Quidel Corporation’s Sofia 2 SARS Antigen Fluorescent Immunoassay, the first COVID-19 antigen test to be granted by the US and Philippines’ Food and Drug Administrations, has been validated by the Department of Health and available for use in the country.
According to Department of Health Memorandum 0468, the antigen tests that are already authorized by the Philippine FDA and validated by an independent or a reputable government or private institution such as the RITM, US Food and Drug Administration, World Health Organization-Foundation of Innovative New Diagnostics, may be used by the public.
“In any setting, only COVID-19 antigen test kits authorized by the Philippine FDA, validated by the RITM, WHO-FIND, and other DOH-designated institutions for test kit validation or those included by the WHO-EUL and have met the minimum regulatory, technical and operational specifications set by the HTAC can be used,” the DOH on supplemental guidance on the use of rapid antigen test kits read.
The Sofia 2 SARS Antigen FIA is the first rapid point-of-care test to be granted Emergency Use Authorization by the US FDA last May.
The game changer antigen test has a sensitivity of 96.7 percent, which is higher than WHO’s 80-percent sensitivity standard.
“We are glad that the Department of Health included the US FDA in the list of validation. It’s a good step because we all know that the US FDA is one of the strictest, most reliable and recognized institutions around the world. Aside from that, out of the five antigen tests that were approved, Sofia has the highest sensitivity,” LabX Corp. Chief Medical Officer and former BFAD director Jose Miguel Vergara said.
“With Sofia’s validation, we can now have a more accurate testing to offer for the Filipinos because we are using fluorescence immunoassay which increases the sensitivity to 15 to 20 percent.”
The antigen test can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity through painless swabs.
It also provides automated and objective results in just 15 minutes, allowing the testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
Sofia 2 also uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2.
Former US FDA Commissioner Scott Gottlieb also described SOFIA 2 as a “real game changer” and said that it greatly enhanced efforts to diagnose cases of COVID-19 in the US.