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.
Eight Chinese naval vessels and 24 military aircraft were detected crossing the median line of the Taiwan Strait between 6am yesterday and 6am today, the Ministry of National Defense said this morning. The aircraft entered Taiwan’s northern, central, southwestern and eastern air defense identification zones, the ministry said. The armed forces responded with mission aircraft, naval vessels and shore-based missile systems to closely monitor the situation, it added. Eight naval vessels, one official ship and 36 aircraft sorties were spotted in total, the ministry said.
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The Ministry of National Defense yesterday reported the return of large-scale Chinese air force activities after their unexplained absence for more than two weeks, which had prompted speculation regarding Beijing’s motives. China usually sends fighter jets, drones and other military aircraft around the nation on a daily basis. Interruptions to such routine are generally caused by bad weather. The Ministry of National Defense said it had detected 26 Chinese military aircraft in the Taiwan Strait over the previous 24 hours. It last reported that many aircraft on Feb. 25, when it spotted 30 aircraft, saying Beijing was carrying out another “joint combat
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