FYI: IGenex Testing thru them: western blot, pcr...

Discussion in 'Lyme Disease Archives' started by victoria, Jun 1, 2006.

  1. victoria

    victoria New Member

    This is quoted directly from them...

    I'm just including the info on the Western Blot/IgG, the one most LLMDs go by, I believe... plus the PCR... you can go to their website and read more.


    Lyme Antibody Serology

    Lyme IgG/IgM Antibody Serology

    The Lyme IgG/IgM Antibody Serology test is an enzyme linked immunoassay (ELISA) which indicates the presence of IgG and IgM antibodies to B. burgdorferi. The IgG antibody often persists long after symptoms have disappeared. The presence of antibody indicates exposure, not necessarily active disease. A positive or equivocal result must be confirmed by both IgG and IgM Western Blots.

    Lyme IgM Antibody Serology

    The Lyme IgM Antibody assay is another serologic test in ELISA format, and it detects the presence of IgM antibodies after exposure to an infected tick. IgM antibodies apppear EARLY in response to infection, and this test may be positive two to six weeks following exposure. Because of the test's lack of specificity, a positive or equivocal result must be confirmed by an IgM Western Blot.

    Lyme Western Blot

    IgG Western Blot

    The IgG Western Blot is a sandwich-type immunoassay performed in a manner that allows the antibody response to be visualized. It is a qualitative test and is generally more sensitive and specific than the ELISA.

    IgG and/or IgM Western Blot

    Polymerase Chain Reaction

    Detection of Borrelia burgdorferi with the Multiplex PCR

    The multiplex polymerase chain reaction (PCR) is a very specific and sensitive assay for the detection of Borrelia burgdorferi-specific DNA in clinical specimens. Theoretically, the assay can be performed on any sample. B. burgdorferi-specific genomic and plasmid DNA are simultaneously selected, amplified, and detected. A negative result implies only that B. burgdorferi-specific DNA was not detected in the test sample. While the PCRs potential sensitivity is tremendous, the sample tested must contain at least one recoverable organism for the genomic assay, and pieces or blebs of antigen for the plasmid assay.

    Which tests to perform?


    There is a logical sequence in selecting laboratory tests to aid in the diagnosis of Lyme disease. Much like the hepatitis model, antigen is present early after initial infection. Later, there is an antibody response in about 70% of patients. IgM appears first and is followed by IgG. There are two different types of antibody assays: the ELISA and the Western Blot. The ELISA is a poor assay, with marginal sensitivity. The Western Blot is the more sensitive test.

    Recurrent and persistent infections offer a unique diagnostic problem, since the IgG response may be absent.

    The antigen detection tests and the PCR can be complementary to one another. Antigen detection assays and/or the PCR should be considered for studying the joint fluid, when indicated, and the cerebral spinal fluid, in the presence of neurological symptoms. All assays, including the PCR and the antigen detection, may be required under certain circumstances.


    The IgG Western Blot is a sandwich-type immunoassay performed in a manner that allows visualization of the patient's antibodies. It is a qualitative test and is generally more sensitive and specific than the ELISA. This test must be used if the Lyme IgG/IgM antibody serology is equivocal or positive. The somewhat-specific Lyme antibodies of importance are against the following molecular weights of the B. burgdorferi antigens: 23-25 kDa (Osp C); 31 kDa (Osp A); 34 kDa (Osp B); 39 kDa; 41 kDa; and 83-93 kDa7. "kDa" is the abbreviation for "kilodalton," which is used for molecular weight designations. "Osp" refers to outer surface protein of the bacteria.

    There are currently multiple criteria that support a positive blot. "Positive" means that certain antibodies to B. burgdorferi are present. The CDC/ASTPHLD criteria are very conservative, require 5 of 10 bands (antibodies) for a positive result, and do not recognize equivocal or borderline results.8,9 These criteria would be more appropriate for a formal clinical study during early Lyme disease.

    IGeneX has several years of clinical data that support more liberal reporting criteria.10 In addition, current studies show that the CDC/ASTPHLD criteria miss some patients with culture-proven erythema migrans (EM).5,11 Both the IGeneX and the CDC/ASTPHLD criteria are included on the IGeneX report form sent to the physician. 3,5,8,9

    The Western Blot involves a highly complex visual determination of protein bands, based on their molecular weights and intensities. The IGeneX report form provides an interpretation along with the results in detail.

