Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?
De zogenoemde DualDur-test dark-field microscopy van Lyme Diagnostics Ltd. (Hongarije).
Op de petitie/het verzoekschrift van EuroLyme; Bron https://www.lymeplus.com/nl/ is een reactie gegeven door de EU Commissie op 3 november 2025 aan de leden van de Commissie verzoekschriften EU!: Notice to Members: Subject: Petition No 0986/2023 by John Vandeput (Belgian), on behalf of EuroLyme, on reliable blood tests for Lyme disease; Bron https://www.europarl.europa.eu/doceo/do ... 964_EN.pdf
..3. Commission reply, received on 27 March 2024
The Commission’s observations
On 15 November 2018, the European Parliament adopted a resolution aimed at allocating additional funding to research on Lyme disease and harmonising research and prevention within the European Union1. Despite the significant progress made; treatment of the infection varies across the Member States. It must be noted that Article 168(7) of the Treaty on the Functioning of the European Union the organisation and delivery of health services, medical care and the organisation of health insurance systems are a national competence. Several bacteria in the Borrelia genus can cause infection and disease in humans; however, the Lyme borreliosis (caused mainly by Borrelia burgdorferi s.l.-) has the highest public health relevance amongst them. Diagnosing Borrelia infections by laboratory diagnostic tests can be challenging. Traditional tests are based on antibody detection in blood or other body fluids. Antibodies take time to develop, so testing too early in the infection course may lead to false negative results.
On the other hand, anti-Borrelia antibodies can persist in the host long after recovery from the disease, therefore the detection of antibodies does not necessarily indicate acute infection or aetiological link to certain clinical manifestations. Additionally, concomitant infections by other pathogens can lead to false positive results. In most European countries a two-tier testing approach has been adopted, whereby an initial screen is performed using ELISA, typically with a multi-strain purified antigen combination to provide a sensitive screen, then reactive samples are verified by immunoblotting improving specificity. There are also other methods used for diagnosis based on detection of activated T cells or on the direct identification of Borrelia (including cultivation, PCR detection of bacterial DNA or specific bacteriophage DNA, microscopic observation after enrichment, etc.) however those are less commonly used.
Tests commercially available in the EU to test for Borrelia for medical purposes must be CE-marked. Health institutions may also manufacture and use tests to be used on their premises ("in-house”) without them being CE-marked, subject to a number of conditions as laid down in Article 5(5) of Regulation (EU) 2017/746. As regards legal requirements on both CE-marked and in-house tests, Regulation (EU) 2017/746 on in vitro diagnostic medical devices states that devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art (Annex I Chapter I, point 1). Moreover, for CE-marked tests, Article 56 of the said Regulation lays down that the manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.
The analytical and clinical performance characteristics of the device must be made available in the instructions for use (see Annex I Section 20.4.1 letters w and x). For devices in risk class C (this is for example the case for tests detecting Borrelia burgdorferi s.l. directly, see guidance document MDCG 2020-16 rev.2 on classification of in vitro diagnostic medical devices2) the manufacturer must also provide a summary of safety and performance (according to Article 29 of the above Regulation). This documentation can already be used for comparison of the performance of those tests listed by the petitioner which are CE-marked. Considering disease severity and the challenges associated with diagnosis of borreliosis, the European Commission has decided3 to include Lyme neuroborreliosis among the diseases to be reported at Union level starting upon the Council recommendation issued in 2018. This decision was based on the scientific advice of independent experts and the European Centre for Disease Control and Prevention (ECDC)4. During the course of 2024, the ECDC is planning to issue the first epidemiological report on neuroborreliosis. In 2023 the European Commission launched a call for the set-up of EU reference laboratories under Regulation (EU) 2022/2371 on serious cross-border threats to health. The function of the laboratories will include strengthening the quality of Lyme disease diagnostic testing providing external quality assurance tools and training and support to national laboratories. The Framework Programmes for Research and Innovation have supported projects aiming to improve the early diagnosis of Lyme disease and overcome the shortcomings of current laboratory testing methods.
Under FP7, two consecutive projects, HILYSENS5 and HILYSENS II6, received in total over EUR 2.37 million for the development and clinical validation of a novel lab-on-a-chip diagnostic device, for a more specific and sensitive detection of anti-Borrelia immunoglobulins, both in the acute and chronic stage of the disease. The prototype included a biochip (LymeCard) and a fluorescence reader. At the end of the HILYSENS II project (2016), the reader and its software were successfully validated and brought to the EU market (CE marking) to operate in clinical laboratories. However, the LymeCard needed further development, which does not appear to have been taken forward to date. Under Horizon 2020, two projects on Lyme disease diagnostics were funded: (i) ID-Lyme7 (EU contribution of EUR 1.9 million) developed a diagnostic test based on cell-mediated immunity (CMI), in an effort to demonstrate that this diagnostic method could outperform other serological tests. This did not prove to be the case for Lyme disease (however the developed device was considered highly useful for taking forward CMI-based diagnostics to other diseases); (ii) the project DualDur8 (EUR 3.5 million) optimised the patented reagent and method DualDur®, which can directly identify the presence of the bacteria B. Burgdoferi in the blood. The ensuing multi-centre diagnostic clinical trial showed better performance of the optimised test compared to other laboratory methods, such as Western blot, Elisa and PCR9. The 2023-2024 Work Programme of Horizon Europe’s Health Cluster includes a call topic on tackling medical conditions that are high-burden for patients but under-researched10. This topic is also relevant to chronic Lyme disease. Evaluation of proposals is ongoing.
Conclusion
Laboratory testing for Borrelia is an important part of posing a diagnosis of Lyme disease, however it can be challenging due to the nature of the infection. Several tests are available in the EU. The EU has limited competence in the organisation and delivery of health services and care according to Article 168(7) of the Treaty on the Functioning of the European Union, and therefore limited possibilities in performing a comparison of tests directly. It has competence for the setting of the overall legislative framework for medical diagnostic tests, which has been updated and reinforced withRegulation (EU) 2017/746 on
The Regulation reinforces the requirements for clinical evidence and independent oversight of tests including tests for Borrelia. According to the Regulation, the manufacturer has to take into account the state of the art in defining the level of sufficient clinical evidence for their device and provide information on the performance of the device. Therefore, it is expected that with improvement of clinical approaches to testing for Borrelia the performance of the tests will also improve.
Furthermore, the EU supported the optimisation of diagnostic tests for Lyme disease through the Framework Programmes for Research and Innovation. There may be further opportunities for funding to support research on testing for Borrelia, in the form of calls to which interested organisations could submit proposals. These will be made available on the Funding and tender opportunities portal11..
Ter verificatie:
Voor Europa geldt: de **IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) is op 26 mei 2022 in werking getreden en vanaf dat moment moeten alle fabrikanten van IVD hulpmiddelen zich aan de nieuwe regels houden; Bron https://www.diagnotix.com/nl/ivdr-validatie en Bron https://www.rijksoverheid.nl/onderwerpe ... lpmiddelen ..Validatie onder de IVDR
Door de invoering van de IVDR en de MDR wordt het toezicht op de productie van medische hulpmiddelen aangescherpt.
In de IVDR wordt uitgebreid beschreven welke validatiestappen benodigd zijn voor een CE-certificering en toelating tot de markt binnen de EU..
..De prestatie-evaluatie dient te bestaan uit de volgende onderdelen (art 58 lid 3 IVDR):
1. Wetenschappelijke Validiteit
2. Analytische Prestaties
3. Klinische Prestaties..