The much-publicized, locally-manufactured COVID-19 test kits from Manila HealthTek have all been recalled due to contamination, the Food and Drug Administration (FDA) announced today.
Speaking to ABS-CBN’s internet radio station Teleradyo, FDA Director-General and Department of Health (DOH) Undersecretary Eric Domingo said the first batch of the test kits, which were developed by scientists from the University of the Philippines, proved unreliable when it was tested at the Research Institute for Tropical Medicine (RITM), the country’s premier lab.
Read: Philippine-made COVID-19 test kits ready this week
“What happened was when they registered it and it was tested and validated at the [Philippine] Genome Center, we saw that its accuracy was 90% so we allowed them [to produce it] and we gave them a special permit. Now the DOH before they use a test kit, they send them to the RITM,” Domingo said in English and Filipino.
“So when the RITM tested it, they saw that it was accurate but 30% of the tests were indeterminate, [they can’t show] if [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 re-do 30% of the tests,” he added.
Domingo said they asked Manila HealthTek to explain why the tests were indeterminate, and the company said they discovered that the reagent, a substance used to produce a chemical reaction, was contaminated.
“Before [those test kits] were used, they recalled them and they are now ordering new reagents so they can produce new test kits…We are waiting for their second production and of course, we’re gonna have that tested again,” Domingo said.
The FDA official said that all test kits were recalled and it was only the Philippine General Hospital that used them. The FDA added that the hospital’s patients have nothing to worry about, however, because they conducted confirmatory tests after ManilaHealth’s kits were used.
The development of the test kits was funded by the Department of Science and Technology and at least 26,000 of them were distributed to several major hospitals including Makati Medical Center and Baguio General Hospital. The kits were hailed as a gamechanger, especially because each cost only PHP1,300 (US$25), cheaper than their imported counterparts, which were being sold for at least PHP8,000 (US$158).
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