    A positive IgG result with clinical history may be indicative of Lyme disease. Patients with other spirochetal disease and/or who test positive for rheumatoid factor or Epstein Barr virus may have cross-reacting antibodies. A positive response in this, as in any antibody assay, indicates sensitization, not necessarily active disease. 12

    Ordering multiple tests, such as the ELISA, Western Blot, Antigen Capture, and PCR, is significantly more efficient in a clinical diagnosis than is any single test.

    Hope this helps!


    IGeneX, Inc.
    795 San Antonio Rd., Palo Alto, CA 94303 USA
    Tel. 650.424.1191 / 800.832.3200 Fax. 650.424.1196
    [This Message was Edited on 06/01/2006]
  2. jarjar

    jarjar New Member

    Dr. C who is very respected in the Lyme world only uses the Igenex IgG and IgM.

    I had an extra Igenex PCR test taken by another Dr. and he said he doesn't use it. His take is the Western Blot is going to tell him what he needs and the PCR is of questionable use for initial diagnosis.

    So my take is save your money for initial test and use the Western Blot mentioned above.


  3. victoria

    victoria New Member

    and I think (my interpretation) that IGenex is just saying that if you have all of it done, the better the substantiation...

    My son's LLMD - also extremely respected - only did the western blot as well Jay, so I agree with you.

    Just thought I'd include it since many docs do order it as well -- or instead - as the more info/knowledge a patient is armed with, the better!


    [This Message was Edited on 06/01/2006]
  4. jarjar

    jarjar New Member

    I should have left the highly respected line out! There are many highly respected LLMD's as I'm sure yours is also.

    My main point was for people to watch out for their pocketbook as test can be draining. My PCR test came back negative but my western blot was a "no brainer" for a lyme diagnosis.

    I remember my Health Insurance company would only pay for 2 lyme test per visit. So they tried to stick me for an extra 200 bucks for the PCR. test. Long story but they finally paid a portion.

  5. victoria

    victoria New Member

    oh - absolutely NO offense taken actually...

    I find it quite interesting how the LLMDs on the frontlines see things a bit differently as to what works, what doesn't, etc...

    I also appreciate the fact that the LLMDs do actually read the research and listen totheir patients!

    but I'm extremely upset by the overall ignorance and indifference of the 'system' to the stealth pathogens! Adding fuel to the fire is getting my copy of 'Project Day Lily" yesterday, just started it.

    all the best,
  6. redsox10

    redsox10 New Member

    HI Victoria,

    What is project Day Lily?

    I am having so many problems getting labs covered. My daughter just had PCR testing done by MDL. I tried to get preauthorization and they refused to pay. My daughters primary care wrote a letter on why she needs this done. My daughter has been doing worse lately and sure enough her Babesia load has increased. I am going to fight this.

    Having 2 children with Lyme is financially breaking us. I know I most likely have Lyme and do not have the financial means to do anything about it right now. A sad world we live in.
  7. victoria

    victoria New Member

    is a book written by Drs. Garth & (wife) Nicolson about their experiences with gulf war illness and their finding that mycoplasma seems to have been bioengineered and experimented with on our troops, probably by our own gov't if not also Iraqi.

    There's several posts about it on the CF/FM board... it is also sold thru Amazon. It's written as a 'fiction' book so they can't get sued by anyone.... but the facts are true even if all the names are not.

    I am not surprised about your insurance company not covering the tests... I think there is balking at it if one does not live in an 'endemic' area or visited there...

    We have so far been paying everything out of pocket anyway since our son is 18... like, who's gonna insure him when he's not a student (can't go to school right now cuz of cognitive problems). - and even if they did, those exclusions are always there!

    .. and anyway, all I can afford is hospitalization. with a high deductible as it is.

    We are working to get him on SSI and hopefully some pt assistance programs for meds... maybe even emergency Medicaid. But even Medicaid only pays for 4 weeks of IV abx if it comes to that....

    It is hard, very hard, to get treated adequately in this country if you do not have $$ or good insurance. I know people who work or work for certain places only for the sole reason of just getting good health insurance. And yet the insurance companies are posting record profits, despite katrina, etc.!

    all the best,

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