《TAIPEI TIMES》 CECC approves limited imports of at-home tests
People line up in the rain for COVID-19 testing in New Taipei City’s Tucheng District yesterday. Photo: CNA
CUSTOMER BEWARE: The center said that people bear responsibility themselves for any results from using products that do not have emergency use authorization
By Lee I-chia / Staff reporter
People can import up to 100 at-home COVID-19 rapid test kits for self-use before June 30, the Central Epidemic Command Center （CECC） said yesterday, as it reported 57,188 new local infections and eight COVID-19-associated deaths.
As domestic demand for COVID-19 rapid test kits has increased with a local outbreak, Food and Drug Administration （FDA） Director Wu Shou-mei （吳秀梅） told a CECC news conference that a flexible measure has been implemented, effective immediately until June 30.
People can import up to 100 at-home COVID-19 rapid test kits for self-use without having to apply to the FDA for special permission, Wu said.
“We would recommend ‘home-use’ test kits, although imports are not limited to products that have obtained an emergency use authorization [EUA] from the FDA,” she said.
However, people will have to bear the responsibility themselves for any effects from using products that have not received an EUA, and results from using such items cannot be used to show compliance with COVID-19-related policies, she said, adding that selling imported test kits for self-use is prohibited.
Meanwhile, a policy to treat positive results in a COVID-19 rapid test for people under home quarantine, home isolation or practicing disease-prevention self-management as confirmed cases — with a physician’s signature — takes effect today.
Minister of Health and Welfare Chen Shih-chung （陳時中）, who heads the CECC, said that if such people test positive with an at-home rapid test, they should book a telemedicine appointment and ask a physician to confirm the test result.
If the physician and the person agree with the result, the physician can report the case through the National Health Insurance （NHI） system and the local health department would arrange isolation or hospitalization according to the CECC’s triage policy, Chen said.
If there is no agreement on the test result, the physician can ask the local health department to arrange a polymerase chain reaction （PCR） test to clarify the diagnosis, he said.
People who test positive with an at-home kit should write their name, the date the test was conducted and take a photograph of the items alongside their NHI card and upload them when booking a telemedicine appointment and show the physician, he said.
There were 57,216 new COVID-19 infections — 57,188 local and 28 imported cases — with 69 moderate or severe cases, and eight deaths, reported yesterday, Chen said.
Centers for Disease Control Deputy Director-General Philip Lo （羅一鈞）, deputy head of the CECC’s medical response division, said that the eight people who died were aged 60 to over 90, with five of them unvaccinated against COVID-19.
Three of the people who died had lost consciousness and had difficulty breathing before they arrived at hospitals, where they tested positive for COVID-19, Lo said.
People should pay special attention to the health of elderly people, especially those at risk, he said.
A medical worker in hazmat suit carries equipment for COVID-19 testing in New Taipei City’s Banqiao District yesterday. Photo: CNA