The Food and Drug Administration (FDA) has approved the use of Abbott’s Panbio COVID-19 Antigen Self-Test kits and SARS-CoV-2 Antigen Rapid Test Kit of Labnovation Technologies, Inc.
FDA OIC Gutierrez announces that two COVID-19 antigen home test kits have been approved and were granted special certification — the Panbio COVID-19 Antigen Self-Test (Abbott), and the SARS-CoV-2 Antigen Rapid Test Kit (Labnovation). pic.twitter.com/RzfUDAV6kB
— PTVph (@PTVph) January 24, 2022
The announcement on the use of self-administered or home COVID-19 test kits was made by FDA officer-in-charge Dr. Oscar Gutierrez on Monday (Jan. 24) night during President Rodrigo Duterte’s public address.
The FDA reminded the public to buy approved test kits from licensed drug outlets and to follow the product instructions. Gutierrez said the two newly approved home test kits have their videos uploaded on the internet regarding their use.
FDA OIC Gutierrez says the two newly approved home test kits have their videos uploaded on the internet regarding their use.
— PTVph (@PTVph) January 24, 2022
“Importante ang accuracy ng self-test kits. Importante na dumaan sa performance evaluation ng RITM [Research Institute for Tropical Medicine], kasi po kung mababa ang sensitivity ay marami po ang false negative na mangyayari,” he said.
In the Jan. 25 Laging Handa briefing, infectious diseases expert Dr. Rontgene Solante said the use of home antigen test kits must focus on symptomatic and vulnerable individuals.
“I-prioritize natin ang paggamit nitong antigen sa may symptoms at vulnerable population, because these are the population na kapag nag-positive may gamot na antivirals para hindi lumala ang infection nila to severe at hindi ma-hospitalize,” he said.
Meanwhile, the FDA also announced prolonging the shelf life of anti-COVID-19 drug molnupiravir from six months to one year.
Gutierrez said the applications of Molnarz and Molnaflu on the drug have also been approved.
“Bale dalawa na po ‘yung nabigyan natin ng EUA [emergency use authorization] at mayroon pa pong nag-a-apply. Mga siyam pa po ang nag-a-apply, aabangan po natin ‘yan kung mabibigyan po ng EUA,” he said. – Reports from Naomi Tiburcio and Mela Lesmoras/AG-rir
