Antigen testing kits still viable for use – FDA

Published October 16, 2020, 12:03 PM

by Manila Bulletin

The Food and Drug Administration of the Philippines (FDA) has clarified that it has not revoked the approval of Antigen Rapid Diagnostic Tests.

FDA Director General Dr. Eric Domingo

“Antigen Rapid Diagnostic Tests, such as the ones provided by Abbott and SD Biosensor, have been extensively researched, and are widely used and accepted even by the WHO,” said FDA Director General Dr. Eric Domingo.

“In fact, SD Biosensor is the first Antigen Rapid Diagnostic Test approved by the World Health Organization (WHO) for its Emergency Use Listing (EUL).”

Some private companies have expressed concern after DoH Undersecretary Rosario Vergeire cited a study conducted by the Research Institute of Tropical Medicine (RITM) in which SD Biosensor allegedly did not meet the 80 percent sensitivity standard of the WHO for diagnostic performance. According to the Health Undersecretary, SD Biosensor “only posted 71 percent sensitivity.”

The FDA chief put these numbers in the right context. “The WHO would not approve SD Biosensor in their EUL if the test did not pass their strict standards and guidelines. They approved it based on several validation tests done in different centers. In the Philippines, the 71.43 percent sensitivity estimate of the RITM (with a 95 percent confidence interval of 55.42-84.28) is not significantly different from their 80 percent requirement,” Domingo said. “It is also important to note that the use of antigen tests is recommended for settings where Reverse Transcription Polymerase Chain Reaction (RT-PCR) are unavailable, or where prolonged turnaround time makes RT-PCR impractical.”

Apart from its wide use across Singapore, Japan, Korean, Malaysia, and the European Union, SD Biosensor’s Standard Q COVID-19 Ag Test is likewise being used in India, Honduras, Colombia, West Africa, and many other low-to-middle income countries (LMIC) because it is part of a global partnership to make test kits readily available for poorer countries. This initiative was executed through the efforts of the WHO, The Bill and Melinda Gates Foundation, Unitaid, Africa Center for Disease Control, Abbott Pharmaceuticals, SD Biosensor, and many other private and government entities.

“At present, RT-PCR techniques are still the gold standard for COVID-19 testing,” Domingo said. “On the other hand, Antigen Rapid Diagnostic Tests may play an important role when used correctly, because they can be done quicker and with considerably less cost. Both can be complementary in the fight against COVID-19,” he said.