Friday, April 19, 2024

Approval of PH-made Covid-19 test kit expected on April 3

The Department of Science and Technology (DOST), which funded a Covid-19 detection kit developed by the University of the Philippines, said it is expecting the approval of the testing tool this week.

In a statement on Monday, March 30, DOST secretary Fortunato dela Pena said the field validation for the Covid-19 testing kits is ongoing and is expected to be finished by Wednesday, April 1.

“The issuance of the Certificate of Product Registration (CPR) from the Food and Drug Administration Philippines (FDA) is expected on Friday, April 3,” Dela Pena stated.

“We have informed the FDA that requirements for CPR Certification will be submitted on Wednesday, April 1 at the latest,” he added.

Manila HealthTek Inc., the company that will manufacture the test kits, reported that the first batch of reagents has arrived which will enable them to start the manufacturing process to create additional kits that can accommodate 120,000 tests.

A total of 1,300 testing kits good for 26,000 tests will be manufactured and prioritized by the DOST for field implementation and distribution to the Philippine General Hospital, Makati Medical Center, The Medical City, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, and Baguio General Hospital.

From April 4 to 25, there will be a field implementation for the 26,000 tests funded under the DOST and UP-National Institutes of Health (UP-NIH) project.

Dela Pena said the remaining kits good for 94,000 tests will be sold commercially by Manila HealthTek at around P1,300 per kit which is cheaper than the units currently being used in hospitals which cost about P8,000.

“The Manila HealthTek said they have enough orders from the private sector who intend to donate them in turn to the Department of Health and other local hospitals,” the DOST chief stated.

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