The Food and Drug Administration has issued special certifications to two self-administered home antigen test kits for COVID-19.
In a report to President Rodrigo Duterte late Monday evening, FDA officer-in-charge Oscar Gutierrez said the applications of Abbott’s Panbio COVID-19 Antigen Self-Test and Labnovation Technologies Inc.’s SARS-COV-2 Antigen Rapid Test were approved.
The FDA received 33 applications for home antigen tests, which were forwarded to the Research Institute for Tropical Medicine (RITM) for performance validation.
This brings to 44 the number of antigen brands approved by FDA, of which 42 can only be administered by a healthcare worker or a health professional.
Gutierrez said the two home antigen test kits will be monitored by the FDA and can be sent to the RITM again for actual use tests.
“We advise the public to buy only FDA-approved test kits following reports of confiscated unauthorized and illegal kits from syndicates,” Gutierrez said.
Last week, government agents seized smuggled fake COVID-19 antigen test kits and other counterfeit health products worth P150 million at a storage facility in Manila.