COVID-19

FDA approves 2 brands of home antigen test kits

Aika Rey
FDA approves 2 brands of home antigen test kits

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The Food and Drug Administration says 31 other brands are still being evaluated

MANILA, Philippines – The Food and Drug Administration (FDA) has certified two brands of self-administered antigen test kits, Officer-in-Charge Oscar Gutierrez told President Rodrigo Duterte on Monday, January 24.

Gutierrez said that Abbott Panbio and Labnovation Technologies COVID-19 antigen self-test kits were approved by the FDA.

Abbott Panbio will be available per piece. It will also be available in boxes containing four, ten, or 20 tests.

Labnovation Technologies, meanwhile, will retail at two, five, and 20 tests per box.

“Yung dalawa, madarag-dagan pa. Meron pang 31 na nasa performance validation ng RITM (Research Institute for Tropical Medicine). Aabangan natin ‘yung iba pang ma-aapprubahan,” said Gutierrez.

(There will be additional brands aside from these two. There are 31 other brands that we are waiting for the performance validation results from RITM. Let’s just wait which ones will be approved.)

With FDA finally giving the green light for home test kits, Gutierrez reminded the public to only buy tests in pharmacies that have been certified by the agency.

Gutierrez said that it was important to buy from FDA-licensed pharmacies because they know how to handle the test kits properly, especially since some kits have temperature requirements.

He also said that consumers should always check the expiration date of the product and read the instructions carefully.

The Department of Health has said that antigen tests are most useful for people with COVID-19 symptoms to find out if they are positive.

An antigen test result that is positive is likely accurate in detecting COVID-19 but a negative test result often needs to be confirmed by an RT-PCR test.

Advocates and concerned citizens have been pushing the government to approve self-antigen test kits since the pandemic began. In other countries, governments have long issued home testing policies and have provided self-test kits to citizens for free.

Earlier, Acting Presidential Spokesman and Cabinet Secretary Karlo Nograles said that the government has always considered the matter, but has to be put on the back burner to prioritize RT-PCR testing. – Rappler.com

Aika Rey

Aika Rey is a business reporter for Rappler. She covered the Senate of the Philippines before fully diving into numbers and companies. Got tips? Find her on Twitter at @reyaika or shoot her an email at aika.rey@rappler.com.