GPO plans quality testing on arriving Chinese Lepu antigen kits
After a rollercoaster ride of okays, protests, pauses, confirmation, cancellation, and reinstatement, 8.5 million controversial Chinese-made Covid-19 antigen test kits are set to arrive in Thailand early next week. The Government Pharmaceutical Organisation now plans on conducting quality testing on the kits made by Lepu Medical Technology with the help of Ramathibodi Hospital to reassure people of their accuracy.
The kits came under scrutiny after it was revealed that in the US, the Lepu test kits were pulled from shelves after the Food and Drug Administration warned that the tests were deemed inaccurate. The Rural Doctors Society fought against the importation, chastising the government for choosing the cheapest option – 70 baht per kit – instead of the most effective.
Now the GPO vows that when the antigen test kits arrive next week they will run ample quality assurance testing and do careful verification of the certification and inspection reports that come with the ATKs. Ramathibodi Hospital hospital will use their labs to run complete testing.
The lab they will use has already run similar quality and accuracy evaluations on 50 different brands of antigen test kits, overseen by the Faculty of Medicine of Mahidol University, and is the go-to testing facility for Thailand’s Food and Drug Administration as a part of their regulatory approval process.
Officials assure that if the Lepu Medical Technology antigen test kits manufactured in China do not pass the rigorous testing, they will not be given the green light for distribution and allowed to be used in medical facilities throughout Thailand. And even once they do pass, kits will be collected from real-world usage and spot-checked, tested for performance and accuracy.
If at any point the kits do not pass the quality assurance tests or live use spot checks, the GPO pledges they will recall the kits. They will demand the kits be replaced with the newest model available, which will also be subject to the same rigorous testing.
SOURCE: National News Bureau of Thailand
