Sofia 2 Antigen Test Gets DOH Validation
Photo Credit: Quidel Official Website
The Department of Health has already validated Quidel Corporation’s Sofia 2 SARS Antigen Fluorescent Immunoassay (FIA) test for use in the country.
Sofia 2 was also validated by the Food and Drug Administrations (FDA) of both the US and Philippines.
“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 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 Sofia 2 test can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity through painless swabs. Results are available in just 15 minutes.
The test has a sensitivity of 96.7 percent, much higher than the WHO’s 80 percent sensitivity standard.
Former US FDA Commissioner Dr. Scott Gottlieb described SOFIA 2 as a real game changer and said that it greatly enhances efforts to diagnose cases of COVID-19 in the U.S.
Under Department of Health 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, US FDA or the World Health Organization-Foundation of Innovative New Diagnostics (WHO-FIND) can be used by the public.
Meanwhile, no antigen test has yet been endorsed by the DOH-Health Technology Assessment Council.
Sofia 2 was also validated by the Food and Drug Administrations (FDA) of both the US and Philippines.
“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 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 Sofia 2 test can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity through painless swabs. Results are available in just 15 minutes.
The test has a sensitivity of 96.7 percent, much higher than the WHO’s 80 percent sensitivity standard.
Former US FDA Commissioner Dr. Scott Gottlieb described SOFIA 2 as a real game changer and said that it greatly enhances efforts to diagnose cases of COVID-19 in the U.S.
Under Department of Health 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, US FDA or the World Health Organization-Foundation of Innovative New Diagnostics (WHO-FIND) can be used by the public.
Meanwhile, no antigen test has yet been endorsed by the DOH-Health Technology Assessment Council.
