THE Food and Drug Administration (FDA) has approved two home self-testing coronavirus disease (Covid-19) rapid antigen kits, FDA officer-in-charge Oscar Gutierrez said on Monday, January 24, 2022.
Gutierrez was referring to the Panbio Covid-19 antigen test kits of Abott and the other that was manufactured by Labnovation Technologies Inc.
He said Panbio is available at one, four, 10 and 20 tests per box, while Labnovation’s is available at two, five and 20 tests per box.
“We have to buy only FDA-certified self-test kits. Sa ngayon po, dalawa po ‘yung ating naaprubahan. Importante po kasi na ‘yung accuracy ng self-test kit importante po na dumaan po talaga sa performance validation ng RITM (Research Institute for Tropical Medicine) kasi po kung mababa ‘yung sensitivity ay marami pong false negative na mangyayari,” Gutierrez said in his report during President Rodrigo Duterte’s Talk to the People Address.
Gutierrez said from March 2020 up to January 24, 2022, 86 antigen test kits were removed from the market.
“Hindi po nila na-meet ang RITM performance validation habang mayroon silang special certification o ‘di kaya hindi po sila rehistrado sa FDA, hindi sila authorized, o kaya sinurrender (surrender) po ng special certification holder iyong kanilang certification,” he said.
“Marami po talaga dito na natanggal po sa market dahil hindi po sila pumasa sa standard po ng FDA,” he added.
But Gutierrez said that self-testing is just one measure to get protected against Covid-19 and prevent the virus from spreading.
He reiterated the importance of getting vaccinated against the virus and the observance of minimum health protocols.
Gutierrez warned the public of fake antigen kits.
He said they are continuously working with the Criminal Investigation and Detection Group to apprehend those selling fake or unregistered rapid antigen test kits. (SunStar Philippines)
Image from Pixabay
January 25, 2022
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