Manila Bulletin

FDA: Antigen testing kits widely used, accepted by WHO


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

“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,” noted FDA Director General Dr. Eric Domingo. “In fact, SD Biosensori­s the first Antigen Rapid Diagnostic Test approved by the World Health Organizati­on (WHO) for its Emergency Use Listing (EUL).”

Some private companies expressed concern after DOH Usec Rosario Vergeire mentioned a study conducted by the Research Institute of Tropical Medicine (RITM), wherein 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 explained the numbers: “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 explained.

“Itisalsoim­portant 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,” Domingo said.

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, RTPCR 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 con

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