The Government Pharmaceutical Organization (GPO) will proceed with its plan to procure 8.5 million sets of Chinese-made antigen test kits (ATKs) from the bid winner, saying the equipment meets quality standards and the bidding process is transparent.
The move came a day after the GPO ordered the suspension of the purchase scheme under the National Health Security Office’s (NHSO) project following criticism and concerns about the quality of the ATKs which are banned in the United States.
Sars-CoV-2 Antigen and Leccurate Antibody Test products by Lepu Medical Technology were recalled in the United States on 28th May due to “a high risk of false results when using these tests”, according to the US Food and Drug Administration (FDA).
Ostland Capital won the bidding held on Tuesday to supply the Sars-CoV-2 Antigen test kits, offering each set for 70 baht.
Dr Paisan Dankum, secretary-general of the FDA, said the ATKs manufactured by Lepu Medical Technology have been approved by the Thai FDA for home use and endorsed by several countries.
He said the antigen and antibody test kits were recalled in the US out of concerns about test reliability concerns because the manufacturer did not apply for registration and the products were not tested.
However, the ATK was tested by experts from the Thai FDA, the Medical Technology Council and real use in labs run by the Faculty of Medicine, Ramathibodi Hospital.
The ATKs have passed the 90% sensitivity test and have 100% specificity when compared with the RT-PCR method, he said.
Dr Dankum insisted the FDA approval process is in line with international standards when asked if the local registration process reflects the World Health Organization or US guidelines.
There are four steps involved before the products are approved, including lab tests at three medical schools and examinations by experts.
“The ATKs that won the bidding are one of 32 kits approved by the FDA for home use. They were recalled in the US because the manufacturer didn’t apply for registration and thus they couldn’t be approved for use,” Dr Dankum said.
GPO director Vitoon Danwiboon insisted that the bidding process was transparent, saying terms and specifications had not been fixed in favour of any supplier.
The test kits have been approved for use in several European countries and also in Japan, he said.
Dr Danwiboon also defended the GPO’s decision to call the bidding after Kriangsak Watcharanukulkiat, the president of Rural Doctor Society (RDS), claimed the NHSO had specified the type of ATKs it wanted, which is allowed in case of emergency use. Instead, the GPO opted to call the bidding.
According to Dr Danwiboon, because the NHSO did not specify the manufacturer, the GPO was required by its procurement regulations to go for the bidding.
Rangsinee Wangman, a product specialist at Ostland Capital, said the ATKs can be imported within 14 days.
