The importation of two types of COVID-19 home testing kits has been approved, the Food and Drug Administration (FDA) said on Saturday.
Three companies that applied for a license to import the kits — “SARS-CoV-2 Antigen Self Test Nasal” by Swiss biotechnology firm Roche and “Check It COVID-19 Test Kit” by US firm Lucira — have been granted approval, FDA Medical Devices and Cosmetics Division specialist Lin Hsin-hui (林欣慧) said.
Lin said she expects that it will take at least a week for the products to become available to Taiwanese customers.
Photo: CNA
The FDA is to issue guidelines on how to conduct home testing before the kits enter the market, Lin added.
The products require users to swab inside their nose, with Roche’s kit testing for COVID-19 antigens and Lucira’s kit testing for the virus’ nucleic acid, she said.
If people test positive in a home test, they should go to a government-run COVID-19 testing site or a licensed medical institution for a polymerase chain reaction test to confirm whether they have the disease, she said.
Photo: Chen Chih-chu, Taipei Times
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 granted after Minister of Health and Welfare Chen Shih-chung (陳時中) on Monday last week announced that the government was considering allowing the self-tests to boost Taiwan’s COVID-19 screening capacity.
Following a surge in local COVID-19 cases in the middle of last month, the government set up testing sites in virus hot spots, such as Taipei and New Taipei City, as well as industrial parks across Taiwan after cluster infections in factories were reported.
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