(FILE) Health Secretary Francisco Duque III/PRESIDENTIAL PHOTO
Health Secretary Francisco Duque III on Friday warned the public against using self-administered COVID-19 test kits being sold online, saying these have not secured approval from the Food and Drug Administration (FDA) and are most likely fake or smuggled.
“If it is not approved by the regulatory body, you can consider that as fake. You should not use it,” he said in a radio interview.
According to Duque, he has already directed the FDA to investigate the sale of antigen test kits for home use and check if these have certificate of product registration issued by the regulating agency.
Duque said that, currently, the approved rapid antigen test kits available in the country were those used in the laboratories.
“We only have rapid antigen test kits that can be used at laboratories or can only be administered by doctors,” he said.
Duque said those who test positive on antigen tests no longer need a confirmatory reverse transcription-polymerase chain reaction (RT-PCR) while those who have symptoms but tested negative must take an RT-PCR test.
Meanwhile, the FDA called on manufacturers and importers of self-administered COVID-19 test kits to register their product so it could be used in the country.
The Department of Health will come out with guidelines on the use of the home test kits, FDA officer in charge Oscar Gutierrez said.“We need guidelines on the use, reporting system, even disposal of the waste, interpretation of the test results, and what actions should the individual take when he finds out that he is positive,” he said on Thursday.
Health Undersecretary Maria Rosario Vergeire on Friday said that once the self-administered test kits were approved, the government would monitor their use so it could get data on the results. The FDA-approved antigen test kits available in the country are recommended to be used and administered only by trained health-care workers, Vergeire said.