FDA approves over the counter test kits

FDA approves over the counter test kits

A health worker holds a rapid antigen test at Irish Air Line Pilots Association headquarters, in Dublin, Ireland, on June 16, 2021. (Reuters photo)
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, after an announcement by the Public Health Ministry authorising over-the-counter sale of this medical device was published on Tuesday in the Royal Gazette.

The kits, however, will not be allowed to be sold over the internet, said Dr Paisal Dunkhum, secretary-general of the FDA.

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 an informed source.

Their prices range from 200 baht to 700 baht apiece, said the source.

"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 Dr Surachok Tangwiwat, 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 in the nasopharynx, which goes deeper into the nasal cavity, he said.

Although less accurate, the rapid test kit is important for people with a high risk of contracting the virus who need early detection if infected, said the doctor.

The FDA and the Department of Medical Science is speeding up production of a short video clip to be released which is aimed at educating consumers on how to use the rapid test kits correctly, he said.

In response to the expected high demand for the Covid-19 rapid test kits, the FDA will be working together with the Ministry of Commerce to ensure these products are sold at reasonable prices, said Dr Paisal.

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