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.
WANG RELEASED: A police investigation showed that an organized crime group allegedly taught their clients how to pretend to be sick during medical exams Actor Darren Wang (王大陸) and 11 others were released on bail yesterday, after being questioned for allegedly dodging compulsory military service or forging documents to help others avoid serving. Wang, 33, was catapulted into stardom for his role in the coming-of-age film Our Times (我的少女時代). Lately, he has been focusing on developing his entertainment career in China. The New Taipei District Prosecutors’ Office last month began investigating an organized crime group that is allegedly helping men dodge compulsory military service using falsified documents. Police in New Taipei City Yonghe Precinct at the end of last month arrested the main suspect,
A cat named Mikan (蜜柑) has brought in revenue of more than NT$10 million (US$305,390) for the Kaohsiung MRT last year. Mikan, born on April 4, 2020, was a stray cat before being adopted by personnel of Kaohsiung MRT’s Ciaotou Sugar Refinery Station. Mikan was named after a Japanese term for mandarin orange due to his color and because he looks like an orange when curled up. He was named “station master” of Ciaotou Sugar Refinery Station in September 2020, and has since become famous. With Kaohsiung MRT’s branding, along with the release of a set of cultural and creative products, station master Mikan
RISING TOURISM: A survey showed that tourist visits increased by 35 percent last year, while newly created attractions contributed almost half of the growth Changhua County’s Lukang Old Street (鹿港老街) and its surrounding historical area clinched first place among Taiwan’s most successful tourist attractions last year, while no location in eastern Taiwan achieved a spot in the top 20 list, the Tourism Administration said. The listing was created by the Tourism Administration’s Forward-looking Tourism Policy Research office. Last year, the Lukang Old Street and its surrounding area had 17.3 million visitors, more than the 16 million visitors for the Wenhua Road Night Market (文化路夜市) in Chiayi City and 14.5 million visitors at Tainan’s Anping (安平) historical area, it said. The Taipei 101 skyscraper and its environs —
Taiwan on Friday said a New Zealand hamburger restaurant has apologized for a racist remark to a Taiwanese customer after reports that it had first apologized to China sparked outrage in Taiwan. An image posted on Threads by a Taiwanese who ate at Fergburger in Queenstown showed that their receipt dated Sunday last week included the words “Ching Chang,” a racial slur. The Chinese Consulate-General in Christchurch in a statement on Thursday said it had received and accepted an apology from the restaurant over the incident. The comment triggered an online furor among Taiwanese who saw it as an insult to the
RSS