The Biden administration has made tackling the coronavirus pandemic its top priority with plans to ramp up both testing and vaccine distribution. The Department of Defence and Department of Health and Human Services have awarded $230 million to Australian biotech firm Ellume to produce a 15-minute COVID test that sends results directly to your phone.
Ellume has not gone through the full FDA approval process, but it received an Emergency Use Authorization (EUA) in December for the test, which is 95 percent accurate in diagnosing SARS-CoV-2 infection. When it got the EUA, Ellume was only manufacturing about 16,000 tests per day. With the influx of cash, Ellume plans to produce 19 million tests per month by the end of 2021. The company plans to ship 100,000 kits per month to the US between February and July.
The Ellume test uses a nasal swab like many of the early COVID tests, but it’s not a “brain tickler” like the test you might have taken a few months ago. The swab only goes into the mid-sinus to collect its sample. The kit, which will be available over the counter, comes with a single-use swab, a vial of reagents, a dropper/mixer, and an analyzer. You’ll have to supply your own smartphone, though.
The analyzer has a Bluetooth radio that links with the Ellume app, available for both iOS and Android. The app also has full animated instructions on how to perform the test. The Ellume test works by binding special fluorescent chemicals to the SARS-CoV-2 nucleocapsid — the external shall of the virus particle. When applied to the tester, the liquid absorbs into an embedded test strip where it encounters antibodies that recognize the SARS-CoV-2 shell. The analyzer reads the fluorescent illumination from different areas of the strip to determine if there is viral antigen in the sample. If the light signature rises to a certain level, that’s a positive test.
The result is beamed over Bluetooth to your connected phone in just 15 minutes. The company says its technique is very accurate, but it’s more likely to return false negatives for asymptomatic individuals. Meanwhile, anyone without symptoms who gets a positive test should consider that a presumptive positive, which should be confirmed via standard molecular testing.
The current plan is to make the Ellume test available over-the-counter. So, you won’t need to visit a doctor to get one. You will, however, have to be lucky. As the first OTC COVID tests in the US, demand will probably be sky-high.
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