New administration signals continued emphasis on COVID-19 testing outside of clinical laboratories
For most of 2020, diagnostic testing for SARS-CoV-2 was performed using either polymerase chain reaction (PCR) testing in clinical laboratories or by using antigen testing that could be performed at the point of care (POC). However, as POC antigen tests have become more widely used, their performance has, at times, been doubted by a high rate of false-positive results.
With fluctuating COVID-19 test volumes one of the concerns of clinical laboratory leaders, several new tests that received emergency use authorizations (EUAs) from the US Food and Drug Administration (FDA) in December 2020 will create a new source of competition—direct-to-consumer (DTC) nonprescription COVID-19 testing.
The first fully at-home COVID-19 test and first over-the-counter (OTC) COVID-19 test each received EUAs within days of each other. This was quickly followed by an EUA for the Ellume COVID-19 Home Test, the first at-home and OTC COVID-19 test (See New EUA Makes COVID-19 Testing Available for Patients Without Clinical Laboratories Playing a Role).
“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Ellume Founder and CEO, Dr. Sean Parsons said at the time. “Ellume’s COVID-19 Home Test delivers this important first line of defense—it can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage.”
Now, DOD Directs Funds for Ellume to Increase Production
With fast, affordable, easy-to-use home testing evidently a top priority, the incoming administration continues to adjust national response to the pandemic. The latest development comes with the Feb. 1, 2021, announcement by the US Department of Defense (DOD) to award $231.8 million for Ellume to produce its at-home, OTC test—and make that test more available throughout the US.
Until this point, Ellume had been producing COVID-19 tests at the company’s primary manufacturing plant in Australia. With the DOD award, the company will establish a significant footprint in the US.
“Ellume has been ramping up manufacturing and will ship 100,000 test kits per month to the US from February through July,” White House Covid-19 Senior Adviser Andy Slavitt said during a White House briefing Monday. “That’s good but it’s obviously not where we’ll need to be.”
The DOD award enables Ellume to significantly increase production in the US and expand the company’s capabilities. According to a recent press release, Ellume anticipated that, “At full capacity, the US facility will be able to produce up to 19 million tests per month.”
Ellume Home COVID-19 Test Relies on Connection to Smartphone App
The Ellume COVID-19 Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens. Intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection, the test provides results in 15 minutes. According to the FDA’s EUA authorization letter issued Dec. 15, 2020, the test kit includes a single-use analyzer and a single-use sampling and processing system that includes a sterile nasal swab with a child adapter, processing fluid, and dropper. To use the product, users must first download the Ellume COVID-19 Home Test App for iOS or Android phones. Results can be tracked, and the test can be performed completely at home without a prescription.
Moreover, data submitted to the FDA shows the Ellume home COVID-19 test to have an accuracy rate of 96%, making it more reliable than many rapid, POC COVID-19 tests. That means this test may avoid some of the pitfalls that other antigen tests have encountered in their rollout.
With about two million COVID-19 tests being performed in the US each day, the large DOD award to Ellume may help to relieve some of the stress that clinical laboratories are experiencing in trying to fill the need for such large volumes of testing. This help, however, creates the potential for almost 20 million fully at-home tests each month entering the US market, leading to increased competition for laboratories at a time when vaccine rollouts may start to decrease testing volumes.
Some good news may be that, in this case, positive results in asymptomatic individuals are presumptive and may need to be confirmed with a molecular assay. Additionally, positive results do not rule out a bacterial infection or co-infection with other viruses, therefore potentially triggering additional testing. The frequency of SARS-CoV-2 asymptomatic testing will be worth watching in the coming months.
—By Caleb Williams, Editor, COVID-19 STAT
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