FDA approves test kits from China, South Korea for commercial use
MANILA, Philippines — As the Philippines scrambles to contain a growing health crisis, the country’s Food and Drug Administration approved four COVID-19 test kits from China and South Korea.
The virus that causes coronavirus disease is spreading locally, infecting 217 people. The country logged 17 deaths.
But there are concerns that the number of COVID-19 cases may be bigger due to the country’s limited testing program. Since January 28, only 1,030 tests have been conducted.
The FDA on Thursday released an initial list of COVID-19 test kits for commercial use. These are polymerase chain reaction-based kits used in laboratories and not point-of-care or do-it-yourself kits.
The FDA said there are still pending applications that are due for evaluation.
"FDA is hard at work in processing COVID-19 related applications during this time. We ask the public and stakeholders to be analytical of COVID-19 test kits that they may encounter as we have identified some applications which appear to be suspicious and unauthorized," FDA Director General Eric Domingo said.
The only COVID-19 diagnostic test kits being used in the country now are the PCR-based lab kits at the Research Institute of Tropical Medicine donated by the World Health Organization.
The test kit developed by the University of the Philippines National Institute of Health approved by the country’s Food and Drugs Administration were scheduled for field testing on Monday.
China, through its embassy in Manila, said it is donating 100,000 test kits and other medical supplies to the Philippines.
Health Secretary Francisco Duque III on Monday said the country is expecting the delivery of 5,000 to 10,000 rapid test kits from South Korea.
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