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FDA approves UP's COVID-19 test kits for commercial use


The Food and Drug Administration (FDA) has approved the test kits for COVID-19 developed by the University of the Philippines-National Institutes of Health and manufactured by Manila HealthTek, Inc.

"Upon the company’s submission of necessary requirements today, the FDA issued a certification for this COVID-19 test kit to be allowed for commercial use," the FDA said.

The UP-NIH-developed test kit is the first locally made PCR based COVID-19 test kit approved by the FDA.

Aside from this PCR based test kit, the FDA has approved one additional rapid test kit on Friday, which brings the total number of COVID-19 approved test kits to 30.

The FDA will continue to update the public on COVID-19 testing kits approval.

According to Dano Tingcungco's Friday report on 24 Oras, the Department of Science and Technology (DOST) is expecting the UP-NIH test kit to have a higher accuracy in comparison to donated test kits.

It will also reportedly increase the testing capability of the country as there is no more need to import additional test kits, Science and Technology Secretary Fortunato De La Pena said.

Of the 120,000 test kits ordered, 26,000 were bought by the DOST to be distributed to hospitals and sub-national laboratories such as:

  •     Philippine General Hospital
  •     Makati Medical Hospital
  •     The Medical City
  •     Vicente Sotto Memorial Medical Center
  •     Southern Philippines Medical Center
  •     Baguio General Hospital


More test kits may be distributed to hospitals as part of the remaining 94,000 test kits were ordered by members of the private sector to be donated.

The UP test kits also reportedly cost less at around P1,300 compared to imported test kits with an average price of P6,000. -NB, GMA News