Health authorities have stepped up reviews and approvals of COVID-19 rapid test kits, as emergency use authorization for 205 types of tests is set to expire at the end of this month, the Food and Drug Administration (FDA) said yesterday.
Fifteen companies have applied for a regular license, with the agency approving two of them, FDA Deputy Director-General Cheng Hwei-fang (陳惠芳) told a regular news briefing in Taipei.
The state of emergency that enabled the agency to issue EUAs has ended following COVID-19’s downgrade to a category 4 infectious disease on May 1, meaning tests must now obtain regular use authorization to be imported, manufactured or sold in Taiwan, she said.
Photo: Taipei Times
The medical device approval process typically takes three months, but the agency will expedite authorization for rapid COVID-19 test kits, Chen said.
Tests already distributed to retailers are not affected by the expiration of the EUA and can be sold as before, she added.
XXB variants are the most common types of SARS-CoV-2 — the virus that causes COVID-19 — found in Taiwan, accounting for 79 percent of all new domestic cases, she said.
Globally, XXB variants were found in 89 percent of all new cases, Chen added.
Amid concerns that XBB1.5 could compromise the accuracy of rapid tests, Chen said that licensed test kits are not affected, as they detect viral nucleocapsid proteins and not the spike protein, which has mutated in this variant.
Data from health authorities in the US, Japan, South Korea, the UK, Germany, the Netherlands, the EU and Singapore suggest that test kits used in Taiwan reported no loss of accuracy with regard to XBB variants, she said.
Nonetheless, the FDA has notified manufacturers to provide within 30 days evaluations on the accuracy of their products in detecting XBB variants, while the agency will conduct a separate evaluation of the efficacy of the tests, Chen said.
In other news, Taiwan yesterday reported six new cases of dengue fever, increasing the total number of cases to 27, local media reports said.
All six were from Tainan — four cases in East District (東區), and one each in Rende (仁德) and Yongkang (永康) districts, the Tainan Public Health Bureau said in a news release.
The new cases are linked to a previously identified infection cluster composed of people residing in high-risk areas, where efforts to eliminate mosquito breeding grounds are being conducted, it said.
Bureau personnel inspected 374 households in the three districts affected by the fever and discovered mosquito spawns in six of the premises, the bureau said, adding that it issued four code violations.
Residents of the area are urged to visit blood test centers in Rende and Shanhua (善化) districts if they have dengue symptoms, the bureau said.
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