COVID-19 test kits from China, South Korea approved by FDA for commercial use

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(Eagle News) — The Food and Drug Administration (FDA) has approved the entry of test kits from abroad, including those to be imported from China and South Korea, saying these had passed their requirements.

“As the Philippine Government continues to exhaust all efforts to respond to the current COVID-19 pandemic, the Food and Drug Administration (FDA) – Philippines hereby provides an initial list of approved COVID-19 Test Kits for commercial use,” the FDA said in an advisory on Thursday, March 19.

It said the approved imported test kits “have complied with the requirements as per FDA Memorandum No. 2020-006 entitled, ‘Issuance of Special Certification for Imported Test Kits of COVID-19.’”

“These are PCR (Polymerase chain reaction) based kits used in laboratories, and not point-of-care kits,” the FDA advisory explained.

The appoved COVID-19 test kits include the Nucleic acid detection kit for 2019 nCov from Shanghai, China; the Novel coronavirus 2019-ncov nucleic acid detection kit (fluorescence PCR method) from Beijing; and the AllplexTM 2019-nCoV Assay and SOLGENT DiaPlexQ™ Novel Coronavirus (2019-nCoV) Detection Kit, both from South Korea.

The initial list of test kit brands from China and South Korea recently approved by the Food and Drug Administration (FDA)/Courtesy FDA

Earlier, the Chinese embassy had said that it is donating about 100,000 test kits and other medical supplies to the Philippines to help in the fight against COVID-19.

The Department of Health had also said that South Korea would soon be delivering some 5.000 to 10,000 rapid test kits.

So far, the only COVID-19 diagnostic kits being used in the country are the PCR-based lab kits at the Research Institute of Tropical Medicine (RITM) donated by the World Health Organization.

Meanwhile, field tests for the test kits developed by the University of the Philippines National Institutes of Health (UP NIH) and Department of Science and Technology (DOST) started on Monday, March 16, 2020.