Eerste hulp bij een tekenbeet!: waar moeten (nieuwe) Lyme patiënten of andere zieke mensen goed op letten?

[Roxy]

Vervolg op; Bron viewtopic.php?f=38&t=2751&start=40#p31475

Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

26 juni 2025: Tezted (Finland) fabrikant! - Making Claims? Here’s What MDR & IVDR Expect of You!; Bron https://www.facebook.com/tickplex/

..Making Claims? Here’s What MDR & IVDR Expect of You!
If you're developing or marketing a medical device or IVD in the EU, your claims—whether on packaging, websites, or in sales brochures—are not just marketing. They're legally binding statements that must be backed by solid evidence.

According to Article 7 of MDR & IVDR:
"It is prohibited to use misleading claims related to the intended purpose, safety, or performance of the device."
So what can you say?
You can state:
- “Detects Borrelia-specific IgG with 96% sensitivity” — if supported by clinical performance studies
- “CE-marked under IVDR for use in diagnostic labs” — if certification is complete
- “For the detection of reactivated viral infections in immunocompromised patients” — if validated by performance evaluation

You cannot say:
- “100% accurate”
- “Safe with zero side effects”
- “Better than all other tests” — without head-to-head data

What You Must Have Internally:
- A complete Clinical Evaluation Report (MDR) or Performance Evaluation Report (IVDR)
- All claims mapped to evidence (scientific literature, clinical data, or validation studies)
- Alignment of claims across your label, IFU, website, and marketing materials

Bottom Line:
Every claim must be justifiable, consistent, and traceable—or you're non-compliant.
Learn more about how our team builds robust, regulation-ready claim portfolios for multiplex IVDs like #TICKPLEX..

..'Learn more about how our team builds robust, regulation-ready claim portfolios for multiplex IVDs like #TICKPLEX'..?

is het gestelde juist? Opmerkelijk.. daar voldoet Tezted (Finland) fabrikant! zelf niet aan!
Ter verificatie: Voor Europa geldt: de **IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) is op 26 mei 2022 in werking getreden en vanaf dat moment moeten alle fabrikanten van IVD hulpmiddelen zich aan de nieuwe regels houden; Bron https://www.diagnotix.com/nl/ivdr-validatie en Bron https://www.rijksoverheid.nl/onderwerpe ... lpmiddelen

..Validatie onder de IVDR
Door de invoering van de IVDR en de MDR wordt het toezicht op de productie van medische hulpmiddelen aangescherpt.
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..

Tezted (Finland) fabrikant! voldoet niet aan de eisen om door middel van een uitgebreidere validatie, wetenschappelijke onderbouwing én studies naar de klinische prestaties te kunnen aantonen dat hun producten werkzaam en veilig zijn !


Wat staat er in Artikel 7 van de de **IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices)?; Bron https://eur-lex.europa.eu/eli/reg/2017/745/oj

..Article 7
Claims
In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device does not have;
(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out..

Ter verificatie:
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 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 geregistreerde leden ILAC MRA Signatory Search; Bron https://ilac.org/signatory-search/
- FINAS Finland (Finnish Accreditation Service) is lid van ILAC MRA.

Leer en lees meer en ter verificatie: over Tezted (Finland) fabrikant!; 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 kostbare en niet-gevalideerde TickPlex testen/IVD ('in-huis ontwikkelde test')/RUO Research Use Only testen van Tezted (Finland) fabrikant!; Bron viewtopic.php?f=38&t=2751&p=30600#p30575

Leer en lees meer informatie ter verificatie over de samenwerkende Laboratorium partner; Bron https://www.tezted.com/partners ArminLabs (Duitsland) verkoper!
In herinnering.. Tezted (Finland) fabrikant! en ArminLabs (Duitsland) verkoper!: de jarenlange samenwerking; Bron viewtopic.php?f=5&t=2595&start=90#p28904 en; Bron viewtopic.php?f=5&t=2595&start=80#p28894 en; Bron viewtopic.php?f=5&t=2595&start=70#p28865

En over de samenwerkende collega Infectolab Americas (Verenigide Staten) verkoper!; 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

[Roxy]

Vervolg op: 'het (onterecht!!) aanprijzen en promoten van de Phelix Phage Borreliat test van Red Laboratories (België) vanaf 2018 door de Lymevereniging, Stichting Lymefonds/het Lymefonds en sommige mensen uit de achterban'; Bron viewtopic.php?f=38&t=2751&start=30#p31209 en Bron; viewtopic.php?f=38&t=2751&start=30#p31210

Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

Over de kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test van Red Laboratories (België).

De geschiedenis van het 'xmrv/mlv debacle' heeft zich duidelijk herhaald!; Bron viewtopic.php?f=37&t=2772&start=10#p30952 en Bron; viewtopic.php?f=38&t=2435&start=140#p27534
De kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test werd door Red Laboratories (België) in 2019 aangekondigd als: ..'A Breakthrough way to detect intracellular bacteria, and an answer to non-diagnosed chronic lyme patients'..
Er zijn en worden sindsdien opnieuw (wereldwijd) veel (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen misleid!!

