FDA accepts application for special certification of COVID-19 home test kits

By: Zacarian Sarao - 3 years ago

The main office of the Food and Drugs Administration in Muntinlupa City. (Photo from the FDA Facebook page)

MANILA, Philippines — The Philippine Food and Drug Administration (FDA) on Thursday announced it has started accepting applications for special certification of COVID-19 test kits for home use.

This was revealed by FDA officer-in-charge Dr. Oscar Gutierrez during a taped meeting with President Rodrigo Duterte.

“As of today, we announce that we are accepting applications for special certification for COVID-19 self-administered or the home test kit,” he said Gutierrez.

He then called on manufacturers and importers to register with the FDA for the said certification.

“We already met with the DOH ((Department of Health) and they will be coming out with an algorithm, actually a guideline or policy on the use of these home test kits considering these products need to be administered by the patient or the household,” he added.

According to Gutierrez, these guidelines will address how an individual will interpret a test result, how to report a positive case, how to dispose of the waste, and what action should the individual take when they find out that they are positive for COVID-19.

“So we need an algorithm from the DOH, and this will be based on the claims made by the manufacturers. But in general, we need a guideline on this,” he said.

These guidelines will be issued by the DOH by January 17, he added.

Gutierrez likewise said it will depend on the registered products if the self-administered home test kits will be a nasal-type or oral-type kit.

KGA