MANILA, Philippines — The Food and Drug Administration (FDA) announced Friday that it has approved the test kits developed by the University of the Philippines-National Institute ofHealth (UP-NIH).
“The Food and Drug Administration (FDA) has now approved the Real-Time PCR for the detection of COVID-19 manufactured by the Manila HealthTek, Inc. for commercial use,” FDA said in an advisory signed by Director General Rolando Enrique Domingo.
“This is the first locally made PCR based COVID-19 test kit approved by the FDA which was developed in collaboration with the University of the Philippines-National institute of Health (UP-NIH), funded by the Department of Science and Technology (DOST),” it added.
FDA said its previous approval of the test kit was for field trials. It also said that the test kit’s name is Genamplifytm Corona Virus Disease-2019 rRt-PCR Detection Kit.
“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,” FDA said.
Aside from the PCR based test kit, FDA said it also approved one more rapid test kit on Friday. It is called Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test.
There are now 30 approved COVID-19 test kits in the country, according to the FDA.
As of April 3, the health department said there are 3,018 COVID-19 positive persons in the country, with the death toll reaching 136.
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