COVID-19: South Korea grants approval for self-test kits amid surge
South Korea granted conditional approval that will allow the public to use two COVID-19 self-test kits for the first time, amid surge.
The ministry said in a statement on Friday, that 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
The decision comes as a result of the struggles a nationwide rise in cluster infections, which made the authorities to urge tougher enforcement of distancing rules to avoid a fourth wave of the pandemic.
The kits could yield results within about 15 minutes, but with an accuracy of 90%, versus the 98% proven for industry-standard PCR tests and specialist-administered rapid tests.
Acting Prime Minister, Hong Nam-ki said, “Despite the differences in accuracy, there is a need to use those kits as a supplementary tool.
“If PCR tests offer microscopic examinations with almost 100% accuracy, self-test kits can be compared to results made with naked eyes.”
Health authorities have warned that the kits have a greater possibility of false negatives if handled by non-professionals, since a high viral load in the nasal passageways is often essential for a reliable result.
Officials have expressed positive views in recent weeks about allowing limited use, amid fears of a potential fourth wave.
Some local government chiefs have urged their use in homes, restaurants, shops and places of worship as a quick and easy way to detect possible infections.
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