Key Takeaways
- The federal government made a deal with an Australian company for rapid at-home tests for COVID-19 infections.
- Widespread rapid COVID-19 testing can help identify infected people who have no symptoms but who may be spreading the virus.
- Identifying who is carrying the virus and where can reduce or slow the pandemic spread.
A new at-home test for COVID-19 may help control the pandemic by letting more people screen themselves regularly and isolate themselves if they find they are infected.
People who don’t know they are infected are a major reason why COVID-19 is still spreading. According to the Centers for Disease Control and Prevention (CDC), about 30% of all people who test positive for COVID-19 have no symptoms. These asymptomatic people may be responsible for unknowingly spreading the disease.
The new test, from Australian company Ellume, received a large boost from the Biden Administration this week. The company reached a $231.8 million agreement with the Department of Defense, which is coordinating with the Department of Health and Human Services. The money will be used to secure 8.5 million of the rapid tests for the federal government to distribute and will fund a manufacturing plant in the United States. Currently, the tests are made in Australia.
Accessible rapid testing is part of the White House’s plan to curb the COVID-19 pandemic.
How Does It Work?
The Ellume COVID-19 Home Test package includes a nasal swab, processing materials, and an analyzer. Users swab their nose and then use the electronic analyzer, which connects via Bluetooth to an app on their smartphone to display results. The swab can be administered at home.
Unlike earlier tests, the swabs only need to be inserted about halfway up the nose, to what is called the mid-turbinate region. It can be used on children as young as 2 years old, but an adult should administer the nasal swab for children under age 16. Test results are available in 15 minutes or less and can be shared securely with healthcare professionals.
Data on positive test results can also be shared with public health officials. Location data are broken down by zip code to show the spread of the infection, but personal information is kept confidential. This geographic data allows public health officials to see not only where the virus is spreading, but how fast.
The Food and Drug Administration (FDA) granted Ellume’s test emergency use authorization in December 2020. It is an antigen test, which is slightly less sensitive than the nucleic acid tests that are used in laboratories. However, government officials believe that the convenience of self-testing at home and the speed at which results can be obtained makes up for the small decrease in sensitivity.
Ellume says the test has an overall accuracy of 96%, based on a clinical study of 198 people who swabbed their noses at five locations in the United States. Test subjects ranged in age from 2 to 82 years old.
How Does Ellume Compare to Other At-Home Tests?
Several COVD-19 tests are on the market that can be used at home, but they require a prescription, which the Ellume test does not. Many tests offer at-home sample collection, but nasal swabs must be sent out to a lab for analysis. This delay in obtaining results means that the spread of the virus cannot be mapped in real time.
Two other tests that give results at home, BinaxNow and Lucira, have been approved by the FDA, but they require a prescription.
Diagnostic vs. Antibody Tests
Ellume, BinaxNow, and Lucira are diagnostic tests. They screen for the presence of an active coronavirus infection in the mucus on a nasal swab. There are also diagnostic tests that use a sample of saliva.
Tests used to determine if a person was infected in the past are called antibody tests and require a small blood sample. Antibody tests should not be used to diagnose COVID-19 because a person may have been infected and recovered weeks ago and may no longer be infectious. It also can take days or weeks for the body to develop antibodies, which means that testing might miss an active infection.
How Can I Get It?
Although the federal government is buying 8.5 million of the tests, there is no word on when Ellume will be widely commercially available in the United States. Other unknowns include whether health insurance companies will make them available to consumers or if they will be available at retail outlets like pharmacies.
“Ellume is still finalizing a retail commercialization plan and they’re in advanced discussions with several potential partners,” company spokesperson Bella Zabinofsky tells Verywell. “We’ll have details to share on the price and insurance reimbursement at that time.”
Zabinofsky said that the test should have no problem with detecting the variant types of the coronavirus that are emerging around the world. It targets antigen proteins that are largely unchanged between the latest variants, she says.
The cost of Ellume’s test may be an impediment to its widespread use. It is currently priced at $30, which means it might not be economically feasible for regular testing that would help curb virus transmission. Other commercially-available tests for coronavirus cost as little as $5. However, because a prescription is not required, people would not need to see a physician or incur a fee for an office or telehealth visit.
In addition, many people do not have access to a smart phone that can show and transmit the test results.
Costs for rapid COVID-19 testing are expected to come down as more companies create new tests and receive FDA authorization for them. Cheaper tests could allow people to screen themselves regularly to check on their infection status.
Ellume is expecting to be able to produce millions of the tests when its American manufacturing site is finished. Zabinofsky said that the company hopes that will be accomplished by the second half of 2021. Once the U.S. manufacturing site is up and running, the company will be able make 19 million tests a month globally. Currently, the tests are made in Australia.
The company also received a $30 million grant for the National Institutes of Health in late 2020.
What This Means For You
While the timing of commercial availability for Ellume’s at-home rapid test is uncertain, it’s expected to be one of many accessible testing options funded by the government. Improved testing with faster results is crucial to curbing COVID-19 spread.
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.