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Two brands of home antigen kits receive approval from FDA




During the Talk to the People of President Rodrigo Duterte last January 24, 2022, Officer-in-Charge Oscar Gutierrez said that two (2) brands of self-administered antigen kits, namely Abbott Panbio and Labnovation Technologies, were already approved by the Food and Drug Agency (FDA).


According to Gutierrez, the two COVID-19 home-antigen kits originated from India, and China passed the evaluation of the FDA, thus allowing them to be available in the market.


Abbott Panbio which is manufactured in India will be sold per piece and in boxes containing 4, 10, and 20 pieces. Meanwhile, China-based Labnovation COVID-19 antigen test kits will be available in 2, 5, and 20 pieces.


According to FDA, there are at least 31 more self-administered test kits under strict evaluation and testing under the Research Institute for Tropical Medicine (RITM).


“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 noted.


Gutierrez also reminded the public only to buy the FDA-approved self-antigen test kits to FDA-recognized pharmacies and carefully check the expiration dates and instructions.


Approximately 116 coronavirus test kits of different types, including PCR, antibody, and antigen, are certified by the FDA.


Meanwhile, Gutierrez said that at least 86 have been pulled out from the market due to low-performance validation results after being certified, voluntary withdrawal of special certification, or uncertified test kit.


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