At-home tests are convenient; ask anyone who has used an over-the-counter pregnancy test. Until now, all Covid-19 testing has been done by a medical practitioner. But, the days of queuing in car lines or at urgent care centers may be over. The FDA has granted Emergency Use Authorization for an at-home testing kit.
The test is made by Ellume, an Australian company.
In a statement from the FDA, Commissioner Stephen Hahn, MD, explained the significance of the authorization. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”
Dr. Hahn explained that this test would also relieve pressure on testing labs. The test is done at home, nothing needs to be sent away to a lab, and all the supplies are included.
So, what is this magical test? The FDA explained in its statement that the test is “… a type of test that runs a liquid sample along a surface with reactive molecules.” But the magic doesn’t include acquiring the sample: The dread nose swabs are still necessary, but they are shorter than the long swabs used by health care providers. People will collect their own sample, and then add it to the test, much as someone would urinate on a pregnancy test. If there are signs of the virus, they will register as a positive when the sample passes over the test strip. The test looks for antigens, those molecules created by the immune system to fight an infection.
According to the FDA statement and the Ellume website, the test was given to 198 people between the ages of 2 and 82. In those with Covid symptoms, the test picked up 96% of the cases. As for asymptomatic cases, the test is slightly less accurate, but still above 90%. Users will download an app for instructions and to get results. The kit comes with a Bluetooth-enabled analyzer.
This is not the first test of its kind to come out this year, but the other test was prescription only. Ellume’s test is over-the-counter, just like aspirin or toothpaste, it will be available to anyone who wants to buy it.
The test results are promised in 20 minutes. The user and health authorities monitoring disease prevalence will receive the results. As for when people can expect to get a test, Ellume promised “to manufacture and deliver 20 million Ellume COVID-19 home tests to the U.S. within the first half of 2021.”