In Italy the race for the miracle pad has started, a million-euro deal. A quick test, with a response in ten minutes, which would have the same sensitivity, and therefore the same confidence on the result, of a molecular swab. The magic name for this test is “microfluidic reading immunofluorescence test”. And to argue that it is as reliable as the molecular is the Ministry of Health, with a circular that accredits this equation with a simple phrase: “They seem to show comparable results”. All based on an opinion from the Italian Microbiologists Association, which in turn is based on studies partly supported by those who produce these tests. Above all, a single company, an English giant in the healthcare sector which in Italy has a Venetian company as its operating arm which in these months of the second wave has been awarded contracts by the Regions for more than 28 million euros. An intertwining of stories, opinions, circulars, experiments that starts from Veneto, arrives in Rome and now unfolds throughout the country, with the Regions actually invited by the ministry officials to buy this new generation rapid test. The key to mega contracts for the immunofluorescence test was given by Luca Zaia’s Veneto thanks to the super-expert chosen after the break with Professor Andrea Crisanti, the cumbersome “father” of the Veneto model now forgotten by the regional leaders. Zaia’s new spin doctor is a doctor from Treviso, Roberto Rigoli, primary microbiologist at the city hospital. Who is also vice-president of the Italian Microbiologists Association. Now, however, after the circular from the ministry, there are those who pose more than one doubt about the real equivalence of the two tests, and some Regions refuse to make purchases without clear and adequate scientific support: effectiveness is at stake. of the test and therefore of the control of the epidemic, but also the tenders of tens and tens of millions of euros announced or already concluded by the Regions.
ZAIA AND THE NORTHEST MUSK
The grand launch of immunofluorescence swabs was held on 2 October last during a press conference by the governor of Veneto Luca Zaia, hosted by Doctor Rigoli, whom the governor nicknamed “the Elon Musk of the Northeast” comparing him to the visionary founder of Tesla . The key role assigned to him by Zaia is that of «coordinator of the operational units of microbiology of the Veneto». He, “the man with swabs”, that day sits smiling to the right of the Northern League governor as a pioneer and innovator of diagnostics on Covid-19. Rigoli is the doctor who introduced rapid antigenic tests in Italy, after having tested them in Veneto. To undergo the test swab, in front of reporters, is Zaia herself. In a few minutes he will receive the result thanks to the device of the company Lumiradx, one of the companies that at that time was in the running for the award of a contract worth 148 million that involved the Veneto and six other Regions: that October 2 the tender procedure was still open but all the cameras end up framing only the instrument sold in Italy by the operating arm of the English company, the Biomedical Service based in Scorzè, in the province of Venice. Three days after that demonstration Rigoli, as coordinator of microbiology in the Veneto region, participates in the reserved session of the competition seat to “verify the suitability of the technical offers” presented by the competing companies. In a subsequent meeting of the commission, on 12 October, Rigoli, with an opinion, proposes, among other things, to buy the tests from operators “able to guarantee deliveries within 7 days”. In the end, the most important contract, in the lot relating to rapid tests with reading instruments, is won by the Biomedical Service which is assigned orders for 4.5 million euros, to which another 2.3 million will be added in one phase next one. On November 18 last, while in Veneto and in the rest of Italy the infections and deaths from coronavirus explode, the Regions indicate a second contract of 257 million to buy rapid tests: and Biomedical Service also in this case wins large orders up to exceed overall the amount of 28 million euros.
Vanin is a former partner of the microbiologist Rigoli in the Biomedical Service: the doctor from Treviso was limited partner (a partner without management powers who, however, participates in the company’s profits) of Biomedical Service Sas until January 1988. Then their paths went are separated: Vanin continued his entrepreneurial career, Rigoli instead became a doctor of the Ulss of Treviso and sold his stake to other people. However, the Covid-19 emergency today sees them again side by side, each in his role: the entrepreneur and the public doctor. First on the molecular swabs front: it is Biomedical itself on its website that explains that it has “developed an automated system” to implement molecular swabs for Covid-19 “in collaboration with the Ulss microbiology complex operating unit 2 Marca Trevigiana ”, directed by Rigoli. Then in the field of new generation rapid tests.
