The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have awarded $230 million to help a company scale up production of the first at-home coronavirus test.
The test, made by Australian manufacturer Ellume, was authorized by the U.S. Food and Drug Administration (FDA) in December.
It comes with a nasal swab analyzer that connects to an app on users’ smartphones and can provide results within 15 minutes.
Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services, revealed on Monday that, under the deal, Ellume will produce 19 million test kits per month by the end of the year – 8.5 million of which are guaranteed to the federal government.
Currently, the company is expected to deliver 100,000 test kits to the U.S. per month between February and July.
On Monday, the HHS and DOD announced they were awarding $230 million to Ellume, which made the first at-home over-the-counter coronavirus test, which can give results in 15 minutes
he test comes with a nasal swab analyzer that connects to an app on users’ smartphone. Under their deal, Ellume will deliver 100,000 test kits to the U.S. per month between February and July
By the end of the year, the company is expected to manufacture 19 million tests per month, 8.5 million of which ar guaranteed to the federal government
‘[The kits] can be used if you feel symptoms of COVID-19 and also for screening for people without symptoms so they can safely go to work, to school and to events,’ Slavitt said during a press briefing.
‘The ability to quickly test, to contact trace and quarantine is a lynchpin of our natural strategy. and will be a vital part of containing the virus and stopping community spread.’
For months, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection.
But the vast majority of tests still require a nasal swab performed by a health processional that must be processed at high-tech laboratories.
That typically means waiting days for the results. About 25 tests allow people to collect their own sample at home – a nasal swab or saliva – but then they are shipped to a laboratory.
Currently the U.S. is testing an average of about 1.8 million people daily. Most health experts agree the country needs to be testing many times more.
Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold-standard approach of tests that look for the genetic material of the virus.
The kit includes a nasal swab, a chemical solution and a testing strip.
The nose sample is collected with a special adapter that can shortened when being used on young children.
Next, a few drops of the solution are added to the sample, which is placed in a small device that connects via Bluetooth to a smart phone app.
The app then displays the results and helps interpret them. Users can also connect with a health professional via the app.
In a clinical study, the test demonstrated 96 percent overall accuracy, correctly identifying 95 percent of positive cases and 97 percent of negative cases.
For people with symptoms, the test correctly identified 96 percent of positive cases and 100 percent of negative cases.
In those without symptoms, the tested correctly identified 91 percent of positive results and 96 percent of negative results.
A company spokesperson said the test will be priced around $30 and be available at pharmacies and for purchase online.
‘This is the first test which is really designed to be a true at-home test yourself and obtain a result,’ Ellume CEO Sean Parsons told NPR before the authorization in December.
‘This could be used for people to test themselves, for example, before going to a sporting event or a concert or going to a church to decrease the chance that they spread it other people.’