Er is van het Patiëntsymposium lyme 2022; Bron viewtopic.php?f=5&t=2595#p28585 en van het Symposium voor wetenschappers en medici 2022; Bron viewtopic.php?f=5&t=2595#p28185 en van de Publicaties en de Proefschriften; Bron viewtopic.php?f=38&t=2751&start=30#p31210 duidelijk niets geleerd?!


Interessante nieuwe Publicatie! Validatie van de test!

Elsevier ScienceDirect
Ticks and Tick-borne Diseases
Volume 16, Issue 4, July 2025, 102488; Bron https://www.sciencedirect.com/journal/t ... 16/issue/4
Publicatie Juli 2025
Original article - 'The real-time PCR targeting the phage terminase (terL) is not suitable for diagnostics of human Borrelia infections in Europe' by Manja Zimmermann, Gabriele Margos, Christine Hartberger, Reto Lienhard, Anna J. Henningsson, Malin Lager, Mateusz Markowicz, Anna-Margarita Schötta, Andreas Sing, Benoit Jaulhac, Per-Eric Lindgren, Alje P. van Dam, Joppe W.R. Hovius, Volker Fingerle; Bron; https://www.sciencedirect.com/science/a ... 9X25000524 en Bron; https://pubmed.ncbi.nlm.nih.gov/40516432/

..Highlights
- Evaluation of a real-time PCR targeting the large subunit of phage terminase (terL).
- terL PCR does not work equally well on all Borrelia species.
- not all isolates of B. afzelii and B. garinii are being detected.
- serum samples of patients with Lyme borreliosis were all PCR negative.
- terL PCR does not improve diagnostics of Lyme borreliosis patients in Europe..

..Abstract
Bacteria of the Borrelia burgdorferi sensu lato (sl) species complex can cause Lyme borreliosis (LB) in humans. PCR plays an important role in the diagnosis of many infectious diseases but it is used auxiliary in LB diagnostics. Here, we re-analysed a previously published real-time PCR targeting the multicopy gene of the large subunit of phage terminase (terL) in Borrelia. We analysed cultured material of Borrelia burgdorferi sl species, serum and clinical tissue samples of LB patients. PCR conditions were as previously described by Shan et al. 2021 but we also investigated PCR modifications.

PCR on cultured specimens showed that whilst all samples of B. burgdorferi sensu stricto (ss) gave a positive result, not all isolates of Borrelia species causing LB in Europe (i.e. B. afzelii, B. garinii) were detected by the terL PCR. Only slight differences in Ct values were detected between PCR runs using the original ZEN/IFBQ double quencher probe compared to other double quencher probes or single quencher probes. Contrary to the hypothesis expressed by the authors of the original paper that the PCR could detect phage DNA in serum, our data show that the terL PCR was negative on all tested serum samples of individuals diagnosed with proven LB. Furthermore, using patient’s tissue samples not all infections with B. afzelii or B. garinii were detected, similar to the results obtained with cultured material or serial DNA dilutions of Borrelia species. We conclude, that the terL PCR in its current form is unsuitable for LB diagnosis in Europe..

..1. Introduction
PCR plays an important role in the diagnosis of many infectious diseases and it is used supportively in the diagnosis of Lyme borreliosis (LB), also known as Lyme disease. LB in humans is caused by bacteria of the Borrelia burgdorferi sensu lato (sl) species complex. PCR allows detection of DNA of these bacteria in patient samples and is useful to support or confirm other testing methods, such as antibody detection in blood, or in early disease before antibodies are detectable (Hofmann et al., 2017; Rauer et al., 2020). By detecting Borrelia DNA in tissue samples or body fluids, PCR can help to achieve an early diagnosis and treatment of LB. However, as there may be very few Borrelia bacteria in infected individuals and, hence, little DNA in tissue samples, a highly sensitive PCR is needed to provide reliable results.

In 2021, Shan and co-authors (Shan et al., 2021) published a paper suggesting that a multicopy prophage gene, the large terminase subunit (terL), would improve diagnostics of LB when used as target in real-time PCR. This PCR is being promoted for diagnostics of LB in humans (R.E.D. Laboratories Belgium, B-1731 Zellik, Belgium; https://www.redlabs.com/p/home.html
, access date 07 April 2025). Targeting multicopy genes for diagnostic purposes can be advantageous as it may increase the sensitivity of PCR and, therewith, improve diagnosis. In silico analyses suggested that the PCR may be suitable for all Borrelia species (Shan et al., 2021). However, in a letter to the editor the reproducibility of the statistical analyses and the specificity of the PCR were questioned (van de Schoor et al., 2021). In a follow up paper (Shan et al., 2023), the usefulness of the approach was highlighted and expanded for detection of Borrelia in ticks.

