Vervolg op; Bron
viewtopic.php?f=5&t=2595&start=540#p30827 en vervolg op '
Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?'; Bron
viewtopic.php?f=38&t=2751&start=10#p30838 21 november 2024: Stichting Tekenbeetziekten - Wetenschappelijke Adviescommissie (WAC); Bron
https://www.tekenbeetziekten.nl/over-on ... issie-wac/ ..Leona Gilbert (PhD) richtte een universitair spin-off bedrijf op om testen te ontwikkelen voor complexe ziekten, waaronder de ziekte van Lyme. Docent Cel- en Moleculaire Biologie. Ze heeft een doctoraat in biotechnologie en een lange ervaring in bio-innovatie en bio-business en ze heeft talrijke PhD-, MSc- en BSc-studenten begeleid. Ze heeft een passie voor nieuwe en spannende mogelijkheden voor samenwerking, synergie en goede wetenschap..
Salliant detail: Gilbert is
LDAA (Lyme Disease Association of
Australia) Scientific Advisory Committee member; Bron
viewtopic.php?f=5&t=2595&start=460#p30438 en men is kennelijk nogal blij met het artikel; Bron
https://www.facebook.com/@LymeDiseaseAustralia/ Helaas worden de patiëntenorganisatie én de patiënten in
Australië ook
misleid!! ..LDAA: I’m seeking confirmation but as far as I know, TICKPLEX testing is available via Armin Labs..
..LDAA: the government will resist as it hasn’t been peer reviewed. Also, the test hasn’t been yet approved by the TGA.
However, given that the ONLY evidence the government defends its position with is a LACK of evidence, this absolutely must make an impact!..
3 december 2024: Tezted (Finland) - Unveiling the Hidden Threat of Tick-Borne Diseases in
Australia; Bron Bron
https://www.facebook.com/tickplex/ ..Unveiling the Hidden Threat of Tick-Borne Diseases in Australia
Did you know that many Australians report debilitating symptoms after tick bites, yet diagnostic tools have left them without answers?
Our groundbreaking study using TICKPLEX®, an advanced diagnostic test, has revealed immune responses in Australian patients that challenge the existing narrative about tick-borne diseases in the region.
- High accuracy in detecting antibodies against multiple pathogens.
- A clear need for better diagnostics in Australia.
- Hope for patients struggling with undiagnosed or misdiagnosed conditions.
By uncovering the complexities of tick-borne infections in Australia, TICKPLEX® is not just transforming diagnostics but empowering patients and clinicians alike..
..Gilbert: The importance of this study is:
- Interesting to note that three journals rejected the manuscript because 'There's No Lyme in Australia'.
- Validation of the correlation of TICKPLEX results to an Australian NATA Lab
- Early evidence of Borrelia, Babesia, and Bartonella immune reactions in Australian patients; larger patient cohorts to follow..
..'Unveiling the Hidden Threat of Tick-Borne Diseases in Australia'..?..'Our groundbreaking study using TICKPLEX®, an advanced diagnostic test'..?..'By uncovering the complexities of tick-borne infections in Australia, TICKPLEX® is not just transforming diagnostics but empowering patients and clinicians alike'..?..'Early evidence of Borrelia, Babesia, and Bartonella immune reactions in Australian patients; larger patient cohorts to follow'..?Pre-prints.org
Publicatie 3 december 2024This version is not peer-reviewed (betekenis: niet door door vakgenoten gecontroleerd!)
Preprint Article:
'Assessing 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 ..Abstract
Tick bites acquired in the northern or southern hemispheres can transmit microbes that may cause illness. The most prevalent infection is Lyme Disease, with all proven cases to date having been acquired in the northern hemisphere. The existence of endemic Lyme disease (LD) in Australia has not been proven explicitly, and there is uncertainty concerning the cause of “Lyme-like” disease (LLD) in Australia. As many tick-borne infections (TBIs) are diagnosed by serology, validated assays for use in both the northern and southern hemispheres are required.
Using a multiplex enzyme-linked immunosorbent assay (TICKPLEX®), two independent laboratories tested a total of 53 well-characterized reference sera that consisted of 33 samples from northern hemisphere patients with confirmed tick-borne disease (TBD) and 20 randomly selected sera from Australian patients with suspected TBIs, presenting with or without LLD. Antibody responses to multiple microbial antigens from causative agents of TBDs were found. High concordance between laboratories was demonstrated on this small set of samples. The results obtained provide the basis for further evaluation of TICKPLEX® on a larger number of samples from Australian patients with suspected TBIs..
..