Certainly there are few companies today capable of producing and marketing these new tests. And the literal definition of “microfluidic immunofluorescence” for its products is one of the prerogatives of the British multinational Lumiradx, a company founded by Ron Zwanziger and a group of experienced managers in rapid diagnostics who gravitated around the galaxy of the pharmaceutical company Abbott. President and CEO of the Italian branch of Lumiradx, the Biomedical Service, is the Venetian entrepreneur Eddo Vanin. An experienced medical product marketing manager who headed Abbott’s rapid testing division in Italy, Abbott Rapid Diagnostics, for a decade until 2018.
Rigoli says he is calm and open to maximum transparency: “I know the representatives of all the companies,” he tells Espresso. “Vanin was in high school with me. When we were students we worked together, then everyone went their own way. I know him but I’ve always tried to be fair. We worked together in the Biomedical Service in the 80s, then I decided to dedicate myself completely to being a doctor. On January 25, 1988 I embarked on a hospital career and sold the shares ».
On the conference on 2 October and the use of the Lumiradx machinery while the race is still in progress Rigoli specifies: «We also brought the devices of the other companies in the race from Zaia. But Menarini’s machine couldn’t be transported because it was too big and Arrow’s device needed to be plugged in, so we didn’t turn it on. The Lumiradx runs on batteries instead. However, I am not in the competition commission, I participated in the organization by setting the parameters reported by the Higher Institute of Health, but I did not assign the score ».
FROM VENETO TO ROME
The Ministry of Health also believes in the “third generation” tests launched by Veneto at the beginning of the year. On January 8, the director of the Prevention department, Giovanni Rezza, signs a circular in which he actually recommends the use of this new type of rapid test: “The latest generation immunofluorescence tests with microfluidic reading”, reads the circular , “They seem to show comparable results to the Rt-Pcr assays (molecular swabs, ed)”. In support of this thesis, Rezza cites the literal passage of the document licensed on January 4, 2021 by the Italian Clinical Microbiologists Association (Amcli): “Operational indications on frequent questions for molecular diagnosis”. An opinion received by the ministry in record time, just four days later. In detail, the association of microbiologists of which Rigoli is vice-president refers to two studies: “Drain and others” of 2020 and a publication on the ECDC last November. The first is a research on the Lumiradx kit, even if at the end of the text it says: «This work was supported by Lumiradx Ltd». The second study speaks in general of restrictions on antigen testing. Rezza explains the circular thus: «It was a compromise between our gold standard, the molecular one, and the direction taken by the Regions that carry out many antigen tests. And then we based on that AMCLI opinion. Now we intend to update the circular by involving various scientific societies for an opinion ».
THE DOUBTS OF EXPERTS AND REGIONS
Some regions did not want to buy the new rapid tests. Francesca Di Gaudio, head of the regional laboratory quality center in Sicily and professor of Biochemistry at the University of Palermo says: “We did not purchase the new generation kits as this term” microfluidic “dictated by the ministerial circular is owned by a single company which is Lumiradx, which sells it at a very high price compared to other material always in immunofluorescence. The last award in Sicily for a similar test was made for 3 euros, while the Lumiradx product costs 15 euros ». In the meantime, even the experts advanced doubts on the equation of molecular swabs and immunofluorescence rapid: “There is no scientific evidence on the matter, the supporting studies are not yet available or at least they are not published, I find it strange that the ministry on the basis of an opinion of an association has issued the circular », says Professor Andrea Crisanti, director of the department of microbiology and virology of the hospital-university of Padua. “Ask Professor Francesco Broccolo if these tests are effective or not,” replies Rigoli. The virologist Broccolo on 11 January gave an interview to Ansa on the ministry’s circular: “Immunofluorescence tests with microfluidic reading have a slightly lower sensitivity, about 5-10 times, to the swab, but the limit is that these tests look for the antigen linked to Covid-19 and we know that the new variant has mutations and we risk having problems with false negatives. In practice, such a test would have been fine in February-April, but now it risks not being reliable, it should be continuously modified to detect new mutations as well ». But the machine that started in October in Veneto has now been launched throughout the country. Tenders for millions of euros have already been awarded and others, for as many millions and millions of euros, will soon be.
Source: L'Espresso – News, inchieste e approfondimenti Espresso by espresso.repubblica.it.
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