Duque to FDA: Ready approval for at-home use COVID-19 antigen test kits
MANILA, Philippines — Health Secretary Francisco Duque III has asked the Food and Drug Administration (FDA) to prepare its approval of registered COVID-19 antigen test kits for home use.
According to Duque, he earlier asked then FDA Director-General Eric Domingo to ensure that the Certificate of Product Registration (CPR) of antigen kits in the country will be revised to expand its approved application.
Domingo recently resigned as FDA chief due to “personal reasons.”
“But I’ve prodded him to make sure that the CPR of the currently available antigen test kits will be revised to include home testing… because now, it’s still done mostly officially in a lab set up,” the DOH chief said during Wednesday’s Go Negosyo forum.
In a separate public briefing, Duque said the DOH is awaiting the recommendation of its technical advisory group on the guidelines for the use of the self-administered COVID-19 antigen test kits.
“Inaantay natin ang rekomendasyon kung ano ang mga dapat malagay sa guidelines para hindi magkamali ang pagbasa ng resulta o pag-interpret ng resulta kung gagamitin ang antigen test kits, self-administered,” he said.
(We are waiting for the recommendation of what are the necessary guidelines in order to prevent error in reading or interpreting the results if antigen tests will be self-administered.)
“Kinakausap ang FDA at sinisiguro natin na magkaroon ng revision dun sa kanilang binigay na CPR kung papano gagamitin ito just in case pahintulutan nila ang self-administered antigen test kits,” he added.
(We are talking to FDA and we are ensuring that there will be a revision of the CPR on how to use the self-administered antigen test kits just in case we approve it.)
Duque also stressed the need to educate the public on how to use the COVID-19 antigen kits.
“The antigen, ‘yung (the) self-administered test, the demand is really great for this, admittedly, but we really have to educate our people how to do it correctly,” he said.
Meanwhile, an infectious disease expert backed the use of antigen kits at home for faster detection of the virus, especially for those exhibiting symptoms.
“The advantage there is if that if you’re asymptomatic and you get the test and you’re positive, you can isolate yourself, you can do contact tracing early on and prevent the transmission compared to going out and having the RT-PCR [test],” Dr. Rontgene Solante said in the same forum.
Solante is the chief of the Adult Infectious Diseases and Tropical Medicine unit of the San Lazaro Hospital and a member of the Department of Science and Technology’s Vaccine Expert Panel.
On Wednesday, the DOH reported 10,775 additional COVID-19 cases, pushing the country’s active infections total to over 39,000.
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