Aprubado na ng Food and Drug Administration (FDA) ang COVID-19 test kits na dinevelop ng mga scientists ng University of the Philippines-National Institute of Health (UP-NIH).
JUST IN: Inaprubahan na ng Food and Drug Administration (FDA) for "commercial use" ang COVID-19 test kits na dinevelop ng UP-NIH. | @BomboRadyoNews pic.twitter.com/1rELYK5me4
— Christian Yosores (@chrisyosores) April 3, 2020
Ito ang kinumpirma ni FDA director general Eric Domingo sa isang advisory, kung saan sinabi nito na maaari ng gamitin for “commercial use” ang naturang polymerase chain reaction (RT-PCR) test kits.
“The test kits was previously approved by the FDA for field trial, with gene sequencing on March 10, 2020. Upon the company’s submission of necessary requirements today, the FDA issued a certification for this COVID-19 test kits to be allowed for commercial use,” ani Domingo.
Una ng sinabi ni Department of Science and Technology Sec. Fortunato de la Peña, na kasama nila ang UP-NIH sa gagawing field implementation ng kits sa pagitan ng mga petsang April 24 at April 25.
“A certain number of testing kits that can do up to 26,000 tests will be prioritized by the Department of Science and Technology (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,” ayon sa Science secretary.
“The remaining testing kits good for around 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 (Philippines) and hospitals.”
Sa kasalukuyan may 21 brand ng RT-PCR kits nang inaprubahan ang FDA.
Ang brand na GENAMPLIFY CORONAVIRUS DISEASE-2019 detection kits na manufactured ng MANILA HEALTHTEK INC. ay kabilang na sa 21 RT-PCR kits na aprubado ng FDA.
— Christian Yosores (@chrisyosores) April 3, 2020
May 9 naman na rapid antibody test kits ang approved sa ngayon. | @BomboRadyoNews pic.twitter.com/2keZT1Cecl
May siyam naman na rapid antibody test kits ang pwede na rin sa commercial use, pero may panuntunan ang Department of Health sa paggamit nito.