A saliva-based COVID-19 test kit produced by iCare Diagnostics International has been granted emergency use authorization (EUA), the Food and Drug Administration (FDA) said on Saturday.
The test kit, under the brand iCare DX, uses a polymerase chain reaction (PCR) test to detect SARS-CoV-2, the virus that causes COVID-19, in saliva samples, the agency said.
In September, the technology was used to confirm that a Hon Hai Precision Industry engineer had become infected, it added.
The kit manufacturer, which was founded by Hon Hai founder Terry Gou (郭台銘), had provided free test kits to the chipmaker’s employees, and the product corroborated a positive result when other test results were ambiguous, it said.
The test kit’s use of PCR technology sets it apart from swab-based rapid field tests, said Lin Hsin-hui (林欣慧), a specialist in the FDA’s Medical Devices and Cosmetics Division.
Regulators from foreign governments have approved other PCR test kits that test saliva samples, she said.
While the saliva swab does not need to be performed by a medical professional, making the test’s deployment more convenient, medical personnel are needed to process and interpret the test results, she said.
The FDA has not approved a saliva-based rapid testing kit for household use, she said, adding that people should not buy products not meant for them to use.
Shih Shin-ru (施信如), head of Chang Gung University’s Research Center for Emerging Viral Infections, said controlled tests by his team showed that the kits are as accurate as swab-based PCR tests.
The kits reduce the risk of virus exposure to medical staff and the public because medical workers do not need to administer the swabs and the kits can be distributed to people in quarantine, he said.
ANOTHER EMERGES: The CWA yesterday said this year’s fourth storm of the typhoon season had formed in the South China Sea, but was not expected to affect Taiwan Tropical Storm Gaemi has intensified slightly as it heads toward Taiwan, where it is expected to affect the country in the coming days, the Central Weather Administration (CWA) said yesterday. As of 8am yesterday, the 120km-radius storm was 800km southeast of Oluanpi (鵝鑾鼻), Taiwan’s southernmost tip, moving at 9kph northwest, the agency said. A sea warning for Gaemi could be issued tonight at the earliest, it said, adding that the storm is projected to be closest to Taiwan on Wednesday or Thursday. Gaemi’s potential effect on Taiwan remains unclear, as that would depend on its direction, radius and intensity, forecasters said. Former Weather Forecast
As COVID-19 cases in Japan have been increasing for 10 consecutive weeks, people should get vaccinated before visiting the nation, the Centers for Disease Control (CDC) said. The centers reported 773 hospitalizations and 124 deaths related to COVID-19 in Taiwan last week. CDC Epidemic Intelligence Center Director Guo Hung-wei (郭宏偉) on Tuesday said the number of weekly COVID-19 cases reported in Japan has been increasing since mid-May and surpassed 55,000 cases from July 8 to July 14. The average number of COVID-19 patients at Japan’s healthcare facilities that week was also 1.39 times that of the week before and KP.3 is the dominant
The Chinese Communist Party’s (CCP) working group for Taiwan-related policies is likely to be upgraded to a committee-level body, a report commissioned by the Mainland Affairs Council (MAC) said. As Chinese President Xi Jinping (習近平) is increasingly likely to upgrade the CCP’s Central Leading Group for Taiwan Affairs, Taiwanese authorities should prepare by researching Xi and the CCP, the report said. At the third plenary session of the 20th Central Committee of the CCP, which ended on Thursday last week, the party set a target of 2029 for the completion of some tasks, meaning that Xi is likely preparing to
US-CHINA TRADE DISPUTE: Despite Beijing’s offer of preferential treatment, the lure of China has dimmed as Taiwanese and international investors move out Japan and the US have become the favored destinations for Taiwanese graduates as China’s attraction has waned over the years, the Ministry of Labor said. According to the ministry’s latest income and employment advisory published this month, 3,215 Taiwanese university graduates from the class of 2020 went to Japan, surpassing for the first time the 2,881 graduates who went to China. A total of 2,300 graduates from the class of 2021 went to the US, compared with the 2,262 who went to China, the document showed. The trend continued for the class of 2023, of whom 1,460 went to Japan, 1,334 went to