Use of UP-developed COVID test kits OK’d

MANILA, Philippines — With the country now under a state of public health emergency, the Food and Drug Administration (FDA) has decided to allow the use of test kits developed by Filipino scientists to confirm a coronavirus disease 2019 (COVID-19) infection.

FDA director general Eric Domingo said they issued a Certificate of Exemption for the use of SARS (Severe Acute Respiratory Syndrome) CoV-2 PCR detection kit, which is owned by the University of the Philippines-National Institutes of Health (UP-NIH), for COVID-19 testing.?

“The increasing number of reported COVID-19 cases will require immediate diagnosis and monitoring. This will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in early screening of positive cases,” he noted. ?He gave assurance that the testing kits – developed by local scientists and funded by the Department of Science and Technology – were validated and found to be accurate.        

“Next step would be to have them validated by the World Health Organization (WHO). But since this will take months, the FDA has allowed them to be used coupled with gene sequencing at the Philippine Genome Center,” Domingo pointed out.

A gene sequencing is done to determine the make-up of a virus – whether it is COVID-19 or not. Subjected to testing are the swab samples taken from a patient’s throat.

Under the plan, testing will be done at the UP-NIH or Philippine General Hospital but more testing centers will be set up to accommodate the rise of cases in the country. 

Domingo assured the public that the guidelines established by the Department of Health (DOH) would be followed in using the testing kits this week. 

The measure, he added, will “expand the present testing capacity that is now being done” at the Research Institute for Tropical Medicine (RITM), the country’s referral center for COVID-19 cases. 

As of last Friday, the RITM reported having only 2,000 testing kits and that it was expecting to receive a thousand more from the WHO this week.

RITM director Celia Carlos said five subnational laboratories have passed the training on the screening of SARS-CoV-2. These are the ones in Baguio General Hospital and Medical Center; San Lazaro Hospital; Lung Center of the Philippines; Vicente Sotto Memorial Medical Center, and the Southern Philippines Medical Center.?These laboratories will assist in surveillance and outbreak response for COVID-19.

“All hands are on deck for the possibility of COVID-19 community transmission. We have to be able to urgently identify PUIs (persons under investigation) using screening tests wherever they may be located, and so the subnational laboratories are being reactivated to augment COVID-19 laboratory support,” Carlos explained.?She added that these laboratories would perform real-time Polymerase Chain Reaction – the molecular diagnostic testing recommended by the WHO for SARS-CoV-2 detection – and expand the surveillance coverage and detection capacity of the DOH.  

Ready for more cases

Carlos said the RITM is ready to see more COVID-19 cases as protocols were put in place, aside from facilities like negative pressure rooms and isolation rooms.

“We have been responding to so many outbreaks, now we are the referral hospitals and laboratories. The other DOH hospitals are working together so we can respond properly to the surge of cases,” she added.

According to her, the RITM no longer accepts any other cases except COVID-19, snakebite and rabies.

“Protocols (have been) practiced for so many years; staff are trained regularly even without outbreaks,” she said, adding that a majority of RITM’s personnel are assigned to manage COVID-19 patients.