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 recently discovered supernova is the brightest and closest to Earth identified in the past decade, and can be observed with basic equipment, the Taipei Astronomical Museum said on Wednesday. The supernova has an absolute magnitude of 14.9 in luminosity and is in the Pinwheel Galaxy (M101) about 21 million light-years from Earth. It was discovered early on May 20 by Japanese amateur astronomer Koichi Itagaki, who immediately reported the finding to the International Astronomical Union, the museum said. The supernova was designated SN 2023ixf following the astronomical naming conventions for supernovas, it added. The museum said that it observed
Tropical storm Guchol is moving in a northeasterly direction off the east coast of the Philippines and will not hit Taiwan, but will impact local weather starting on Friday, the Central Weather Bureau said Thursday. The storm would bring a low-pressure system northward toward the vicinity of Taiwan, forecaster Chao Hung (趙竑) said. Northern Taiwan will see intermittent rain showers in the morning, and thunderstorms in the afternoon on Friday, he said, adding that rain would be heavier on the east coast and in the central-southern mountainous areas. Rainfall would continue into Saturday, and would spread throughout Taiwan proper, he
Exiled Chinese democracy advocate Wang Dan (王丹) yesterday denied an accusation by former Taiwanese political worker Lee Yuan-chun (李援軍) that Wang had sexually harassed him in a hotel room in New York nine years ago. There was a huge gap between Lee’s accusation and his own understanding and memory, Wang wrote on Facebook, adding it was hard for him to respond further regarding a “unilateral description” made by someone else. Wang made the remarks after his initial response on Facebook was met with criticism, with people saying he did not directly address the allegation. Lee on Friday wrote on Facebook that he
A man was arrested in Hsinchu on Saturday on suspicion of filming women in the women’s washroom of a shopping mall in the city, local Chinese-language media reported on Thursday. The man was arrested at around noon on Saturday when a woman using a stall in the mall’s washroom noticed a cellphone being held above her from the neighboring stall, reports said. The woman ran out of the washroom and yelled to her husband to help her, after which the suspect – who was dressed as a woman – attempted to flee, but was subdued by other men until police
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