Yahoo News Coronavirus tests: California company develops at-home Covid-19 kit, but FDA approval could take weeks
A California company has developed an at-home coronavirus test people can administer on themselves, but the test could take weeks to roll out pending emergency approval from the Food and Drug Administration (FDA).
Scanwell Health, a California-based testing company, licensed the rights to a test developed by China that uses a patient's blood to determine if they have Covid-19, Time first reports.
Chinese company Innovita created the test that was later approved by China's Centres for Disease Control and Prevention. Instead of using the test at home, though, it was employed at hospitals and across the country to help test thousands of citizens for the novel virus.
But Scanwell Health sees potential in the test to be self-administered by people who believe they might be infected.
"The advantage of a rapid test like we're working on is that it can be performed completely at home by the patient," Dr Jack Jeng, chief medical officer of Scanwell, told Time. "It can be widely scalable rapidly and quickly deployed."
This would be the first blood-based test for Covid-19 in the US, as current testing relies on swabs.
If rolled out in America, patients would first check-in with a health app, developed by telehealth company Lemonaid, to describe the symptoms they are feeling. If it is warranted, a testing kit would then be sent to the user.
The test involves the person mixing two drops of blood in with a solution provided, wait 15 minutes, and then share the results via the app. Doctors who work with Lemonaid would then advise the patient on if they should monitor their symptoms or seek help from medical professionals.
The test will detect the presence of the antibodies IGM in the blood, which emerges in the early stages of infection, and IGG, which increases during the body's response to the virus.
What is delaying the roll out of this at-home test is approval from the FDA.
Scanwell Health requested emergency authorisation from the agency, but this approval could take six to eight weeks.
The UK is also pushing to roll out its own at-home testing kit that would also take the antibodies from blood to determine if someone has Covid-19 or not.
Initially, it was believed the test could be offered to citizens within days. But UK government's Chief Medical Officer Chris Whitty told reporters on Wednesday the country was looking at weeks instead of days.
"The one thing worse than no test is a bad test," Mr Whitty said. "I do not think, and I want to be clear, that this is something we'll be ordering from the internet in a matter of weeks."
Other start-up companies in the US attempted to profit off at-home coronavirus tests that involved swabbing for specimens in the nose and throat to then mail into labs.
But the FDA informed consumers last week it has yet to authorise any testing that involved people collecting their own specimen.
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