16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amsterdam

Voor nieuws, actualiteiten en acties specifiek over Lyme-Borreliose.
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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Vr 28 Feb 2025, 17:33

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=560#p31021 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=560#p31022 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=560#p31024

Disease Association of Australia (LDAA): :arrow: Senate Inquiry - What happens next? The Community Affairs References Committee will provide a Final Report by 26 March 2025; Bron https://www.facebook.com/@LymeDiseaseAustralia/

15 January 2025: Senate Inquiry - Submission 102 Tezted (Finland); Bron https://www.aph.gov.au/Parliamentary_Bu ... ubmissions
..Regarding the following Australian Senate inquiry into "Access to diagnosis and treatment for people in Australia with tick-borne diseases," please accept this as our submission with the intent to highlight the need for better clinical pathway judgments than debilitating symptom complexes attributed to ticks (DSCATT) and the need for better testing for Australian patients. More specifically, this submission provides evidence that affects the following four terms of reference outlined by the Australian Parliament's Senate:
a. the initiatives and resources developed to improve awareness, diagnosis, treatment, and management of tick-borne diseases in Australia since the release in 2016 of the Community Affairs References Committee Report Growing evidence of an emerging tick-borne disease that causes a Lyme-like illness for many Australian patients;
b. the adequacy and effectiveness of the 'debilitating symptom complexes attributed to ticks' clinical pathway to support patients;
c. current research to advance the management of complex inflammatory diseases; and
d. any other related matters.
This submission provides evidence that Australian patients suffer from Lyme disease and other tick-borne diseases and that DSCATT has substantial pitfalls that support the immediate development of better testing and treatment management of Australian patients..

..Concerning providing solid evidence that Australian patients are suffering from Lyme Disease and other tick-borne diseases, :arrow: our recent study titled "Assessing interlaboratory performance and concordance of tick-borne disease testing using multiplex enzyme-linked immunosorbent assay" (Garg et al. 2024 and see attachment 1) has substantial implications for the comprehension and diagnosis of tick-borne illnesses (TBDs) in Australia. Our study, conducted collaboratively between research laboratories in Finland, Mexico, and Australia, assessed the efficacy of a novel diagnostic tool for identifying antibodies to pathogens linked to tick-borne diseases. Specifically, this novel diagnostic tool tested for immune responses from Australian patients, specifically against Borrelia burgdorferi sensu lato species in spirochete and persistent forms, co-infections, and opportunistic microbes associated with a tick bite. Specifically, the index test included antigens from Borrelia burgdorferi sensu stricto, Borrelia afzelii, Borrelia garinii in spirochete and persistent forms, Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, Rickettsia akari, Coxsackievirus, Epstein–Barr virus, Human Parvovirus B19, Mycoplasma fermentans, and Mycoplasma pneumoniae. The key findings for this proof-of-concept study are the following:
1. Enhanced Diagnostic Potential: Using a novel diagnostic tool, we identified immune responses to multiple pathogens in Australian patients, including microbes associated with Lyme disease and other tick-borne co-infections. This highlights the diagnostic tool's
ability to screen for a broad range of pathogens with a single test, which is particularly valuable given the diverse nature of TBDs;
2. Australian Relevance: Despite uncertainties surrounding the existence of endemic Lyme disease in Australia, our findings suggest that Australian patients exhibit immune responses consistent with exposure to tick-borne microbes. This aligns with the increasing recognition of "Lyme-like" disease and underscores the need for improved diagnostic capabilities in this region; and
3. Interlaboratory Reliability: High concordance was achieved between testing sites in Australia and Finland, validating the reproducibility and reliability of this novel diagnostic tool, such as TICKPLEX, results across different settings.

In addition to :arrow: this proof-of-concept study (Garg et al. 2024), an additional 15 patients who sought out commercially TICKPLEX diagnostic testing (http://www.tezted.com, CE-IVD accredited and validated diagnostic test) from an accredited laboratory in Germany (http://www.ArminLabs.com) provided confirmatory and supporting evidence that this more advanced diagnostic test provides clinical utility in Australia. The following figure demonstrates that this simple novel diagnostic tool can detect immune responses to diverse pathogens, including those linked to Lyme disease and tick-borne co-infections, providing crucial insights into "Lyme-like" diseases in Australian patients and emphasizing the need for enhanced diagnostics in this region..

..The impact on Australian patients of these studies is profound with easy solutions. This research highlights the promise of innovative and superior diagnostic techniques to rectify persistent deficiencies in diagnosing TBDs in Australia. This is especially pertinent for patients suffering from persistent, debilitating symptoms linked to tick bites, a condition frequently neglected or misunderstood. Innovative diagnostic techniques could facilitate early diagnosis and focused therapy through a more complete diagnostic approach, enhancing patient outcomes and quality of life. We assert that these findings signify a crucial advancement in acknowledging and tackling the intricate issues presented by TBDs in Australia..

..Therefore, we aimed to furnish additional evidence through a scientific critique of the peer-reviewed article titled "Characterising DSCATT: A case series of Australian patients with debilitating symptom complexes attributed to ticks"
( :arrow: Schnall et al. 2021), which sought to present the inaugural case series of patients with DSCATT, while precariously classifying these individuals as having medically unexplained conditions. The following outlines the 10 most significant scientific pitfalls in Schnall et al. 2021, and it is recommended that this paper is not usedas evidence to support DSCATT:..

:arrow: The shortcomings in the study are not solely academic errors but pose significant concerns for Australian patients. They can sustain cycles of misdiagnosis, financial detriment, and emotional turmoil while obstructing advancements in the comprehension and treatment of tick-borne diseases. Rectifying these deficiencies is crucial to mitigate harm and enhance patient outcomes via precise diagnoses, focused therapies, and a more inclusive research methodology.

To tackle the identified issues, Australia needs to implement sophisticated diagnostic instruments such as TICKPLEX to enhance the precision and dependability of tick-borne disease (TBD) diagnosis and establish a national surveillance system and reference laboratory to monitor and standardize testing. It is imperative to revise the deficient DSCATT Clinical Pathway using evidence-based, internationally standardized criteria alongside physician education and augmented research funding to investigate new infections and therapies. Support for patient advocacy organizations, equal access to healthcare, and elimination of psychosocial stigma are essential for facilitating patient-centred care. Comprehensive, rigorous studies must supplant deficient research to guide policies, while a centralized patient registry can monitor outcomes and enhance treatment pathways. These initiatives will improve patient outcomes, promote TBD research, and cultivate equitable, evidence-based healthcare..
:arrow: 'Characterising DSCATT: A case series of Australian patients with debilitating symptom complexes attributed to ticks' by Schnall et al. 2021; Bron https://journals.sagepub.com/doi/10.117 ... 4211043788

:arrow: Preprint Article: 'Assessing :arrow: Interlaboratory Performance and Concordance of Tick-Borne Disease Testing Using Multiplex Enzyme-Linked Immunosorbent Assay' by Kunal Garg, Fausto Villavicencio-Aguilar, Flora Solano-Rivera, Leona Gilbert; Bron https://www.preprints.org/manuscript/202412.0220/v1
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Vr 28 Feb 2025, 17:52

Vervolg

Disease Association of Australia (LDAA): :arrow: Senate Inquiry - What happens next? The Community Affairs References Committee will provide a Final Report by 26 March 2025; Bron https://www.facebook.com/@LymeDiseaseAustralia/

16 January 2025: Senate Inquiry - Submission 122 ArminLabs (Duitsland); Bron https://www.aph.gov.au/Parliamentary_Bu ... ubmissions
..Thank you for the opportunity to provide this submission regarding the urgent need for improved diagnosis and treatment for people in Australia with tick-borne diseases. We are writing to highlight that many Australians are, in fact, affected by Lyme disease and other tick-borne infections—challenges currently underscored by the term “debilitating symptom complexes attributed to ticks” (DSCATT). We believe there is a pressing need to expand clinical pathways and testing options, ensuring that patients and healthcare providers receive the clarity and support they deserve.

In support of the four terms of reference set by the Senate, we submit the following evidence:
1. Australian Lyme Disease and Other Tick-Borne Illnesses
A retrospective audit of our records at ArminLabs (2022–2024) showed that 117 Australian patients have sought comprehensive testing from us, including CE-IVD (Conformité Européenne – In Vitro Diagnostic) assays for immune responses to various infectious pathogens. We found:
o Up to 35% (35% IgM and 19% IgG) of these individuals had antibodies against Borrelia burgdorferi sensu lato.
o Up to 32% (32% IgM and 19% IgG) had antibody responses against persistent forms of Borrelia burgdorferi sensu lato.
These results indicate that a significant portion of Australians tested had measurable markers of Lyme disease or persistent forms of the infection, aligning with previous :arrow: studies such as Garg et al. 2004 (https://doi.org/10.20944/preprints202412.0220.v1).
2. Internationally Recognized Testing Standards
ArminLabs is a leading Germany-based laboratory specializing in advanced diagnostic testing for tick-borne infections. We are proud to be accredited under CLIA (Clinical Laboratory Improvement Amendments), CAP (College of American Pathologists), DAkkS (Deutsche Akkreditierungsstelle), and received a Certificate of Equivalence from UKAS for our existing accreditations, ensuring that our services meet the highest standards of quality and reliability.
3. :arrow: Global Accreditation and Mutual Recognition
Accreditation in Australia is managed by the National Association of Testing Authorities (NATA) under ISO 15189. CAP and DAkkS also follow ISO 15189 criteria in their accreditation processes. Since Australia is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), Australian authorities acknowledge and respect the ISO 15189 standard set by equivalent bodies, including CAP and DAkkS.
Under the ILAC MRA, all accreditation organizations must comply with :arrow: ISO/IEC 17011, relevant ILAC guidance, and other criteria, ensuring that accredited laboratories meet ISO 15189 or other pertinent standards. This global framework empowers labs around the world to provide accurate, reliable results that reinforce trust and confidence in medical testing.
4. Enhancing Clinical Pathways and Patient Care
We respectfully urge the Senate to consider the importance of widely accessible, high-quality testing and clinical pathways for individuals who may be suffering from tick-borne infections. By recognizing the validity of advanced diagnostic methods and supporting their integration into Australian healthcare, we can foster better patient outcomes and encourage earlier, more accurate diagnoses.

Patients seeking testing from international labs like ours indicate the gaps in local diagnostic and treatment options. Strengthening and broadening the frameworks within Australia will reduce the need for international referrals, helping more Australians receive the care they need—sooner and closer to home.

