The Food and Drug Administration (FDA) announced on Tuesday that it allowed the use of testing kits developed by local scientists to help in the detection of coronavirus disease 2019 (COVID-19) cases in the country.
In a statement, the FDA said that it issued a “certificate of exemption” for the testing kit developed by the University of the Philippines-National Institute for Health (UP-NIH), which was funded by the Department of Science and Technology (DoST).
“The increasing number of reported COVID-19 cases will require immediate diagnosis and monitoring,” said FDA Director-General Rolando Enrique Domingo.
“This will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in the early screening of positive cases,” he added.
Domingo said that the testing kits will be used for field testing “coupled with gene sequencing at the Philippine Genome Center.”
In an interview, the FDA official said that the testing kit is not yet approved by the World Health Organization (WHO) but assured that it is “accurate” in giving results.
“Nung nakita naman natin, sinuri natin at talagang very accurate ‘yung test pero meron naman tayong condition na pag ginamit nila ito, kailangan yung mga test result magkakaroon din ng genetic sequencing dito sa Philippine Genome Center,” said Domingo.
The FDA official said that the genetic sequencing can also help in determining where the patient contracted the virus.
“Makakatulong ‘yun para ma-trace kung saan nanggaling ‘yung virus. Yung virus as it travels all over, nagkakaroon s’ya ng mga konti-konting pagbabago. So halimbawa, nakita mo ‘yung genetic sequencing ng virus — malalaman mo kung nanggaling sa Japan, or China, or nanggaling sa Taiwan halimbawa or nanggaling sa ibang lugar,” he said.
Domingo said that the testing kit can produce the result after about two hours.
“Itong test kit na dinevelop ng local scientists natin mabilis sya. Less than two hours. Pagkatapos noon, mag-ge-genetic sequencing– ayun one day iyon, pero kung positive or negative malalaman na agad,” he added.
To note, it takes 24 to 48 hours before the results come out in the testing process of the Research Institute for Tropical Medicine (RITM).
Domingo said that the test kits are expected to be available at the UP-NIH and the Philippine General Hospital.
“They will be able to set it up, then train people, and start testing within a week,” he said.
The DoH recently said that five other laboratories have already been accredited to test samples of COVID-19, aside from the Research Institute for Tropical Medicine (RITM) in Muntinlupa, City.
“The five sub-national labs who are being provided capacity to do test — completed their training on COVID identification and the proficiency test, all of them passed,” said RITM Director Celia Carlos in a previous press conference, adding that “they could start any moment from now” to do the testing.
The five laboratories are the San Lazaro Hospital and Lung Center of the Philippines in Manila; Baguio General Hospital and Medical Center in Northern Luzon; Vicente Sotto Memorial Medical Center in the Visayas region; and Southern Philippines Medical Center in Mindanao. (Analou de Vera)