,” FDA chief scientist Denise Hinton wrote in a statement. letter to James Li, the CEO of Cellex.
“The known and potential benefits of your product when used to diagnose COVID-19 outweigh the known and potential risks of your product.”
The tests currently in use include a nose or throat swab and try to identify the genetic material of the virus to see if someone is currently infected.
This new test requires blood to be collected through a vein and can only be analyzed in a certified laboratory. It seems that someone has been exposed and is now immune.
According to the FDA, the antibodies to the new coronavirus are “generally detectable in the blood a few days after the initial infection.”
But the agency warned in its letter that “levels during the infection are not well characterized.”
The Centers for Disease Control and Prevention says it’s working on its own serological test, which can detect antibodies in people with mild or even no symptoms.
It comes on the heels of news from a company called Bodysphere that erroneously says Tuesday that the FDA has issued an emergency use for its antibody test.
The alleged test can detect coronavirus antibodies in just two minutes after a pinprick of blood from a finger.
The FDA later said it had not approved the test. On Wednesday, the company returned, admitting that it never got permission.
In the U.S., there are currently more than 236,000 confirmed cases of the virus and more than 5,000 deaths.