The Food and Drug Administration (FDA) yesterday said companies that have import permits for three COVID-19 at-home rapid test kits did not submit an evaluation report on whether their products can test for Omicron subvariant XBB, so their efficacy is unknown, but they can still be sold.
As the current dominant SARS-CoV-2 virus globally and in Taiwan is the Omicron subvariant XBB, the FDA in June asked companies that have a permit for importing or manufacturing COVID-19 rapid test kits to submit an evaluation report on whether their products can test for XBB, within a month after they had been notified.
FDA Deputy Director Cheng Hwei-fang (陳惠芳) yesterday said that of the 43 types of COVID-19 rapid test kits, 25 companies have provided the required data proving that their products can test for XBB.
Photo: Tang Shih-ming, Taipei Times
There were also permits for eight products that were not actually imported and the permits for five products have expired, while two products are out of stock, she said, adding that reports for three types of imported test kits were not submitted.
Chen said the three types of imported test kits are “PCL Self Test-Covid19 ag” imported from South Korea by two different companies, with two different Chinese product names (易可安唾液家用抗原檢測套組 and 五鼎捷測唾液型家用新冠抗原), and “Indicaid covid-19 rapid antigen at-home test” (集克家用新冠病毒抗原快速檢測試劑盒) imported from Hong Kong.
There are still about 358,000 kits of the three types in stock or being sold, but as the nucleocapsid protein of XBB is the same as Omicron subvariant BA.5, and the tests kits had all been tested for efficacy against BA.5 when it was the dominant variant, and there are no global warning signs that existing rapid test kits have worse efficacy for testing XBB, the three products can still be sold in Taiwan, she said.
Chen said the three products met the criteria for Emergency Use Authorization when they applied for import permits, so although they did not provide reports on their efficacy for testing XBB, there is also no evidence that they have worsened efficacy when testing for XBB, so the FDA would not ask them to pull their products unless data prove otherwise.
The names of the products have been publicized so that consumers know and can carefully consider whether to purchase the test kits, she said, adding that people should also check the expiration date before using a test kit.
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