UP TEST KIT READY FOR ROLLOUT THIS WEEK
THE field validation for the coronavirus disease 2019 (Covid-19) testing kit developed by the University of the Philippines’ National Institute of Health (UP-NIH) is expected to be finished by this Wednesday, Science and Technology Secretary Fortunato de la Peña announced on Monday.
In a statement, de la Peña said the Food and Drug Administration (FDA) would issue the Certificate of Product Registration (CPR) for the SARS CoV-2 PCR Detection Kit on Friday.
SARS CoV- 2 — severe acute respiratory syndrome coronavirus 2 — is the virus that causes Covid-19.
The FDA already issued a Certificate of
Exemption for the detection kit last March 10.
The SARS CoV- 2 PCR Detection Kit technology was developed by local scientists led by Dr. Raul Destura of UP-NIH.
De la Peña said the Manila HealthTek Inc. reported that the first batch of reagents has arrived, which would enable them to start manufacturing kits that can accommodate 120,000 tests.
De la Peña said 1,300 testing kits good for 26,000 tests manufactured by the Department of Science and Technology will be distributed for validation to the following designated testing centers: Philippine General Hospital,
Makati Medical Center, The Medical City, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, and Baguio General Hospital and Medical Center from April 4 to 25.
The remaining kits that are good for 94,000 tests will be sold commercially by Manila HealthTek at around P1,300 per kit, cheaper than the P8,000-kit being used in hospitals.
“The Manila HealthTek said it has enough orders from the private sector who intend to donate them in turn to the Department of Health and hospitals,” de la Peña said.
The FDA has already approved 18 Covid-19 test kits for commercial use.
Dr. Benedict Maralit, program director at the UP Genome Center, which was also deeply involved in developing the SARS CoV-2 PCR Detection Kit, said part of the procedure is to determine the type of virus and its origin.
Maralit, whose expertise is DNA core sequencing, said some 6,000 kits were ready for testing and they are confident that they will surpass the international standard and help the government in eliminating the virus.