‘Groundbreaking’ Coronavirus saliva test gets FDA approval

New method could relieve pressure on supplies of reagents crucial for existing tests

Andrew Naughtie@andrewnaughtie
Monday 17 August 2020 16:14
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Bill Gates says US coronavirus testing is 'most worthless in the world'

A new saliva-based coronavirus test developed at Yale University has been given emergency use authorisation by the FDA, raising hopes that a cheap and reliable alternative to current methods could be rolled out nationwide.

Developed at Yale’s School of Public Health, the SalivaDirect test is being tested on players and staff from the National Basketball Association. Early results apparently show that it is both highly sensitive and roughly as accurate as currently used nose and throat swabs.

Announcing of the authorisation, the FDA explained that among the method’s biggest benefits is that unlike other tests, it does not require either expensive collection equipment or a separate nucleic acid extraction step – one of the key elements of testing that has so far drained supplies of extraction kits.

And because SalivaDirect does not rely on proprietary equipment, labs across the US will be able to request the “open source” testing protocol and begin collecting and processing samples themselves.

FDA commissioner Stephen Hahn celebrated the “groundbreaking” test’s authorisation, and particularly that it comes at a time when national and global pressure on supplies and resources is so intense.

“Providing this type of flexibility for processing saliva samples to test for Covid-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” he said in a statement.

Problems with testing have dogged the US’s coronavirus response since the start of the outbreak, with the Centres for Disease Control struggling to come up with a reliable test until well after the virus began appearing across the country.

While testing capacity across the country has since been rapidly expanded, with around 1.5 to 2 million tests now conducted each week, serious problems remain, particularly when it comes to turnaround time and testing supplies.

There are also signs that the testing effort is not reaching the right people. In a recent interview, philanthropist Bill Gates said that “The access to that testing system is very unequal. The wrong people are being tested and any time you don’t get results in less than 24 hours, the value of the test is dramatically reduced.”

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