We are grateful for your attention to this critical matter and hope our submission highlights the undeniable presence of Lyme disease and other tick-borne conditions in Australia. We can ensure that these conditions are properly identified and managed with continued collaboration, innovation, and a commitment to evidence-based standards. In doing so, we will significantly improve the lives of those affected and protect the broader community’s health and well-being.
I appreciate your consideration. We remain committed to working with the Senate, healthcare providers, and accreditation bodies to ensure a brighter future for all Australians impacted by tick-borne diseases..

Is het door Tezted (Finland) en ArminLabs (Duitsland) gestelde juist? Ter verificatie:
ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- FINAS Finland (Finnish Accreditation Service) is lid van ILAC MRA maar Tezted - Finland heeft :arrow: géén ISO 15189 accreditatie van het FINAS Finland (Finnish Accreditation Service).
- DAkkS Duitsland (Deutsche Akkreditierungsstelle) is lid van ILAC MRA maar de cellulaire test voor Borrelia de EliSpot/iSpot Lyme test van ArminLabs - Duitsland staat niet in de lijst van DAkkS.

Tezted - Finland fabrikant! heeft énkel een ISO 13485 certificatie van Lloyds; Bron https://www.tezted.com/_files/ugd/68942 ... 116b89.pdf of van LRQA; Bron https://www.tezted.com/_files/ugd/68942 ... 215052.pdf
Tezted - Finland is een commercieel laboratorium en heeft :arrow: géén ISO 15189 accreditatie van het FINAS Finland (Finnish Accreditation Service); Bron https://www.finas.fi/sites/en/Pages/default.aspx

In de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle) staan namelijk de Borrelia testen genoemd; Bron https://www.dakks.de/en/accredited-body ... 2296-01-00
..Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: ELISA
Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: Line blot
Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: Microarray..
Wie goed oplet en de informatie nog eens goed naleest valt op dat de cellulaire test voor Borrelia de EliSpot/iSpot Lyme test die na validatie onbetrouwbaar is gebleken niet in de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle) staat.
En ook de niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test; en de niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test; en de niet-gevalideerde ToxiPlex test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test staan niet in de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle).
Meest recente informatie (2025) bij DAkkS; Bron https://www.dakks.de/en/search-result.html en Bron; https://www.dakks.de/en/accredited-body ... 2296-01-00


ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- NATA Australië (National Association of Testing Authorities) is lid van ILAC MRA.
- DAkkS Duitsland (Deutsche Akkreditierungsstelle) is lid van ILAC MRA
- FINAS Finland (Finnish Accreditation Service) is id van ILAC MRA.
- RvA Nederland (Raad voor Accreditatie) is id van ILAC MRA.

..'Under the ILAC MRA, all accreditation organizations must comply with :arrow: ISO/IEC 17011, relevant ILAC guidance, and other criteria, ensuring that accredited laboratories meet ISO 15189 or other pertinent standards. This global framework empowers labs around the world to provide accurate, reliable results that reinforce trust and confidence in medical testing'..?

Ter verificatie:
- ANAB Amerika (ANSI National Accreditation Board) is lid van ILAC MRA. ANSI - Overzicht van ISO/IEC 17011; Bron https://blog.ansi.org/anab/overview-of-iso-iec-17011/
..Conformiteitsbeoordelingsactiviteiten
Conformiteitsbeoordelingsinstanties voeren conformiteitsbeoordelingsactiviteiten uit. Conformiteitsbeoordelingsactiviteiten die doorgaans onder accreditatie vallen, omvatten testen, kalibratie, inspectie, biobanking, certificering van managementsystemen, personen, producten, processen en diensten, het leveren van bekwaamheidstests, productie van referentiematerialen en validatie en verificatie. Het zijn deze activiteiten die worden gedocumenteerd op een gedefinieerde scope van accreditatie op basis van de accreditatienorm en het accreditatieprogramma, zoals ISO/IEC 17025 voor laboratoria , ISO/IEC 17065 voor productcertificatie-instanties en ISO/IEC 17021-1 voor managementsysteemcertificatie-instanties..

Nieuws 12 juli 2019: Raad voor Accreditatie (RvA) - Accreditatie ringonderzoek-organisatoren nu ook mondiaal erkend; Bron https://www.rva.nl/nieuws/accreditatie- ... al-erkend/
..De RvA is één van de 13 Europese accreditatie-instanties die ondertekenaar is geworden van de ILAC-MRA voor de accreditatie van organisatoren van ringonderzoeken volgens ISO/IEC 17043. Hiermee wordt de gelijkwaardigheid van ringonderzoeken niet alleen op Europees niveau maar nu ook daarbuiten bevestigd..
Nieuws 17 mei 2023: Raad voor Accreditatie (RvA) - Herziening ISO/IEC 17043 gepubliceerd; Bron https://www.rva.nl/nieuws/herziening-is ... ubliceerd/
..Op 8 mei is de 2023-versie van ISO/IEC 17043 gepubliceerd. Deze norm gaat over de organisatie van zogeheten ‘Proficiency testings’; hier in Nederland meestal organisatoren van ringonderzoeken genoemd. Laboratoria gebruiken deze ringonderzoeken om aan te tonen dat hun resultaten gelijkwaardig zijn aan de resultaten van andere laboratoria. De International Laboratory Accreditation (ILAC) is overeengekomen dat er een overgangsperiode van drie jaar zal zijn. Aan het einde van deze periode moeten aanbieders die wereldwijd zijn geaccrediteerd volgens EN-ISO/IEC 17043:2010 zijn beoordeeld en geaccrediteerd volgens de EN-ISO/IEC-17043:2023. Dit houdt in dat alle bestaande accreditaties tegen de EN-ISO/IEC-17043:2010 versie vóór 8 mei 2026 omgezet moeten zijn naar de EN-ISO/IEC-17043:2023 versie..

Preprint Article: 'Assessing :arrow: Interlaboratory Performance and Concordance of Tick-Borne Disease Testing Using Multiplex Enzyme-Linked Immunosorbent Assay' by Kunal Garg, Fausto Villavicencio-Aguilar, Flora Solano-Rivera, Leona Gilbert; Bron https://www.preprints.org/manuscript/202412.0220/v1

Ter verificatie:
Is er sprake in de Publicatie van het Preprint Artcile van :arrow: Interlaboratorium-vergelijkingen volgens de ILAC Mutual Recognition Arrangement (ILAC MRA)?..
Informatie van Raad voor Accreditatie (RvA) - Nieuwe versie RvA-T030-NL Proficiency Testing, Externe kwaliteitsbeoordeling & Interlaboratoriumvergelijkingen; Bron https://www.rva.nl/nieuws/55191/
..Raad voor Accreditatie
..1 Inleiding
Dit document beschrijft het RvA-beleid ten aanzien van het gebruik van proficiency testing-activiteiten, externe kwaliteitsbeoordeling en interlaboratoriumvergelijkingen in het accreditatieproces van conformiteitsbeoordelingsinstellingen (hierna: instelling).
Het RvA-beleid is gebaseerd op ILAC P9 “ILAC Policy for Participation in Proficiency Testing Activities” en op EA-4/18 G “Guidance on the level and frequency of proficiency testing participation”.

In dit document wordt onder instelling verstaan:
- test- en kalibratie-laboratoria volgens de EN ISO/IEC 17025;
- medische laboratoria volgens de EN ISO 15189;
- biobanken volgens de EN ISO 20387;
- inspectie-instellingen volgens de EN ISO/IEC 17020, voor zover deze in het kader van haar inspecties (ook) analytische testen uitvoeren;
- producenten van referentiematerialen volgens de EN ISO 17034;
- aanbieders van proficiency testing volgens de EN ISO/IEC 17043:2023..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Wo 05 Mar 2025, 16:10

Vervolg op 'Patiëntsymposium lyme 2022'; Bron viewtopic.php?f=5&t=2595#p28587 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=410#p30195 en vervolg op: 'promoten van Disulfiram'; Bron viewtopic.php?f=5&t=2595&start=430#p30221

Frontiers in Medicine
Publicatie 4 maart 2025
Clinical Trial Article - 'A Pilot Study of Disulfiram for Individuals with Persistent Symptoms despite Prior Antibiotic Treatment for Lyme Disease' by Maria (Mara) Kuvaldina, Jessica Preston, Denise McClellan, Martina Pavlicova, Thomas H Brannagan, Brian A Fallon; Bron https://www.frontiersin.org/journals/me ... 4/abstract
..In vitro studies report that disulfiram is effective in killing Borrelia burgdorferi. Case series suggest disulfiram may help to reduce the symptoms of patients with persistent symptoms despite prior antibiotic treatment for Lyme disease. This pilot study assessed safety, tolerability, and signs of clinical response.

Materials and Methods
Participants with a history of previously treated Lyme disease and persistent fatigue were randomly assigned in a double-blinded fashion to either Group A (disulfiram for 4 weeks and placebo for 4 weeks) or Group B (disulfiram for 8 weeks). Primary outcome endpoint was at 10 weeks with a follow-up at 14 weeks. The primary aim was to assess safety and tolerability. A clinical aim assessed signs of clinical improvement using well-validated measures, focusing on improvement in fatigue and quality of life. Target enrollment was 24 participants.

Results
940 individuals were screened, 11 were enrolled and 9 participated in the trial. Dosing started low and increased based on response and tolerance to a maximum of 500 mg daily.

Safety
Two participants discontinued medication due to clinical worsening, one of whom was briefly hospitalized. Three additional participants were withdrawn from treatment due to lab test abnormalities.

Tolerability
Only 3 of 9 participants completed the full course of treatment (2 in Group A and 1 in Group B). Lower doses were better tolerated than the highest dose.

Clinical response
Of 9 participants, clinically meaningful improvement was noted in fatigue for 6 and in quality of life for 4. Among the 6 fatigue responders, improvement was also noted on an index of multiple domain symptom index (6 of 6), overall symptom burden (5 of 6), and functional impairment (4 of 6). The study was terminated early due to end of project funding, higher than expected adverse events, and recognition that sufficient information was gathered to inform future studies.

Conclusions and Relevance
This study reveals the risks associated with disulfiram, especially at higher doses, while suggesting potential clinical benefits among some participants. Efficacy could not be assessed given the small sample size and the lack of a placebo-control group..