In Europe, the most common Borrelia species that cause human LB are B. afzelii and B. garinii (Hofmann et al., 2017; Rauer et al., 2020), which are also the most prevalent Borrelia species found in ticks (Rauter and Hartung, 2005; Strnad et al., 2017). Therefore, a new PCR should detect those species. In this study, we have used the real-time PCR published by Shan et al. (2021) in its original form and in a modified version to re-analyse clinical samples that were diagnosed as Borrelia positive in several laboratories using clinical assessment of the patients as well as p41 (Flagellin B (flaB)) (Schwaiger et al., 2001; Venczel et al., 2015) and outer surface protein A (ospA) (Ivacic et al., 2007; Briciu et al., 2016) as PCR targets. We also used cultured isolates of the Borrelia species commonly involved in clinical LB in Europe, i.e. B. afzelii, B. bavariensis, B. burgdorferi sensu stricto (ss), B. garinii, and B. spielmanii to analyse whether the PCR published by Shan et al. 2021 was suitable for detection of defined amounts of Borrelia DNA and to determine its detection limit. Published protocols for PCR on 16S rRNA (Gyllemark et al., 2021), flaB (Schwaiger et al., 2001), 5S-23S intergenic spacer (IGS) ((Strube et al., 2010), and unpublished) were used in parallel. Analyses were performed independently by three different laboratories..

..2. Materials and methods
Samples included. DNA purified from in vitro cultures (n = 32) was included in the analyses. These included B. afzelii n = 10, B. burgdorferi ss (Bbss) n = 8, B. garinii n = 6, B. spielmanii n = 2, B. valaisiana n = 1, B. miyamotoi n = 1, B. recurrentis n = 2, B. hispanica n = 1, B. hermsii n = 1 (Table 1). We further analysed DNA of samples included in a panel that contained serial dilutions of DNA from nine Borrelia species (15 isolates) and single concentrations of specificity controls (four species, five isolates) (supplementary material Table S1). In Table 2 a subset of these samples is shown comparing the original terL PCR set up (master mix, double quencher probe) with a real-time PCR targeting a different locus (see Table heading for details). DNA dilutions ranged from 1 × 104 to 1 × 10–1 per 5 µl. Pre-treatment serum samples (Table 3a) from 15 patients with proven LB diagnosed by clinical assessment in combination with positive Borrelia-specific antibody titres or positive in vitro Borrelia culture from tissue biopsy were included. Furthermore, clinical samples (n = 26; Table 3b) of LB patients were included that had previously been diagnosed based on clinical symptoms, patient history and positive PCR using p41 (flaB) (Schwaiger et al., 2001; Venczel et al., 2015) and ospA (Ivacic et al., 2007; Briciu et al., 2016) as targets..

..4. Discussion
..In conclusion, use of the current form of the terL PCR assay cannot be recommended for the diagnosis of LB in patients in Europe and Asia. Furthermore, it is not suitable for detecting B. burgdorferi sl DNA in serum samples from infected individuals..

Conclusie & wake-up call: Veel mensen-patiënten zijn jarenlang(!) en worden tot op heden nog steeds misleid!!!; Bron viewtopic.php?f=38&t=2751#p30574 en; Bron viewtopic.php?f=38&t=2751#p30595 en; Bron viewtopic.php?f=38&t=2751&start=10#p30838 en; Bron viewtopic.php?f=38&t=2751&start=20#p31137
De ziekte van Lyme en chronische Lyme zijn een verdienmodel geworden! En allerlei commerciële partijen schromen er niet voor om over de rug van (erg) zieke mensen, Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen veel geld te verdienen.

Patiënten moeten beter leren om zich zélf ook goed in de materie te leren verdiepen én goed te leren lezen! 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.

Conclusie: Met de kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test van Red Laboratories (België) kan géén diagnose Borrelia burgdorferi sensu lato (s.l) en of B. miyamotoi/Relapsing Fever worden gesteld!

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.[/quote][/quote]

[Roxy]

Vervolg

En vervolg op; Bron viewtopic.php?f=5&t=2595&start=340#p30016 en vervolg op; Bron viewtopic.php?f=5&t=2595&start=520#p30624

Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

Over de kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test van Red Laboratories (België).

Het door Gilbert van Tezted (Finland) gestelde in het boek is onjuist gebleken! Lees en leer meer: Interessante nieuwe Publicatie! Validatie van de test!; Bron viewtopic.php?f=38&t=2751&start=60#p31508

In herinnering:. De inhoud van het nieuwe boek (NB: kost veel geld $199 is €196; eBook €149) van Gilbert - 'Borrelia burgdorferi Methods and Protocols' zal bij menigeen de wenkbrauwen kunnen doen fronsen; Bron https://link.springer.com/book/10.1007/ ... 716-3561-2 en 'Table of contents (18 protocols)'; Bron https://link.springer.com/book/10.1007/ ... 3561-2#toc

3 januari 2024: Chapter 8 - Use of Specific Borrelia Phages as a New Strategy for Improved Diagnostic Tests - Jinyu Shan, Ying Jia & Tatjana Mijatovic; Bron https://link.springer.com/protocol/10.1 ... 6-3561-2_8

14 augustus 2024: Tezted (Finland) - Chapter 8 Revealed ( wordt herhaald; Bron viewtopic.php?f=5&t=2595&start=400#p30177 ..); Bron https://www.facebook.com/tickplex/

..Chapter 8 Revealed.
Revolutionizing Lyme Disease Diagnosis: The Power of Borrelia Phages
Researchers Jinyu Shan, Ying Jia, and Tatjana Mijatovic are pioneering the fight against tick-borne infections with a new potential diagnostic approach: Borrelia-specific phages.

