Home tests are convenient; Ask anyone who's done an over-the-counter pregnancy test. So far, all Covid-19 tests have been carried out by a doctor. But the days of queuing in car lines or emergency centers may be over. The FDA has issued an emergency approval for a home test kit.
The test is carried out by Ellume, an Australian company.
In a statement from the FDA, Commissioner Stephen Hahn, MD explained the importance of the approval. "By approving an over-the-counter test, the FDA allows it to be sold in places like drug stores, where a patient can buy it, wipe their nose, take the test, and find out the results in just 20 minutes."
Dr. Hahn explained that this test would also relieve the test laboratories. The test is done at home, nothing need to be sent to a laboratory, and all consumables are included.
What is this magical test? The FDA stated in its statement that the test "… is a type of test in which a liquid sample runs along a surface with reactive molecules". But the magic doesn't involve taking the sample: the dread-nose swabs are still necessary, but they are shorter than the long swabs used by healthcare providers. People collect their own sample and then add it to the test, just like someone would urinate on a pregnancy test. If there are signs of the virus, they will be registered as positive when the sample passes over the test strip. The test looks for antigens, which are molecules that the immune system makes to fight infection.
According to the FDA statement and the Ellume website, the test was performed on 198 people between the ages of 2 and 82 years. In patients with Covid symptoms, 96% of the cases were recorded. In asymptomatic cases, the test is a little less accurate, but is still over 90%. Users download an app for instructions and results. The kit comes with a Bluetooth enabled analyzer.
This isn't the first test of its kind coming out this year, but the other test was only available on prescription. Ellume's test is over-the-counter, as is aspirin or toothpaste. It is available to anyone who wants to buy it.
The test results are promised in 20 minutes. The user and the health authorities who monitor disease prevalence receive the results. When people can expect a test, Ellume pledged to "manufacture and ship 20 million Ellume COVID-19 home tests to the US in the first half of 2021".