In herinnering:. Disulfiram is niet dé oplossing gebleken voor de (chronische) Lyme patiënten. Zie de resultaten van de pilot-studie; Bron https://clinicaltrials.gov/study/NCT03891667 en; Bron viewtopic.php?f=5&t=2595&start=410#p30195

Disulfiram (indicaties: als hulpmiddel bij de psychosociale begeleiding van alcoholisme, ter ondersteuning van het stoppen met drinken van alcohol) - Farmacotherapeutisch Kompas; Bron https://www.farmacotherapeutischkompas. ... disulfiram

:arrow: De resultaten van de pilot-studie (voorlopige studie ter verkenning) met 24 personen.
Initial Study - 'Disulfiram: A Test of Symptom Reduction Among Patients With Previously Treated Lyme Disease' by Brian A Fallon; Bron https://clinicaltrials.gov/ct2/show/NCT03891667
..The investigators propose therefore a small 14-week randomized placebo-controlled pilot study enrolling 24 patients with persistent symptoms despite prior antibiotic treatment for Lyme disease (known as Post-treatment Lyme Disease Syndrome). Among the 24 disulfiram-treated patients, half will get 8 weeks of disulfiram and the other half will get a shorter duration of disulfiram for 4 weeks followed by 4 weeks of matching placebo. After week 8, patients will be off pills for 2 weeks for the primary week 10 evaluation and then for another 4 weeks for the week 14 follow-up evaluation. This will be a double-blinded study; neither physician nor patient will know which treatment group the patient is assigned to.

With this initial study, the investigators will be able to evaluate the side effects, tolerability and initial signs of the effectiveness of disulfiram in reducing symptoms among the 24 patients assessed. The results of this study will guide the investigators regarding whether a larger definitive randomized trial should be conducted and which treatment schedule is optimal..
De studie is uiteindelijk gedaan met 11 personen.
De resultaten zijn gepubliceerd op 5 juni 2023; Bron https://classic.clinicaltrials.gov/ct2/ ... CT03891667


:arrow: Brochure Lymevereniging - ICLB & Patiëntensymposium 2022; Bron https://lymevereniging.nl/wp-content/up ... 221115.pdf
..5. Brian Fallon (Columbia universiteit): Wanneer symptomen persisteren/ Symptomen na behandeling
..Maar: disulfiram-gerelateerde risico's kunnen ernstig zijn.
Fallon bespreekt veel voorkomende bijwerkingen: vergiftiging van de lever en ernstige bijwerkingen voor het perifere en centrale zenuwstelsel. Meestal zijn de bijwerkingen omkeerbaar na stoppen van de behandeling. Disulfiram kan ook nadelige interacties hebben met andere geneesmiddelen..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Wo 05 Mar 2025, 18:13

Vervolg

Het intensief promoten van Disulfiram bij de (chronische) Lyme patiënten en de :arrow: *Ilads artsen en de therapeuten; Bron https://lymeherstel.nl/besmetting-zelfs ... voor-lyme/ in Nederland gebeurt vanaf 2019; Bron viewtopic.php?f=5&t=2595&start=220#p29602
Lymevereniging Jaarverslag 2019; Bron https://lymevereniging.nl/plannen-en-verslagen/
..Congressen
Masterclass
Op 19 juni heeft Dr. Richard Horowitz op uitnodiging van de Lymevereniging in congrescentrum De Nieuwe Liefde in Amsterdam een masterclass gegeven voor :arrow: *zo’n tachtig zorgverleners. Met inzichten over nieuwe persister-protocollen, o.a. met Dapsone, over behandeling met antibiotica en aanvullende middelen, over co-infecties, over zijn 16-punten plan ontwikkeld naar aanleiding van zijn decennialange ervaring met complexe lymepatiënten, en als de grand finale case studies van patiënten die na langdurige ziekte en een lange zoektocht met een gecombineerde aanpak toch opknapten. De boodschap van Dr. Horowitz voor patiënten: er is hoop!

Patiëntenmiddag ‘This Is Why’
Op 20 juni is in De Flint in Amersfoort ‘This is Why’ gehouden, een informatief en inspirerend evenement over chronische lyme en andere tekenbeetinfecties voor *ongeveer honderdvijftig patiënten, partners, ouders en andere naasten. Hierbij werden o.a. de wereldwijd bekende arts dr. Richard Horowitz, singer/songwriter Jesse Ruben en meerdere chronisch lymepatiënten geïnterviewd. Ook dit evenement is gelivestreamd vanaf onze Facebook-pagina..
..*Therapeut:.Dr. Horowitz was erg enthousiast over een nieuw medicijn genaamd Disulfiram. Dit wordt met name gebruikt voor alcoholisten die van hun verslaving af willen komen.
Het lijkt erop dat dit medicijn goed ingezet zou kunnen worden voor mensen die last blijven houden van terugvallen. Hij gaf als voorbeeld zijn vrouw die al jaren kampt met chronische lyme. Ze ging dan vaak weer een paar maanden goed, waarna toch altijd weer een terugval volgde. Er is net een onderzoek hierover afgerond, ook al betreft het een heel klein onderzoek, Dr Horowitz was enorm enthousiast..

Disulfiram is (wereldwijd) gepromoot door de oud-voorzitter van de Lymevereniging bij de (chronische) Lyme patiënten.
Forbes
26 februari 2020
Tipping Point: The Resistance Is Gaining In The Lyme Wars; Bron https://www.forbes.com/sites/marybethpf ... 352ee45d5a
Fred Verdult, a longtime activist who was knighted for his work in The Netherlands, exemplifies the problem and progress. He takes one pill daily for HIV infection and has never been ill from AIDS. He has been disabled by, and treated with dozens of pills daily, for Lyme disease. “The contrast with Lyme couldn’t be greater,” he wrote in answer to my survey.

He nonetheless sees a corner turning, in particular in *the use of repurposed drugs (Disulfiram); Bron https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6627205/ that are helping patients like him. “It will take years,” he told me. “But the final result is very clear: In 2030, Lyme and other tick-borne diseases will be considered as normal diseases.”
Er werd verwezen naar een *Case-study een kleine studie met slechts 3 patiënten als bewijs?..

En zijn er intussen al Nederlandse patiënten blijvend verbeterd of genezen van (chronische) Lyme én Bartonella) met de kostbare en experimentele Disulfiram en DDDCT (double dose dapsone combination therapy) en HDDCT (short-term high dose pulsed dapsone combination therapy) en Quadruple Dapsone Treatment (4x Dapsone) behandelingen bij de artsen en de therapeuten in Nederland of in het buitenland?; Bron viewtopic.php?f=5&t=2595&start=270#p29801 en Mold (Schimmelvergiftiging) behandeling?; Bron viewtopic.php?f=5&t=2595&start=340#p30018

Belangenverstrengeling (?!).. de bevriende en behandelende arts; Bron https://www.flickr.com/photos/182216562 ... 9914854271 en Bron https://www.flickr.com/photos/182216562 ... 029468162/

Er wordt steeds weer hoop verkocht; Bron https://nl-nl.facebook.com/lymeverenigi ... 2200404636 en Bron https://nl-nl.facebook.com/lymeverenigi ... 8409168871 en Bron https://nl-nl.facebook.com/lymeverenigi ... 9736792808 aan de Lyme community (wereldwijd).

Intussen is duidelijk dat de door de Lymevereniging, Stichting Lymefonds/het Lymefonds en Stichting Tekenbeetziekten aangehangen; Bron viewtopic.php?f=5&t=2595&start=190#p29443 en Bron viewtopic.php?f=5&t=2595&start=230#p29628 verschillende zogenoemde :arrow: 'Lyme-helden' Ilads Lyme artsen in Nederland en in het buitenland. En de aangehangen commerciële laboratoria en zogenoemde :arrow: 'Nederlandse vrienden van Tezted (Finland)' (Testimonials from our friend associations and patients' mei 2023; Bron https://www.tezted.com/lymeawarenessmonth en leden en vertegenwoordiger(s) van de Nederlandse patiëntenorganisaties; Bron viewtopic.php?f=5&t=2595&start=160#p29290) in het buitenland de laatste tijd meer en meer :arrow: door het ijs zijn gaan zakken!!!; Bron viewtopic.php?f=5&t=2595&start=220#p29589 en Bron viewtopic.php?f=5&t=2595&start=220#p29590
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Di 25 Mar 2025, 14:18

Vervolg op; Bron viewtopic.php?f=5&t=2322&start=1120#p30383 en vervolg op; Bron viewtopic.php?f=5&t=2322&start=1120#p30394 en vervolg op; Bron viewtopic.php?f=5&t=2322&start=1120#p30386

27 maart 2025: Health-RI - Biobanks & Collecties Dag 2025 - Locatie: Experience Center- Radboudumc, Nijmegen; Bron https://www.health-ri.nl/over-ons/organ ... ollections en; Bron https://www.aanmelder.nl/biobankenencol ... g2025/home
..Over het evenement
Health-RI nodigt je uit voor de tweede editie van de Nationale Biobanken & Collecties Dag op donderdag 27 maart 2025 in Nijmegen. Deze dag zal weer in het teken staan van kennisdeling, netwerken en samenwerking binnen de nationale Biobanken & Collecties-gemeenschap. Het evenement richt zich op een breed scala aan professionals, waaronder onderzoekers, analisten, datamanagers, IT-specialisten, patiënten en patiëntvertegenwoordigers die betrokken zijn bij biobanken, collecties en gezondheidsregistraties. Tijdens deze dag zullen we ons verdiepen in initiatieven en ervaringen delen t.a.v., biomateriaal-protocollen en -kwaliteit, ELSI-standaarden en -procedures, en (meta)data FAIRificatie. Verdere details van het programma en de mogelijkheid om te registreren zullen de komende maanden gedeeld worden. Hopelijk mogen we je verwelkomen op 27 maart!..
Programma & Sprekers; Bron https://www.aanmelder.nl/biobankenencol ... g2025/home en; Bron https://www.aanmelder.nl/biobankenencol ... /contact-2
..Stichting Lymefonds/het Lymefonds
27 maart 2025 | 15:55 - 16:35 CET
Burgerinitiatieven - Presentaties
Nothing About Us Without Us: Patient registry from HIV to PAIS, Fred Verdult, Lymefonds..
..'Is Stichting Lymefonds/het Lymefonds als patiënt(en) of patiëntvertegenwoordiger(s) betrokken bij biobanken en bij collecties en gezondheidsregistraties'..?


Een landelijke patiëntenregistratie voor de ziekte van Lyme is er in Nederland (nog) niet. Er is (nog) geen meldingsplicht; Bron https://www.rivm.nl/meldingsplicht-infe ... gsplichtig en; Bron https://www.rivm.nl/meldingsplicht-infectieziekten voor de ziekte van Lyme in Nederland.

