People are demanding the availability to test, and the United States’ response from the beginning has been slow. Now there’s more red tape.
Private companies were racing to try and supply people with tests they can “do at home.”
But On March 21st, the U.S. Food and Drug Administration (FDA) has updated its Emergency Use Authorization guidelines to private labs that specifically prevent the use of at-home sample collection.
While they are balancing safety and efficacy, and trying to prevent more fraudulent testing, you have to ask, Is now is the time to be enforcing more rules?
“Unleashing innovation is the solution.”
The FDA was overloaded with requests from people who WANT TO MAKE TESTS.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said: “Since the beginning of this outbreak, more than 60 developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process.”
Imagine how many tests would be available if they allowed them to be produced?
Startups, including Everlywell, Carbon Health, and Nurx, will have to discontinue their testing programs and shut down production immediately.
There are two ways to get tested for COVID-19
A nose swab test that is confirmed by a lab
A blood antibody test -
Rapid testing, but only if you go to the clinic.
The United States is the only country that mandates that doctors administer these tests and that only CLA certified labs can run these tests. Do they have to be done in a clinic in person? “The Centers for Disease Control and Prevention recommends that health care professionals first and foremost collect nasopharyngeal samples — the ones involving the long swabs through the nose. “ But doctors and nurses have better things to do with their time then swab our noses and throats.
OR privately, you can order these antibody tests internationally for a few dollars.
Think about the kits you can do at home, a pregnancy test, ketosis test, insulin tests, at-home drug tests, or 23 & me.
Also, if you’re one of the many private companies here in the United States that have the reagents and methods to produce an at-home antibody test, you have to wait a couple of months for FDA approval to start selling them on the market without the fear of getting sued.
Scanwell has developed an in-home test that includes the diagnostics, using a serological test that looks for the presence of antibodies in a person’s blood. This is still pending FDA approval, and the company is seeking that under the emergency use authorization, with an anticipated approval process time of around six to eight weeks. WE DON’T HAVE SIX TO EIGHT WEEKS.
It’s not that these tests are expensive either…
Biomerica said its test sells for less than $10, and the company already has orders from Europe and the Middle East. Chembio Diagnostics Inc CMI.O of New York said it received orders for its COVID-19 antibody test.
It’s not just that FDA is worried about swab kits being ineffective because “The Gates Foundation and others are optimistic that self-collected swabs might prove effective for the coronavirus.” So why all the delay?
The reason why at-home testing is so attractive:
You don’t have to leave your house
The REAL-TIME data it provides on the people in your area
People who become immune can donate their blood for treatment and go back to work Example: if your Governor knows just how many people are infected or not in the region they can lift bans on companies and schools if their community is immune
We need broad ubiquitous testing and epidemiological surveillance. A protocol that can allow everyone to be tested.
This method of testing everyone at home for an extended period will allow us to know who should be allowed to work again or not to reopen America.
United Biomedical in San Miguel county outside of telluride, colorado, was able to test every resident who wanted too early on. The local paramedic and clinic were able to test antibodies with high specificity and began to detect antibodies ten days after infection. They did not follow the rules, so they were able to get ahead of it with broad testing to track the spread of the disease.
Moving forward residents could get tested twice two weeks apart.
But people don’t want to go back to work unless they can be sure that they are not harming others.
Nobody wants to sacrifice grandma for the economy.