Self-test kits for Covid-19 that haven’t been approved by the FDA could be fake: Duque
The use of self-administered or home Covid-19 test kits that have not been certified by the Food and Drug Administration was warned against by Health Secretary Francisco Duque III on Friday (FDA).
Duque stated in a radio broadcast that the kits on the market are most likely counterfeit and smuggled.
“Malamang hindi aprubado ‘yan, kaya hindi ka basta basta dapat bumibili ng mga ganoon,” he said. “Ang utos ko sa FDA, pa-imbestigahan lahat ‘yan para makita kung ‘yan ba ay dumaan sa kanilang pagsusuri at ‘yan
The National Bureau of Investigation is also keeping an eye on such kits, he added.
Products that have not been approved by a regulatory agency, such as the FDA, are considered phony, according to Duque.
The FDA is now investigating the source of online-sold self-administered Covid-19 test kits.
According to Duque, the FDA has approved fast antigen test kits for use exclusively in laboratories or by clinicians.
As the public clamor for mass testing grows in the face of rising diseases, FDA Deputy Director-General Oscar Gutierrez called on test kit producers to apply for CPR on Thursday.
Nasal samples obtained with the kit would differ from nasopharyngeal samples obtained during reverse transcription-polymerase chain reaction and other swab tests performed by health professionals, according to Gutierrez.
Such kits, he claimed, are “less invasive” since they “do not reach the pharynx or the top section of the throat behind the nose.”
By January 17, the public should anticipate guidelines on how to utilize the kits properly.
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