DOH says no self-administered antigen test kit has been registered with FDA
A COVID-19 Lateral Flow (LFT) self-test kit, containing a SARS-CoV-2 Antigen Rapid Test. (Photo by Ben STANSALL / AFP)
MANILA, Philippines — No self-administered COVID-19 antigen test kit has been registered with the Food and Drug Administration (FDA) despite its sale online, the Department of Health (DOH) said Friday.
“At present, no antigen test kit that are self-administered has been registered with the Food and Drug Administration yet,” Health Undersecretary Maria Rosario Vergeire said in a Palace press briefing.
“Not all antigen tests are created equal,” Vergeire added. She noted that those designed to be used by health workers require training to obtain a correct sample. Meanwhile, self-test kits are easier to use.
The health official made the reminder a day after after FDA officer-in-charge Dr. Oscar Gutierrez announced that the agency has started accepting application for special certification of COVID-19 test kits for home use.
In a radio interview, Health Secretary Francisco Duque III said the public should not just buy self-administered antigen test kits. He stressed that these should be registered with the FDA. Otherwise, the product may be fake or smuggled.
Duque said he had already asked the FDA to prepare its approval of registered COVID-19 antigen test kits for home use.
