FDA approves home test kits

The Food and Drug Administration (FDA) now expects Covid-19 antigen test kits to be made available for sale over the counter by next week.

FDA approves home test kits
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FDA approves home test kits

published : 14 Jul 2021 at 09:23

writer: Gary Boyle


A health worker holds a rapid antigen test at Irish Air Line Pilots Association headquarters, in Dublin, Ireland, on June 16, 2021. (Reuters photo)

The Food and Drug Administration (FDA) now expects Covid-19 antigen test kits to be made available for sale over the counter by next week.

The kits , however, will not be allowed to be sold over the internet.

Only authorised medical institutions, medical clinics , medical technology clinics and pharmacies with a licensed pharmacist on duty will be allowed to sell the test kits , he said.

About seven out of all 24 companies whose products have been registered with the FDA for sale in Thailand have agreed to adjust their Covid-19 test kits to make them suitable for self-testing, he said.

Several Covid-19 antigen test kits have already been advertised on various online shopping platforms, most of which are products made in China, South Korea and Indonesia which will be shipped to Thailand in four days to a week, said a source .

Their prices range from 200 baht to 700 baht each.

"Honestly, the FDA is still worried that not all consumers will be able to use the test kits correctly and the fact that the [rapid antigen] test kit may not be as accurate as the Reverse Transcription Polymerase Chain Reaction [RT-PCR] test," said the deputy secretary-general of the FDA.

Because the rapid antigen test kit works best on people with a high volume of the new coronavirus that causes Covid-19, a repeat test is required three days later if the first test gives a negative result, he said.

The difference between the rapid antigen test and the RT-PCR test is the former relies on specimens collected by nasal swabbing while the latter test uses specimens collected deeper into the nasal cavity , he said.


  • antigen : a harmful substance that causes your body to produce antibodies to fight it - แอนติเจน, สารที่กระตุ้นการสร้างแอนติบอดี้, สารก่อภูมิต้านทาน, สิ่งแปลกปลอมที่เข้าไปในร่างกาย แล้วร่างกายจะผลิตสารซึ่งเรียกว่าแอนติบอดีขึ้นมาต่อต้าน หรือทำลายสิ่งแปลกปลอมนั้น ๆ
  • approve : to give official permission - อนุมัต
  • cavity : a hole or empty space inside something solid - หลุม, ช่อง
  • clinic : a place where a person goes to receive medical treatment -
  • kit (noun) : a set of things used to do some activity or job - ชุดเครื่องมือสำหรับใช้
  • nasal : related to the nose -
  • over the counter (adj.) : when a drug can be bought by a patient without permission or a "prescription" from a doctor -
  • pharmacist : someone whose job is to prepare medicines for sale in a shop or in a hospital. A pharmacist’s shop is called a pharmacist, a pharmacist’s, or a pharmacy - เภสัชกร
  • self- : does it to them self, not others -
  • source : a place where information comes from; someone who gives information - แหล่งข่าว
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