Food and Drug Administration Director-General Eric Domingo (File photo)
MANILA – An official of the Food and Drug Administration (FDA) on Thursday said test kits for coronavirus disease 2019 (Covid-19) developed by the University of the Philippines-National Institutes of Health are currently unavailable for commercial use.
This, after the Research Institute for Tropical Medicine (RITM) spotted a "minor defect" in the reagent used in the test kits.
In a radio interview, FDA Director-General Eric Domingo said the test kits were first registered, tested, and validated at the Philippine Genome Center.
"We saw that its accuracy was 90 percent so we allowed them [to produce it] and we gave them a special permit. Now the DOH (Department of Health) before they use a test kit, they send them to the RITM," Domingo said in a mix of Filipino and English.
While the test kits were accurate, Domingo said the RITM saw 30 percent of the tests were indeterminate — incapable of showing whether the sample is positive or negative.
"So, they have to run the test again. So their finding is, it’s accurate but it’s hard to use because you have to redo 30 percent of the tests,” he added.
The Manila HealthTek, manufacturer of the test kits, told FDA the test results were indeterminate due to a contamination of the reagent, which is the substance used to produce a chemical reaction in tests.
Domingo said the first batch of test kits have been recalled and the Manila HealthTek will produce new test kits with new reagents.
“We are waiting for their second production, and of course, we’re going to have that (the test kits) tested again,” Domingo said.
He added that the test kits were used only at the Philippine General Hospital. (PNA)
