An official of the Research Institute for Tropical Medicine (RITM) reminded the public to only use COVID-19 self-administered antigen test kits that were already approved by the country’s Food and Drug Administration (FDA).
"Mahalaga po na iyong gagamitin natin na mga kit sa pag-test ay otorisado po ng ating FDA na siyang pangunahing ahensiya po na nag-a-approve ng mga authorization nito (It is important that the testing kits we use are authorized by our FDA, which is the main agency that provides authorization)," said RITM Laboratory Chief Armando Tandoc III on Wednesday, Jan. 26, in a briefing.
Tandoc said this is important to ensure the accuracy of the test result. “So, napakahalaga po na mayroon pong certification ng FDA (it is very important that it has a FDA certification),” he added.
The RITM official assured the public that the approved self-test kits are effective in detecting the virus that causes COVID-19. He said that they require manufacturers who are seeking to secure a special certification from FDA to submit "technical documents" on the “performance and validation” of their respective products.
The Department of Health (DOH) is expected to release the guidelines on the use of COVID-19 self-administered test kits in the coming days.
The two FDA-approved COVID-19 self-test kits were: SARS-CoV-2 Antigen Rapid Test of Labnovation Technologies Inc. and Panbio COVID-19 Antigen Self-Test of Abbott Rapid Diagnostics.
"These kits can be used by individuals to detect SARS-CoV-2 antigen from nasal swab of probable COVID-19 patients. Guidelines for the use of these kits shall be released by the Department of Health," the FDA said.
"We ask the public and stakeholders to be vigilant in the purchase of these COVID-19 test kits. To ensure safety, efficacy and quality of these health products, you are advised to source your COVID-19 test kits from FDA authorized importers who are holders of the Certification for the COVID-19 test kits or their duly authorized FDA licensed distributors," it added.