The US Food and Drug Administration has authorised the first prescription molecular diagnostic test for Covid-19, which can be performed entirely at home.
The FDA issued an Emergency Use Authorisation (EUA) to Lucira Health, Inc for its single-use Covid-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes, according to a statement from the company.
The Lucira test kit is promoted as having a simple "swab, stir and detect" design.
The company says clinical trials showed 100 per cent of patients were successfully able to perform the Lucira test in about two minutes. Labs currently take between two to seven days to generate test results.
The Lucira Covid-19 All-In-One Test Kit is expected to be first made available to patients in Northern California, and in Miami-Fort Lauderdale. The company said it is could be available nationally through healthcare providers by the northern spring of 2021.
The kit was originally being developed as a flu test but technicians changed their focus as the Covid pandemic bore down on the US.
"There are currently two types of Covid-19 tests that detect whether a person is infected and potentially infectious," said Lucira Health CEO Erik Engelson.
"Antigen tests detect viral proteins and can provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Molecular tests like Lucira's are 50 to 60 times more sensitive than antigen tests, and considered the 'gold standard' for determining if someone is infected."
The kit, which fits in the palm of a hand, extracts genetic material from the virus and amplifies it. The process could take up to 30 minutes, but a positive test result could be generated as soon as 11 minutes.
To date, the FDA has authorised nearly 300 tests for coronavirus. The vast majority require a nasal swab performed by a health professional and must be processed at laboratories using high-tech testing equipment.
A handful allow people to collect their own sample at home - a nasal swab or saliva - that's then shipped to a lab, which usually means waiting days for results.
Health experts have for months called for options to allow people to test themselves at home, reducing turnaround times and the potential spread of the virus to health care workers.
Dr John Chou, a physician with the Palo Alto Foundation Medical Group, said being able to quickly determine whether a person is infected, or not, has been a global problem.
"We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic."
Dr Chou was affiliated with Sutter Health and a Principal Investigator on the Lucira Health Community Testing Study submitted to the FDA.
The company said Lucira's single-use device has been developed over five years, initially as a flu test kit, that patients would eventually be able to purchase from local drug stores.
When the pandemic began early this year, Lucira redirected its efforts to Covid-19.
- Additional reporting from Associated Press.