After being recalled over “minor defects” in May, coronavirus testing kits developed by the University of the Philippines (UP) are now ready for commercial use. 

The Department of Health (DOH) made the announcement on Sunday, July 19, after the Manila Health Tek team worked with the agency’s independent laboratory expert panel for months to address issues in the earlier kits named GenAmplify version 1.

“After several months of collaboration, we are proud to say GenAmplify version 2, the country’s very own RT-PCR (reverse transcription polymerase chain reaction) test kit, is finally ready for commercial use,” the DOH said. 

Boosting supply

The UP-developed test kits will help to further stabilize the supply of kits needed to strengthen the country’s testing efforts, while providing more options for labs to use. 

For months now, the DOH has struggled to meet its target of 30,000 samples tested daily due to operational issues such as the lack of materials and lab personnel to carry out testing as well as encode results. 

The agency also faced challenges with acquiring an adequate supply of test kits, though this has since been partly addressed with the recent purchase of some 1 million kits. 

Recent DOH data showed coronavirus testing labs in the country tested a high of 26,968 samples in a single day on July 17.

Previous issues

The UP-developed test kits had been ready for mass use last April, but they were later recalled in May. This was after minor defects in contaminated reagents may have resulted in 30% of samples yielding “indeterminate” results.

New reagents were ordered to produce a new batch of test kits which were later validated by the Research Institute for Tropical Medicine. 

The DOH said the performance of the UP-developed GenAmplify version 2 test kits will be regularly monitored in compliance with standards for medical products and devices. – Rappler.com