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Nanotrap Lyme Test Shows Promise

Discussion in 'Lyme Disease and Co-Infections' started by duncan, Nov 7, 2015.

  1. duncan

    duncan Senior Member

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    Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis
    Magni R, Espina BH, Shah K, Lepene B, Mayuga C, Douglas TA, Espina V, Rucker S et al.
    Journal of Translational Medicine 2015 Nov 4;13(1):346.

    http://doi.org/10.1186/s12967-015-0701-z

    Abstract

    Objectives
    Prompt antibiotic treatment of early stage Lyme borreliosis (LB) prevents progression to severe multisystem disease. There is a clinical need to improve the diagnostic specificity of early stage Lyme assays in the period prior to the mounting of a robust serology response. Using a novel analyte harvesting nanotechnology, Nanotrap particles, we evaluated urinary Borrelia Outer surface protein A (OspA) C-terminus peptide in early stage LB before and after treatment, and in patients suspected of late stage disseminated LB.

    Method
    We employed Nanotrap particles to concentrate urinary OspA and used a highly specific anti-OspA monoclonal antibody (mAb) as a detector of the C-terminus peptides. We mapped the mAb epitope to a narrow specific OspA C-terminal domain OspA236-239 conserved across infectious Borrelia species but with no homology to human proteins and no cross-reactivity with relevant viral and non-Borrelia bacterial proteins. 268 urine samples from patients being evaluated for all categories of LB were collected in a LB endemic area. The urinary OspA assay, blinded to outcome, utilized Nanotrap particle pre-processing, western blotting to evaluate the OspA molecular size, and OspA peptide competition for confirmation.

    Results
    OspA test characteristics: sensitivity 1.7 pg/mL (lowest limit of detection), % coefficient of variation (CV) = 8 %, dynamic range 1.7–30 pg/mL. Pre-treatment, 24/24 newly diagnosed patients with an erythema migrans (EM) rash were positive for urinary OspA while false positives for asymptomatic patients were 0/117 (Chi squared p < 10 −6 ). For 10 patients who exhibited persistence of the EM rash during the course of antibiotic therapy, 10/10 were positive for urinary OspA. Urinary OspA of 8/8 patients switched from detectable to undetectable following symptom resolution post-treatment. Specificity of the urinary OspA test for the clinical symptoms was 40/40. Specificity of the urinary OspA antigen test for later serology outcome was 87.5 % (21 urinary OspA positive/24 serology positive, Chi squared p = 4.072e −15 ). 41 of 100 patients under surveillance for persistent LB in an endemic area were positive for urinary OspA protein.

    Conclusions
    OspA urinary shedding was strongly linked to concurrent active symptoms (e.g. EM rash and arthritis), while resolution of these symptoms after therapy correlated with urinary conversion to OspA negative.
     
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  2. duncan

    duncan Senior Member

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    Beyond the increased rapid use for early Lyme, I found very interesting the 41% positive rate for suspected chronic Lyme patients.

    Should the promise of this test bear out, the implications to IDSA pronouncements of conventional treatment's near-universal efficacy may be substantial.

    Not to mention what it would mean to their dismissal of the concept of chronic Lyme, and even to the concept of PTLDS.

    Question: How does one account for the other 59%? Does it reduce to a function of when these 100 patients suspected of chronic Lyme received treatment, i.e., early stage vs late stage?
     
    Last edited: Nov 7, 2015
    Helen likes this.
  3. halcyon

    halcyon Senior Member

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    Misdiagnosis?
     
  4. duncan

    duncan Senior Member

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    Perhaps.

    The 100 subset cohort was comprised of Lyme patients that had been treated and then gone on to report persistent symptoms well after treatment. I cannot figure out if these were confirmed sero-positive patients prior to treatment.

    I know that all 100 were 2T negative at the time of the nano test, so certainly post-treatment.

    I'm trying to glean from the full study but my brain is not cooperating.
     
    Last edited: Nov 7, 2015
  5. duncan

    duncan Senior Member

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    I don't think the study tells us the 100 were ever 2T positive.

    That would certainly leave room for misdiagnosis in at least some of that 59%.

    One has to wonder: Were the authors deliberately embracing the IDSA's version of what constitutes chronic Lyme, that is, no supporting serology? (If so, there may be a "gotcha" factor the authors and inventors enjoyed. :) )
     
    Last edited: Nov 7, 2015
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  6. aaron_c

    aaron_c Senior Member

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  7. duncan

    duncan Senior Member

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    If you're in the US, you may wish to make sure insurance will cover it. I think it is a cool sounding test. I cannot remember if it has been independently validated yet, though.
     
  8. aaron_c

    aaron_c Senior Member

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    They say on the website that insurance won't cover it. I haven't heard that it has been independently verified. I know that even if I get a "positive" result, it will be questionable...but I got sick a month after a tick bite (no bullseye rash) and have had two negative test results from IGeneX. So it seems worth a try to me.
     
    Mel9 likes this.

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