Nilinaw ng Food and Drug Administration (FDA) na hindi aprubado ng kanilang tanggapan ang ano mang binibentang test kits ngayon na walang certificate of approval.
Ayon kay FDA director general Eric Domingo, posibleng nilusot ang mga ito ng importers nang walang permit at kahit hindi pinayagang ma-release ng Bureau of Customs.
“Businessmen should not import these products before they are certified by the FDA. An application for product certification of a diagnostic kit is not equal to an approval to sell or distribute,” ani Domingo.
Sa ngayon, 15 COVID-19 test kits na ang inaprubahan ng FDA for commercial use.
Ang apat ay mula China, tatlo ang brand na galing South Korea, tig-dalawa sa Singapore at Amerika, at ang iba ay mula Spain, Germany, at UK.
Wala pa rin dito ang UP-NIH test kits na as of the moment ay hindi pa rin daw tapos ang field validation ayon kay Sec. Duque.
“As stated in the Department of Health (DOH) Circular No. 2020-0143, there is currently no clear evidence to support the use of point-of-care tests (lateral flow rapid tests) in the diagnosis of COVID-19.”
“The FDA continuously reviews all applications on COVID-19 test kits, and expedites processes. We are streamlining procedures to efficiently facilitate COVID-19 associated health commodities. We understand the urgency of the situation, but we cannot compromise the quality and safety of these kits without scientific evidence and proper documentary basis.”