Disease Association of Australia (LDAA):

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,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 tothis 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"
(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:..
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..


