Pinoy version na RT-PCR Test Kit, aprub sa DFA

Ni Raiza F. Cabugwang
GenAmplify Coronavirus Disease 2019 RT-PCR Detection Kit

MANILA, Philippines “After several months of collaboration, we are proud to say, GenAmplify version 2, the country’s very own RT-PCR test kit, is finally ready for commercial use.”

Ito ang ipinahayag ng Department of Health (DOH) noong Hulyo 19 matapos aprubahan ng Food and Drug Administration (FDA) ang commercial use ng GenAmplify version 2, ang reverse transcription-polymerase chain reaction o RT-PCR test kit na gawa ng grupo ng mga siyentipiko mula sa University of the Philippines – National Institutes of Health (UP-NIH), sa pakikipagtulungan ng Philippine Genome Center (PGC) at ng Department of Science and Technology – Philippine Council for Health Research and Development. 

Ang nasabing test kit ay nakapasa rin sa confirmatory testing na isinagawa ng Research Institute for Tropical Medicine at ng Committee on Laboratory Expert Panel. 

Ang tagumpay na ito ay nangangahulugang makakatipid ang bansa sa panahon at perang gugugulin para matugunan ang kinakailangang suplay ng Coronavirus disease 2019 (COVID-19) test kits sapagkat hindi na kinakailangan pa itong iangkat mula sa ibang bansa at higit na mababa ang halaga nito kung ikukumpara sa imported test kits. 

Ang gawang-Pinoy na test kit na ito ay nagkakahalaga ng higit P1,000 at maaaring umabot hanggang P3,500 kung isasama ang processing at operational costs ng mga ospital — mas abot-kaya pa rin kumpara sa P6,000 na presyo ng test kits mula sa ibang bansa. 

Ang GenAmplify version 2 ay mayroong PCR technology na siyang itinuturing na “gold standard” sa pagsusuri ng coronavirus disease. Kaya nitong makita ang presensya ng virus, taliwas sa rapid antibody test kits na kaya lamang matukoy ang antibodies ng isang indibidwal, at hindi ang mismong virus. 

Ang mga lisensyadong COVID-19 testing laboratory lamang ang maaaring magkaroon ng access at makabili sa test kit na ito.

Pinondohan ng Department of Science and Technology ang paglikha rito at bilang bahagi ng Field Implementation Program ng Kagawaran, ipamamahagi ang unang batch ng GenAmplify version 2 kits sa COVID-19 testing laboratories ng UP-NIH, Philippine General Hospital, The Medical City, Makati Medical Center, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, Baguio General Hospital and Medical Center, Western Visayas Medical Center, Mariano Marcos Memorial Hospital and Medical Center, Bicol Diagnostic and Reference Laboratory, Eastern Visayas Regional Medical Center, PGC, UP Diliman, Lung Center of the Philippines, at sa University of San Agustin, Iloilo City para sa West Visayas State University Medical Center. 

Ang test kit na ito ay maaari ring i-export alinsunod sa mga polisiya ng tatanggap na bansa.

Nauna nang inaprubahan ng FDA noong Abril ang commercial use ng unang bersyon ng nasabing test kit ngunit ipinabalik ito para sumailalim sa revalidation dahil sa minor deficiency na naging dahilan ng “indeterminate” o hindi matukoy na resulta mula sa 30% na samples. 

Upang matugunan ito, nakipagtulungan ang research and development company na Manila HealthTek, Inc. sa laboratory expert panel ng DOH.

“We appreciate the Manila HealthTek team for their commitment to excellence and safety, as they work closely with our independent laboratory expert panel in addressing key issues of version 1 of GenAmplify,” pagpapasalamat ng Kagawaran. 

Ayon pa sa DOH, kagaya ng iba pang mga produkto at kagamitang pangmedikal, patuloy ang gagawin nitong pag-monitor sa GenAmplify version 2 upang masiguro na maayos ang kalidad at performance nito.

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