UP-developed test kits recalled due to contamination: FDA


Posted at May 21 2020 11:46 AM

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MANILA - The government is waiting for another batch of locally-produced COVID-19 test kits after its first batch was recalled due to contamination, the Food and Drug Administration said Thursday.

FDA director-general Undersecretary Eric Domingo said the Research Institute for Tropical Medicine (RITM) ran tests using the UP-developed kit and found 30 percent of the results were indeterminate.

"Ang finding nila accurate siya pero mahirap gamitin kasi parang 30 percent inuulit mo. Pinaexplain po natin nitong Manila HealthTek at ang sagot po nila nakita nila 'yung reagent na ginagamit nila ay mukhang contaminated for the batch na 'yun," he told ABS-CBN's Teleradyo.

(They found it accurate but hard to use because you need to re-do 30 percent of the tests. We asked Manila HealthTek to explain and they said the reagents they used seemed to be contaminated for that batch.)

"Bago magamit, nirecall muna nila yung existing test kits at nag-o-order sila ng bagong reagent para magproduce ng bagong test kits."

(It was recalled before it was used and they have order another reagent for the production of new test kits.)

The tests kits were only used during its first run of validation tests at the UP-Philippine General Hospital, which also ran confirmatory tests, Domingo said.

"Hinihintay natin ang second production nila and we’ll have that tested. Sa ngayon wala ng available na commercial," he said.

The test kits, which were approved for commercial sale in early April, are supposedly cheaper than its imported counterparts.

As of May 14, the Philippines can conduct 9,000 coronavirus tests daily.