Radboudumc - Zorgpad lymeziekte onderzoeken en behandelingen; Bron https://www.radboudumc.nl/patientenzorg ... lymeziekte en NLe Biobank; Bron https://www.expertisecentrumlyme.nl/onderzoek/biobank
..Nederlands Lymeziekte-expertisecentrum (NLe) Biobank
De afdelingen Infectieziekten van het Radboudumc en het AmsterdamUMC (locatie AMC) hebben samen de NLe Biobank opgezet. Met deze biobank willen we wetenschappelijk onderzoek doen naar Lymeziekte om de diagnostiek, behandeling en prognose van patiënten in de toekomst te verbeteren.

Wat is de NLe Biobank?
De NLe Biobank bevat lichaamsmateriaal (urine en bloed) en gegevens uit het medisch dossier (alles anoniem) o.a. over tekenbeten, lichamelijk klachten, antibioticumgebruik van deelnemende patiënten. Dit lichaamsmateriaal gebruiken we voor wetenschappelijk onderzoek. Het gaat bij de NLe Biobank niet om één onderzoek, maar om meerdere toekomstige onderzoeken naar Lymeziekte; zoals nieuwe diagnostische testen, nieuwe behandeling en meer inzicht in hoe de ziekte bij borrelia infectie werkt..

Patiëntenregistratie Lymeziekte - Amsterdam UMC en Radboudumc; Bron https://www.amsterdamumc.nl/nl/verwijze ... entrum.htm en Bron https://www.amsterdamumc.nl/nl/lyme/over.htm
..Onderzoek
Sinds 2021 vragen wij alle poliklinische patiënten met een verdenking op lymeziekte die het spreekuur bezoeken van de infectieziekten of ze mee willen doen aan de nationale lymeziekte biobank en patiëntenregistratie. Dit is een initiatief van het Nederlands lymeziekte-expertisecentrum; Bron https://www.expertisecentrumlyme.nl/ ..

..Tevens vragen we sinds 2021 aan elke patient die de Lymepoli’s van Amsterdam UMC en het Radboudumc of ze willen deelnemen aan de gezamenlijke biobank en patiëntenregistratie..

Lymevereniging - Veelgestelde vragen over het Nederlands Lymeziekte-expertisecentrum (NLE) juni 2017; Bron https://lymevereniging.nl/vragen-en-ant ... df01c-ef1f en Biobank; Bron https://lymevereniging.nl/dossiers/lyme ... secentrum/
..Wat betekent het Lymeziekte-expertisecentrum voor de huidige, zieke lymepatiënt?
Het expertisecentrum bundelt kennis, kunde en ervaringen. Tevens gaat het onderzoeken en projecten uitvoeren. Mede door de duidelijke patiëntenparticipatie in het centrum staat het belang en de stem van de patiënt centraal. De projecten op het gebied van scholing en afstemming van zorg hebben effect op kortere termijn. Er zijn veel mensen met een verdenking op Lymeziekte, door de ingezette acties, verwachten we een snellere en verbeterde diagnosestelling en daarmee juiste behandeling. Voor een deel is er ook een langere termijn resultaat: zoals het opzetten van een Biobank, patiëntenregistratie en de validatie van testen..


In herinnering.. 3 juni 2024: Stichting Lymefond/het Lymefonds - PAIS bijeenkomst en Nieuwspoort; Bron https://www.nieuwspoort.nl/programma/pa ... -den-haag/
..De bijeenkomst wordt gepresenteerd door Lymefonds-directeur Fred Verdult samen met Tweede-Kamerlid Julian Bushoff.
Wat bespreken we?
- Tegen welke problemen lopen mensen met PAIS aan?
- Welke concrete oplossingen kan de politiek bieden?
- Wat kan patiëntenregistratie betekenen?..
..1 oktober 2024: Patiëntenalliantie PAIS; Bron https://www.lymefonds.nl/samenwerkingsv ... ndoeningen ..Voor de PAIS Alliantie heeft Lymefonds-directeur Fred Verdult een plan van aanpak opgesteld en afgestemd voor een haalbaarheidsonderzoek om te komen tot een patiëntenregistratie. Een registratie niet alleen van mensen met chronische lyme, maar voor mensen met alle post-acute infectieziekten. Er zijn veel uitdagingen om te komen tot zo’n patiëntenregistratie. Zo’n haalbaarheidsonderzoek is er juist om alle uitdagingen onder ogen te zien én de toegevoegde waarde van zo’n patiëntenregistratie in kaart te brengen..
En vervolg op; Bron viewtopic.php?f=5&t=2322&start=1130#p30434 en vervolg op; Bron viewtopic.php?f=5&t=2322&start=1130#p30435 en vervolg op; Bron viewtopic.php?f=5&t=2322&start=1130#p30437

:arrow: Patiëntenregistratie voor post-acute infectieziekten (PAIS)?..
Is het gestelde juist? Dat zal voor bijvoorbeeld Lyme lastig zijn omdat een grote groep van de achterban van de Lymevereniging en Stichting Lymefonds/het Lymefonds; Bron viewtopic.php?f=5&t=2595&start=440#p30370 zijn en worden getest met de LTT-EliSpot/iSpot Lyme test en de LTT-MELISA test die na validatie onbetrouwbaar zijn gebleken en of met de andere experimentele en niet-gevalideerde testen ( :arrow: als de Phelix Phage Borrelia test, de Nederlandse Fish test, de TickPlex testen; Bron viewtopic.php?f=38&t=2751#p30574) van de commerciële laboratoria in Nederland of in het buitenland waar géén diagnoses (chronische) Lyme of (chronische) neuroborreliose en of coinfecties mee kunnen worden gesteld!; Bron viewtopic.php?f=5&t=2595&start=290#p29876

31 mei 2024: Lymevereniging - Heb je tips voor het vinden van lyme-vriendelijke artsen of zorgverleners?; Bron https://www.facebook.com/lymevereniging/?locale=nl_NL
..Heb je tips voor het vinden van lyme-vriendelijke artsen of zorgverleners?
Deel je ervaringen en aanbevelingen met de community en wie weet help je zo een medepatiënt op de goede weg!..
..Reacties:..Ilads artsen, Balans Arnhem, Ducclinic Arnhem..
Hiermee worden medepatiënten niet op de goede weg geholpen! De werkwijze (diagnosestelling en behandelingen) van de Ilads artsen en de therapeuten zijn bovendien niet geschikt om mee te kunnen doen aan patiëntenregistratie of een landelijke patiënten-registratie.
:arrow: Waarom niet?: 1). Er wordt getest door de Ilads artsen met de kostbare LTT-EliSpot/iSpot Lyme test en de LTT-MELISA test die :arrow: *na validatie onbetrouwbaar zijn gebleken :arrow: en of met de andere kostbare en experimentele en niet-gevalideerde testen (als de Phelix Phage Borrelia test, de Nederlandse Fish test, de TickPlex testen; Bron viewtopic.php?f=38&t=2751#p30574) van de commerciële laboratoria in Nederland of in het buitenland waar géén diagnoses (chronische) Lyme of (chronische) neuroborreliose en of coinfecties mee kunnen worden gesteld!; Bron viewtopic.php?f=5&t=2595&start=290#p29876
2). Er wordt door :arrow: de therapeuten getest met holistische/alternatieve testen waarmee géén diagnoses kunnen worden gesteld!
3). Er wordt door de Ilads artsen en de therapeuten gewerkt met kostbare en experimentele en langdurige behandelingen en of met kostbare holistische/alternatieve en langdurige behandelingen die medisch én wetenschappelijk absoluut niet zijn onderbouwd!

:arrow: De gevolgen voor de (geteste en te testen) patiënten zijn: een onjuiste testuitslag, een gemiste diagnose, een verkeerd gestelde diagnose, een verkeerde voorgeschreven behandeling, veroorzaakte (blijvende) schade aan de gezondheid.
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Do 27 Mar 2025, 15:54

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31031 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31033
..Slides van 14 februari 2025: The Academy of Nutritional Medicine (AONM) (Engeland)/ArminLabs(Duitsland) - How ISO 13485:2016 and ISO 15189 are Revolutionising Lyme Disease Testing - Acceptance of Foreign Test Results; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf

..'That means NATA should have accepted and allowed these accredited overseas labs performing approved test kits'..?

:arrow: Slide 19; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf ..'Human Rights Implications - Denying recognition of validated foreign tests can lead to delayed diagnoses and treatment, potentially infringing on the right to health'..?.
..'Recognizing these tests ensures equitable access to high-quality diagnostics, regardless of geographical origin, aligning with the country’s commitment to upholding human rights and health equity'..?


:arrow: Slide 20; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf ..'No laboratory or clinician should question the validity of Lyme disease diagnostics if the laboratory adheres to ISO 15189 and the IVD is manufactured under ISO 13485:2016 standards'..?..

:arrow: Is het door Tezted (Finand) fabrikant! gestelde in de presentatie(s) en in het :arrow: Preprint Article 'Assessing Interlaboratory Performance and Concordance of Tick-Borne Disease Testing Using Multiplex Enzyme-Linked Immunosorbent Assay' juist?

26 maart 2025: Parliament of Australia - Final Report of the The Community Affairs References Committee; Bron https://www.aph.gov.au/Parliamentary_Bu ... ses/Report
Chapter 2 - Research and guidelines; Bron https://www.aph.gov.au/Parliamentary_Bu ... guidelines
..Access to diagnosis and treatment for people in Australia with tick-borne diseases
..Diagnostic testing
2.23 As noted above, the Clinical Pathway states that a diagnosis of overseas-acquired Lyme Disease requires testing through a NATA/RCPA laboratory. Further, such testing ‘should only be initiated following advice from appropriate experts such as a consultant physician practising in his or her speciality of infectious diseases or a specialist microbiologist…’[23]

2.24 It states that it is ‘essential to use :arrow: NATA/RCPA-accredited, internationally recognised laboratories for diagnostic testing’ because such accreditation provides a means of ‘determining, formally recognising and promoting that an organisation is competent’. It notes that NATA/RCPA accredited laboratories can detect tick-borne illnesses.[24]

2.25 In Australian diagnostic laboratories, the current standard protocol for diagnosing Lyme Disease is a two-tier serology system. The first stage involves screening with an enzyme-linked immunosorbent assay (ELISA), and if positive, then an immunoblot assay (Western blot).[25]

2.26 The Clinical Pathway notes that a review conducted by the National (Serology) Reference Laboratory (NRL) of serological assays to diagnose Lyme Disease ‘determined the tests used by accredited laboratories to diagnose Lyme disease had equivalent reliability to tests used in overseas laboratories’. This therefore means that:

Australian NATA/RCPA accredited laboratories are able to confidently diagnose classical Lyme disease acquired in patients who have travelled to endemic areas and have contracted the infection more than four weeks prior to testing, noting that most patients seroconvert within four to eight weeks of infection.[26]

2.27 The Clinical Pathway notes that ‘some people believe that they have acquired Lyme disease in Australia because the results of screening antibody tests to B. burgdorferi are positive’. It states however that ‘these positives are all likely to be false positive test results’.[27]

2.28 The Clinical Pathway recommends the avoidance of a number of alternative methods of diagnostic testing including:
- capture assays for antigens in urine
- culture, immunofluorescence staining, or cell sorting of cell wall-deficient or cystic forms of B. burgdorferi
- lymphocyte transformation tests
- quantitative CD57 lymphocyte assays
- “Reverse Western blots”
- in-house criteria for interpretation of immunoblots
- measurements of antibodies in joint fluid (synovial fluid), and
- IgM or IgG tests without previous ELISA/EIA/IFA[28]..

ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- :arrow: NATA Australië (National Association of Testing Authorities); Bron https://nata.com.au/ is lid van ILAC MRA.

Informatie Australië - NSW Health; Bron https://www.health.nsw.gov.au/Infectiou ... dvice.aspx
.. - Diagnosis of Lyme disease is based on clinical presentation and history, and laboratory testing performed in an Australian accredited pathology laboratory..

..Diagnosis of lyme disease
Testing for Lyme disease should be performed by an Australian laboratory accredited by the :arrow: National Association of Testing Authorities, Australia (NATA). Testing performed by non-accredited laboratories (including overseas) may be unreliable..
The Royal College of Pathologists of Australia :arrow: (RCPA); Bron https://www.rcpa.edu.au/ en NSW Health; Bron https://www.health.nsw.gov.au/Infectiou ... sease.aspx
..The Royal College of Pathologists of Australia (RCPA) have advised caution in interpreting the results of tests for Lyme disease performed in non-NATA/RCPA accredited laboratories in Australia and overseas (mainly USA and Germany), as many of the tests performed by such laboratories have not been validated to diagnose Lyme disease..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Do 27 Mar 2025, 17:20

Vervolg

26 maart 2025: Parliament of Australia - Final Report of the The Community Affairs References Committee; Bron https://www.aph.gov.au/Parliamentary_Bu ... ses/Report
Chapter 5 - Committee view and recommendations; Bron https://www.aph.gov.au/Parliamentary_Bu ... mendations
..Recommendation 7
5.27 The committee recommends that the Australian Government urgently review diagnostic testing available internationally to determine the efficacy and suitability for use in Australia..

Chapter 3 - Diagnosis and treatment; Bron https://www.aph.gov.au/Parliamentary_Bu ... _treatment
..3.35 Many submitters who provided evidence told the committee that they sought and obtained diagnostic testing at international laboratories in countries such as Germany or the United States of America. Many of these submitters stated that these tests returned positive results for a range of pathogens.[34] Dr Leona Gilbert, Chief Executive Officer of Tezted a company based in Finland developing diagnostic tests for tick-borne illnesses, told the committee that in Australian patients tested overseas:

We are seeing Babesia, Bartonella, Ehrlichia, Rickettsia, coxsackievirus—these are the opportunist viruses that are not coming from the tick. They're opportunists because these individuals have a suppressed immune system. When they have a better immune system, they finally elicit an antibody response, as our colleagues have mentioned. So the ideal test kit should have these immune markers there to actually address immune fitness. Our test does that. So these individuals are suffering not only from tick borne pathogens but also from opportunist infections because they have been chronically ill.[35]

3.36 One of the reasons for seeking diagnostic testing overseas include the availability of tests not provided in Australia. For example, Dr Hugh Derham, Board Member, Australian Chronic Infectious and Inflammatory Disease Society (ACIIDS), told the committee that:

Most of my patients elect to get tested through Germany, with the lymphocyte transformation tests and IgA tests which are not available in Australia and provide good evidence of infection.[36]

3.39 Tezted also provided evidence regarding a study it undertook of Australian patients. The study, conducted collaboratively between research laboratories in Finland, Mexico, and Australia ‘assessed the efficacy of a novel diagnostic tool for identifying antibodies to pathogens linked to tick-borne diseases’. Tezted submitted:

Specifically, this novel diagnostic tool tested for immune responses from Australian patients, specifically against Borrelia burgdorferi sensu lato species in spirochete and persistent forms, co-infections, and opportunistic microbes associated with a tick bite. Specifically, the index test included antigens from Borrelia burgdorferi sensu stricto, Borrelia afzelii, Borrelia garinii in spirochete and persistent forms, Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, Rickettsia akari, Coxsackie virus, Epstein–Barr virus, Human Parvovirus B19, Mycoplasma fermentans, and Mycoplasma pneumoniae.[39]

3.40 Tezted highlighted that this study ‘identified immune responses to multiple pathogens in Australian patients, including microbes associated with Lyme disease and other tick-borne co-infections’. Further, the ‘findings suggest that Australian patients exhibit immune responses consistent with exposure to tick-borne microbes. This aligns with the increasing recognition of "Lyme-like" disease and underscores the need for improved diagnostic capabilities in this region’.[40]

3.42 Dr Leona Gilbert, Tezted, also gave evidence that patients are being ‘failed’ by current diagnostic tests in Australia. Dr Gilbert explained:

…the diagnostic test kits currently used at in-hospital and clinical laboratories are testing one microbe at a time or one species of that particular microbe at a time. We need to change that, and we need to test multiple microbes at a time and test multiple species. Eighty-five per cent of these chronic patients are suffering from multiple microbes. That needs to be put into this clinical pathway.[42]

3.46 It was noted that overseas laboratory results may not be ‘recognised’ by medical practitioners in Australia. However, Dr Gilbert, Tezted, told the committee that overseas tests and laboratories that follow international standards should be accepted and accredited in Australia.


3.37 ArminLabs, a laboratory based in Germany specialising in ‘advanced diagnostic testing for tick-borne infections’ told the committee:

A retrospective audit of our records at ArminLabs (2022–2024) showed that 117 Australian patients have sought comprehensive testing from us, including CE-IVD (Conformité Européenne – In Vitro Diagnostic) assays for immune responses to various infectious pathogens. We found:
- Up to 35% (35% IgM and 19% IgG) of these individuals had antibodies against Borrelia burgdorferi sensu lato.
- Up to 32% (32% IgM and 19% IgG) had antibody responses against persistent forms of Borrelia burgdorferi sensu lato.
These results indicate that a significant portion of Australians tested had measurable markers of Lyme disease or persistent forms of the infection…[47]


3.38 ArminLabs concluded thatpatients seeking testing from international labs…indicate the gaps in local diagnostic and treatment options’. It recommended:

Strengthening and broadening the frameworks within Australia will reduce the need for international referrals, helping more Australians receive the care they need—sooner and closer to home..[38]

Conclusie: opmerkelijk.. ook de Australische Ilads/AVIG werkende Lyme artsen en de holistisch werkende Lyme natuurartsen zijn niet goed geïnformeerd en worden inclusief de Australische patiënten misleid!

Ter verificatie:
.. :arrow: Slide 17; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf ..'Case Study ArminLabs: ISO15189 is equivalent and UKAS will provide letter to attest'..?

Is het gestelde juist? Bij Academy of Nutritional Medicine (AONM) (Engeland)/ArminLabs(Duitsland) staat over accreditatie genoemd; Bron https://aonm.org/accreditation/
..With regards to accreditation in the UK, ArminLabs has received a letter from UKAS (UK Accreditation Service) confirming that it has “confidence in the accreditation system operated by Deutsche Akkreditierungsstelle GmbH (DAkkS), and considers that the accreditation system operated by DAkkS is equivalent to UKAS’ own accreditation system.” Whilst it is not within UKAS’s mandate to provide specific accreditation to foreign laboratories it clearly has confidence in the German accreditation procedures (DAkkS) and ArminLabs is fully accredited by DAkkS..
De verstrekte informatie kan verwarring geven en misleidend zijn!
In de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle) staan namelijk de Borrelia testen genoemd; Bron https://www.dakks.de/en/accredited-body ... 2296-01-00
..Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: ELISA
Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: Line blot
Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: Microarray..
Wie goed oplet en de informatie nog eens goed naleest valt op dat de cellulaire test voor Borrelia de EliSpot/iSpot Lyme test die na validatie onbetrouwbaar is gebleken niet in de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle) staat.

En ook de niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test; en de niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test; en de niet-gevalideerde ToxiPlex test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test staan niet in de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle).
Meest recente informatie (2025) bij DAkkS; Bron https://www.dakks.de/en/search-result.html en Bron; https://www.dakks.de/en/accredited-body ... 2296-01-00

Tezted (Finland) is een commercieel laboratorium en heeft :arrow: géén ISO 15189 accreditatie van het FINAS Finland (Finnish Accreditation Service); Bron https://www.finas.fi/sites/en/Pages/default.aspx

ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- FINAS Finland (Finnish Accreditation Service) is lid van ILAC MRA.
- UKAS Engeland (United Kingdom Accreditation Service) is lid van ILAC MRA.
- DAkkS Duitsland (Deutsche Akkreditierungsstelle) is lid van ILAC MRA.
- RvA Nederland (Raad voor Accreditatie) is id van ILAC MRA.

:arrow: Slide 17; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf
..Case Study ArminLabs
- use validated tests (validation should include published evidence on the test methodology, its relation to Lyme disease and independent reports of performance) and
* CE and IVD marked diagnostic kits that follow national and EU regulation for selling must have QMS (ISO13485 equivalent) as mandated by Medicines and Healthcare products Regulatory Agency (MHRA).
* :arrow: RUO does not qualify with this mandate..
Tezted (Finland) en ArminLabs (Duitsland) spreken zichzelf tegen?..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Vr 28 Mar 2025, 17:59

Vervolg

Disease Association of Australia (LDAA): :arrow: Senate Inquiry - What happens next? The Community Affairs References Committee will provide a Final Report by 26 March 2025; Bron https://www.facebook.com/@LymeDiseaseAustralia/

26 maart 2025: Parliament of Australia - Final Report of the The Community Affairs References Committee; Bron https://www.aph.gov.au/Parliamentary_Bu ... ses/Report
..Reactie LDAA:.We are hopeful that the report will be a powerful call for real and meaningful action by government. Every patient, every patient advocate has been consistent in reporting the inadequacy of the government response to the last inquiry. There is no doubt that the Senators have heard and understood and share our frustration. We are confident they’ll do their utmost on behalf of our community..
Conclusie & wake-up call: Veel mensen-patiënten zijn jarenlang(!) en worden tot op heden nog steeds misleid! Patiënten moeten beter leren om zich zélf ook goed in de materie te leren verdiepen en hetgeen dat wordt gepromoot & geadviseerd door anderen (patiëntenorganisaties, patiënten, 'activistische Lyme organisaties&groepen', Ilads Lyme&me/cvs artsen, AVIG Lyme artsen, natuurartsen, therapeuten en behandelaars in privé-klinieken) goed te verifiëren en daarmee het risico te vermijden om ergens (onwetend, in goed vertrouwen, naïef, 'blind') achter aan te gaan lopen of achter zogenoemde op een voetstuk geplaatste 'Lyme-helden' aan te gaan lopen.

