FDA approves another COVID-19 antigen self-test kit brand

Food and Drug Administration (FDA) certified another self-administered COVID-19 test kit.

According to a performance evaluation by the Research Institute for Tropical Medicine, this is MOHS Analytics Inc.’s nasal swab test kit, with a 96.43 percent sensitivity to detect COVID-19.


As a result, up to 3 self-administered COVID-19 test kits have been FDA-certified.

The use of antigen self-test kits by Abbott Panbio and Labnovation Technologies was previously approved.

Based on the updated circular of the Department of Health (DOH), each self-test kit must be sold at a price not to exceed P350.


The retail price cap for the rapid antigen test kit is also P350, which requires professional medical assistance to use.

If the operation cost of testing in a laboratory is to be added, the price of the entire service, including the test kit, should be only up to P660.

“‘Pag sosobra, maaari kayong tumawag sa FDA hotline, maaaring tumawag sa DOH hotline para mapaimbestigahan ‘yan,” said Health Undersecretary Maria Rosario Vergeire.


Meanwhile, the FDA has also given emergency use authorization to molnupiravir manufactured by local manufacturer Lloyd Laboratories.

According to FDA officer-in-charge Oscar Gutierrez, because the local manufacturer is the source of this molnupiravir, all their supplies are reserved for the country.

FDA approves another COVID-19 antigen self-test kit brand

“Ang Lloyd Labs, kaya nila mag-produce ng 1 million capsules per year. Sasapat po ito sa 25,000 to 50,000 patients. Itong ipo-produce ay dedicated para sa Pilipinas lang po,” said Gutierrez.

You can also expect a lower price of molnupiravir from Lloyd Laboratories than the molnupiravir that is on the market today.

Because molnupiravir has only been issued by the EU, it cannot be sold commercially.

According to the EUA, DOH, and the National Task Force Against COVID-19, only Lloyd Laboratories can procure molnupiravir and distribute it to health care providers.

A prescription is still needed before you can get or buy a drug.

According to Gutierrez, the public can also expect the availability of FDA-licensed online pharmacies.

But only over-the-counter drugs can be bought at online pharmacies.

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