FDA approves use of UP COVID-19 test kits

March 10, 2020

The Food and Drug Administration (FDA) Tuesday approved the use of test kits for Coronavirus Disease 2019 (COVID-19) developed by local scientists.

In a statement, FDA Director General Eric Domingo said they issued a Certificate of Exemption to use SARS CoV-2 PCR Detection Kit, which is owned by the University of the Philippines-National Institute of Health (UP­-NIH), developed by local scientists, and funded by the Department of Science and Technology (DOST).

"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," Domingo said.

He said the test kit must be used for field testing coupled with gene sequencing at the Philippine Genome Center.

"It is partnered with gene sequencing so that there is confirmation of test results," Domingo explained in a separate interview.

Domingo said 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," said Domingo.

According to the Research Institute on Tropical Medicine (RITM), the present stock of COVID-19 test kits is good for 2,000 tests.

On Monday, President Rodrigo Duterte of a state of Public Health Emergency due to to the emergence of a COVID-19 local transmission.

It also comes after the Department of Health (DOH) raised the COVID-19 Alert System to Code Red Sublevel 1. DMS