Sofia 2 SARS Antigen Fluorescent Immunoassay (FIA), the first coronavirus antigen test to be granted authorization by the United States and Philippines' Food and Drug Administration (FDA), is already validated by the Department of Health (DOH).
According to DOH Memorandum No. 0468, 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 Research Institute for Tropical Medicine (RITM), US FDA, or World Health Organization-Foundation of Innovative New Diagnostics (WHO-FIND) can 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 in the WHO-EUL (Emergency Use Listing) and have met the minimum regulatory, technical and operational specifications set by the HTAC (Health Technology Assessment Council) can be used,” the DOH on supplemental guidance on the use of rapid antigen test kits read.
Quidel Corporation's Sofia 2 SARS Antigen FIA is the first rapid point-of-care test to be granted Emergency Use Authorization (EUA) by the US FDA last May. It received DOH's certification last June.
The 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 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 Bureau of Food and Drugs director Dr. 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,” he added.
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 for testing of patients suspected of COVID-19 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 Dr. 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.