Public agency looking into suitability of rapid antigen tests
Ljubljana - The Agency for Medicinal Products and Medical Devices has decided to carry out an extraordinary inspection of the suitability of the rapid antigen tests the Health Ministry purchased in December from the company Majbert Pharm. The decision comes after suspicion has been raised in the public about the reliability of these tests.
"As this is a large-scale activity that may be connected with risks, we have - as is required by law - decided to carry out inspection ... to examine the compliance of the supplied medical device with legislative requirements," the agency said on Wednesday.
It added that the scope and duration of inspection could not be estimated at the moment, as this would depend on the findings made during the inspection.
Under scrutiny are rapid antigen tests from China supplied at EUR 1.982 apiece by the company Majbert Pharm, after the Health Ministry said in December it was buying half a million tests for the mass testing of population for the novel coronavirus.
Suspicion has been raised lately in the public about the reliability of these tests, with the web portal Necenzurirano reporting that the tests had shown a false positive result in several cases.
Some of the tests were reportedly delivered to Slovenia with damaged plates, with the litmus paper coming off the plate, and there are also questions whether such tests may be applied outdoors, in the cold and moist environment.
Stanislav Pušnik, the director of the Ravne na Koroškem community health centre, has told the STA that their examination of rapid antigen tests has not produced the expected result.
For this reason, the centre also used tests of its own and informed the Health Ministry about that. It has received 1,525 such tests from the ministry, with which 225 persons have so far been tested and 25 positive persons identified.
While not commenting on the quality of the different rapid antigen tests, the Ljubljana community health centre said that, in principle and based on its experience, PCR tests were more reliable to a certain extent than rapid antigen tests.
According to Necenzurirano, which possesses a copy of the contract that former Health Minister Tomaž Gantar signed on the last day of his term with Majbert Pharma director Klemen Nicoletti, the state may claim a refund or terminate the contract early if the tests do not meet the required quality standards.
Gantar told the STA in a response that the purchase of rapid antigen tests had been urgent, as otherwise it would be impossible to carry out mass testing as recommended by the European Centre for Disease Prevention and Control (ECDC) and the European Commission.
The former minister said that the selected supplier had meet all the criteria, presented all required documentation and offered by far the most favourable price. The ministry had no other choice but to sign the contract, he added.
Gantar welcomed the agency's decision to examine the quality of the tests, while he personally believes that the supporting certificates are genuine.
State Secretary Marija Magajne said on Monday that the Health Ministry would keep tabs on all information regarding possible non-compliance of rapid antigen tests and take appropriate measures.
As for their reliability, Magajne said that a positive test very probably meant that the person was infected, while caution was needed in the case of a negative test, as it applied only to the moment of testing. There is also a possibility of a falsely negative test.
When asked about the reliability of rapid antigen tests from China, government spokesman Jelko Kacin said on Tuesday that the selected tests had all required documentation and that they had been produced in a special industrial zone close to Hong Kong.
The owners of Majbert Pharm, which is registered as a trader in medical devices, is owned as of 2021 by Amadej Alan Eferl and Klemen Nicoletti, who are known, according to media reports, for pyramid schemes involving cryptocurrencies and multi-level marketing schemes.
Nicoletti has in recent years reportedly been involved in the cryptocurrency project called Coinspace, in which millions of investors around the world have allegedly lost their money.
Last March, immediately after the coronavirus pandemic was declared in Europe, Eferl and Nicoletti established a company in London to supply protective equipment together with Mario Pejčić, who admitted in court in 2019 a bank robbery in Cerklje.
According to media reports, their business partners include Luka Lah, a former member of the youth wing of the ruling Democrats (SDS).
Lah has raised some dust in the public with a recent video on social media in which he is posing in front of a private jet that was supposedly to take the rapid antigen tests to Ljubljana.
The aircraft did not take off in what was the pilot's decision because Lah had affixed a promotional sticker on the aircraft.
Gantar said that he had not been acquainted with the ownership structure of Majbert Pharm or possible party connections, adding that he had not participated in the supply procedure.
He signed the contract after the tender commission had assured him that all required conditions had been met and that the company had offered the lowest price.
Majbert Pharm was selected in a repeated procedure after none of the bidders in the first tender at the beginning of December met the required criteria or offered a suitably low price.
In the subsequent procedure, a total of 16 bidders applied and four met the required technical specifications.