FDA allows use of coronavirus test kits developed by UP scientists

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    Metro Manila (CNN Philippines, March 10) — The Food and Drug Administration on Tuesday approved the use of test kits developed by scientists at the University of the Philippines to confirm cases of the coronavirus disease or COVID-19 in the country.

    FDA Director General Eric Domingo said the test kits created by the University of the Philippines National Institutes of Health (UP-NIS) will be used for field testing, coupled with gene sequencing, at the Philippine Genome Center. It was developed early this year after the World Health Organization released the whole genome sequence of the virus.

    “The Food and Drug Administration (FDA) today issued a Certificate of Exemption for the SARS-CoV-2 PCR Detection Kit,” he said in a statement. SARS-CoV-2 is the official name of the coronavirus that causes COVID-19.

    The test kits are funded by the Department of Science and Technology. It has yet to be rolled out in local hospitals pending clearance and approval from the World Health Organization (WHO).

    Health Secretary Francisco Duque III said they are aiming for UP-NIH to start carrying out tests this week.

    He added the WHO is looking into the testing capabilities of UP-NIH and five other sub-national reference laboratories namely Southern Philippines Medical Center in Mindanao, Vicente Sotto Medical Center in Visayas, Baguio General Hospital in Northern Luzon, and the Lung Center of the Philippines in Metro Manila.

    “Ang WHO, nagpadala ng mga eksperto para tulungan suriin ang kakayahan. Kung sila ay pumasa sa criteria, sila po ay pahihintulutan ng RTIM na magsagawa na ng testing,” he said in an interview.

    The FDA go-signal comes a day after it was revealed during a Senate panel hearing that only 2,000 testing kits are left at the Research Institute for Tropical Medicine.

    Health Assistant Secretary Maria Rosario Vergeire earlier said the number of test kits started at 4,500, but had since been depleted as more people come forward to be tested for COVID-19.

    Duque admitted that the coverage of the coronavirus tests in the country has been limited due to lack of testing supplies, adding it may have led to a possible “underreporting” of COVID-19 cases in the country.

    Domingo said the new kits will help laboratories accomodate the growing number of patients to be tested and aid in early screening of positive cases.

    “This will provide greater access to a less costly diagnostic procedure,” he said.

    COVID-19 cases in the country more than doubled overnight after authorities announced Monday that there are now 24 patients, with 21 of them admitted in the hospitals. Two have recovered, while one Chinese man died.

    Source : CNN Philippines

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