Research results behind DualDur

DualDur has proven its performance in the widest Lyme diagnostic clinical research in Europe, on the basis of which it received the European Diagnostic Registration (IVD CE). Since 1986, the scientific results have been published in four publications, and their results have been presented to hundreds of Lyme specialists at conferences. Specific immunofluorescence tests have been used to confirm that the samples indeed contain Borrelia, and the latest PCR results confirm the presence of the bacterium. However, in addition to the scientific results, the most important thing is the feedback from Lyme specialists who use DualDur, who found it to be the most effective in both diagnosis and treatment efficiency control.

The medical history of DualDur

DualDur started from the highest level professional laboratory in Hungary, the serology laboratory of the National Institute of Public Health (later Johann Béla OKI). The method, developed by the team of Dr. Béla Pál Bózsik, one of the world's still active first-generation Lyme researchers, was necessary because serological solutions could not adequately support medical diagnosis (then, just as now). Doctor Bózsik also played a leading role in the description of the first domestic cases, and soon realized that due to the special immune evasion mechanisms of the pathogen, new solutions may be needed in the case of "seronegative Lyme borreliosis".

The methodology, which is presented in detail in patents, professional publications and international professional lectures, medical trainings and further trainings, ensures the direct detection of pathogens and avoids problems that arise in direct examinations. The detection of the presence of Borrelia was checked by several different methods in the laboratory of OKI and in research institutes (e.g. electron microscopy, immunofluorescence microscopy), and in 1986 the method began to be used in parallel with serological examinations.

The data analysis of the more than thirty thousand tests was presented at international conferences, and then another ten thousand tests were carried out in private laboratories.

From 2012, based on the opinion of an international team of doctors, it began to be used outside the EU, and then there was interest from several EU countries. Although it was legal to use the test in an accredited laboratory, the inventor and his associates decided to obtain the EU marketing license, the IVD CE mark. To this end, the DualDur research project was established, which was also mentioned by the European Parliament as an example in its resolution and selected by the European Commission as a model project for research for the health of EU citizens.

Within the framework of the DualDur project, with the help of medical, laboratory, development, engineering, software, image recognition, artificial intelligence, clinical research and economic experts, the method was applied to modern laboratory conditions. Human error can be minimized due to full automation, artificial intelligence recognition and the development of online human validation. Independent preclinical and analytical studies have confirmed the favorable laboratory properties of DualDur over decades.

The largest stage of the project was clinical research with the participation of 8 Lyme clinics in 6 countries. This was designed and carried out with the help of an independent organization and laboratory. This was one of the few European clinical trials whose design was published in an independent database before the start of the research – thus avoiding the possibility of subsequent manipulation.

The research data were made available to the Competent Authorities and Ethics Committees, whose approval opened up the possibility of medical diagnostic registration.

The IVD CE mark means registration as an in-vitro medical diagnostic device, during which the Competent Authority (OGYÉI) checks the manufacturer's processes, declarations and test results for the performance of the device. Based on this, DualDur was IVD CE certified in 2020, which means that it can be used in any EU and associated countries without any further acceptance.

The crowning achievement of several decades of research were the two recent publications in renowned professional journals, which were published in a prestigious international journal with the so-called "impact factor". Further publications are under preparation, as DualDur has played a significant role in clinical research and laboratory studies and case studies, as the only method that has been proven to be able to detect the pathogen before, during and after treatment.

The results of two clinical trials were presented at a conference of an international Lyme physician association (ILADS) in 2024 and 2025, where DualDur played a significant role in establishing and confirming the diagnosis.

References

  1. Bózsik B.P., Bózsik A.P., Bózsik B. Patent: Direct Detection Method for Tick-Borne Infections and a Cell Technology Medium for the Method. WO2020194003, 2020.
  2. András P. Bózsik, Béla P. Bózsik P. FIRST APPLICATION OF AN IMPROVED-RESOLUTION DARK-FIELD MICROSCOPY SETUP, COMBINED WITH A NOVEL DIRECT-STAINING LIVE IMMUNOFLUORESCENCE INVESTIGATION METHOD, VISUALISING THE MOTION OF BORRELIA BURGDORFERI SPIROCHETES. acta [Internet]. 2024 Jun 14 [cited 2024 Jun 28];33(1). Available from: https://acta-microscopica.org/acta/article/view/698
  3. Bózsik, A.P.; Déri, J.; Bózsik, B.P.; Egri, B. Presence of Borrelia Spirochetes in White Stork (Ciconia ciconia), White-Tailed Eagle (Haliaeetus albicilla), and Eastern Imperial Eagle (Aquila heliaca): Hospitalized in a Wild Bird Hospital and Sanctuary (Hortobágy, Hungary). Animals 2024, 14, 3553. https://doi.org/10.3390/ani14243553
  4. European Parliament resolution of 15 November 2018 on Lyme disease (Borreliosis) [Internet]. 2018/2774(RSP Nov 15, 2018. Available from: https://www.europarl.europa.eu/doceo/document/TA-8-2018-0465_EN.html