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]