Result in 20 minutes, without a prescription and for only $ 30: A home corona test that will change the rules of the game
The FDA today granted approval for emergency use for the Australian test, which will arrive in the United States early next year and will be sold in various stores for only $ 30. The result will be received directly to the smartphone, and can be forwarded to a doctor or any other party. These tests may come into use at airports and schools
The US Food and Drug Administration (FDA) earlier today (Tuesday) approved the first home corona test, which can deliver a result in about 20 minutes, without the need to send a sample to a lab or doctor’s prescription.
The new test provides the results via smartphone (Photo: Ellume)
The FDA’s emergency approval can be tested developed by the Australian company Ellume, which is an antigen test that is considered the least reliable compared to a PCR test.
However, the FDA explained that the test was very reliable, and the results of the trials indicated a correct identification of 96% of the positive samples and 100% of the negative samples of corona patients who developed symptoms. For those who did not develop symptoms, the test was able to identify 91% of the positive samples and 96% of the negative ones.
Today, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for # COVID19. The Ellume COVID-19 Home Test is authorized for people 2 years old and up, including those not showing symptoms. https://t.co/fdd2B7fYPE pic.twitter.com/eAHMKcZ4MV
– US FDA (@US_FDA) December 15, 2020
Similar to a home pregnancy test, there is no need to obtain a prescription from a doctor or send a sample to a lab. In fact, the test is done by taking a sample from the nose using a pen, and inserting it into a device that connects to a smartphone via Bluetooth. The result is obtained within about 20 minutes, and can be sent to the family doctor or any other medical professional.
The company announced that it is expected to produce 3 million test kits during January, and will be available for purchase at pharmacies, department stores and the like for $ 30.
Alum’s test kit (Photo: Ellume)
Now, after FDA approval, it is possible that other organizations and entities will decide to make use of the new corona tests, and not necessarily just private individuals. For example, these tests could be used at airports, schools (when reopening) and even the largest sports stadiums in the United States.
However, it is important to emphasize again that this is an antigen test, and therefore it is less sensitive compared to a PCR test. As a result, it may provide a false negative result – that is, the subject is infected with corona, but the antigen test is not sensitive enough to detect the virus.
“Like any other antigen test, this test is less sensitive,” explained Dr. Jeff Shoren, a senior FDA official. To the global epidemic. “
The FDA even explained that it is recommended that those who are diagnosed as positive for corona through the Alum test, undergo a PCR test to verify the result. Also, those with symptoms that get a negative result are advised to undergo a PCR test.