FDA probes self-home antigen test kits

The Food and Drug Administration is already looking into the certification of self-home antigen test kits that are being sold online, Health Secretary Francisco Duque III said in a report by GMA News.

This came after the FDA said it will soon begin accepting applications for certification for the test kits.

Duque said those that are not approved by the country’s regulatory body can be considered as fake.

“Kaya nga sabi ko sa FDA, paimbisitigahan lahat ‘yan para makita ‘yan ba ay dumaan sa kanilang pagsusuri at ‘yan ba ay nabigyan ng certificate of conduct registration,” Duque said in an interview on Super Radyo dzBB.

(That’s why I told the FDA to investigate if these underwent inspection and if these were given a certificate of product registration.)

“Pinapatingnan ko na nga yung regulatory field office investigators ng FDA ay sa kasalukuyan tinitingnan na ‘yan, tinitingnan na ‘yung link kung saan galing ‘yan,” he later added.

(I’m asking regulatory field office investigators of FDA, they are currently looking into it, they are checking the link on where these came from.)

Duque advised the public to refrain from buying the self-home test kits.

“Meron lang tayo yung ating rapid antigen test kits na sa laboratory ginagamit o sa mga doktor, mga healthcare professionals lamang ang authorized to conduct the rapid antigen test kit,” he said.

(We only have the rapid antigen test kits in the laboratory that are used by doctors. Only healthcare professionals are authorized to conduct the rapid antigen test kit.)

Meanwhile, Duque said those that test positive on antigen tests no longer need a confirmatory RT-PCR while those that test negative must take an RT-PCR test.

“Kung positive ka hindi ka na kailangan mag RT-PCR confirmation, okay, you consider that already positive,” Duque said.

(If you are positive, you don’t need an RT-PCR confirmation, you already consider that positive.)

“Number two, kung negative ka, pero halimbawa, symptomatic ka negative ka, kailangan ka magpa RT-PCR confirmatory para ka talaga malaman sa sintomas mo,” he added.

(Number two, if you are negative but symptomatic, you need an RT-PCR confirmatory test.)