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.
A group of Taiwanese-American and Tibetan-American students at Harvard University on Saturday disrupted Chinese Ambassador to the US Xie Feng’s (謝鋒) speech at the school, accusing him of being responsible for numerous human rights violations. Four students — two Taiwanese Americans and two from Tibet — held up banners inside a conference hall where Xie was delivering a speech at the opening ceremony of the Harvard Kennedy School China Conference 2024. In a video clip provided by the Coalition of Students Resisting the CCP (Chinese Communist Party), Taiwanese-American Cosette Wu (吳亭樺) and Tibetan-American Tsering Yangchen are seen holding banners that together read:
UNAWARE: Many people sit for long hours every day and eat unhealthy foods, putting them at greater risk of developing one of the ‘three highs,’ an expert said More than 30 percent of adults aged 40 or older who underwent a government-funded health exam were unaware they had at least one of the “three highs” — high blood pressure, high blood lipids or high blood sugar, the Health Promotion Administration (HPA) said yesterday. Among adults aged 40 or older who said they did not have any of the “three highs” before taking the health exam, more than 30 percent were found to have at least one of them, Adult Preventive Health Examination Service data from 2022 showed. People with long-term medical conditions such as hypertension or diabetes usually do not
POLICE INVESTIGATING: A man said he quit his job as a nurse at Taipei Tzu Chi Hospital as he had been ‘disgusted’ by the behavior of his colleagues A man yesterday morning wrote online that he had witnessed nurses taking photographs and touching anesthetized patients inappropriately in Taipei Tzu Chi Hospital’s operating theaters. The man surnamed Huang (黃) wrote on the Professional Technology Temple bulletin board that during his six-month stint as a nurse at the hospital, he had seen nurses taking pictures of patients, including of their private parts, after they were anesthetized. Some nurses had also touched patients inappropriately and children were among those photographed, he said. Huang said this “disgusted” him “so much” that “he felt the need to reveal these unethical acts in the operating theater
Heat advisories were in effect for nine administrative regions yesterday afternoon as warm southwesterly winds pushed temperatures above 38°C in parts of southern Taiwan, the Central Weather Administration (CWA) said. As of 3:30pm yesterday, Tainan’s Yujing District (玉井) had recorded the day’s highest temperature of 39.7°C, though the measurement will not be included in Taiwan’s official heat records since Yujing is an automatic rather than manually operated weather station, the CWA said. Highs recorded in other areas were 38.7°C in Kaohsiung’s Neimen District (內門), 38.2°C in Chiayi City and 38.1°C in Pingtung’s Sandimen Township (三地門), CWA data showed. The spell of scorching