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.
The military has spotted two Chinese warships operating in waters near Penghu County in the Taiwan Strait and sent its own naval and air forces to monitor the vessels, the Ministry of National Defense (MND) said. Beijing sends warships and warplanes into the waters and skies around Taiwan on an almost daily basis, drawing condemnation from Taipei. While the ministry offers daily updates on the locations of Chinese military aircraft, it only rarely gives details of where Chinese warships are operating, generally only when it detects aircraft carriers, as happened last week. A Chinese destroyer and a frigate entered waters to the southwest
A magnitude 6.1 earthquake struck off the coast of Yilan County at 8:39pm tonight, the Central Weather Administration (CWA) said, with no immediate reports of damage or injuries. The epicenter was 38.7km east-northeast of Yilan County Hall at a focal depth of 98.3km, the CWA’s Seismological Center said. The quake’s maximum intensity, which gauges the actual physical effect of a seismic event, was a level 4 on Taiwan’s 7-tier intensity scale, the center said. That intensity level was recorded in Yilan County’s Nanao Township (南澳), Hsinchu County’s Guansi Township (關西), Nantou County’s Hehuanshan (合歡山) and Hualien County’s Yanliao (鹽寮). An intensity of 3 was
Japanese Prime Minister Sanae Takaichi’s comment last year on Tokyo’s potential reaction to a Taiwan-China conflict has forced Beijing to rewrite its invasion plans, a retired Japanese general said. Takaichi told the Diet on Nov. 7 last year that a Chinese naval blockade or military attack on Taiwan could constitute a “survival-threatening situation” for Japan, potentially allowing Tokyo to exercise its right to collective self-defense. Former Japan Ground Self-Defense Force general Kiyofumi Ogawa said in a recent speech that the remark has been interpreted as meaning Japan could intervene in the early stages of a Taiwan Strait conflict, undermining China’s previous assumptions
Taiwan Railways Corp (TRC) today announced that Shin Kong Mitsukoshi has been selected as the preferred bidder to operate the Taipei Railway Station shopping mall, replacing the current operator, Breeze Development Co Ltd. Among eight qualified firms that delivered presentations and were evaluated by a review committee, Shin Kong Mitsukoshi was ranked first, while Breeze was named the runner-up, the rail company said in a statement. Contract negotiations are to proceed in accordance with regulations, it said, adding that if negotiations with the top bidder fail, it could invite the second-ranked applicant to enter talks. Breeze in a statement today expressed doubts over
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