2. Materials and MethodsWithin
this study, two independent laboratories, Tezted Ltd. (FIN) and Royal North Shore Hospital, New South Wales Pathology [North Sydney, Australia (AUS)],
used the multiplex enzyme-linked immunosorbent assay
TICKPLEX® (
Garg et al., 2021) to evaluate the performance of the test in Australia for the first time
under Research Use Only (
RUO)
conditions using the ODI.
TICKPLEX® has been
validated by the manufacturer to determine TBD-specific antibody responses (IgG and IgM) in human sera or plasma with or without glycerol.
TICKPLEX® PLUS (hereon referred to as
TICKPLEX® or Index test or Index Assay) is a
CE-IVD registered product (European In-Vitro Diagnostic Devices Directive (98/79/EC) and legacy compliant 2017/746
IVDR) manufactured under ISO 13485:2016 accredited facility in Tezted Ltd, Jyväskylä, Finland. For this evaluation, we used the
TICKPLEX® PLUS FOR RESEARCH USE ONLY Instructions (Version 17). This Index Assay was chosen because it can simultaneously test for IgM and IgG antibodies to multiple microbes (Garg et al., 2021). If one were to replicate all the testing of what
TICKPLEX® can do,
30 tests would be needed instead of one. The Index Assay is an
indirect ELISA that measures the immunoglobulin M (IgM) and immunoglobulin G (IgG) responses in human serum samples
against Borrelia burgdorferi sensu lato species in spirochete and persistent forms,
coinfections, and
opportunistic microbes associated with a tick bite.
Specifically,
the index test includes 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..
..
4. Discussion..
These results provide the basis for further evaluation of TICKPLEX® on a larger number of samples from Australian patients with suspected tick-borne infections (TBIs)..
..Goede wetenschap? En is het gestelde juist?..Ter verificatie: informatie
Australië - Tick bites; Bron
https://www.healthdirect.gov.au/tick-bites en
SA Health;Bron
https://www.sahealth.sa.gov.au/wps/wcm/ ... prevention en
NSW Health; Bron
https://www.health.nsw.gov.au/Infectiou ... dvice.aspx..Lyme disease (Lyme borreliosis) is a multisystem tick-borne zoonosis caused by spirochaetes of the Borrelia burgdorferi genospecies complex. Ticks with Borrelia burgdorferi infection are found in temperate forested areas of northern Asia, Europe and North America.
- In Australia, Lyme disease has been detected in returned travellers who have acquired the infection while travelling overseas.
- Although clinical presentations of a Lyme illness, without a history of overseas travel are reported in Australia, the cause of such conditions has not been determined. While locally-acquired Lyme disease cannot be ruled out, there is currently little evidence that it is transmitted in Australia.
- Clinicians should keep an open mind about the possibility of locally-acquired Lyme disease. Constellations of chronic debilitating symptoms require specialist consultation.
- 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 National Association of Testing Authorities, Australia (NATA). Testing performed by non-accredited laboratories (including overseas) may be unreliable..
..Can ticks cause disease?
Tick bites from Australian ticks can sometimes cause illnesses such as:
- rickettsial diseases including Flinders Island spotted fever
- Queensland tick typhus
- Lyme disease-like conditions, known as Debilitating Symptom Complexes Attributed to Ticks (DSCATT)
Australian ticks are not known to carry borrelia burgdorferi, the bacteria that causes Lyme disease in other parts of the world.
What are the different types of tick bites?
There are over 70 different types of ticks in Australia. They are especially common along the east coast.
In eastern Australia, most tick bites are caused by the paralysis tick Ixodes holocyclus (also sometimes called a grass tick, seed tick or bush tick). Ticks can vary in size from the size of a pinhead to as large as a marble, depending on the stage in their life cycle..
Informatie -
Australian Paralysis Tick: scientific name
Ixodes holocyclus; Bron
https://australian.museum/learn/animals ... ysis-tick/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
Leer en lees meer informatie ter
verificatie 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..'Clinically proven: 1500 patiënts tested for 20 microbes from a tick bite Garg et al
2018, Garg et al
2021, Xi et al 2023'..?Het door Tezted (Finland)
fabrikant! genoemde
validation material; Bron
https://www.tezted.com/tickplex-validation kan niet dienen als
validatie en als
medisch én wetenschappelijk bewijs!
2018: Het gepubliceerde artikel -
**'Evaluating polymicrobial immune responses in patients suffering from tick-borne diseases' by Kunal Garg, Leena Meriläinen, Ole Franz, Heidi Pirttinen, Marco Quevedo-Diaz, Stephen Croucher & Leona Gilbert van
29 oktober 2018; Bron
https://www.nature.com/articles/s41598-018-34393-9 is zelfs
ingetrokken op
21 februari 2022.
..The Editors have retracted this Article.
