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.
China has reserved offshore airspace in the Yellow Sea and East China Sea from March 27 to May 6, issuing alerts usually used to warn of military exercises, although no such exercises have been announced, the Wall Street Journal (WSJ) reported yesterday. Reserving such a large area for 40 days without explanation is an “unusual step,” as military exercises normally only last a few days, the paper said. These alerts, known as Notice to Air Missions (Notams), “are intended to inform pilots and aviation authorities of temporary airspace hazards or restrictions,” the article said. The airspace reserved in the alert is
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The first bluefin tuna of the season, brought to shore in Pingtung County and weighing 190kg, was yesterday auctioned for NT$10,600 (US$333.5) per kilogram, setting a record high for the local market. The auction was held at the fish market in Donggang Fishing Harbor, where the Siaoliouciou Island-registered fishing vessel Fu Yu Ching No. 2 delivered the “Pingtung First Tuna” it had caught for bidding. Bidding was intense, and the tuna was ultimately jointly purchased by a local restaurant and a local company for NT$10,600 per kilogram — NT$300 ,more than last year — for a total of NT$2.014 million. The 67-year-old skipper
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