FDA warns public: Online selling of COVID-19 test kits prohibited
MANILA, Philippines — The Food and Drug Administration has reminded the public that COVID-19 tests are purely for medical professional use and are not sold online.
In an advisory, the FDA said their mandate to protect the public welfare and safety through regulation of health products covers in-vitro diagnostic medical devices in the country.
The regulatory body told the public and the general public “that online selling of all types of FDA certified COVID-19 test kits (RT-PCR, antibody, antigen based) is strictly prohibited.”
“These COVID-19 test kits with FDA special certification are strictly for medical professional use and not intended for personal use,” it added.
The RT-PCR of the Reverse Transcription Polyamerase Chain Reaction test, considered the “gold standard” in testing, detects the virus’ genetic material through nasal and throat swabs. The rapid antibody tests meanwhile detects the antibodies in blood of people believed to have been infected with the disease.
Antigen tests diagnose active COVID-19 infections with quicker turnaround period, although negative test results may need to be confirmed by an RT-PCR test.
FDA Director General Enrique Domingo directed the agency’s regional field offices and regulatory enforcements units to monitor online platforms on such selling.
Domingo also ordered its regional offices and units to “pursue and implement immediate regulatory and enforcement actions as warranted.” — Kristine Joy Patag with report from Bella Perez-Rubio
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