13 december 2021
New peer-reviewed publication using Phelix Borrelia Phage Test; Bron https://blog.redlaboratories.be/2021/12 ... using.html
De artsen van Biologix Center in Amerika vertrouwen (blind) in hun gepubliceerde artikel over INPT op de 'Phelix Phage Borrelia test' (experimentele en niet-gevalideerde test) en op de bevindingen/claims van Teulières en Mijatovic bij Ilads Conferentie 2020?; Bron https://www.ilads.org/ilads-conference/ ... ecific-pcr en Bron https://www.ilads.org/ilads-conference/ ... se-culpritWe are happy to share a new peer-reviewed publication using Phelix Borrelia Phage Test by Dr David Jernigan et al.
Biologix Center; Bron https://www.facebook.com/BiologixCenter/
24 november 2021
Cureus..We are very pleased to announce that Dr. Jernigan's research surrounding his patent-pending innovation, Induced Native Phage Therapy, will be published in a peer-reviewed medical journal next week. We would like to thank all of the doctors, staff, and patients that have helped us achieve this milestone and look forward to sharing the article, titled “Induced Native Phage Therapy for the Treatment of Lyme Disease and Relapsing Fever: A Retrospective Review of First 14 Months in One Clinic," with you soon.
Please turn on our post notifications to stay up to date on all future posts regarding this breakthrough that has never been accomplished in the history of medicine. We are beyond excited to share this news with you! #MedicalAdvancements #TheFutureOfMedicine #InducedNativePhageTherapy #INPT..
Publicatie 29 november 2021
Original article A Retrospective Review - 'Induced Native Phage Therapy for the Treatment of Lyme Disease and Relapsing Fever: A Retrospective Review of First 14 Months in One Clinic' by David A. Jernigan , Martin C. Hart, Keeley K. Dodd, Samuel Jameson, Todd Farney; Bron https://www.cureus.com/articles/76183-i ... one-clinic
..Introduction
With the advent of the Phelix Borrelia-phage (PBP) testing, we can now determine the presence or absence of Borrelia infection with a much higher degree of certainty..
..Phelix Borrelia-phage testing
No published normative data existed for the use of INPT in patients with LD or RF in that it is an emerging technology; however, prior peer-reviewed technologies support the premise [21]. The clinical advancements of the technologies leading up to the development of INPT took place over the course of 26 years, the effects of which were largely restricted to clinical observation and adjunctive BES testing incorporated into the standard programs of care, until the introduction of the newly released laboratory test, PBP qPCR [22]. High-sensitivity of >90% and 100% specificity, showing no false positives and few false negatives, combined with the speed of verification of treatment effect being only four days post-bacterial clearance, made the PBP testing ideal for detection of early or late LD/RF.
Conventional antibody testing, such as Lyme Western blot testing would not be of use because antibodies remain circulating in the body for years after the infection is gone, and the testing presents a lack of sensitivity, especially in late-stage illness [23]. The limitations of immunoglobulin M/immunoglobulin G antibody testing and the need for more sensitive testing for Borrelia species are well documented [24]. Discussions of any current assay being able to determine an active or inactive infection are not relevant to this review. More important to this review is the apparent frank presence or absence of the infection as indicated by the presence or absence of the bacteria’s native phages. This criterion is achieved only by the PBP test.
The PBP test undergoes quadruplicate real-time polymerase chain reaction (PCR) tests for three different targets (B. burgdorferi sl, B. miyamotoi, and RF group) for a total of 12 assessments. All positive-like samples are submitted to confirmatory sequencing to rule out false-positive results. The Phelix Phage test (patent no. WO2018083491A1) is performed on whole blood from two ethylenediaminetetraacetic acid (EDTA) tubes. The very first step consists of extracting the DNA using a specific manual method to ensure the best possible recovery of the pathogenic DNA. The extracted DNA undergoes three different qPCRs using proprietary primers and probes for phage-specific detection. The three qPCRs aim to detect the following targets (i) Borrelia miyamotoi, (ii) Borrelia burgdorferi sensu lato (B. burgdorferi ss, B. bissettii, B. bavariensis, B. valaisiana, B. afzelii, and B. garinii), and (iii) RF (B. hermsii, B. recurrentis, B. crocidurae, B. duttonii). Each target is tested in a quadruplicate. The amplified fragments are then analyzed by sequencing to confirm the positivity of the sample (i.e., to rule out false positives)..
..Results
The PBP qPCR test was utilized as our standard due to its very high sensitivity to detecting the presence of infection and the immediate evidence of the absence of infection post-treatment. As presented by Louis Teulieres, MD, at the 2019 International Lyme and Associated Diseases Society conference, the PBP testing is statistically the most accurate test..
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
Samenwerking: partijen: 1). Radboudumc Nijmegen, Department of Internal Medicine, Radboudumc Center for Infectious Diseases and Radboud Institute of Health Sciences, 2). Center for Experimental and Molecular Medicine; Amsterdam Institute for Infection and Immunology, Amsterdam UMC, University of Amsterdam; 3). Epidemiology and Data Science, Amsterdam Public Health; 4). German National Reference Centre for Borrelia, Bavarian Health and Food Safety Authority, Oberschleißheim, Germany; 5). ESCMID Study Group for Lyme Borreliosis, Basel, Switzerland.
