FDA approves 2 brands of self-test kits

In a briefing with President Rodrigo Duterte, FDA OIC Oscar Gutierrez confirmed that the two brands of self-test kits received special certification from the regulator.

He added that 31 more brands are under performance evaluation of the Research Institute for Tropical Medicine (RITM) and are waiting for approval.

Gutierrez advised the public to purchase self-test kits from licensed drug stores, as proper handling, storage and distribution are important. He also urged the consumers to check the expiration dates and read the instructions carefully.

The FDA has approved a total of 116 COVID-19 test kits including RT-PCR, antibody, and antigen tests.

“Importante po talaga na dumaan sa performance validation ng RITM. Kasi po kung mababa po ang sensitivity ay marami pong false negative po na mangyayari,” Gutierrez said.