DOH says self-test kits need FDA approval, not RITM - SunStar

DOH says self-test kits need FDA approval, not RITM

AMID the emergence of more self-test kits in the market, the Department of Health (DOH) on Saturday, January 22, 2022, reminded the public that it is the Food and Drug Administration (FDA) that issues the approval for them, not the Research Institute for Tropical Medicine (RITM).

In a radio interview, Health Undersecretary Maria Rosario Vergeire said the public should not fall for sellers that offer “RITM-approved” self-test kits.

“What we need to look for in the labels would be the registration of FDA. This means that it has been certified by the FDA already,” said Vergeire.

“RITM is just part of the process of evaluation by the FDA. But it’s the FDA that issues the registration,” she added.

The health official said the FDA has yet to approve any self-administered test kits in the country.

She said this is because all 11 applications are still being assessed and evaluated by the FDA.

“These 11 self-administered test kits are still being evaluated by the FDA. They will release their findings soon,” said Vergeire.

Parallel to FDA’s evaluation, she said the DOH is already drafting guidelines for the use of self-administered test kits.

This is to make sure that the public will be using them correctly and avoid getting false results.

“We are now drafting the guidelines at the DOH on how these self-administered kits will be used. These guidelines will specifically instruct the citizens how they can use it,” said Vergeire.

All rapid antigen test kits in the market are to be administered and interpreted by healthcare workers.

Similarly, reverse transcription-polymerase chain reaction or RT-PCR tests must only be conducted by medical professionals.

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