COVID-19 testing was a massive challenge in the early days of the coronavirus pandemic, but the speed and accuracy of the tests have improved greatly throughout 2020. Now, instead of having to find a public location that offers testing, individuals have access to at-home COVID-19 tests.
The newest COVID-19 test to receive emergency authorization from the FDA comes from Ellume. The Australian digital diagnostics company has produced the first COVID-19 test that you can purchase without a prescription and administer yourself.
Which companies make at-home COVID-19 tests?
Ellume isn't the first company to develop an at-home COVID-19 test, but it's the first company to create an at-home COVID-19 test that doesn’t require a prescription. Dr. Sean Parsons, the CEO of Ellume, said that the product will start shipping in January 2021. By February or March, most eligible retailers should have the tests available for customers.
CNBC reported that Abbott also received clearance on Dec. 16 from the FDA for its BinaxNOW rapid coronavirus test. Unlike Ellume's COVID-19 test, Abbott's test requires a prescription.
A COVID-19 nasal swab test from California-based Lucira Health was approved in November. Lucira Health's COVID-19 test was the first test that enabled users to take the test and receive the results at home.
An at-home COVID-19 test costs $30
Ellume's nasal at-home COVID-19 test will cost about $30, according to NBC News. Once the tests are widely available, people will be able to get them from drugstores and pharmacies as well as online.
Dr. Parsons said that Ellume expects to produce at least 20 million of the tests during the first half of 2021.
How an at-home COVID-19 test works
Some options for COVID-19 testing include a saliva test and a breath test. The newly approved Ellume test is a nasal-swab antigen test, which “is designed to detect fragments of viral proteins that trigger an immune response in the body,” according to NBC News.
Dr. Parsons explained that after swabbing the nasal cavity, you place your sample into a digital analyzer with a Bluetooth-connected instrument. Once results are ready, they are sent to the individual through a smartphone app.
Ellume’s over-the-counter test showed that among individuals with symptoms, it was 96 percent accurate in positive diagnoses and 100 percent accurate in negative diagnoses. Among individuals who were asymptomatic, the test correctly identified 91 percent of the positive samples and 96 percent of the negative samples, according to NBC News.
False negatives are still a possibility with antigen testing, so the FDA recommends that individuals who show symptoms but test negative to see a healthcare professional.
Do you need a prescription to get an at-home COVID-19 test?
Prior to the test developed by Ellume, all of the at-home COVID-19 tests required a prescription for purchase. Ellume’s test will streamline the process of getting quick and accurate results. People will be able to purchase the test, take the test, and get results in as little as 20 minutes.
FDA Commissioner Dr. Stephen Hahn called the development of an over-the-counter test a “major milestone” in coronavirus testing, as reported by CNBC.