MANILA (2nd UPDATE) — The Food and Drug Administration said Tuesday it had allowed the use of a novel coronavirus testing kit that a research center at the University of the Philippines-Manila developed, after cases of the respiratory disease in the country increased.
The agency said it issued a "certificate of exemption" that would allow the detection kits developed by the UP-National Institute of Health to be "used for field testing coupled with gene sequencing at the Philippine Genome Center."
"The increasing number of reported COVID 19 cases will require immediate diagnosis and monitoring," FDA Director General Eric Domingo said in a statement.
The kits "will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in early screening of positive cases" and "will provide greater access to a less costly diagnostic procedure", he added.
Dr. Raul Destura, director of the Institute of Molecular Biology and Biotechnology, earlier said Filipino scientists developed the test kits after the World Health Organization released the whole genome sequence of the virus.
There is a "global shortage" of kits for testing potential COVID-19 cases, Health Secretary Francisco Duque III earlier said, quoting the World Health Organization.
The Philippines currently has 4,500 testing kits and expects to receive 2,000 more from the WHO, he said.
The Philippine Amusement and Gaming Corporation earlier committed P2 billion for purchasing additional test kits, said the Health Secretary.
"Mayroon namang pondo. Ang naging problema d'yan, iyong global supply. Iyon ang number one challenge," he said
(There are funds. The problem there is the global supply. That's the number one challenge.)
The WHO has "pre-qualified" testing kits developed by the University of the Philippines-National Institutes of Health, which appear to yield "accurate" results in 2 hours, said Duque.
Meanwhile, WHO Philippines Representative Rabindra Abeyasinghe said they have yet to evaluate the said test kits.
"We would really appreciate it if the FDA and the producers can share the information with us. We've set up an emergency list that we are using to rapidly assess how the test kits perform. It's critically important that when you use the test kit, if you have a negative or a positive result, that should really be so," he told ANC.
"You shouldn't be getting either false positives or false negatives, they both could have very severe implications," Abeyasinghe added.
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