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2 antigen self-test kits get green light from FDA

SWAB TEST BEFORE FLYING.Marivic Radam (left), an overseas Filipino worker, undergo a swab test Monday (Jan. 24, 2022) before going back to her job in Kuwait. OFWs need to presenta negative RT-PCR test results before boarding their flights.(PNA photo by Gil Calinga) MANILA - The Food and Drug Administration (FDA) has approved the use of two home self-testing antigen kits for coronavirus disease 2019 (Covid-19). In a Talk to the People briefing on Monday, FDA officer-in-charge Oscar Gutierrez said the kits are manufactured by Abbott and Labnovation Technologies, Inc., both of which will be sold in FDA-licensed drug outlets. The "Panbio Covid-19 Antigen Self-Test" of Abbott will be available in boxes of 1, 4, 10, and 20 tests while "SARS-CoV-2 Antigen Rapid Test" of Labnovation may be bought in boxes of 2, 5, and 20 tests. Gutierrez reminded the public to buy only FDA-certified self-test kits as these have undergone necessary tests to ensure their results' accuracy ....

Panbio Covid , Karlo Nograles , Oscar Gutierrez , Drug Administration , Labnovation Technologies Inc , Research Institute For Tropical Medicine , Labnovation Technologies , Research Institute , Tropical Medicine , Swab Test Before Flying Marivic Radam Left , N Overseas Filipino Worker , Ndergoa Swab Test Monday Jan 24 , 022 Before Going Back To Her Job In Kuwait Ofws Need Presenta Negative Rt Pcr Test Results Boarding Their Flights Pna Photo By Gil Calinga Manila The Food And Drug Administration Fda Has Approved Use Of Two Home Self Testing Antigen Kits For Coronavirus Disease 2019 Covid 19 Ina Talk People Briefing On Monday , Da Officer In Charge Oscar Gutierrez Said The Kits Are Manufactured By Abbott And Labnovation Technologies , Oth Of Which Will Be Sold In Fda Licensed Drug Outlets The Quot Panbio Covid 19 Antigen Self Test Abbott Available Boxes 1 , Nd 20 Tests While Quot Sars Cov 2 Antigen Rapid Test Of Labnovation May Be Bought In Boxes , Nd 20 Tests Gutierrez Reminded The Public To Buy Only Fda Certified Self Test Kits As These Have Undergone Necessary Ensure Their Results 39 Accuracy Quot Importante Po Na Dumaan Talaga Sa Performance Validation Ng Ritm Research Institute For Tropical Medicine Kasi Kung Mababa Ang Sensitivity Ay Marami Pong False Negative Mangyayari It 39s Important That Underwent By Because If Is Low , Here Would Be Instances Of False Negative Results , Uot He Warned The Official Said Some 86 Antigen Test Kits Were Removed From Market After Failing To Pass Ritm 39s Evaluation At Present , 1 More Self Administered Antigen Test Kits Are Undergoing Ritm Validation Quot Mayroon Pang 31 Tayong Inaabangan Na Application So Hindi Po Kami Mangangako Lahat 39 Yon Ay Maaaprubahan Dahil Depende Yan Sa Magiging Findings Ng Kasi Din Silang Minsan Talagang Pumapasa Performance We Waiting For Cannot Promise That These Will All Get Approval Because It Still Depend On The Of , Uot Gutierrez Said Malacanang , For Its Part , Ees The Self Test Kits As Another Tool To Strengthen Country 39s Testing Capacity This It Assured Public That Would Continue Conducting Rt Pcr Tests , Hich Remains The Gold Standard For Covid 19 Testing Quot At Least May Mga Choices Options Na Po Ang General Public , Akaka Access Na Po Sila Ng Kanilang Self Administered Home Kit Para Additional Iyon Sa Arsenal Natin Testing While Rt Pcr Is Still There And We Will Do Responsible Gamit Iyong At Least The General Public Now Have Choices Options , Hey Can Already Access The Self Administered Home Kit ,

2 antigen self-test kits get special certification – FDA – Manila Bulletin

The Food and Drug Administration (FDA) has given special certification to two labs for their home-administered test kits, it announced on Monday, Jan. 24.


(Photo from Unsplash)
During the President's pre-recorded public address, FDA-OIC Director-General Oscar Gutierrez reported that two kits wer ....

Davao City , Oscar Gutierrez , Drug Administration , Health Undersecretary Maria Rosario Vergeire , Research Institute For Tropical Medicine , General Oscar Gutierrez , Rapid Test , Labnovation Technologies , Research Institute , Tropical Medicine , Undersecretary Maria Rosario Vergeire ,