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Taiwan FDA approves imports of COVID-19 home test kits

2021-06-14
Focus Taiwan
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Photo courtesy of New Taipei Social Welfare Department
Photo courtesy of New Taipei Social Welfare Department

Taipei, June 12 (CNA) Imports of two types of COVID-19 home test kits to Taiwan have been approved, the Food and Drug Administration (FDA) said Saturday.

Three companies that applied to import two COVID-19 home test kit products -- Swiss biotech company Roche's "SARS-CoV-2 Antigen Self Test Nasal" and American medical technology firm Lucira's "Check It COVID-19 Test Kit" -- have received approval from regulators, according to FDA official Lin Hsin-hui.

Since companies need to gain approval before they can import the test kits, Lin said she expects it will take at least a week for the products to hit the market in Taiwan.

The FDA will issue a protocol on how to conduct home testing for the public before the products become available in Taiwan, she added.

According to Lin, both products require users to swab inside their nose, with Roche's product testing for antigens of the coronavirus, and Lucira's testing for nucleic acid from the virus.

If users test positive, Lin said they should go to a testing site set up by the government or a medical institution for a polymerase chain reaction (PCR) test to confirm whether they have the disease.

Only licensed vendors of medical equipment, such as pharmacies, can sell the home test kits, and they cannot be sold online, Lin said.

The approval was announced after Health Minister Chen Shih-chung said Monday that the government was considering allowing people to test themselves at home to boost the country's overall COVID-19 screening capacity.

Since an uptick in locally-transmitted cases in mid-May, the government has set up testing sites in hotspots, such as Taipei and New Taipei, as well as industrial parks around Taiwan because of cluster infections in factories.

As of Saturday, Taiwan has reported a total of 12,746 COVID-19 cases since early 2020, of which over 11,000 are domestic infections recorded since May 15, the first day the country reported over 100 cases.

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