Te verwachten is dat de Australische minister VWS met dezelfde uitkomst zal komen als de Schotse minister VWS.
In herinnering:. :arrow: De Schotse Petitie is afgerond en gesloten op 17 november 2021 en de ingebrachte gronden op 8 november 2021 over de niet-gevalideerde TickPlex test door Dr J.L en collega Dr J.C (Petitioner en trustee van Lyme Resource Centre (LRC)) zijn door de Schotse Citizen Participation and Public Petitions Committee en door de Schotse Minister VWS terecht afgewezen; Bron viewtopic.php?f=5&t=2322&start=980#p29056

Schotse VWS
30 oktober 2020 - Brief van Schotse VWS - PE1662/PP Minister for Health, Sport and Wellbeing submission of 30 October 2020; Bron https://www.parliament.scot/S5_PublicPe ... 662_PP.pdf
..SLDTRL is committed to investigating new testing methods and technologies and is constantly aiming to adapt and improve the service provided. However, as the NICE guidelines state, :arrow: tests should only be used if they have been sufficiently validated, and this validation should include peer-reviewed published evidence on the test methodology, its relation to Lyme disease and independent reports of performance. To their knowledge, there are no other tests available that fulfil these criteria..

Parliament of Australia - Final Report of the The Community Affairs References Committee - Chapter 2 - Research and guidelines; Bron https://www.aph.gov.au/Parliamentary_Bu ... es/Senate/
..Diagnostic testing
2.23 As noted above, the Clinical Pathway states that a diagnosis of overseas-acquired Lyme Disease requires testing through a NATA/RCPA laboratory. Further, such testing ‘should only be initiated following advice from appropriate experts such as a consultant physician practising in his or her speciality of infectious diseases or a specialist microbiologist…’[23]

2.24 It states that it is ‘essential to use :arrow: NATA/RCPA-accredited, internationally recognised laboratories for diagnostic testing’ because such accreditation provides a means of ‘determining, formally recognising and promoting that an organisation is competent’. It notes that NATA/RCPA accredited laboratories can detect tick-borne illnesses.[24]

2.25 In Australian diagnostic laboratories, the current standard protocol for diagnosing Lyme Disease is a two-tier serology system. The first stage involves screening with an enzyme-linked immunosorbent assay (ELISA), and if positive, then an immunoblot assay (Western blot).[25]

2.26 The Clinical Pathway notes that a review conducted by the National (Serology) Reference Laboratory (NRL) of serological assays to diagnose Lyme Disease ‘determined the tests used by accredited laboratories to diagnose Lyme disease had equivalent reliability to tests used in overseas laboratories’. This therefore means that:

Australian NATA/RCPA accredited laboratories are able to confidently diagnose classical Lyme disease acquired in patients who have travelled to endemic areas and have contracted the infection more than four weeks prior to testing, noting that most patients seroconvert within four to eight weeks of infection.[26]

2.27 The Clinical Pathway notes that ‘some people believe that they have acquired Lyme disease in Australia because the results of screening antibody tests to B. burgdorferi are positive’. It states however that ‘these positives are all likely to be false positive test results’.[27]

2.28 The Clinical Pathway recommends the avoidance of a number of alternative methods of diagnostic testing including:
- capture assays for antigens in urine
- culture, immunofluorescence staining, or cell sorting of cell wall-deficient or cystic forms of B. burgdorferi
- lymphocyte transformation tests
- quantitative CD57 lymphocyte assays
- “Reverse Western blots”
- in-house criteria for interpretation of immunoblots
- measurements of antibodies in joint fluid (synovial fluid), and
- IgM or IgG tests without previous ELISA/EIA/IFA[28]..

ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- :arrow: NATA Australië (National Association of Testing Authorities); Bron https://nata.com.au/ is lid van ILAC MRA.

Informatie Australië - NSW Health; Bron https://www.health.nsw.gov.au/Infectiou ... dvice.aspx
.. - Diagnosis of Lyme disease is based on clinical presentation and history, and laboratory testing performed in an Australian accredited pathology laboratory..

..Diagnosis of lyme disease
Testing for Lyme disease should be performed by an Australian laboratory accredited by the :arrow: National Association of Testing Authorities, Australia (NATA). Testing performed by non-accredited laboratories (including overseas) may be unreliable..
The Royal College of Pathologists of Australia :arrow: (RCPA); Bron https://www.rcpa.edu.au/ en NSW Health; Bron https://www.health.nsw.gov.au/Infectiou ... sease.aspx
..The Royal College of Pathologists of Australia (RCPA) have advised caution in interpreting the results of tests for Lyme disease performed in non-NATA/RCPA accredited laboratories in Australia and overseas (mainly USA and Germany), as many of the tests performed by such laboratories have not been validated to diagnose Lyme disease..

In herinnering:.
10 augustus 2021: Medium - Filmmaker Joonas Berghäll stumbles upon a hidden pandemic-Lyme Disease- in his documentary The Red Ring; Bron https://medium.com/@insikten/the-red-ri ... a1c5128ad9
..Finally Joonas found doctor number 83, Erkki Antila. The finish professor decides to test him for Lyme Disease with blood tests Joonas never had been offered before..
..“We have a clear positive for borrelia…”
“…The protezoan parasite Babesia. Positive for Bartonella henselae bacteria. Positive for Ehrlichia cheffeensis and Rickettsia.” The list of tickborne infections is long. But in Joonas eyes there is relief. “Borellia seldom come alone”. The doctor tells him..

..In spring 2017 his health rapidly declines. This time Professor Antila is unable to help him. Joonas isn’t the only one trying to get help in Finland and too many patients are before him. This may not come as a surprise as Jonas later finds out that one of the most prestigious infectious disease doctors in Finland refuses to look at his lab results because some of them were from Germany..

..A 24.000 dollar bank loan later and we are back to the start of the film, in Germany :arrow: at the clinic St Georg for Joonas hyperthermia treatment.
“This treatment is insane”. Jonas says to Satu over the phone after having read the terms and conditions for his treatment. He blows the candles from the 40-year old birthday and talks to Kajsa over the phone. She was there for him when his mother was very sick. And she is there for him now.
Jonas brutally awakes from the sedation from the hyperthermia, where his body reached over 41 degrees. A temperature that in combination with antibiotics kills the bacterium, according to the clinic’s chief doctor..

..Back home in Finland. Joonas is well again. Or so he thought until a new tick bite sends Joonas back into a journey through hell. Joonas takes a flight to the US, to get treatment from one of the most famous Lyme disease doctors in the world, Dr. Horowitsz..
..Schwarzbach is/was bestuurder bij de St George clinic in Duitsland; Bron https://www.klinik-st-georg.de/en/contact/legal-notice/ en Bron https://www.northdata.de/Medicum+Bad+Ai ... +HRB+27384
In herinnering:.
29 maart 2022: Yle (Yleisradio Oy of Rundradion Ab, afgekort als Yle, is een Finse publieke omroep); Bron https://yle.fi/aihe/a/20-10002473
Vertaald:..Ten slotte ontmoet Berghäll dokter Erkki Antila, die hem vertelt dat de symptomen worden veroorzaakt door secundaire infecties van chronische borreliose. Antila is een controversieel figuur in de Finse medische gemeenschap en
:arrow: Valvira heeft haar medische rechten beperkt
.

De diagnose is problematisch en er is geen bewijs voor de effectiviteit van de behandelingen die Berghäll voor tienduizenden euro’s in het buitenland kocht..

..Dit is geen wetenschappelijk document, maar het trieste, persoonlijke via dolorosa van één persoon, zegt specialist en onderzoeker in de klinische microbiologie, professor Olli Vapalahti van de Universiteit van Helsinki..

..In de documentaire worden ook diagnostiek gepresenteerd. Het document stelt dat de Borrelia-antilichaamtest, de ELISA-test, die veel wordt gebruikt in Finland, niet alomvattend genoeg zou zijn. In Duitsland wordt Berghäll aan verschillende tests onderworpen en blijkt dat hij positief is voor tal van virussen en bacteriën.

Het blijkt dat de in :arrow: Duitsland gebruikte test eigenlijk het in Finland ontwikkelde :arrow: Tickplex-testpakket is, dat niet alleen Borrelia identificeert, maar ook andere door teken overgedragen bacteriën, virussen en hun ondersoorten, evenals veelvoorkomende virussen die van persoon op persoon worden overgedragen.

De onderzoeksresultaten verkregen met de testmethode zijn echter :arrow: vanwege wetenschappelijke fraude uit wetenschappelijke publicaties verwijderd. De uitvinder van de test, Leona Gilbert, die ook in de documentaire werd geïnterviewd, werd ontslagen bij de Universiteit van Jyväskylä nadat de fraude aan het licht kwam.

