FDA Approves Over-the-Counter Sale of Antigen Test Kits

The Food and Drug Administration (FDA) said that Covid-19 antigen test kits could be available for sale over the counter starting next week.

The announcement comes after the Public Health Ministry reported through the Royal Gazette that it authorized the over-the-counter sale of those medical devices on Tuesday.

However, FDA Secretary-General Dr. Paisal Dunkhum clarified that the kits could not be sold over the Internet.

They would only be available for sale at licensed medical institutions, medical technology clinics, medical clinics, and pharmacies with a licensed pharmacist on duty, he added.

Dr. Paisal also said that at least seven of the 24 companies that developed FDA-registered products for sale in Thailand agreed to make the kits suitable for self-testing.

The FDA and the Department of Medical Sciences have been working to speeding up the production of a short video on the kits’ use.

The clip aims to educate consumers and give people clear instructions on how to employ rapid test kits properly.

Meanwhile, FDA Deputy Secretary-General Dr. Surachok Tangwiwat said they were still concerned that not all consumers might be able to use the test kits correctly.

Additionally, he mentioned that rapid antigen tests might not be as accurate as Reverse Transcription Polymerase Chain Reaction tests, also known as RT-PCR.

He also explained that a repeat test is required three days after the first negative test because the kits work better in people with a high volume of the virus.

The RT-PCR test uses specimens collected from the nasopharynx, which penetrates deeply into the nasal cavity.

Instead, the rapid antigen test is based on samples collected by nasal swabbing.

While the latter is less accurate, it is important for people at high risk of catching the virus who also need early detection if they get infected, the doctor explained.

The FDA said it would work together with the Ministry of Commerce to ensure that Covid-19 rapid test kits are sold at reasonable prices considering the high demand for these medical devices, Dr. Paisal stated.

Various online shopping platforms have already started offering different Covid-19 antigen test kits, mostly made in China, South Korea and Indonesia, informed sources said.

Prices for the kits, which will ship to Thailand in about a week, range from 200 baht to 700 baht each, they added.