Using the accuracy of real-time PCR, the method targets circulating bacteriophage DNA, allowing a direct detection of Borrelia that is much better than traditional PCR tests.

Why phages? These viruses, which are intimately linked to their bacterial hosts, are usually more abundant in the blood, thus enabling a higher rate of detection. Plus, they can distinguish between different Lyme and Relapsing Fever-causing Borrelia strains, ensuring accurate diagnosis from early to late stages..

..'Revolutionizing Lyme Disease Diagnosis: The Power of Borrelia Phages'..?
..'Why phages? These viruses, which are intimately linked to their bacterial hosts, are usually more abundant in the blood, thus enabling a higher rate of detection. Plus, they can distinguish between different Lyme and Relapsing Fever-causing Borrelia strains, ensuring accurate diagnosis from early to late stages'..?


Veel mensen-patiënten zijn jarenlang(!) en worden tot op heden (wereldwijd) nog steeds misleid!!! De ziekte van Lyme en chronische Lyme zijn een verdienmodel geworden! En allerlei commerciële partijen schromen er niet voor om over de rug van (erg) zieke mensen, Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen veel geld te verdienen.

En ook Jernigan (natuurarts, géén onderzoeker & wetenschapper) van Biologix Center (Verenigde Staten) heeft onjuiste informatie gegeven en veel patiënten worden misleid!!; Bron viewtopic.php?f=38&t=2435&start=180#p29119

..De 'claims' van Jernigan natuurarts (Biologix Center Verenigde Staten) over de experimentele en niet-gevalideerde Phelix Phage Borrelia test: 'high-sensitivity of >90% and 100% specificity'; Bron https://www.cureus.com/articles/76183-i ... one-clinic en '96% of People in this Study Did Not Have Classic Lyme Borrelia maar B. miyamotoi/Relapsing Fever'; Bron https://biologixcenter.com/lyme-disease ... -borrelia/ en Bron https://biologixcenter.com/lyme-disease ... e-disaease
Not Every Lyme Disease Lab Test Is Very Sensitive - Why The Phelix Phage Borrelia Test is the New Gold Standard for Lyme Disease and Relpasing Fever; Bron https://biologixcenter.com/inpt-phage-t ... r-testing/ ..

[Roxy]

Vervolg

Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

Over de kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test van Red Laboratories (België).

Lees en leer meer: Interessante nieuwe Publicatie! Validatie van de test!; Bron viewtopic.php?f=38&t=2751&start=60#p31508

De geschiedenis van het 'xmrv/mlv debacle' heeft zich duidelijk herhaald!; Bron viewtopic.php?f=37&t=2772&start=10#p30952 en Bron; viewtopic.php?f=38&t=2435&start=140#p27534
De kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test werd door Red Laboratories (België) in 2019 aangekondigd als: ..'A Breakthrough way to detect intracellular bacteria, and an answer to non-diagnosed chronic lyme patients'..
Er zijn en worden sindsdien opnieuw (wereldwijd) veel (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen misleid!!

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.


Claims in 2020 van Mijatovic (Red Laboratories België); Bron https://www.iddoctor.eu/docs/Crypto-Inf ... atovic.pdf De clinicus en collega promotor van de Phelix Phage Borrelia test werkt al vele jaren samen met collega Mijatovic; Bron https://www.researchgate.net/scientific ... 2144765546
2020: Clinicus stelt zich drie vragen; Bron https://www.zonmw.nl/sites/zonmw/files/ ... irleir.pdf

..Latente actieve infecties?
1. Tot nu toe ongekende infecties.
50% Borrelia infectie (B. Miyamotoi, B. Recurrent fever type, B. Burgdorferi) – nieuwe onderzoekstechnieken (phage Borrelia qPCR)
Andere: Yersinia Pseudotuberculosis, Tularemie, andere gramnegatieve bacteriën, parasieten, enkele virussen zoals Parvovirus B19..

2020: In 2020 wordt gesteld dat me/cvs patiënten B. miyamotoi/Relapsing Fever hebben - 'Bacteriophage Lyme Test Offers ME/CFS Patient New Possibility'; Bron https://www.healthrising.org/blog/2020/ ... eriophage/ De diagnose wordt gesteld met de experimentele en niet-gevalideerde Phelix Phage Borrelia test. Mensen krijgen erg kostbare experimentele en zware behandelingen (waarvan géén medische en wetenschappelijke onderbouwing beschikbaar is!!) voorgeschreven.