- Het bijzondere aan de documentaire is dat deze zich richt op borreliose, maar uit de tests blijkt dat de patiënt tegelijkertijd een tiental andere infecties heeft, waarvan sommige nog minder met de symptomen van Berghäll te maken hebben dan met borreliose, zegt Vapalahti..
:arrow: Valvira National Supervisory Authority for Welfare and Health is: de nationale toezichthoudende autoriteit voor welzijn en gezondheid is een gecentraliseerd orgaan dat onder het ministerie van Sociale Zaken en Volksgezondheid in Finland valt; Bron https://valvira.fi/en/frontpage

Leer en lees meer en ter verificatie: over Tezted (Finland); Bron viewtopic.php?f=38&t=2751&p=30600#p30574 en Bron viewtopic.php?f=38&t=2751&p=30600#p30594 en over Research misconduct (fraude) en ontslagen; Bron viewtopic.php?f=38&t=2751&start=10#p30777 En over de IVD ('in-huis ontwikkelde test')/RUO Research Use Only testen van Tezted (Finland); Bron viewtopic.php?f=38&t=2751&p=30600#p30575

:arrow: Leer en lees meer informatie ter verificatie over ArminLabs (Duitsland); Bron viewtopic.php?f=38&t=2751#p30595 en over de na validatie onbetrouwbaar gebleken EliSpot/Lyme iSpot test (Autoimmun Diagnostika GmbH (AID)/GenID) en de niet-gevalideerde TickPlex testen/IVD ('in-huis ontwikkelde test')/RUO Research Use Only testen en de CD3/CD57 testen; Bron viewtopic.php?f=5&t=2595&start=400#p30176
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Di 01 Apr 2025, 18:48

Vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31031 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31033 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31087 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31088 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=570#p31090

Australian Lyme Disease Association (LDAA) - Senate Inquiry 2025: The Final Report --> Review; Bron https://lymedisease.org.au/senate-inqui ... al-report/
..The Australian Lyme Disease Association (LDAA) presents an analysis of the 2025 Senate Inquiry’s Final Report on access to diagnosis and treatment for tick-borne diseases in Australia. While the LDAA welcomes some of the recommendations, it also highlights significant shortcomings, particularly the lack of urgency, enforceability, and meaningful collaboration with experienced practitioners and patient representatives..

..Recommendation 7: Reviewing International Diagnostic Testing
The committee recommends that the Australian Government urgently review diagnostic testing available internationally to determine the efficacy and suitability for use in Australia.

This recommendation fails to recognise that Australian clinicians should already be accepting results from labs accredited under the ILAC MRA agreement – International Laboratory Accreditation Cooperation Mutual Recognition Arrangement.

Australian health authorities continue to reject these results, insisting on National Association of Testing Authorities, Australia (NATA) accreditation, despite ILAC MRA signatory labs meeting equivalent or superior international standards.

This recommendation risks further delay in diagnosis and treatment for patients in need.
However, given that this recommendation has been made, to drive meaningful change, it must result in:
- Expanded diagnostic criteria reflecting global best practices and the heterogeneous nature of tick-borne illnesses,
- Mandatory clinician training to improve test interpretation, treatment protocols, and awareness of co-infections, and
- Government-subsidised funding to ensure equitable patient access to accurate testing.

Without binding commitments to these measures, the review risks becoming a performative exercise rather than a catalyst for progress.

Criteria for Efficacy/Suitability: The committee should clarify these parameters transparently to avoid ambiguity and ensure accountability.

? Was there a similar recommendation in 2016’s Final Report?
Not exactly. The 2016 Senate Inquiry recommended the Department of Health collaborate with stakeholders after the National Serology Reference Laboratory (NSRL) review to discuss its implications for Lyme disease testing. The review was limited to Australian laboratories. This earlier recommendation lacked actionable steps to address systemic issues like test validation or clinician education, which remain unresolved..
De beoordeling door Australian Lyme Disease Association (LDAA) is onjuist en er is onvoldoende kennis over NATA en ILAC MRA en ILAC Mutual Recognition Arrangement. Tezted (Finland) fabrikant! en de samenwerkende partner ArminLabs (Duitsland) verkoper! worden 'blindelings' nagepraat.. en waarmee de (nieuwe) Lyme patiënten (wereldwijd) echter verkeerd worden geïnformeerd.

In herinnering:.
..Slides van 14 februari 2025: The Academy of Nutritional Medicine (AONM) (Engeland)/ArminLabs(Duitsland) - How ISO 13485:2016 and ISO 15189 are Revolutionising Lyme Disease Testing - Acceptance of Foreign Test Results; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf

..'That means NATA should have accepted and allowed these accredited overseas labs performing approved test kits'..?

:arrow: Slide 19; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf ..'Human Rights Implications - Denying recognition of validated foreign tests can lead to delayed diagnoses and treatment, potentially infringing on the right to health'..?.
..'Recognizing these tests ensures equitable access to high-quality diagnostics, regardless of geographical origin, aligning with the country’s commitment to upholding human rights and health equity'..?


:arrow: Slide 20; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf ..'No laboratory or clinician should question the validity of Lyme disease diagnostics if the laboratory adheres to ISO 15189 and the IVD is manufactured under ISO 13485:2016 standards'..?..

.... :arrow: Slide 17; Bron https://aonm.org/wp-content/uploads/202 ... esting.pdf ..'Case Study ArminLabs: ISO15189 is equivalent and UKAS will provide letter to attest'..?

Is het gestelde juist? Bij Academy of Nutritional Medicine (AONM) (Engeland)/ArminLabs(Duitsland) staat over accreditatie genoemd; Bron https://aonm.org/accreditation/
..With regards to accreditation in the UK, ArminLabs has received a letter from UKAS (UK Accreditation Service) confirming that it has “confidence in the accreditation system operated by Deutsche Akkreditierungsstelle GmbH (DAkkS), and considers that the accreditation system operated by DAkkS is equivalent to UKAS’ own accreditation system.” Whilst it is not within UKAS’s mandate to provide specific accreditation to foreign laboratories it clearly has confidence in the German accreditation procedures (DAkkS) and ArminLabs is fully accredited by DAkkS..
De verstrekte informatie kan verwarring geven en misleidend zijn!..

Ter verificatie:
ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- FINAS Finland (Finnish Accreditation Service) is lid van ILAC MRA maar Tezted - Finland heeft :arrow: géén ISO 15189 accreditatie van het FINAS Finland (Finnish Accreditation Service).
- DAkkS Duitsland (Deutsche Akkreditierungsstelle) is lid van ILAC MRA maar de cellulaire test voor Borrelia de EliSpot/iSpot Lyme test van ArminLabs - Duitsland staat niet in de lijst van DAkkS.

Tezted - Finland fabrikant! heeft énkel een ISO 13485 certificatie van Lloyds; Bron https://www.tezted.com/_files/ugd/68942 ... 116b89.pdf of van LRQA; Bron https://www.tezted.com/_files/ugd/68942 ... 215052.pdf
Tezted - Finland is een commercieel laboratorium en heeft :arrow: géén ISO 15189 accreditatie van het FINAS Finland (Finnish Accreditation Service); Bron https://www.finas.fi/sites/en/Pages/default.aspx

In de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle) staan namelijk de Borrelia testen genoemd; Bron https://www.dakks.de/en/accredited-body ... 2296-01-00
..Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: ELISA
Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: Line blot
Analyte (measuremet parameter): Borrelia IgG, IgM Testmaterial (matrix): Serum Test technique: Microarray..
Wie goed oplet en de informatie nog eens goed naleest valt op dat de cellulaire test voor Borrelia de EliSpot/iSpot Lyme test die na validatie onbetrouwbaar is gebleken niet in de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle) staat.
En ook de niet-gevalideerde TickPlex Basic test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test; en de niet-gevalideerde TickPlex Plus test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test; en de niet-gevalideerde ToxiPlex test/IVD ('in-huis ontwikkelde test')/RUO Research Use Only test staan niet in de lijst van DAkkS Duitsland (Deutsche Akkreditierungsstelle).
Meest recente informatie (2025) bij DAkkS; Bron https://www.dakks.de/en/search-result.html en Bron; https://www.dakks.de/en/accredited-body ... 2296-01-00


ILAC Mutual Recognition Arrangement (ILAC MRA); Bron https://ilac.org/ en de :arrow: geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- NATA Australië (National Association of Testing Authorities) is lid van ILAC MRA.
- DAkkS Duitsland (Deutsche Akkreditierungsstelle) is lid van ILAC MRA
- FINAS Finland (Finnish Accreditation Service) is lid van ILAC MRA.
- RvA Nederland (Raad voor Accreditatie) is lid van ILAC MRA.


:arrow: ArminLabs (Duitsland) en Tezted (Finland) noemen:..'Under the ILAC MRA, all accreditation organizations must comply with
:arrow: ISO/IEC 17011, relevant ILAC guidance, and other criteria, ensuring that accredited laboratories meet ISO 15189 or other pertinent standards. This global framework empowers labs around the world to provide accurate, reliable results that reinforce trust and confidence in medical testing'..?


Ter verificatie:
- ANAB Amerika (ANSI National Accreditation Board) is lid van ILAC MRA. ANSI - Overzicht van ISO/IEC 17011; Bron https://blog.ansi.org/anab/overview-of-iso-iec-17011/
..Conformiteitsbeoordelingsactiviteiten
Conformiteitsbeoordelingsinstanties voeren conformiteitsbeoordelingsactiviteiten uit. Conformiteitsbeoordelingsactiviteiten die doorgaans onder accreditatie vallen, omvatten testen, kalibratie, inspectie, biobanking, certificering van managementsystemen, personen, producten, processen en diensten, het leveren van bekwaamheidstests, productie van referentiematerialen en validatie en verificatie. Het zijn deze activiteiten die worden gedocumenteerd op een gedefinieerde scope van accreditatie op basis van de accreditatienorm en het accreditatieprogramma, zoals ISO/IEC 17025 voor laboratoria , ISO/IEC 17065 voor productcertificatie-instanties en ISO/IEC 17021-1 voor managementsysteemcertificatie-instanties..

Nieuws 12 juli 2019: Raad voor Accreditatie (RvA) - Accreditatie ringonderzoek-organisatoren nu ook mondiaal erkend; Bron https://www.rva.nl/nieuws/accreditatie- ... al-erkend/
..De RvA is één van de 13 Europese accreditatie-instanties die ondertekenaar is geworden van de ILAC-MRA voor de accreditatie van organisatoren van ringonderzoeken volgens ISO/IEC 17043. Hiermee wordt de gelijkwaardigheid van ringonderzoeken niet alleen op Europees niveau maar nu ook daarbuiten bevestigd..
Nieuws 17 mei 2023: Raad voor Accreditatie (RvA) - Herziening ISO/IEC 17043 gepubliceerd; Bron https://www.rva.nl/nieuws/herziening-is ... ubliceerd/
..Op 8 mei is de 2023-versie van ISO/IEC 17043 gepubliceerd. Deze norm gaat over de organisatie van zogeheten ‘Proficiency testings’; hier in Nederland meestal organisatoren van ringonderzoeken genoemd. Laboratoria gebruiken deze ringonderzoeken om aan te tonen dat hun resultaten gelijkwaardig zijn aan de resultaten van andere laboratoria. De International Laboratory Accreditation (ILAC) is overeengekomen dat er een overgangsperiode van drie jaar zal zijn. Aan het einde van deze periode moeten aanbieders die wereldwijd zijn geaccrediteerd volgens EN-ISO/IEC 17043:2010 zijn beoordeeld en geaccrediteerd volgens de EN-ISO/IEC-17043:2023. Dit houdt in dat alle bestaande accreditaties tegen de EN-ISO/IEC-17043:2010 versie vóór 8 mei 2026 omgezet moeten zijn naar de EN-ISO/IEC-17043:2023 versie..

