Up-developed COVID-19 test kits approved by FDA

THE FOOD and Drug Administration (FDA) has allowed on Tuesday, March 10 the use of locally made testing kits to help detect the novel coronavirus disease (COVID-19) as it continues to climb in numbers in the Philippines.

The testing kits for the detection of SARS COV-2, the virus that causes COVID-19, were developed by scientists from the University of the Philippines National Institute of Health (UPNIH) and has been issued a Certificate of Exemption by the FDA.

“This supports the CODE RED status raised by the Department of Health (DOH) and the recent declaration of President Rodrigo Duterte of a state of Public Health Emergency,” the FDA said in a statement.

The kit will be “used for field testing coupled with gene sequencing at the Philippine Genome Center” and is funded by the Department of Science and Technology (DOST). It will help the DOH to detect the respiratory disease from possible carriers through samples.

“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,” FDA Director General Eric Domingo said in a statement.

“Furthermore, this will provide greater access to a less costly diagnostic procedure,” he added.

“The FDA maintains its mandate in ensuring the safety and efficacy of products and devices to protect public health, and commits to cooperate with all agencies in ensuring a prompt response to this global crisis,” Domingo concluded.

Health Secretary Francisco Duque III said earlier that there is a “global shortage” of test kits for COVID-19 cases. Duque also mentioned that the Philippines currently has 4,500 test kits and expects another 2,000 from the World Health Organization.

The Health Secretary said that the results from the test kits developed from UPNIH “appear to yield `accurate’ results in 2 hours.” ■

DEPARTMENT OF HEALTH (PHILIPPINES) / FACEBOOK FDA Director General Eric Domingo.