Duque cautions public on use of COVID-19 home test kits sans FDA approval

Health Secretary Francisco Duque III (Screengrab from Senate livestream)

MANILA, Philippines — Health Secretary Francisco Duque III on Friday advised the public against using self-administered COVID-19 test kits that have not secured approval from the Food and Drug Administration (FDA), noting that these are most likely counterfeit and smuggled.

Duque said he had asked the FDA to investigate the sale of antigen test kits for home use to check if these have secured a Certificate of Product Registration (CPR) from the regulating body.

“Malamang hindi aprubado ‘yan kaya hindi ka basta basta dapat bumibili ng mga ganoon, kaya ang utos ko sa FDA, paimbestigahan lahat ‘yan para makita kung ‘yan ba ay dumaan sa kanilang pagsusuri at ‘yan ba ay nabigyan ng Certificate of Product Registration,” Duque said in a radio DZBB interview.

(It is most likely not approved that’s why you should not just buy these items. I have instructed the FDA to investigate these and to check if these were products that have secured CPR.)“So kung wala ‘yan (CPR), mga smuggled siguro ‘yang mga ‘yan, at alam ko pinaiimbestigahan na rin ‘yan sa NBI (National Bureau of Investigation),” he added.

(If the product does not have a CPR, it is most likely smuggled. I think this is also being investigated by the NBI.)

Duque issued the reminder a day after FDA officer-in-charge Dr. Oscar Gutierrez announced that the agency has started accepting applications for special certification of COVID-19 test kits for home use.

According to Duque, products not approved by the FDA can be considered fake.

“Well, kung hindi siya aprubado ng regulatory body, you can consider that as peke. Hindi dapat ginagamit ‘yan,” he noted.

(If it is not approved by the regulatory body, you can consider that as fake. You should not use it.)

“Huwag muna tayong bibili niyan dahil kailangan dumaan muna ‘yan sa approval ng FDA. Mayroon lang tayo na rapid antigen test kit na sa laboratoryo ginagamit o mga doktor lamang ang authoritized to conduct the rapid antigen test kit use,” he added.

(Let us not buy these products because they have to first secure approval from the FDA. We only have rapid antigen test kits that can be used at laboratories or can only be administered by doctors.)

Duque said the FDA is trying to identify the source of the self-test kits being sold online.

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