:arrow: Tezted (Finland) noemt:.our recent study titled: Preprint Article: 'Assessing :arrow: Interlaboratory Performance and Concordance of Tick-Borne Disease Testing Using Multiplex Enzyme-Linked Immunosorbent Assay' by Kunal Garg, Fausto Villavicencio-Aguilar, Flora Solano-Rivera, Leona Gilbert; Bron https://www.preprints.org/manuscript/202412.0220/v1

Ter verificatie:
Is er sprake in de Publicatie van het Preprint Artcile van :arrow: Interlaboratorium-vergelijkingen volgens de ILAC Mutual Recognition Arrangement (ILAC MRA)?..
Informatie van Raad voor Accreditatie (RvA) - Nieuwe versie RvA-T030-NL Proficiency Testing, Externe kwaliteitsbeoordeling & Interlaboratoriumvergelijkingen; Bron https://www.rva.nl/nieuws/55191/
..Raad voor Accreditatie
..1 Inleiding
Dit document beschrijft het RvA-beleid ten aanzien van het gebruik van proficiency testing-activiteiten, externe kwaliteitsbeoordeling en interlaboratoriumvergelijkingen in het accreditatieproces van conformiteitsbeoordelingsinstellingen (hierna: instelling).
Het RvA-beleid is gebaseerd op ILAC P9 “ILAC Policy for Participation in Proficiency Testing Activities” en op EA-4/18 G “Guidance on the level and frequency of proficiency testing participation”.

In dit document wordt onder instelling verstaan:
- test- en kalibratie-laboratoria volgens de EN ISO/IEC 17025;
- medische laboratoria volgens de EN ISO 15189;
- biobanken volgens de EN ISO 20387;
- inspectie-instellingen volgens de EN ISO/IEC 17020, voor zover deze in het kader van haar inspecties (ook) analytische testen uitvoeren;
- producenten van referentiematerialen volgens de EN ISO 17034;
- aanbieders van proficiency testing volgens de EN ISO/IEC 17043:2023..
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~

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Roxy
Berichten: 8130
Lid geworden op: Wo 29 Okt 2014, 12:14

Re: 16th International Conference on Lyme Borreliosis and other Tick-borne diseases (ICLB) 4 t/m 7 September 2022 Amster

Berichtdoor Roxy » Vr 04 Apr 2025, 15:25

26 maart 2025: Parliament of Australia - Final Report of the The Community Affairs References Committee; Bron https://www.aph.gov.au/Parliamentary_Bu ... ses/Report

Vervolg en vervolg op; Bron viewtopic.php?f=5&t=2595&start=550#p30976
..29 januari 2025:. Testing failure
The tests required to properly diagnose patients are not available in Australia, but they are available overseas, the committee heard.

They are not approved in Australia, but they should be, said Dr Leona Gilbert, an adjunct professor in cellular molecular biology who is the CEO of Tezted Ltd, a company that’s developing diagnostic tests, as well as Lyme Disease Association of Australia Scientific Advisory Committee chair.

The TGA uses ISO accreditations 13485 as a standard for tests, and NATA has accredited international labs by signing an international recognition agreement regarding the ISO 15189 standard, she said.

That means NATA should have accepted and allowed these accredited overseas labs performing approved test kits,” said Dr Gilbert. “How we can do better is acknowledging these agreements; that actually there is good testing available. However, it’s not being employed in this country. There is Australian utility… and there are novel, innovative diagnostics like AI to be used on data from patients.”..

..“We’re failing the patients,” said Dr Gilbert.

“We have the tests – advanced serology tests – and they need to be used correctly, at the right time, with an understanding of what their limitations are. “Having false positive is an easy and very lazy way of disregarding test results,” she said..

Medical Republic
2 april 2025
Tick-borne diseases inquiry makes seven recommendations; Bron https://www.medicalrepublic.com.au/tick ... ons/115730
..Dr Leona Gilbert, an adjunct professor in cellular molecular biology, who is the CEO of Tezted Ltd – a company that’s developing diagnostic tests – as well as Lyme Disease Association of Australia scientific advisory committee chair, was a witness at the inquiry.

She told TMR the very limited evidence base for DSCATT was one of the reasons many of the witnesses “tore it apart”.

Dr Gilbert’s testimony to the inquiry was mainly related to the issue of tests that are available to people overseas, but not in Australia.

Recommendation 7 is for the government to “urgently review diagnostic testing available internationally to determine the efficacy and suitability for use in Australia”.

Dr Gilbert told TMR the recommendation was “limiting, but encouraging”.

“It’s limiting in the fact that they’re only doing a review of the suitability and efficacy in Australia, but there aren’t a lot of studies published on different diagnostic kits being used on Australian patients.”

There are only two such papers, said Dr Gilbert, but even so, “these two papers do demonstrate, even though there’s that not many patients being covered in those two papers, that these patients are chronically ill from tick borne diseases and multiple microbes.

“But if they do in the review in the sense of what’s internationally available, and correlate that with the ISO standards and the laws and the agreements that the Australian government adheres to, like the Ilac agreements; Bron https://ilac.org/ilac-mra-and-signatories/ then that would be great,” said Dr Gilbert.

The Australian government just needs to adopt them, because they agree to them. Why aren’t we doing that?”..
Is het gestelde juist? Lees en leer meer; Bron viewtopic.php?f=5&t=2595&start=570#p31101


En vervolg op; Bron viewtopic.php?f=5&t=2595&start=560#p31018

2 april 2025: Tezted (Finland) - Join Us for the 1st Annual Conference on Chronic Infection Pathologies! September 5-7, 2025 | Jyväskylä, Finland; Bron https://www.facebook.com/tickplex/ en Sprekers; Bron https://www.tezted.com/cip2025
..Exploring Cutting-Edge Science, Big Data, and Innovative Diagnostics in Chronic Infections
The 1st Annual Conference of Chronic Infection Pathologies: SHOW ME THE DATA!, hosted by CiPRESS, is a pioneering international event bringing together scientists, healthcare professionals, and patients in a unified effort to advance the understanding, prevention, and treatment of infectious chronic illnesses. Taking place from 5–7 September 2025 in Jyväskylä, Finland, this first-of-its-kind conference fosters collaboration, cutting-edge research, and practical clinical applications. Through keynote talks, research presentations, workshops, and networking opportunities, it bridges the gap between research, medical practice, and patient advocacy, creating a shared platform for innovation and progress in chronic infection pathology.

Why Attend?
This groundbreaking conference brings together leading scientists, clinicians, researchers, and patient advocates to explore the latest advancements in chronic infection pathologies, including tick-borne diseases, long COVID, and polymicrobial infections.

Key Themes & Highlights
Big Data & Patient Perspectives
- The role of citizen science and big data in shaping the future of tick-borne disease research.
- Patient-driven insights from Australia, UK, Ireland, and Canada.
- AI-powered analysis of chronic infection debates and diagnostics.

Chronic Pathology & Infection Mechanisms
- Understanding long COVID vs. long Lyme: Clinical similarities and differences.
- Borrelia and Bartonella co-infections: Emerging evidence and transmission insights.
- Persistent topical infections: New strategies for diagnosis, therapy, and prevention.

Innovative Diagnostics
- Machine learning models predicting clinical and nutritional features in chronic infections.
- Advancements in Lyme disease serological testing and diagnostic accuracy.
- Outcome prediction models from large-scale Lyme disease cohort studies.

Innovative Treatment Approaches
- Controversy in Lyme testing: Addressing challenges in biological tests.
- Post-COVID/post-vaccine syndromes: How to manage chronic symptoms.
- AI-assisted treatment assessment for vector-borne diseases.
- Integrative & polymicrobial treatment approaches for chronic tick-borne infections.

Exclusive Networking & Research Opportunities
- Breaking Science Pitches: Presentations on the latest research abstracts.
- Think Tank Session: Interactive discussions on key challenges in chronic infection pathologies.
- Poster sessions featuring emerging research and real-world applications.
- Evening networking events, including a boat to sauna experience and an exclusive event at Alvar Aalto.

Who Should Attend?
- Researchers & Scientists exploring chronic infections and innovative diagnostic tools.
- Clinicians & Healthcare Professionals treating tick-borne and persistent infections.
- Patient Advocates & Organizations driving research and policy changes.
- Industry Leaders & Innovators in medical diagnostics and AI-driven healthcare.
- Prizes for best poster and pitch
- Student/patient support. Inquire more at Leona.gilbert@tezted.com
Secure Your Spot Today!
Don't miss this opportunity to be part of a transformative conversation on chronic infections..
Is het gestelde juist? ..'it bridges the gap between research, medical practice, and patient advocacy, creating a shared platform for innovation and progress in chronic infection pathology'..?
..'Exploring Cutting-Edge Science, Big Data, and Innovative Diagnostics in Chronic Infections'..?
..'This groundbreaking conference brings together leading scientists, clinicians, researchers, and patient advocates to explore the latest advancements in chronic infection pathologies, including tick-borne diseases, long COVID, and polymicrobial infections'..?
..'Patient-driven insights from Australia, UK, Ireland, and Canada'..?
..'Advancements in Lyme disease serological testing and diagnostic accuracy'..?

Leer en lees meer en ter verificatie: over Tezted (Finland); Bron viewtopic.php?f=38&t=2751&p=30600#p30574 en Bron viewtopic.php?f=38&t=2751&p=30600#p30594 en over Research misconduct (fraude) en ontslagen; Bron viewtopic.php?f=38&t=2751&start=10#p30777 En over de IVD ('in-huis ontwikkelde test')/RUO Research Use Only testen van Tezted (Finland); Bron viewtopic.php?f=38&t=2751&p=30600#p30575

:arrow: Leer en lees meer informatie ter verificatie over ArminLabs (Duitsland); Bron viewtopic.php?f=38&t=2751#p30595 en over de na validatie onbetrouwbaar gebleken EliSpot/Lyme iSpot test (Autoimmun Diagnostika GmbH (AID)/GenID) en de niet-gevalideerde TickPlex testen/IVD ('in-huis ontwikkelde test')/RUO Research Use Only testen en de CD3/CD57 testen; Bron viewtopic.php?f=5&t=2595&start=400#p30176
~ I may not be there yet, but I'm closer than I was yesterday ~
~ There is nothing more beautiful than a rainbow but it takes both rain and sunshine to make a rainbow ~
~ So encourage each other and build each other up - Positive connections ~


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