South Korea granted conditional approval that will allow the public to use two coronavirus self-test kits for the first time, as a surge in infections has rekindled calls to step up testing.
The decision comes as South Korea grapples with a nationwide rise in cluster infections, spurring authorities to urge tougher enforcement of distancing rules to avert a fourth wave of the pandemic.
The makers of the kits, SD Biosensor Inc and Humasis Co Ltd , were given three months to provide further clinical trial data on self-testing as a condition of the approval, the drug safety ministry said in a statement.
The kits could yield results within about 15 minutes, but with an accuracy of 90 per cent, the ministry added, versus the 98pc proven for industry-standard PCR tests and specialist-administered rapid tests.
