The makers of the kits, SD Biosensor and Humasis Co, 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 98 per cent proven for industry-standard PCR tests and specialist-administered rapid tests.
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