FDA approves 2 brands of antigen at-home test kits

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Metro Manila (CNN Philippines, January 24) — The Food and Drug Administration (FDA) on Monday said it has approved the use of two brands of self-administered COVID-19 antigen test kits.

In the weekly televised meeting with President Rodrigo Duterte and Cabinet officials, FDA officer-in-charge Oscar Gutierrez said one of the products is the Panbio COVID-19 antigen self-test kit manufactured by Abbot, while the other is the SARS-CoV-2 antigen rapid test for home use made by Labnovation Technologies, Inc.

So far, only the two brands of self-test kits have been issued special certification by the regulatory agency. The FDA said 31 others have been turned over to the Research Institute for Tropical Medicine (RITM) for evaluation.

Gutierrez reminded the public to only buy FDA-certified test kits to ensure accuracy of results.

“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,” he said.

[Translation: It is important that the test kits undergo performance validation by the RITM. Because if these kits’ sensitivity is low, there may be a lot of false negative results.]

He also urged consumers to only go to licensed drug outlets, as well as to take note of expiration dates and carefully follow instructions found in the package insert.

The FDA has certified a total of 116 coronavirus test kits of different types, including PCR, antibody, and antigen.

Meanwhile, Gutierrez said 86 have been removed from the market. He explained this could be over low performance validation results after the product was already approved, voluntary surrender of special certification, or the test kit was found to be uncertified.