2 makers of self-administered COVID-19 test kits apply for FDA registration: DOH

Katrina Domingo, ABS-CBN News

Posted at Jan 11 2022 07:35 PM

MANILA - At least two manufacturers of self-administered COVID-19 test kits are seeking certificates of product registration from the Food and Drug Authority (FDA), the Department of Health (DOH) said Tuesday.

The FDA is "expediting" the review process so that Filipinos can access these home test kits, said Undersecretary Maria Rosario Vergeire, spokesperson of the DOH.

"Kaya wala pa po sa merkado ng Pilipinas ito ay dahil kakasumite pa lang po ng manufacturers ng kanilang application to register their product at hindi po dahil hindi sila nakapasa doon sa regulatory clearance na ating prinoproseso," she said in a virtual press conference.

(These are not yet available in the Philippines because the manufacturers have just submitted their application to register their product and not because they have failed the regulatory clearance we process.)

The availability of this product in the market is expected to address the rising demand for COVID-19 test kits in the Philippines as the country experiences a new surge in fresh cases.

Some 67,500 people have been undergoing RT-PCR tests daily and several laboratories are having a hard time processing this volume, Health Secretary Francisco Duque III said in a Palace briefing, late Monday.

"Mayroon pa rin pong mga laboratoryo na hindi po nakakapagsumite ng kanilang mga resulta sapagkat ilan po sa kanila ay nag-i-isolate o ‘yung iba nagqua-quarantine dahil sila din po ay nagkaroon ng infection," he said.

(There are also laboratories that have yet to submit their results as some of their personnel are in isolation or in quarantine due to infection.)

DOH officials said the country is set to shift its policy of not testing all symptomatic patients and instead "focus" on testing the elderly and persons who are more vulnerable to the disease.

"That's really where a lot of countries are going now kasi it is becoming less and less efficient to have to test every single sick person na alam naman natin karamihan diyan bakunado, hindi sila mamamatay kasi nagmimistulang trangkaso lang yan," said Dr. Edsel Salvana, member of the DOH's technical advisory group.

(That's really where a lot of countries are going now because it is becoming less and less efficient to have to test every single sick person. We know that most of them are vaccinated, so the effect of the virus on them would be similar to having a flu.)

"Dati, iba yung thrust kasi kino-contain natin kasi (The thrust was different before when we were just trying to contain the virus and) it wasn't this terrible where a patient can pass the virus to 3 or 4 other people," he said.

"Ngayon, nakikita natin na kaka-detect mo pa lang ng isa, yung buong bahay nahawa na. Parang inumpog mo yung ulo mo sa dingding. Hindi mo matatalo yung dingidng, so what we have to do is focus," he said.

(Now we see that as soon as we detect one case, he or she has already infected his or her entire household. It's like banging your head against a wall. You cannot defeat the wall that way, so what we have to do is focus.)

President Rodrigo Duterte has ordered the DOH to procure more RT-PCR test kits to meet the demand, while the FDA has yet to approve the self-administered testing alternatives.


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