Covid test kits in shelved deal meet Thai standards, says FDA

A deal for 8.5 million ATKs made by Chinese company Lepu Medical Technology was halted on Friday following news that the US FDA had banned their use over quality concerns.

The Thai FDA said the Lepu Medical Technology ATKs were among 84 antigen test kits it had registered for use in Thailand – 34 for home use and 52 for professional use.

The medical regulator explained that all ATKs were tested at Ramathibodi Hospital, Prince of Songkla University and Chulalongkorn University. Quality was therefore guaranteed, it added.

The Government Pharmaceutical Organisation had been poised this week to buy 8.5 million ATKs from Lepu Medical Technology at 70 baht per kit. However, it was discovered the kits were recalled in the United States on May 28 due to "a high risk of false results when using these tests", according to the US FDA.

The GPO decided to postpone the purchase of the ATKs indefinitely after “parties expressed concerns about the product quality”, GPO board president Dr Kiattiphum Wongrajit said.