Self-test kits for Covid-19 sans FDA approval may be fake: Duque

By Ma. Teresa Montemayor

January 7, 2022, 9:16 pm

<p>Health Secretary Francisco Duque III <em>(File photo)</em></p>

Health Secretary Francisco Duque III (File photo)

MANILA – Health Secretary Francisco Duque III on Friday warned the public against the use of self-administered or home Covid-19 test kits that have not been approved by the Food and Drug Administration (FDA).

In a radio interview, Duque noted the kits that are circulating in the market are most likely counterfeit and smuggled.

Malamang hindi aprubado ‘yan kaya hindi ka basta basta dapat bumibili ng mga ganoon, kaya ang utos ko sa FDA, pa-imbestigahan lahat ‘yan para makita kung ‘yan ba ay dumaan sa kanilang pagsusuri at ‘yan ba ay nabigyan ng (You shouldn’t buy these kits as they may not be approved so I instructed the FDA to investigate whether the kits have) Certificate of Product Registration [CPR],” he said.

Such kits are also being monitored by the National Bureau of Investigation, he added.

Duque reminded that products lacking the approval of a regulatory body, such as the FDA, are considered fake.

Currently, the FDA is tracing the source of self-administered Covid-19 test kits being sold online.

The FDA has allowed rapid antigen test kits but for use only in laboratories or by doctors, Duque added.

On Thursday, FDA Deputy Director General Oscar Gutierrez called on manufacturers of the test kits to apply for CPR as public demands for mass testing rise amid increasing infections.

Gutierrez explained that nasal samples taken using the kit would be different from nasopharyngeal samples taken during reverse transcription-polymerase chain reaction and other swab tests administered by health professionals.

He said such kits “are less invasive and will not reach the pharynx or the upper part of the throat found behind the nose”.

The public could expect the release of guidelines on the proper use of the kits by January 17. (PNA)