The FDA has approved two antigen self-test kits.
The Food and Drug Administration (FDA) has approved the use of two antigen kits for coronavirus illness that can be used at home (Covid-19).
FDA officer-in-charge Oscar Gutierrez said the kits are manufactured by Abbott and Labnovation Technologies, Inc., both of which will be offered in FDA-licensed drug stores, in a Talk to the People briefing on Monday.
Abbott’s “Panbio Covid-19 Antigen Self-Test” will be sold in boxes of 1, 4, 10, and 20 tests, while Labnovation’s “SARS-CoV-2 Antigen Rapid Test” will be sold in boxes of 2, 5, and 20 tests.
Gutierrez advised the public to purchase only FDA-certified self-test kits, which have passed the necessary testing to verify the accuracy of their results.
“Important po na dumaan sa performance validation ng RITM (Research Institute for Tropical Medicine) kasi po kung mababa po ang sensitivity ay marami pong false negative po may mangyayari,” he said.
After failing to pass RITM’s review, 86 antigen test kits were taken off the market, according to the official.
RITM is currently validating 31 more self-administered antigen test kits.
“Mayroon, mayroon, mayroon, mayroon, mayroon, mayroon, mayroon, mayroon, mayroon, mayroon, may So hindi po kami mangangako na lahat ‘yon ay maaaprubahan dahil depende ‘yan sa magiging findings ng RITM kasi mayroon din silang findings minsan na talagang hindi pumapasa sa performance validation (We’re still waiting for 31 more.) We can’t guarantee that all of these will be approved because it will depend on RITM’s results), “According to Gutierrez.
Self-test kits, on the other hand, are seen as another instrument by Malacanang to boost the country’s testing capabilities. This came as it reassured the public that RT-PCR tests, which are still the gold standard for Covid-19 testing, will continue.
“At least may mga choices at options na po ang general public, makaka-access na po sila ng kanilang self-administered home kit para additional na iyon sa arsenal natin sa testing while RT-PCR is still there and we will still do responsible testing gamit iyong RT-PCR (At least the general public now has choices and options, they can already access the self-ad
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