Dalawang manufacturers ng self-administered COVID-19 test kits, nag-apply ng Special Certification sa FDA
Dalawang manufacturers ng self-administered COVID-19 test kits ang nag-apply na ng Special Certification sa Food and Drug Administration (FDA).
Sa Laging Handa Public Briefing, sinabi ni FDA officer-in-charge Director Oscar Gutierrez Jr. na ito ay ang mga kompanyang Clearbridge Medical Philippines, Incorporated at MOHS Analytics, Incorporated.
Kailangan aniyang mayroong 97 percent na specificity at 80 percent na sensitivity ang mga test kits.
Ayon kay Gutierrez, ang Research Institute for Tropical Medicine (RITM) ang nagtakda ng mga requirement.
Kapag natanggap na aniya ng FDA ang validation performance report ng RITM sa dalawang manufacturers, pagdedesisyunan nila ito kung aaprubahan o hindi.
Ayon kay Gutierrez, mataas ang demand sa self-administered antigen COVID-19 test kit dahil sa biglang pagtaas ng kaso ng mga tinatamaan ng COVID-19.
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