Gene sequences and PCR results
..We would be very interested to see how Borrelia afzelii and Borrelia garinii would have performed in analyses using spiked blood samples, as these are the most common genospecies causing clinical symptoms in Europe, but have—according to the authors' Table 1—fewer cp32 plasmids (n = 8, n = 4, respectively). In their paper, the geographical origin of patients is not described, but the authors state that “patients were diagnosed by Dr. LT,” referring to Louis Teulières, who is based in Paris, France, where—like in the rest of the European continent—LB is caused mainly by B. afzelii and B. garinii (Stanek et al., 2012). However, the test method is based on the terL gene derived from the North American strain of B. burgdorferi s.s. B31. Furthermore, the authors include extremely low-positive signals in their results. Of the 23 healthy controls, 21 showed a positive signal in the terL PCR in at least one of the 12 samples. Whereas incidental carriage of Borrelia-DNA in blood of healthy persons, as suggested by the authors, might occur, it is highly unlikely that this would be found in over 90% of the population. This strongly suggests that at least some low-positive results represent unspecific signals or signals which are a result of DNA cross-contamination..
Selection Criteria LB Patients
..Another concern is the patient selection and interpretation of the clinical data. The manuscript lacks any description of patient characteristics, and does not report inclusion or exclusion criteria. Absence of clear eligibility criteria may indicate selection bias. Criteria for patient selection in an LB-related diagnostic test accuracy study should be clear and unambiguous, for example based on European guidelines (Mygland et al., 2010; Stanek et al., 2011; Hofmann et al., 2017). The authors refer to the ILADS guideline (Cameron et al., 2014), which in itself does not contain any diagnostic criteria. Without unambiguous criteria, one cannot ensure that these individuals were in fact patients with LB (Stanek et al., 2011; Lantos et al., 2021). It is also unclear what is meant by “early LD” and “late LD.” Would Lyme neuroborreliosis (LNB) be classified as early or late LD, for example (Koedel and Pfister, 2017)? Were there any LNB patients at all? If so, how were they diagnosed?..
The Conclusions are Not Supported by the Data
..The aforementioned considerations cast substantial doubt on the reliability of the results, but—when interpreted with caution—do not undermine the value of the authors' hypothesis. Unfortunately, the conclusions drawn by the authors from the results are inappropriate. The authors state that their assay can distinguish early LB, late LB, and HVs. These conclusions are not supported by the data.
The mean/median copy numbers may be significantly different at a group level—even though we have shown in this manuscript's Figures 1B,C and Supplementary Table 1 that they are not for most comparisons—but that does not imply diagnostic power. Only if there is little or no overlap between numeric values, will the assay be able to distinguish a patient from a non-patient. A simple scatterplot of the data shows there is a high degree of overlap between the groups. Subsequent ROC-analysis Figures 1C,D on the mean/median copy numbers shows that—when a minimally acceptable specificity of 90% is applied—the maximally attainable sensitivity is 62% (WB-MEAN: HV vs. early, cutoff at 1.275) or 57% (WB-MEAN: HV vs. late, cutoff at 1.283). This is worse than single-tier or modified two-tiered testing (MTTT) serology in EM and far worse than any type of serology in late LB (Leeflang et al., 2016; Waddell et al., 2016; Branda et al., 2017). Additional ROC-analyses show that the ability to discriminate between early vs. late LB is even (much) worse (data not shown). Please note that these analyses were performed with a small number of samples (early: n = 13; late: n = 42; HV: n = 23). It is much more likely that the assay lacks specificity and that many HVs had false-positive results, rather than suffer from asymptomatic B. burgdorferi infection, as the authors claim.
We must also point out that the manuscript suffers from flawed circular reasoning and over-interpretation. The fact that the groups differ with respect to the primary study parameter does not prove that they are LB patients or HVs. Participants' status as belonging to either group is the starting point for investigating potential differences in terL levels, not a conclusion that can be drawn when these groups are indeed shown to be different on this outcome. The authors postulate that their test could be used to monitor LB treatment outcomes, yet, this study does not report on any follow-up samples or treatment outcome to support this claim. They further state that the Ter-qPCR could be used to indicate which treatment option may work best, however, the choice of treatment option is not supported by any of the data in this article..
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..
Belangrijk nieuws voor de mensen die met de 'Phelix Phage Borrelia test' zijn getest uit de landen als Nederland, België, Frankrijk, Duitsland, VK, Rusland, Verenigde Staten, Canada, etc., en een diagnose Borrelia burgdorferi sensu lato (s.l) en of B. miyamotoi/Relapsing Fever hebben gekregen. 'Newsletter PHELIX décembre 2019'; Bron https://iforlyme.org/downloads/phelix-p ... 201912.pdf
En 'Newsletter PHELIX novembre 2020'; Bron https://iforlyme.org/downloads/phelix-p ... 202011.pdf..Depuis fin août le test est mis à la disposition dupublicet près de 2000 tests ont été réalisés. (Provenance surtout Belgique France, RU, Allemagne, Pays bas (Nederland), et depuis notre présentation à l’ILADS de Chicago le 1er novembre, des Etats Unis et du Canada)..
Met de 'Phelix Phage Borrelia test' kan géén diagnose B. miyamotoi/Relapsing Fever en of Borrelia burgdorferi sensu lato (ziekte van Lyme) worden gesteld.