UP developed COVID-19 test kit ready for relaunch — DOH

MANILA, Philippines — The Department of Health (DOH) on Friday announced that the COVID-19 test kit developed by the University of the Philippines (UP) is now ready for roll out after the deficiency that caused its recall has been fixed.

In an online media forum, Health Undersecretary Maria Rosario Vergeire said the UP-made test kits have already secured a special certification from the Food and Drug Administration.

“Nakapagsubmit na sila ng bago, na-validate na ng Research Institute for Tropical Medicine (RITM), (at) tinutulungan na natin sila ngayon para maumpisahan na natin ang paggamit sa piling laboratoryo dito sa ating bansa,” Vergeire said.

(They have already submitted another certification, it has been validated by RITM already and we are now helping them so we can start using the test kits in selected laboratory in our country.)

Last April, the FDA approved the locally-made kits for commercial use after being tested by the Philippine Genome Center.

However, upon undergoing validation by the RITM, it was found out that 30% of the test kits yielded “indeterminate” results in finding out whether the specimen is positive or negative for the coronavirus.

A final advisory from the DOH is all that is needed before laboratories can start using the UP-made test kits, Vegeire said.

“May mga kailangan kasing sundin na instructions ‘yung laboratories before they can use that. They have to undergo training, of course, kasi bagong test kit ‘yan at kailangan may proficiency test sila for that,” she said.

(There is a need to follow the instructions before the laboratories can use that. They have to undergo training, of course, because that’s a new test kit and they need to have proficiency test for that.)

The GenAmplify™ Corona Virus 2019 (COVID-19) rRT PCR Detection kit, which was manufactured by Manila HealthTek, Inc. and developed by the UP-National Institutes of Health, was previously estimated to cost P1,320 per test— cheaper than its foreign counterparts which cost P8,500 per test.

/MUF