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» LymeNet Flash » Questions and Discussion » Medical Questions » IGeneX WB Results

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Author Topic: IGeneX WB Results
MarsyNY
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I am posting results of my 1st IgeneX WB as
I need feedback. I have read all information
pertaining to CDC bands and borrelia associated bands.
I am thinking that if my indeterminate bands are
borrelia specific I should have further testing?
Also confusion created in my mind by reading Dr.
Charle Jones - He says that band 18 is highly
specific to Lyme and is enough to conclude
a positive test. However I do not see any reference to this band anywhere else. Not much
about my positive 30 band either. What next?
More Lyme tests? co-infections tests? or Abx?
IND is described by Igenex as Band present with
intensity less than the weak - not to clear on
what that means either. I am obviously perplexed
by these results- have not shared with DR. yet.


IGENEX IGM RESULT : INDETERMINATE
18 +
22 -
**23-25 -
28 -
30 +
**31 -
**34 IND
37 -
**39 IND
**41 ++
45 -
58 IND
66 IND
73 -
83 -
93 -

INGENEX IGG RESULT : NEGATIVE
18 -
22 -
**23-25 -
28 -
30 -
**31 -
**34 -
37 -
**39 -
**41 ++
45 -
58 +
66 IND
73 -
83 -
**93 IND

Posts: 465 | From New York, NY | Registered: Aug 2005  |  IP: Logged | Report this post to a Moderator
treepatrol
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I would get a LLMD and have him/her do a 3 day urine test while on High dose of abx that way you would free up the rest of the antigens if there buzy fighting Bb {attached} to Bb abx will free them thus a better positive test.

If a third test is needed, a Lyme Urine Antigen Test {LUAT} is done instead of a third Western blot. Positive LUATs correspond very highly to patients getting better with antibiotics. False positive LUATs have not been a problem in my practice. The LUAT finds the actual antigen {Borrelia burgdorferi itself}, so arguably it should be the test of choice, but the Western blot is rn6re widely accepted, even though it looks for the antibodies against Borrelia burgdorferi. http://flash.lymenet.org/ubb/Forum1/HTML/022767.html


IGENEX IGM RESULT : INDETERMINATE
18 +
30 +
**41 ++
IgM levels usually peak 3-6 weeks after infection. From CDC
**34 IND
**39 IND
58 IND
66 IND
The antibody specificities of importance for the IgM blot are similar to those for the IgG blot {with the exception of 83-93 kDa, which is still being investigated for significance.} The CDC/ASTPHLD criteria for a positive result are two of the following three bands: 23-25 kDa (Osp C); 39 kDa; and/or 41 kDa.8,9 IGeneX adds the 31 kDa Osp A, and/or the 34 kDa Osp B to the criteria,10,12 with the argument that these two antigens are used for the vaccines and therefore their antibodies should be included in the interpretation of positivity. The IgM Western blot is often positive in patients with persistent infection.6 Sometimes it is the only antibody marker detected.
http://www.igenex.com/lymeset2.htm

INGENEX IGG RESULT : NEGATIVE
**41 ++
58 +
IgG antibodies begin to be detectable several weeks after infection. From CDC
66 IND
**93 IND
http://www.fda.gov/cdrh/lyme.html take with grain if salt.

Lyme Dot-Blot Assay LDA:3day urine test
The LDA was designed for the qualitative detection of Borrelia burgdorferi-specific antigens in human urine. The assay detects B. burgdorferi-specific antigens 23-25kD, 31kD, 34kD, 39kD, and 93kD. The test is now also available for Cerebral Spinal Fluid CSF.

Hope this helps [Eek!]
http://flash.lymenet.org/ubb/Forum1/HTML/026659.html

--------------------
Do unto others as you would have them do unto you.
Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.

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Posts: 10564 | From PA Where the Creeks are Red | Registered: Jun 2003  |  IP: Logged | Report this post to a Moderator
treepatrol
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18 kDa >.#p18 flagellin fragment
22 kDa >Immunogenic integral membrane lipoproteins. Cross-reactive with other spirochetes/bacteria. Depending on source, may be specific for Bb or cross-reactive. [Coleman]

23-25 kDa >OspC. 25 kDa is specific for Bb
28 kDa >.#OspD, Oms28. Specific for Bb
30 kDa >OspA substrate binding protein
31 kDa >OspA
34 kDa >OspB. Specific for Bb
37 kDa >p37, FlaA gene product. Specific for Bb
39 kDa >BmpA. Specific for Bb
41 kDa >FlaB
45 kDa >[Flisiak]; appears for HGE [Ravyn]
66 kDa >p66 Oms66 Hsp outer/integral membrane protein
83 kDa >p83 high molecular mass protein.Specific for Bb
93 kDa >an immunodominant protoplasmic cylinder antigen, associated with the flagellum. Specific for Bb

