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FDA approves commercial COVID-19 test kits


The Food and Drug Administration (FDA) on Thursday announced that it has initially approved four commercial test kits for coronavirus disease 2019 (COVID-19).

“Maari nang gamitin ang kits sa mga hospital at laboratory na papayagan ng Departent of Health na mag-test for COVID,” FDA director general Eric Domingo told GMA News Online in a text message.

In an advisory, the FDA listed the following approved test kits—manufactured by China and South Korea—for commercial use:

  • Nuclec acid detection kit for 2019-nCoV; manufacturer from Shanghai, China
  • Novelcoronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method); manufacturer from Beijing, China
  • AllplexTM 2019-nCoV Assay; manufacturer from Seoul, Republic of Korea
  • SOLGENT DiaPlexQ Novel Coronavuris (2019-nCoV) Detection Kit; manufacturer from Daejeon South Korea

Domingo earlier said the test kits are not similar to pregnancy tests which can be taken personally.

A sample from the patient will be taken through a swab, which will be brought to an authorized laboratory where the kits will be used. — BM, GMA News

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