..My wife has been ill for over seven years. She has done countless urine, feces, blood, breath, hair and saliva tests – effectively every available type of laboratory test across two continents. This included tests for Lyme and other tick-borne diseases with a specialist laboratory in the United States (ELISA, Western Blot, PCR, etc.)..

..In March, my wife tried a newly developed blood test for bacteria of the borellia genus by Phelix. The result was *positive* for Borrellia miyamotoi (one of many “cousins” of Borellia burgdorfi, the well-known bacteria that causes Lyme disease)..

..Her test results have shown some abnormalities (e.g., gut dysbiosis, abnormal metabolites, poor mitochondrial function, adrenal insufficiency, impaired T4 to T3 conversion, etc.), but never a pathogen. Like so many people with ME/CFS, she has a complex illness without a clear origin – if only she had an identifiable “bad bug” to explain it all!..

..Her doctor indicated that this pathogen could explain her very severe ME/CFS symptoms. We could hardly believe it!..

..I have learned that the new blood test is **a break-through for the tick-borne illness community – and may also be **a break-through for some ME/CFS patients..

..Unfortunately, it is very difficult to rid a body of tick-borne bacteria: patients describe months and years of grueling IV and oral antibiotic treatments. Yet we are encouraged by recent trials that have had positive results on defeating “persistent” bacteria based on off-label uses of existing drugs (c.f. dapsone and disulfiram)..

..After years of searching, I am hopeful that this is a big step towards understanding and solving my wife’s very severe ME/CFS..

2023: Ilads Conference Boston, MA 19-22 October 2023; Bron https://www.ilads.org/ilads-conference/ ... ce-boston/
Conference Schedule & Speakers; Bron https://www.ilads.org/ilads-conference/ ... ce-boston/

..21 October 2023 8:05-8:40 AM: Phage Borrelia qPCR Diagnostics in ME/CFS Patients: Results of Several Clinical Studies - Kenny De Meirleir, MD, PhD..

En; Bron viewtopic.php?f=5&t=2595&start=190#p29447

2023: Die Deutsche Borreliose-Gesellschaft e.V. Freitag 10 & Samstag, 11 November 2023 - Herbsttagung/Jahrestagung 2023 der DBG: Lyme-Borreliose und andere persistierende Infektionen; Bron https://www.borreliose-gesellschaft.de/ ... nfektionen
Programm; Bron https://www.borreliose-gesellschaft.de/ ... nfektionen

..10 november 2023: 16.45 - 17.30: Phage Borrelia qPCR - 4 years of experience with this new diagnostic tool. - de Meirleir..

18 januari 2023: Presentatie: 'Phage Borrelia qPCR in ME/CFS patients' by K. De Meirleir1-2, T. Mijatovic3, V.C. Lombardi4; Bron https://www.ctmassociates.co/post/dr-de ... s-patients en de zogenoemde Studie met 130 ME/CFS patients en de zogenoemde Results; Bron viewtopic.php?f=5&t=2595&start=400#p30158

..METHODS
130 ME/CFS patients (29 males, 101 females)..

..RESULTS
- ME/CFS patients: 106/130 positive for Phage Borrelia qPCR

93 Borrelia miyamotoi
13 Borrelia of relapsing fever group
2 Borrelia miyamotoi + relapsing fever group
1 Borrelia miyamotoi + Borrelia burgdorferi

81,5% of the ME/CFS patients tested positive for phage Borrelia qPCR

Controls:
18/90 positive for Phage Borrelia qPCR
10 Borrelia miyamotoi 8 Borrelia of the relapsing fever group
2 Borrelia miyamotoi and a Borrelia of the relapsing fever group

Borrelia miyamotoi Phages are significantly (72% vs 11%) more present in ME/CFS vs controls

Borrelia of the relapsing fever Phages are present in ± 10% of ME/CFS patients and controls

Lyme Borrelia Phages were detected in 0,8% of ME/CFS patients and in 0% of controls..

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 'Lyme-helden' Ilads Lyme artsen in Nederland en in het buitenland. En de aangehangen commerciële laboratoria en zogenoemde 'Nederlandse vrienden van Tezted (Finland)' (Testimonials from our friend associations and patients' mei 2023; Bron https://www.tezted.com/lymeawarenessmonth en (oud)leden en (oud)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 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

[Roxy]

Vervolg op: 'interessante nieuwe Publicatie! Validatie van de kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test van het commerciële laboratorium Red Laboratories (België)'; Bron viewtopic.php?f=38&t=2751&start=60#p31508

Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

Hoe de (nieuwe) patiënten en andere (zoekende, hoopvolle of wanhopige) zieke mensen opnieuw jarenlang worden misleid!!

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.

