FDA approves 4 Covid-19 test kits

(AP Photo)
(AP Photo)

THE Food and Drug Administration (FDA) on Thursday, March 19, released an initial list of Covid-19 detection kits that have been approved for commercial use in the Philippines.

The list includes the following:

Nucleic acid detection kit for 2019-nCoV, which is manufactured by Shanghai GenoeDx Biotech Co. Ltd. in Shanghai, China and distributed by S&S Enterprise; Novel coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method), manufactured by Beijing Applied Biological Technologies Co. Lt. in Beijing, China and distributed by Sahar International; AllplexTM 2019-nCoV Assay by Seegene Inc. in Seoul, South Korea and distributed by Endure Medical Inc.; and SOLGENT DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit, which is manufactured by Solgent Co. Ltd in Daejeon, South Korea and distributed by Wellness Pro Incorporated.

In a statement, the FDA said the kits on the list 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 based kits used in laboratories, and not point-of-care kits,” the agency said.

The list will be updated as more kits are approved for commercial distribution in the country.

Earlier, the FDA also approved for field testing the detection kits developed by scientists at the University of the Philippines National Institutes of Health and manufactured by the Manila Healthtek.

These have not been approved for commercial use. (MVI/SunStar Philippines)

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