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Government warned over test kit deal

BANGKOK: The Rural Doctors Society (RDS) has warned that the Government Pharmaceutical Organization (GPO) and other state agencies must take responsibility if they proceed with a plan to procure 8.5 million sets of Chinese-made antigen test kits (ATKs).

By Bangkok Post

Sunday 15 August 2021, 08:47AM

Photo: AFP

Photo: AFP

“The GPO, the Food and Drug Administration (FDA), Rajavithi Hospital and the Public Health Ministry must take responsibility for the decision to procure the ATKs which have questionable quality,” the group said yesterday (Aug 14).

ATKs play a crucial part in containing the COVID-19 pandemic so it is necessary to use those of the highest available quality so medical personnel can treat patients straight away without the need to carry out RT-PCR testing again, it said.

Early treatment can help curb infection and fatality rates, the RDS said.

The GPO has insisted it will proceed with the procurement from the bid winner, saying the equipment meets quality standards and the bidding process was transparent.

The move comes despite the kits being 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 May 28 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 last Tuesday with an offer of B70 a set.

Dr Paisan Dankum, secretary-general of the FDA, has said the Lepu Medical Technology brand has 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 and Medical Technology Council and passed the 90% sensitivity test and have 100% specificity when compared with the RT-PCR method, he said.

The RDS said that although the ATKs passed a health technology assessment by Ramathibodi Hospital, studies published in international journals such as Virology Journal were not positive.

The RDS also said that the B70 price offered by Ostland Capital is still expensive because the wholesale price of the kit is only US$1 (about B35).

The RDS said the four agencies must make it clear how they will take responsiblity if damage arises as a result of the procurement of the ATKs. They did not specify what “damage” they had in mind.

Sirinuch Cheewanpisalnukul, deputy managing director of the GPO, said Rajavithi Hospital sent specifications for the bidding process to the GPO on Aug 1.

The GPO then informed 24 companies of the specs on Aug 3 with some contesting nasal swab and saliva sample requirements, Ms Sirinuch said. Therefore, the GPO asked the hospital and the National Health Security Office about the matter and saliva sample collection was excluded, she said.

Arnond Sakworawich, a lecturer at the National Institute Development Administration, said he has obtained an audio clip in which a doctor allegedly tried to persuade the GPO to fix the specifications and when met with a refusal, threatened to have the GPO managing director removed from office.

Kiattiphum Wongrajit, permanent-secretary for public health, said he will launch a probe into the leaked clip, and insisted the Chinese ATKs are up to standard.

Arak Wongworachart, director of Sichon Hospital in Nakhon Si Thammarat, admitted to Top News that he was the man speaking in the audio clip and said he would pursue legal action against anyone involved in the leak. Dr Arak alleged the person who released the clip was a “Dr Withoon”. It is unclear if he was referring to Withoon Danwiboon, managing director of the GPO.

Dr Arak said he sits on the NHSO’s price bargaining and negotiation committee, so he called to ask Dr Withoon why the ATKs had not yet been procured. “That’s my voice. Recording the conversation and releasing it is illegal,” Dr Arak said.

“In the clip, I made it clear the specs and standards must not be compromised. I did not threaten anyone.”

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