MANILA, Philippines — The coronavirus disease 2019 (COVID-19) test kits developed by the University of the Philippines are now ready for commercial use, after being recalled in May over “very minor” defects.
The Department of Health (DOH) made this announcement on Sunday, saying that the performance of the kits will be regularly monitored as with other medical products and devices.
“After several months of collaboration, we are proud to say, GenAmplify version 2, the country’s very own RT-PCR test kit, is finally ready for commercial use,” the DOH said in a statement.
“We appreciate the Manila HealthTek team for their commitment to excellence and safety, as they worked closely with our independent laboratory expert panel in addressing key issues of version 1 of GenAmplify,” the department added.
The Food and Drug Administration earlier approved the test kits for commercial use in April, but upon undergoing validation by the Research Institute for Tropical Medicine, it was found out that 30 percent of the test kits yielded “indeterminate” results in finding out whether the specimen is negative or positive of the new coronavirus.
Health Undersecretary Maria Rosario Vergeire later said on July 10 that the UP-developed test kits have already secured a special certification from the Food and Drug Administration after the defects had been fixed.
“We, at the DOH and DOST-PCHRD (Department of Science and Technology-Philippine Council for Health Research and Development), are proud of our homegrown scientists who continue to use their talent to benefit not only the Filipino people but the rest of humanity as well,” added the DOH.