Abbreviations:
Bb Borrelia burgdorferi
Bmp Bacterial membrane protein
Fla Flagellin
HGE Human granulocytic ehrlichiosis
kDa kilodalton = molecular weight
Oms Outer membrane-spanning
Osp Outer surface proteins
p Protein

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:::::::::::::::::

Each part of the Lyme bacteria weighs a certain amount. For example, the tail of the Lyme bacteria weighs 41 kilodaltons (kDa). Think of kilodaltons like pounds, ounces or kilograms. The numbers on a Western blot such as 23, 31, 34 or 39 refer to how much that particular part of the bacteria weighs in kilodaltons. The significant antibodies, in my opinion, are the 18, 23-25, 28, 30, 31, 34, 39, 58, 66 and 93.
Dr C in M

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DIAGNOSTIC HINTS
http://www.ilads.org/burrascano_1102.htm#lyme_bor

Lyme is diagnosed clinically, as no currently available test, no matter the source or type, is definitive in ruling in or ruling out infection with these pathogens, or whether these infections are responsible for the patient's symptoms. The entire clinical picture must be taken into account, including a search for concurrent conditions and alternate diagnoses, and other reasons for some of the presenting complaints. Often, much of the diagnostic process in late, disseminated Lyme involves ruling out other illnesses and defining the extent of damage that might require separate evaluation and treatment.

Consideration should be given to tick exposure, rashes (even atypical ones), evolution of typical symptoms in a previously asymptomatic individual, and results of tests for tick-borne pathogens. Another very important factor is response to treatment -- presence or absence of Jarisch Herxheimer-like reactions, the classic four-week cycle of waxing and waning of symptoms, and improvement with therapy.


ERYTHEMA MIGRANS

Erythema migrans (EM) is diagnostic of Bb infection, but is present in fewer than half. Even if present, it may go unnoticed by the patient. It is an erythematous, centrifugally expanding lesion that is raised and warm. Sometimes there is mild stinging or pruritus. The EM rash will begin four days to several weeks after the bite, and may be associated with constitutional symptoms. Multiple lesions are present less than 10% of the time, but do represent disseminated disease. Some lesions have an atypical appearance and skin biopsy specimens may be helpful. When an ulcerated or vesicular center is seen, this may represent a mixed infection, involving other organisms besides B. burgdorferi.

After a tick bite, serologic tests (ELISA. IFA, western blots, etc.) are not expected to become positive until several weeks have passed. Therefore, if EM is present, treatment must begin immediately, and one should not wait for results of Borrelia tests. You should not miss the chance to treat early disease, for this is when the success rate is the highest. Indeed, many knowledgeable clinicians will not even order a Borrelia test in this circumstance.


DIAGNOSING LATER DISEASE

When reactive, serologies indicate exposure only and do not directly indicate whether the spirochete is now currently present. Because Bb serologies often give inconsistent results, test at more than one laboratory using, if possible, different methods. The suggestion that two-tiered testing, utilizing an ELISA as a screening tool, followed, if positive, by a confirmatory western blot, is illogical in this illness. The ELISA is not sensitive enough to serve as an adequate screen, and there are many patients with Lyme who test negative by ELISA yet have fully diagnostic western blots. I therefore recommend against using the ELISA. Order IgM and IgG western blots -- but be aware that in late disease there may be repeatedly peaking IgM's and therefore a reactive IgM may not differentiate early from late disease, but it does suggest an active infection. When late cases of LB are seronegative, 36% will transiently become seropositive at the completion of successful therapy.

Western blots are reported by showing which bands are reactive. 41KD bands appear the earliest but can cross react with other spirochetes. The 18KD, 23-25KD (Osp C), 31KD (Osp A), 34KD (Osp B), 37KD, 39KD, 83KD and the 93KD bands are the most specific but appear later or may not appear at all. You need to see at least the 41KD and one of the specific bands. 55KD, 60KD, 66KD, and 73KD are nonspecific and nondiagnostic.

