Monday, July 4, 2022

2 Antigen Self-Test Kits Get Green Light From FDA

2 Antigen Self-Test Kits Get Green Light From FDA


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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.

“Importante po na dumaan po talaga sa performance validation ng RITM (Research Institute for Tropical Medicine) kasi po kung mababa po ang sensitivity ay marami pong false negative po na mangyayari (It’s important that the kits underwent performance validation by RITM because if the sensitivity is low, there would be instances of false-negative results),” he warned.

The official said some 86 antigen test kits were removed from the market after failing to pass RITM’s evaluation.

At present, 31 more self-administered antigen test kits are undergoing RITM validation.

“Mayroon pang 31 tayong inaabangan na application. 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 are waiting for 31 more. We cannot promise that these will all get approval because it will still depend on the findings of RITM),” Gutierrez said.

Malacañang, for its part, sees the self-test kits as another tool to strengthen the country’s testing capacity. This as it assured the public that it would continue conducting RT-PCR tests, which remains the gold standard for Covid-19 testing.

“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 have choices and options, they can already access the self-administered home kit, which is an addition to our testing arsenal while we conduct responsible testing with the use of RT-PCR),” Cabinet Secretary and acting presidential spokesperson Karlo Nograles said Tuesday. (PNA)

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