This week marks a significant step in the global campaign to detect and defeat the COVID-19 virus. The U.S. Food and Drug Administration (FDA)) issued an Emergency Use Authorization (EUA) for COVID-19 home tests from two companies. After successful clinical studies of the tests with symptomatic and asymptomatic users, the FDA issued EUAs for Ellume Health‘s eponymous Ellume COVID-19 home test and Abbott’s BinaxNOW.
Both tests use swabs and the packages include everything needed to get a result at home in 15 to 20 minutes, according to the developers. Each test includes a smartphone app that walks the user through self-testing and displays the result. Both tests will be available for in the U.S. in the first quarter of 2021. While it’s wonderful to have two choices for at-home COVID-19 testing, the Abbott and Ellume tests are not the same. Actually they differ in several significant ways.
The Ellume EUA allows the company to make the test available without a prescription to adults and children aged 2 years and above, with or without symptoms. Ellume has already begun production and is on track to create more than 100,000 tests per day in January 2021. Ellume plans to deliver 20 million tests to the U.S. in the first half of 2021. The Ellume self-test kit includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth connected Analyzer that works with a smartphone app. The mid-turbinate nasal swab is inserted straight back along the nasal floor until the stopper hits the nostril. The swab then is dipped in the processing fluid and inserted in the Analyzer. The Analyzer transmits the test results to the smartphone app in 15 minutes or less. The user also can choose whether or not to share the results with healthcare professionals. The Ellume clinical testing took place in a simulated home settings with 198 subject aged 2 to 82 in five locations in the U.S. Measured against a standard RT-PCR laboratory test, the Ellume COVID-19 Home test was 96% accurate overall, with 95% sensitivity for positive test results and 97% specificity for negative test agreement. The Ellume test kit will cost $30.
Abbott is working with digital health solutions provider eMed to deliver and administer the BinaxNOW COVID-19 Ag Card rapid test via EUA-approved virtual guided online service. The cost will be $25 per test. Abbott expects to deliver 30 million at-home tests in the first quarter of 2021 and 90 million more in the second quarter. The BinaxNOW will be available by prescription only. People who want to take the test must first access eMed through Abbott’s NAVICA smartphone app. If the subject meets eligibility requirements, then eMed will ship the test to the user. The test consists of a nasal swab, a test card, and the mobile app. Users do not self-test independently, but take the test under the guidance of eMed personnel. The guide instructs the user how to use the swab to get a nasal sample and to insert the swab into the test card. The test returns the result within 20 minutes. The test results are also reported to public health officials. Abbott tested BinaxNOW in several clinical settings with 52 people following symptom onset. The subjects ranged from less than one-year old to 63 years of age. Overall, compared to lab-based PCR testing, BinaxNOW testing scored 91.7% sensitivity with positive results and 100% specificity with negative results.
We are looking forward to hearing more about the Ellume and Abbott-eMed home testing. We also expect there will be other companies with home tests. The EUA status is temporary and further tests will be required in order for the tests to qualify for full approval. It’s nice that users will have a choice between two very different tests from the beginning of approved home testing.
