Manila Bulletin

FDA: Anti­gen test­ing kits widely used, ac­cepted by WHO

- Health · Pharmaceutical Industry · Industries · U.S. Food and Drug Administration · Philippines · World Health Organization · World Health Organization · New Doha International Airport · Singapore · Japan · Malaysia · European Union · India · Honduras · Colombia · West Africa · Africa · The Bill and Melinda Gates Foundation · Melinda Gates · U.S. Centers for Disease Control · Abbott Laboratories · Rosario, Cavite · Institute of Tropical Medicine · Unitaid

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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