The Food and Drug Administration (FDA) today warned the public against buying non-FDA approved COVID-19 testing kits being sold online, saying they have “very low reliability and accuracy.”
“We are asking the public to be cautious. These are not registered with the FDA and if they use it, we cannot guarantee the quality and accuracy of the results,” FDA Director General and Health Undersecretary Eric Domingo told radio station DZMM today.
“Tests that produce instant results, if true, have very low reliability and accuracy,” he added.
Domingo said that while the agency recently approved the sale of four brands of testing kits from South Korea and China, the kits are not being sold to the public and will only be brought to government and private hospitals.
“These can only be sold to hospitals and laboratories because these are not instant do-it-yourself kits,” Domingo said, adding that the tests need to be processed in laboratories approved by the Department of Health (DOH) to yield accurate results.
The Research Institute of Tropical Medicine in Muntinlupa is currently the Philippines’ sole COVID-19 testing facility. Domingo said that the DOH is authorizing more hospitals to process tests next week.
A Senate hearing in early March found that the DOH only had some 2,000 kits for the country’s more than 100 million citizens. The shortage brought about a DOH policy that prioritizes testing of elderly and symptomatic suspected patients.
Yesterday, Cabinet Secretary Karlo Nograles, told reporters that the government may change it’s COVID-19 testing rules with the expected arrival of tens of thousands of additional screening kits, both donated and purchased.
The Department of Science and Technology (DOST), which funded the research on the kits, said on Wednesday that it is working on meeting the government’s initial order of 26,000 test kits, which will eventually be distributed to hospitals that have the capacity to run tests.
DOST Secretary Fortunato de la Peña however said that the UP test kits are not yet ready for full commercial use, and will be subjected to a field validation testing prior to release, in compliance with FDA protocol.
Manila HealthTek Inc, which manufactures the COVID-19 detection kits, told ABS-CBN News that the results of the field testing will be made available within two to three weeks.
“We will only start distribution of the kits once we get the go signal from FDA,” the manufacturers said.