The main method utilised in this study is an ELISA assay. An investigation by the University of Jyväskylä, Finland, has concluded that the patient selection and description in this Article, and in an unpublished report validating the methods used, do not justify the results presented. The Editors therefore no longer have confidence in the results and conclusions presented in this Article..
2021: MPDI
Tropical Medicine and Infectious Diseases
Publicatie 17 maart 2021**Article -
'Assessing the Need for Multiplex and Multifunctional Tick-Borne Disease Test in Routine Clinical Laboratory Samples from Lyme Disease and Febrile Patients with a History of a Tick Bite' by Kunal Garg, T. Sakari Jokiranta, Sanna Filén and Leona Gilbert; Bron
https://www.mdpi.com/2414-6366/6/1/38.. 2. Materials and Methods
2.1. Index Test and Interpretation
TICKPLEX® PLUS (herein, TICKPLEX®) is an ELISA index test used in this study that is a CE-IVD registered product (i.e., European In-Vitro Diagnostic Devices Directive (98/79/EC) compliant) manufactured in an ISO 13485:2016 accredited facility at Tezted Ltd, Jyväskylä, Finland..
.. 2.5. Index Test and Interpretation
TICKPLEX® PLUS (herein, TICKPLEX®) is an ELISA index test used in this study that is a CE-IVD registered product manufactured in an ISO 13485:2016 accredited facility at Tezted Ltd. TICKPLEX® can measure IgM and IgG immune responses in human serum samples against Borrelia burgdorferi sensu lato species in spirochete and persistent forms, coinfections, and opportunistic microbes. Mainly, TICKPLEX® includes Borrelia burgdorferi sensu stricto, Borrelia afzelii, and Borrelia garinii in spirochete and persistent form, Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, Rickettsia akari, Coxsackievirus, Epstein–Barr virus, Human parvovirus B19, Mycoplasma fermentans, and Mycoplasma pneumoniae[25]. The clinical relevance for all TICKPLEX® microbes in TBD patients has been previously demonstrated **[25]..
..'
The clinical relevance for all TICKPLEX® microbes in TBD patients has been previously demonstrated [25] '..? ![Pijl :arrow:](./images/smilies/icon_arrow.gif)
Het artikel -
**'Evaluating polymicrobial immune responses in patients suffering from tick-borne diseases' by Kunal Garg, Leena Meriläinen, Ole Franz, Heidi Pirttinen, Marco Quevedo-Diaz, Stephen Croucher & Leona Gilbert; Bron
https://www.nature.com/articles/s41598-018-34393-9 is immers
ingetrokken!
Een test kan pas betrouwbaar worden ingezet voor de medische diagnostiek als deze klinisch is gevalideerd.Er wordt niet voldaan aan de eisen van de wettelijke regels
IVDR (In Vitro Diagnostics Regulation). De IVDR is op
26 mei 2022 in werking getreden en vanaf dat moment moeten alle
fabrikanten van
IVD hulpmiddelen zich aan de nieuwe regels houden; Bron
https://www.diagnotix.com/nl/ivdr-validatie en Bron
https://www.rijksoverheid.nl/onderwerpe ... abrikanten ..Validatie onder de IVDR
Door de invoering van de IVDR en de MDR wordt het toezicht op de productie van medische hulpmiddelen aangescherpt. Fabrikanten moeten door middel van een uitgebreidere validatie, wetenschappelijke onderbouwing én studies naar de klinische prestaties van hun producten aantonen dat hun product werkzaam en veilig is.
In de IVDR wordt uitgebreid beschreven welke validatiestappen benodigd zijn voor een CE-certificering en toelating tot de markt binnen de EU..
..De prestatie-evaluatie dient te bestaan uit de volgende onderdelen (art 58 lid 3 IVDR):
1. Wetenschappelijke Validiteit
2. Analytische Prestaties
3. Klinische Prestaties..
Zijn er een uitgebreide
validatie,
wetenschappelijke onderbouwing én
studies naar de
klinische prestaties van de
niet-gevalideerde TickPlex/IVD (
'in-huis ontwikkelde test')/
RUO Research Use Only
testen beschikbaar waaruit blijkt dat de test werkzaam en veilig is? Nee!
Een belangrijke
stelling behorende bij het
proefschrift M.E. Baarsma: Lymeziekte | Ontwikkelingen in diagnostiek en klinische aspecten; Bron
https://dare.uva.nl/search?field1=keywo ... startDoc=2....4. Fabrikanten hebben een morele verplichting om diagnostische tests grondig en transparant te valideren, voordat ze deze aan de eindgebruiker aanbieden - dit proefschrift..
De
fabrikant! Tezted (Finland) (ontwikkelaar/
developer!) en ArminLabs (Duitsland) de
verkoper! voelen de morele verplichting die zij hebben naar de eindgebruiker toe (de zieke mensen, patiënten) niet?!