Ter verificatie:
Ilads European Conference May 1-3, 2025 Lisbon, Portugal; Bron https://www.ilads.org/ilads-conference/ ... onference/
Conference Schedule & Speakers (Conference Schedule* *Subject to change); Bron https://www.ilads.org/ilads-conference/ ... onference/

..3 May 2025: 2:30-3 PM Neglected Infections and Gastrointestinal Dysregulations in Patients with Active Borrelia Infections - Tatjana Mijatovic, PhD

..3 May 2025: 3-3:30 PM Bacteriophages as Biomarkers for Lyme Disease and Co-Infections: Why Should We Care? - Jinyu Shan, PhD..

In herinnering:.. Presentatie Mijatovic (Red Laboratories (België)) Ilads Scientific Virtual Conference, 10 - 13 september 2020 - Lyme Disease: Are we looking for a wrong culprit?; Bron https://www.youtube.com/watch?v=Mr2hKGOjCZM

En Crypto-infections Conference 26 - 27 september 2020 Dublin - Mijatovic (Red Labotarories België) - 'Neglected infections and gastrointestinal issues in patients with Lage/Persistent/Chronic Vector-Borne Infections'; Bron https://www.youtube.com/watch?v=iJd0F-DrFMQ en de Slides; Bron https://www.iddoctor.eu/docs/Crypto-Inf ... atovic.pdf

En Voordracht 2019 Lyme Resource Centre (LRC) Dublin - Bacteriophages as diagnostic markers and therapeutic agents for Lyme disease - Dr. Jinyu Shan; Bron https://www.youtube.com/watch?v=KK4z--6myYQ


Ter verificatie:
Ilads European Conference Starnberg Germany April 19-21, 2024; Bron https://www.ilads.org/ilads-conference/2024-germany/
Conference Schedule & Speakers (Conference Schedule* *Subject to change); Bron https://www.ilads.org/ilads-conference/2024-germany/

..20 April 2024: 8:45-9:25 AM: Growing Evidence on RF and B miyamotoi Incidence and Prevalence in Europe, and Neurotropic Viruses–Bacteria Interactions in late LD, PLDTS - Louis Teulieres, MD, PhD..

..21 April 2024: 10-10:30 AM: What we learned from testing ticks - Multipathogen study in European ticks Claims (110 geteste teken); Bron viewtopic.php?f=5&t=2595&start=520#p30650 - Tanja Mijatovic, PhD..

Ilads Annual Scientific Conference November 7-10, 2024 San Antonio, TX; Bron https://www.ilads.org/ilads-conference/ ... n-antonio/
Conference Schedule & Speakers (Conference Schedule* *Subject to change); Bron https://www.ilads.org/ilads-conference/ ... n-antonio/

..9 November 2024: 8 AM: Combination Sequential Therapies Guided by Highly Specific Direct Diagnostic Methods in Chronic (Persistent) Borreliosis and PLDTS: Selected Case Studies - Louis C. Teulieres, MD, PhD..

Ilads European Conference Starnberg Germany April 19-21, 2024; Bron https://www.ilads.org/ilads-conference/2024-germany/
Conference Schedule & Speakers (Conference Schedule* *Subject to change); Bron https://www.ilads.org/ilads-conference/2024-germany/

..20 April 2024: 8:45 - 9:25 AM: Growing Evidence on RF and B miyamotoi Incidence and Prevalence in Europe, and Neurotropic Viruses–Bacteria Interactions in late LD, PLDTS - Louis Teulieres, MD, PhD..

..21 April 2024: 10 - 10:30 AM: What we learned from testing ticks - Multipathogen study in European ticks - Tanja Mijatovic, PhD..

Ilads Conference Boston, MA 19-22 October 2023; Bron https://www.ilads.org/ilads-conference/ ... ce-boston/
Conference Schedule & Speakers; Bron https://www.ilads.org/ilads-conference/ ... ce-boston/

....21 October 2023 8:05-8:40 AM: Phage Borrelia qPCR Diagnostics in ME/CFS Patients: Results of Several Clinical Studies - Kenny De Meirleir, MD, PhD..

..21 October 2023 10:35-11:05 AM: Bacteria- Viruses Interactions: Implications for Persistent or Slow Infections Diagnostic and Treatments - Louis C. Teulieres, MD, PhD..

..21 October 2023 4:15-4:45 PM: What We Learned from Testing Ticks - Multipathogen Study in European Ticks - Tatjana Mijatovic, PhD..

2020 ILADS Annual Scientific Virtual Conference, ONE HEALTH LYME – The intersection of Lyme and COVID 10-13 September 2020; Bron https://www.ilads.org/ilads-conference/ ... rence-2020
Conference Schedule & Speakers; Bron https://www.ilads.org/ilads-conference/ ... ence-2020/

..12 september 2020 11:50 AM: Lyme Disease - Are we Looking for the Wrong Culprit? Claims; Bron https://www.ilads.org/ilads-conference/ ... se-culprit - Tatjana Mijatovic, PhD..

..12 september 2020 12:00 PM: Specific PCR Phages Tests Show Borrelia miyamotoï More Realistic Prevalence in Europe. COVID/LD Co-Infection Markers and Shared Treatments Claims; Bron https://www.ilads.org/ilads-conference/ ... ecific-pcr - Louis C. Teulieres, MD, PhD..

