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DOH: No FDA approved self-administered COVID-19 antigen test kit yet

Published Jan 9, 2022 02:18 pm

DOH

The Food and Drug Administration (FDA) has not approved any self-administered COVID-19 antigen test kit in the country so far, the Department of Health (DOH) reminded the public.

DOH Undersecretary Maria Rosario Vergeire said that all antigen tests should still be done by medical professionals at this time.

"Currently, there are no FDA approved COVID-19 self testing kits," she said.

"The administering of antigen tests should be done by trained healthcare workers in order to ensure accurate results," she added.

Vergeire reminded those who are experiencing symptoms of COVID-19 to seek advice from medical professionals.

"The DOH urges people who experience flu-like symptoms or have been in close contact with a confirmed or probable case to self-isolate, consult telemed, and get tested," she said.

"In this way, we can immediately respond to the threats of transmission of the virus," she added.

The DOH spokesperson also noted that "the gold standard for testing is still RT-PCR" method.

"Antigen tests should be used only for symptomatic COVID-19 patients, close contacts and those with history of exposure, in outbreaks and in areas without access to RT-PCR confirmatory testing," she said.

On Jan. 6, the FDA announced that it is already accepting applications for special certification of self-administered COVID-19 test kits.

"I am calling all the manufacturers and even the importers of self-administered COVID-19 test kits to register their product in a form of special certification," said FDA Officer-in-Charge Oscar Gutierrez.

READ: FDA accepting applications for special certification of COVID-19 self-test kits

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Department of Health (DOH) Food and Drug Administration self-administered COVID-19 antigen test kit
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