New test kit mystery
Antigen test kits (ATK), used in detection of the coronavirus, are now more than just a medical device; they are also the latest strategic tool for reopening business and activities. Therefore, the Ministry of Public Health is obliged to clear the air over a new scandal involving 8.5 million antigen test kits made by China-based Lepu Medical Technology that it bought to provide to the public.
A senior doctor in Nakhon Si Thammarat province has made headlines after ordering hospitals in the province not to use this ATK brand.
It remains unknown why this hospital managed to use Lepu for patients. This ATK brand is normally reserved for home use, not hospitals. Nevertheless, the report again puts a big question mark over the credibility of the Lepu ATKs.
According to Nakhon Si Thammarat public health chief Charaspong Sukkree, many cases have given the wrong results as the results from the test kits were positive but after double-checking with a RT-PCR test, they turned out negative or vice versa.
He claimed that 1,000 villagers in Thung Yai district were tested by doctors using Lepu test kits and that of them, 187 tested positive for Covid-19. However, when double-checked with RT-PCR tests, only 92 cases, or half, were confirmed infected.
Dr Charaspong urged hospitals not to use the Lepu device to screen patients, especially if they choose these kits just to reduce operating costs.
The doctor’s blatant warning suggests misuse of the product by several health organisations.
Dr Charaspong’s warning deserves attention as there are grounds for suspicion that such problems may be more prevalent. He also deserves praise for his courage in speaking up, as other doctors may hesitate to do so.
The 600-million-baht Lepu procurement from Ostland Capital was a scandal from the beginning. In August, the Rural Doctors Society raised the red flag, questioning the quality of the product.
Its concerns prompted the government to delay the contract for a few days before it eventually decided to pursue the procurement.
The Government Pharmaceutical Organization (GPO) defended the procurement, which it said passed Thai FDA approval, and simply went ahead.
Witoon Danwiboon, GPO managing director, was adamant the procurement was made in line with specifications by the National Health Security Office (NHSO), which said the the ATKs were for home and not professional use.
The NHSO said it had distributed more than 470,000 kits as of Oct 6. Of the total, 230,000 items were provided to the public via the state Paotang app. About 45% of the recipients used the kits, and 1,144 were positive. There is no explanation for the slow distribution involved, either.
Another health expert at Ramathibodi Hospital, meanwhile, doubted the allegations over Lepu’s inaccuracy.
In an interview with a TV programme, Dr Ekawat Pasomsap, chief of Ramathibodi Hospital’s Virology Unit, insisted the device, if applied correctly, carried only a 5% risk of error. Some mistakes might have been a result of using it wrongly, he said.
Needless to say, the silence of the Public Health Ministry, and the GPO in particular, bodes ill for the Covid-19 situation as public anxiety intensifies.
The ministry must launch a transparent probe into the case and investigate the accuracy rate as well as claims of suspected misuse. Any mistakes may derail plans by the government to reopen the country.