Conclusie & wake-up call: Patiënten én patiëntenorganisaties, 'activistische Lyme organisaties&groepen' én Ilads Lyme&me/cvs artsen, AVIG Lyme artsen, natuurartsen, therapeuten en behandelaars in privé-klinieken (wereldwijd) worden misleid!!

[Roxy]

Vervolg

Waar moeten de (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen goed op letten?

En hoe er véél geld wordt verdiend over de rug van (erg) zieke mensen!

Ter verifcatie:
Kosten: zogenoemde PhBor; Phage Borrelia qPCR test kost €297; PhRick; Phage Rickettsia qPCR test kost €235; PhCombo1; Phage Borrelia & Rickettsia qPCR kost €455; Bron https://drive.google.com/file/d/1XQXmUj ... B2lWR/view
Verdiensten Red Laboratories (België) 2023: €383.724 of €587.860.
Verdiensten Red Laboratories (België) 2022: €519.750 of €796.250.
Verdiensten Red Laboratories (België) 2020 (2200 samples): €653.400 of €1.196.800.

Ter verificatie: Stand van zaken Phelix Research & Development (Engeland); Bron https://phelix.info/about/team/ & Phelix France (Frankrijk); Bron https://zb14927861.phelix.org.uk/team/ periode t/m 31 december 2023; Bron https://zb14927861.phelix.org.uk/about-us/

..During the year, the charity received income totalling £45.0045 and incurred expenditure of £41.390, giving a net surplus position of £3.655.

Phelix R&D recognised income of £45.001 from RedLab Belgium form the commercialisation of the Phage based test for the year 2023..

..Activity update
Activity 2023:
- Red Labs sold 1,292 tests in 2023 versus 1,750 in 2022, a drop of 26% YoY.
- Phelix R&D negotiated with the University of Leicester to reduce its contribution to the research. The University found some internal resources to fund itself for the first half of 2023, while the Charity financed the research for the second half of 2023.
- The research primarily focused on understanding why the traditional Borrelia strain (BB31) is less prevalent in Europe than in de US.
- The University of Leicester kept developing new primers for Bartonella strains.
- The University of Leicester, in collaboration with Red Laboratories, focused on implementing a series of triplicate qPCR assays for Borrelia burgdorferi sensu lato.

Phelix R&D in the partnership of the University of Leicester to publish a research paper titled 'Combining Combining Citizen Science and Molecular Diagnostic Methods to Investigate the Prevalence of Borrelia burgdorferi s.l. and Borrelia miyamotoi in Tick Pools Across Great Britain'; Bron https://www.frontiersin.org/journals/mi ... 26498/full

The University of Leicester, Phelix R&D and Red Laboratories have finalized and published a research article in the European Society of Medicine: Overcoming the Challenges of Lyme Disease Diagnosis: The Role of Phage-based Testing; Bron https://esmed.org/MRA/mra/article/view/4650

Phelix R&D and Red Laboratories attended the ILADS conference in Boston in October 2023. They presented Phelix R&D's research to medical professionals and a panel of university researchers.

..Whilist the trustees are aware of the need to build reserves for a substaniable future. This is not considered necessary at this time due to the support of the trustees..

Stand van zaken Phelix Research & Development (Engeland); Bron https://phelix.info/about/team/ & Phelix France (Frankrijk); Bron https://zb14927861.phelix.org.uk/team/ periode t/m 31 december 2022; Bron https://zb14927861.phelix.org.uk/about-us/

..During the year, the charity received income totalling £60.205 and incurred expenditure of £80.501, giving a net loss position of £20.269.

Phelix R&D recognised income of £52.908 from RedLab Belgium form the commercialisation of the Phage based test for the year 2022..

..Activity update
Activity 2022:
- Improving the sensitivity of the Phage Based borrelia test with our partner in Belgium, RedLabs, who are in charge of the commercialisation of the Test.
- Exploring new technologies in order to automate the DNA extraction from biological samples.
- University of Leicester and Phelix Research and Development: Trying to redesign a Phage Based test for Bartonella sp. as the previous test did not show promising sensitivity.
- University of Leicester and Phelix Research and Development: working on the next research paper on Borrelia Miyamotoi.
- Finalising the documents for the filing of the Patent of the Borrelia phage based test: UK, USA, EU (Patent attorney Murgitroyd law firm)..

..Whilist the trustees are aware of the need to build reserves for a substaniable future. This is not considered necessary at this time due to the support of the trustees..

Stand van zaken: Phelix Research & Development (Engeland); Bron https://phelix.info/about/team/ & Phelix France (Frankrijk); Bron https://zb14927861.phelix.org.uk/about-us/ periode t/m 31 december 2021; Bron http://phelix.info/en/about/what-is-phelix/

..Our agreement with Red Laboratories in Belgium helped us to gain some returns from our joint patent in order to finance the research..

