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FDA warns public vs. unregistered COVID-19 test kits in Philippines

The Food and Drug Administration (FDA) warned Friday the public against buying any kits sold in the local market for the detection of coronavirus disease 2019 (COVID-19) as there are none registered for commercial distribution yet.

"Sa ngayon, wala pang registered na testing kit para dito sa COVID-19 so kung anuman ang ibinebenta diyan at mga nakikita nilang advertisement o nakikita nila online, ito pong mga ito ay unregistered, hindi po natin alam kung saan galing ito, saan na-manufacture at kung ano ang accuracy nito," FDA officer-in-charge Undersecretary Eric Domingo told reporters in a phone interview.

"Ang babala lang natin, kahit po gamitin ninyo ito hindi naman natin alam kung valid at acceptable ang mga resulta nito at kung sino naman po ang doktor na maniniwala sa resulta ng mga ito at gagamitin siya to manage a patient. Baka masayang lang ang pera ninyo," he added.

On Thursday, the FDA issued Circular No 2020-004 prohibiting the selling of COVID-19 testing kit without the agency's authorization.

"All concerned establishments are warned not to distribute, advertise, or sell COVID-19 testing kit until a corresponding authorization has been issued by FDA; otherwise, regulatory actions and sanctions shall be strictly pursued," it stated.


Asked what prompted FDA to issue the circular, Domingo said they received reports of such violation.

"Marami talagang nagre-report hindi lang sa Metro Manila, kundi sa mga probinsya at saka 'yung mga online sales," he said.

Domingo reiterated that COVID-19 test kits are not like pregnancy and blood sugar test kits which can be used at home.

He said there are only two legitimate types of COVID-19 test kits in the country--the one donated by the World Health Organization to the Research Institute for Tropical Medicine and the one that has been developed by scientists from the University of the Philippines.

The locally-developed test kits must first undergo field testing before being rolled out to the market for wider use, Domingo reiterated.

He added once the FDA approves the results of the field testing, up to 1,000 test kits can be manufactured in a week.

Despite the breakthrough, there will still be a screening process on who would be prioritized in COVID-19 laboratory tests, according to the health official.

"Susunod pa rin sa guidelines ng DOH. 'Yung workflow ng mga pasyente kung sino ang magpapatest, susunod pa rin sila sa guidelines ng DOH," Domingo added.—AOL, GMA News