PCR tests are now available, and although they are very specific, sensitivity remains poor, possibly less than 30%. This is because Bb causes a deep tissue infection and is only transiently found in body humors. Therefore, just as in routine blood culturing, multiple specimens must be collected to increase yield; a negative result does not rule out infection, but a positive one is significant. You can test whole blood, buffy coat, serum, urine, spinal and other body fluids, and tissue biopsies. Several blood PCRs can be done, or you can run PCRs on whole blood, serum and urine simultaneously at a time of active symptoms. The patient should be antibiotic free for at least six weeks before testing to obtain the highest yield.

Antigen capture is becoming more widely available, and can be done on urine, CSF, and synovial fluid.

Sensitivity is still low, but specificity is high.

Spinal taps are not routinely recommended, as a negative tap does not rule out Lyme. Antibodies to Bb most commonly are found in Lyme meningitis, but are rarely seen in non-meningitic CNS infection, including even advanced encephalopathy. Even in meningitis, antibodies are detected in the CSF in less than 20% of patients with late disease. Therefore, spinal taps are only performed on patients with pronounced neurological manifestations in whom the diagnosis is uncertain, if they are seronegative, or are still significantly symptomatic after completion of treatment. When done, the goal is to rule out other conditions, and to determine if Bb antigens or nucleic acids are present. It is especially important to look for elevated protein and mononuclear cells, which would dictate the need for more aggressive therapy, as well as the opening pressure, which can be elevated and add to headaches, especially in children.

I strongly urge you to biopsy all unexplained skin lesions/rashes and perform PCR and careful histology. You will need to alert the pathologist to look for spirochetes.

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DIAGNOSTIC CHECKLIST

To aid the clinician, a workable set of diagnostic criteria was developed with the input of dozens of front line physicians. The resultant document has proven to be extremely useful not only to the clinician, but it also can help clarify the diagnosis for third party payers and utilization review committees. It is important to note that the CDC's published reporting criteria are for surveillance only, not for diagnosis.

LYME BORRELIOSIS DIAGNOSTIC CRITERIA RELATIVE VALUE
1
Tick exposure in an endemic region 2
Historical facts and evolution of symptoms consistent with Lyme
Systemic signs & symptoms consistent with Bb infection (other potential diagnoses excluded):
Single system, e.g., monoarthritis 1
Two or more systems, e.g., monoarthritis and facial palsy 2
Erythema migrans, physician confirmed 7
Acrodermatitis Chronica Atrophicans, biopsy confirmed 7
Seropositivity 3
Seroconversion on paired sera 4
Tissue microscopy, silver stain 3
Tissue microscopy, monoclonal immunofluorescence 4
Culture positivity 4
B. burgdorferi antigen recovery 4
B. burgdorferi DNA/RNA recovery 4

DIAGNOSIS

Lyme Borreliosis Highly Likely 7 or above
Lyme Borreliosis Possible 5-6
Lyme Borreliosis Unlikely 4 or below

I suggest that when using these criteria, you state Lyme Borreliosis is ``unlikely,'' ``possible,'' or ``highly likely'' based upon the following criteria--then list the criteria.

--------------------
Do unto others as you would have them do unto you.
Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.

Newbie Links

Posts: 10564 | From PA Where the Creeks are Red | Registered: Jun 2003  |  IP: Logged | Report this post to a Moderator
MarsyNY
LymeNet Contributor
Member # 7766

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Tree,

I like this idea of antibiotics followed by
3 day urine test - LDA however not available
in New York State.

What about the LUAT is that availabe here?
Which lab does this test. And should it be
done before after or while on antibiotics?

I do not see this test listed in the IgeneX folder.

Maybe a Bowen test is next. Certainly a picture
of spirochetes in my blood would not have me
hestitate to take antibiotics.

Just not sure ....

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8man12
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Are Igenex tests FDA,approved? I was just wondering,i had a doctor tell me to throw mine in the trash.Then i had to get one from Stoneybrook,dont know what it was all about,except it was alot of cash to throw away.
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MarsyNY
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8Man,

It is my understanding that some of the tests
are FDA approved like the Elisa, C6 peptide assay and Western Blot
Others like the Lyme urine antigen are not.

How did your Stonybrook tests turn out? Mine
were always negative. I'd be interested to know
what your IgeneX tests showed before they went
in the trash!

What kind of Dr. says that anyway?

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MarsyNY
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Member # 7766

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Tree,

I found a publication that states that the LUAT
you referred to has been replaced by the LDA.
(2002)Next generation - it states that the concept of antigen testing is the same for both
methods, but the methods are different.

I would have to be a resident
of another state to have this test done.

Looks like it is a wonderful diagnostic test
early and late when the serological response
has disappeared.

Anybody reading had this test? & what were
the results?

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