..During the year, the charity received income totalling £95.193 and incurred expenditure of £95.918, giving a net loss position of £725.

Phelix R&D recognised income of £90.243 from RedLab Belgium form the **commercialisation of the Phage based test for 2021..

..Whilist the trustees are aware of the need to build reserves for a substaniable future. This is not considered necessary at this time due to the support of the trustees..

Ter verificatie: 9 juni 2024: Het lukt de wetenschapper/onderzoeker Shan; Bron https://phelix.info/about/team/ niet om subsidie gelden te krijgen voor zijn 'Startup'; Bron viewtopic.php?f=38&t=2435&p=30466#p30465 en; Bron viewtopic.php?f=38&t=2435&start=220#p30236 en; Bron viewtopic.php?f=38&t=2435&start=220#p30237


In herinnering:..Leer en lees meer: ter verificatie:
Frontiers in Microbiology
OPINION article
Publicatie 13 december 2021
Opinion: 'Methodological Shortcomings in the Study on a Prophage-based PCR Test for Lyme Borreliosis' by Freek R. van de Schoor, M. E. Baarsma, Mariska M. G. Leeflang, Volker Fingerle, Gabriele Margos, Joppe W. Hovius and Alje P. van Dam; Bron https://www.frontiersin.org/articles/10 ... 02131/full en; Bron https://pmc.ncbi.nlm.nih.gov/articles/PMC8710760/ en; Bron viewtopic.php?f=5&t=2322&start=750#p27953

..We read the article by Shan et al. (2021) with great interest, as new diagnostic tests for Lyme borreliosis (LB) are urgently needed (Cruickshank et al., 2018; Dessau et al., 2018). The article represents a proof of principle paper and an initial validation of an already commercially available test [Phelix Phage Borrelia—R.E.D. Laboratories (redlabs.be)]. We have various concerns regarding the study design, novelty of the approach, technical aspects of the assay, statistical analyses, and the conclusions, which must be addressed. Of note, several statements in the introduction are speculative and not supported by the references, but unfortunately, the word limit of our opinion does not allow us to elaborate on this..

..Conclusions
We conclude that while this technique might be promising, the paper provides more questions than answers, and contains a large number of inaccuracies. We would be interested to see the Ter-qPCR be validated on a cohort of clearly described LB patients and healthy controls from both North America and Europe before we could draw any conclusions on the diagnostic performance of the Ter-qPCR..

Teulières ( natuurarts; géén wetenschapper & onderzoeker!!) en de collega onderzoekers/wetenschappers van Phelix Research & Development (Engeland); Bron https://phelix.info/about/team/ & Phelix France (Frankrijk); Bron https://zb14927861.phelix.org.uk/team/ en; Bron https://zb14927861.phelix.org.uk/about-us/ en Mijatovic (Red Laboratories België) hebben tot nu toe (nog) niet gereageerd op het Opinie artikel van het team wetenschappers-onderzoekers.
Interessant gaat worden of er op de nieuwe Publicatie: Validatie van de test zal worden gereageerd!


20 oktober 2022 - 'Proefschrift M.E Baarsma: Lymeziekte | Ontwikkelingen in diagnostiek en klinische aspecten' - Chapter 8 Opinion: Methodological shortcomings in the study on a prophage-based PCR test for Lyme borreliosisLyme borreliosis; Bron https://dare.uva.nl/search?identifier=d ... 4db3f0865e en; Bron https://pure.uva.nl/ws/files/87978512/Chapter_8.pdf

Een belangrijke stelling behorende bij het proefschrift M.E. Baarsma: Lymeziekte | Ontwikkelingen in diagnostiek en klinische aspecten; Bron https://dare.uva.nl/search?identifier=d ... 4db3f0865e

..4. Fabrikanten hebben een morele verplichting om diagnostische tests grondig en transparant te valideren, voordat ze deze aan de eindgebruiker aanbieden - dit proefschrift..

Mijatovic van Red Laboratories (België) en de leden van Team Phelix Research & Development (Engeland); Bron https://phelix.info/about/team/ & Phelix France (Frankrijk); Bron https://zb14927861.phelix.org.uk/team/ voelen de morele verplichting die zij hebben naar de eindgebruiker toe (de zieke mensen, patiënten) duidelijk niet!

De geschiedenis van het 'xmrv/mlv debacle' heeft zich duidelijk herhaald!; Bron viewtopic.php?f=37&t=2772&start=10#p30952 en Bron; viewtopic.php?f=38&t=2435&start=140#p27534
De kostbare experimentele en niet-gevalideerde Phelix Phage Borrelia test werd door Red Laboratories (België) in 2019 aangekondigd als: ..'A Breakthrough way to detect intracellular bacteria, and an answer to non-diagnosed chronic lyme patients'..
Er zijn en worden sindsdien opnieuw (wereldwijd) veel (nieuwe) Lyme patiënten of chronische Lyme patiënten of andere (zoekende, hoopvolle of wanhopige) zieke mensen misleid!!

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.