FDA: Approval of antigen rapid diagnostic test not revoked


The Food and Drugs Administration (FDA) clarified that it has not revoked the approval of antigen rapid diagnostic test.

FDA Director General Eric Domingo released a statement saying that the antigen rapid diagnostic tests such as those manufactured by Abbott and SD Biosensor have been “extensively researched, and are widely used and accepted even by the World Health Organization (WHO).”

He added that the SD Biosensor is the first antigen rapid diagnostic test approved by WHO for its Emergency Use Listing (EUL).

Meanwhile, the local government of General Santos City started shifting from rapid antibody test to antigen test which is faster and more affordable. The LGU aims to test the returning Overseas Filipino Workers (OFWs) and Locally Stranded Individuals (LSIs). However, the local Inter-Agency Task Force (IATF) stated that those who test positive in the antigen test will still undergo RT-PCR.

The Department of Health (DOH) reminded that the use of antigen test for screening is still prohibited by the Health Technology Assessment Council. The result in the Baguio Pilot Study must still be confired to ensure that the test is appropriate for those who are without symptoms and exposure. – Report from Mark Fetalco

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