2 antigen self-test kits get special certification – FDA

Published January 24, 2022, 11:45 PM

by Dhel Nazario

The Food and Drug Administration (FDA) has given special certification to two labs for their home-administered test kits, it announced on Monday, Jan. 24.

(Photo from Unsplash)

During the President’s pre-recorded public address, FDA-OIC Director-General Oscar Gutierrez reported that two kits were the first to get special certification.

One of the self-test kits was thePanbio COVID-19 antigen self-test from Abbot which will be available in 1, 4, 10, or 20 tests per box.

The other is the Sars-Cov-2 Antigen Rapid Test from Labnovation Technologies, INC which will be available in 2, 5, or 20 tests per box.

Meanwhile, he also reported that from March 2020 to Jan. 24, 2022 a total of 86 antigen test kits were banned for sale after failing to pass the post-market surveillance and product monitoring. He added the FDA was able to seize last week 50,000 test kits and 70,000 boxes of fake medicine and antigen tests in Manila.

He also mentioned that the FDA was able to inspect all 551 drug outlets in the country wherein they were to confiscate 11 suspected counterfeit health products including three rapid antigen tests in Guagua, Pampanga; Bataan, and Makati.

Gutierrez has said that once the product such as the self-test kit which was given special certification reaches the market, they still conduct continuous monitoring, wherein they collect samples and send them back to the Research Institute for Tropical Medicine (RITM) to test them for actual use.

Health Undersecretary Maria Rosario Vergeire has explained that the RITM is the office mandated to do performance validation of testing kits.

On Jan. 18 Gutierrez said that they have so far received 11 applications from manufacturers. He said that they will issue a special certification for self-test kits to make it accessible and available for households and individuals.

 
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