FDA approves 4 coronavirus test kit products for commercial use

Bonz Magsambol

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FDA approves 4 coronavirus test kit products for commercial use


The Department of Health clarifies that the test kits can only be used by hospitals or laboratories with testing capacity

MANILA, Philippines – The Food and Drugs Administration (FDA) has approved 4 novel coronavirus test kit products for commercial use, the Department of Health (DOH) said on Friday, March 20.

“Meron na po ang naaprubahan ang FDA na 4 na testing kits na puwedeng gamiting for commercial use (The FDA has approved 4 testing kits that can be used for commercial use),” DOH Undersecretary Maria Rosario Vergeire said in a press briefing in Malacañang aired on PTV-4.

Vergeire clarified that these kits “can only be used by hospitals or laboratories with testing capacity.” (READ: Where are testing centers for coronavirus in PH?)

According to the FDA, the 4 products have complied with its requirements under Memorandum No. 2020-006 on the Issuance of Special Certification for Imported Test Kits of COVID-19.

Screenshot from the FDA website

The FDA had earlier warned the public against buying coronavirus home test kits being sold online. (READ: FDA warns public vs unregistered coronavirus home test kits sold online)

The country’s testing capacity remains limited because of the lack of test kits. The Department of Health said, however, that more test kits are due to arrive to boost its capacity to test more people for the virus. (READ: 125,000 test kits from China, South Korea to arrive in PH on March 21)

The Research Institute for Tropical Medicine, as of Friday, can perform 450 tests per day. The 4 new laboratories which were recently accredited by the World Health Organization (WHO), were only given 100 test kits each due to the limited supply.

The lack of test kits available in the country has forced the DOH to prioritize tests on persons under investigation (PUI) with severe symptoms. Elderly who manifest COVID-19 symptoms, whether mild or severe, and those who have underlying medical conditions will automatically get tested for possible infection. (READ: When should you get tested for coronavirus?)

As of Thursday, the Philippines has 217 confirmed cases of coronavirus, 17 deaths, and 8 recoveries. – Rappler.com





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Bonz Magsambol

Bonz Magsambol covers the Philippine Senate for Rappler.