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I'm Designing a Molecular Onychosis Panel - Need Help Regarding Pathogens

Discussion in 'General Issues and Discussion Forum' started by Molecular Test Designer, Mar 9, 2022.

  1. Molecular Test Designer

    Molecular Test Designer Welcome New Poster


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    Hello all,

    I’m the molecular biology lab manager and assay developer at a lab in Sandy Springs, GA. I’m currently in the process of developing an onychosis PCR panel to detect various nail pathogens, and I would like know the actual pathogen prevalence many of you are observing among the patients you serve. This will help me make a better-informed decision as to what pathogens to include and omit on our PCR panel so that the patients receive medically relevant test results and don’t get billed for unnecessary tests. If interested in helping me with the knowledge you possess, please feel free to answer any of the questions below:
    1. The main categories of nail pathogens we plan to screen for are Fungi (primarily Dermatophytes), Saprophytic Molds, Candida-Species Yeasts, and Pseudomonas aeruginosa. Are there any other pathogen categories that should be considered?
    2. Out of the Fungi, Mold, and Yeast pathogen categories, what multiple species would it be medically relevant to isolate because it requires a species-specific treatment (e.g. T. rubrum, Epidermophyton, C. albicans, etc.)?
    3. What are the common treatments prescribed for Pseudomonas aeruginosa, which leads to Green Nail Syndrome?
    4. What are the common treatments prescribed for Fungi (also treatments for specific species, if applicable, like Terbinafine for Dermatophytes)?
    5. What are the common treatments prescribed for Yeasts (also treatments for specific species, if applicable)?
    6. What are the common treatments prescribed for Saprophytic Molds (also treatments for specific species, if applicable)?
    7. Finally, have you seen a prevalence or need to identify the pathogens Botryodiploida theobromae, Onychochola canadensis, and/or Pyrenochaeta unguis-hominis?
    I appreciate any help you're able to give,

    MD
     
  2. Robert Spalding DPM

    Robert Spalding DPM Welcome New Poster

    I would hope you include your listed suspected pathogens plus some of the bacteria as even studies have shown that Staph Epidermitis acts as a keratolytic organism and may act as a precursor (or as I suspect a pre-digester of nails or part of a biofilm) that allows other pathogens to function or become more active as pathogens when by themselves they are considered non-pathogens. Even your listed “pathogens” were not considered pathogens at all 20+plus years ago by all the smarts in dermatology or microbiology if it wasn’t T.rubrum or T.menta. The insurance companies latched on to that and restricted who got antifungals. Onychomycosis is much more complicated than what we currently know and only expanded PCR panels showing bacteria and fungi will pave the way.
     
  3. Molecular Test Designer

    Molecular Test Designer Welcome New Poster


    Thank you, Dr. Spalding! That's exactly what I'm trying to develop--an expanded PCR panel that takes new research and factors into consideration. Bako (a company in which I have intimate, insider knowledge of) is the current "unicorn" of podiatry PCR testing, but they have rested on their laurels for quite some time. I am keeping no secrets as to what I'm developing, because I don't want to have a "Ready, Fire, Aim" approach to the new panel. It's paramount that the pathogens detected with the forthcoming panel are what a DPM believes to be critical for patient evaluation and treatment, even if an organism like S. epidermitis should be included and is considered an important precursor, yet we can't bill for it. As stated above, the test will screen for general Fungi, Molds, Yeasts, and P. aeruginosa. If a patient is detected positive for a Fungi, Mold, or Yeast on the screen, it will then be reflexed and our current pathogen list for each category is as follows:

    Fungi:
    • T. mentagrophytes
    • T. rubrum
    • Epidermophyton spp
    • Microsporum spp
    Yeasts:
    • C. albicans
    • C. parapsilosis
    • M. guilliermondii (anamorphic form is C. guilliermondii)
    • C. tropicalis
    • C. dubliniensis
    Molds:
    • Rhizopus microspores
    • Rhizopus oryzae
    • Mucor circinelloides
    • Aspergillus flavus
    • Aspergillus terreus
    • Aspergillus fumigatus
    • Histoplasma capsulatum var. capsulatum
    • Histoplasma capsulatum var. duboisii
    • Coccidioides immitis
    • Coccidioides posadasil
    • Paracococcidioides brasiliensis
    • Blastomyces dermatitidis
    Other pathogens under consideration: Acremonium spp, Alternaria spp, Fusarium spp, Scytalidium spp, Scopulariopsis spp, Curvularia spp, Botryodiplodia theobromae, Onycochola canadensis, Pyrenochaeta unguis-hominis, and (now thanks to you, Dr. Spalding) S. epidermitis.

    Again, I don't want to develop primers and probes to detect organisms that are clinically insignificant or unimportant for podiatrists. Thank you for the time you've given me so far and if you would care to shed more light on this additional information given, I'd be most grateful. If you would prefer a phone call, my number is (706) 878-0781. I promise the call would be pleasant and informative, and I can also share more details about my previous 7+ year history with testing for nail pathogens and why I desire to develop a better and more informative molecular panel.

    Thank you,

    MD
     
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