Ramathibodi Hospital to check quality of Lepu Medical’s test kits
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BANGKOK (NNT) - The 8.5 million COVID-19 antigen test kits from Lepu Medical are expected to arrive in Thailand early next week. The Government Pharmaceutical Organization has announced they will be working with Ramathibodi Hospital to conduct quality tests on these kits, addressing any doubts concerning quality.
Mrs Nuntakan Suwanpidokkul, a senior expert at the Government Pharmaceutical Organization (GPO) has disclosed the GPO will be conducting a quality assurance test of COVID-19 antigen test kits from China’s Lepu Medical Technology, after the expected delivery of 8.5 million kits.
Upon arrival, the attached certifications and inspection reports will be verified by the GPO to ensure compliance with the procurement terms of reference, followed by a laboratory test at Ramathibodi Hospital.
This particular laboratory run by Mahidol University’s Faculty of Medicine at Ramathibodi Hospital has already performed quality assessment inspections on each of some 50 test kit brands, as part of their regulatory approval filing process with the Food and Drugs Administration (FDA).
The quality assurance test to be performed with Lepu Medical’s test kits will follow the Thai FDA’s specifications. If passed, the 8.5 million test kits will be cleared for distribution to healthcare facilities.
Once the test kits enter real world use, some of the kits will be randomly collected for testing and analysis to check their accuracy and performance.
The GPO will recall the test kits should they fail quality assurance tests, requiring the importer to replace the kits with a newer model, which are also subject to the quality assurance protocol.
Information and Source
Reporter : Tanakorn Sangiam
Rewriter : Hugh Brammar
National News Bureau : http://thainews.prd.go.th
