FDA careful in approving Covid-19 test kits to ensure accuracy

DOH Undersecretary Maria Rosario Vergeire made the assurance after Spain stopped using Chinese-made test kits for Covid-19 due to the inaccuracy of the test results. (PIA file photo)

MANILA – The Food and Drug Administration (FDA) is careful in approving test kits for the coronavirus disease 2019 (Covid-19) to ensure that results are accurate, the Department of Health (DOH) said on Friday.

DOH Undersecretary Maria Rosario Vergeire made the assurance after Spain stopped using Chinese-made test kits for Covid-19 due to the inaccuracy of the test results.

During the “Cabinet Report sa Teleradyo” program aired on state-run Radyo Pilipinas, Vergeire said the DOH would make sure that Covid-19 tests in the Philippines are safe and reliable.

“Ang ating bansa ay sisiguraduhin pa ring maigi na lahat ng papasok na produkto ay dadaan sa regulatory measures natin kasi nga gusto nating siguraduhin ang safety nito (Our country would make sure that all the products will undergo regulatory measures because we want to ensure its safety),” she said.

Madrid sent back 58,000 test kits made by Chinese manufacturer Shenzhen Bioeasy Biotechnology upon learning that these only had 30-percent accurate detection rate.

The Chinese embassy in Spain has announced that Shenzhen Bioeasy Biotechnology is not licensed to sell its products and not on the “approved supplier list” China had provided to Spain.

Last week, China donated a total of 100,000 test kits for Covid-19 to the Philippines.

The FDA has so far approved at least 18 test kits for Covid-19.

Vergeire assured the public that the FDA-approved tests kits for Covid-19 underwent careful evaluation.

“Ini-evaluate po iyan maigi para makita na makakapagbigay po ng accurate results para sa ating mga kababayan, para wala ho tayong makukuhang false negative or false positive results (The test kits have been evaluated carefully so they can provide accurate results to our countrymen, so we cannot get false negative or false positive results),” she said.

Vergeire’s assurance came as the number of people infected with Covid-19 in the Philippines climbed to 803, as of Friday.