US strikes deal for breakthrough DIY Covid test

The Biden administration is spending $231.8 million to ramp up production of the country’s first over-the-counter, at-home rapid Covid test that does not require medical professionals.

Andy Slavitt, White House senior adviser for Covid-19 response, told a press briefing that these self-performed diagnostic tests “can detect Covid-19 with roughly 95 per cent accuracy within 15 minutes.”

The deal was struck with Ellume, an Australian digital diagnostics company, and will help the firm to scale up manufacturing of the test kits.

The Ellume test is expected to cost $30 and will be available to purchase in pharmacies, drug stores and online. It was FDA-approved in December after its promising clinical trial results in the US – where it correctly identified 95 per cent of positive samples and 100 per cent of negative samples.

While two other Covid home-testing kits have been FDA-approved, this is the first which neither requires a doctor’s prescription nor involves sending samples to a lab. In this respect, it has been likened to a pregnancy test.

To perform Ellume’s lateral-flow antigen test, you simply download a smartphone app and swab your nose. You then place the nasal swab into a bluetooth-connected digital analyser, and results will be sent to your phone within 15 minutes. The app requires people to give their zip code and date of birth, with optional fields including name and e-mail address, and reports the results to public health authorities to monitor infection rates.

In the coming months, the availability of these tests in the US will be limited: Ellume will ship 100,000 test kits per month from Australia to the US from February through to July. Yet crucially, the $231.8 million contract will fund construction of an Ellume manufacturing plant in the US which will significantly ramp up production capacity. Once up and running (expected in the third quarter of this year), Slavitt predicts that the firm will be able “to manufacture 19 million test kits per month.”

The hope is that introducing such a hassle-free testing option will encourage more people to get tested, reduce the number of infected patients entering clinics and hospitals and ease the burden on laboratories.

Some public health experts have flagged the $30 price tag as a drawback, however. Dr Michael Mina, a Harvard epidemiologist and vocal advocate of widespread rapid tests says we need something Americans can afford to buy and use routinely. Rapid tests, she says, won’t be gamechangers until they cost $5 (or less) per test.

Ellume’s founder, Sean Parsons, told the Washington Post that he hopes increasing production capacity for the tests will allow the price to come down. Building a manufacturing plant in the US, for instance, will cut the cost of having to ship tests from Australia. Slavitt echoed Parsons’ sentiment on Monday: “The cost will only come down if we get to that mass production and scale”.

The Ellume test is not yet commercially available in the US – or elsewhere – and no equivalent test exists in the UK. Rapid testing – with a 30-minute wait for results – is an option for Brits but only through visiting an NHS rapid testing site or paying for a rapid test at a number of pharmacies (where the test is conducted by a member of staff). Alternatively, people can order an NHS home-test but the kit must be sent back to a lab and results take up to 72 hours.

An over-the-counter, fully at-home testing kit, with a 15-minute wait time, would be an attractive addition.