Re: More on Klempner's deceptiveness


derdrittemann2...@xxxxxxxxx wrote:
> GregGerber wrote:
>
> > I am saying that these criteria ARE diagnostic criteria, as well.
> > Dearborn is two things:
> >
> > 1. a surveillance and research standard as part of the case
> definition
> > 2. a diagnostic standard for confirmation of Lyme disease beyond
the
> > rash stage.
>
> Well, in what sense do you mean that Dearborn is "a diagnostic
> standard"?

In the sense that it IS a seroDIAGNOSTIC standard.

It is the criteria by which laboratories are supposed to interpret WB
results to determine whether they are "positive" or not.

Now, it is another issue what role serological results are supposed to
play in the diagnosis of Lyme--in the "clinical" diagnosis of Lyme.

According to the FDA bulletin, and the FDA licenses the manufacturers
of test kits who distribute their WB tests to various commercial labs,
results are not supposed to be used to make or break a Lyme diagnosis,
that clinical corroboration is required due to the unreliability of the
tests.

Lyme Disease Test Kits: Potential for Misdiagnosis
http://www.fda.gov/medbull/summer99/Lyme.html

FDA Medical Bulletin * Summer 1999 * Final Issue

Lyme Disease Test Kits: Potential for Misdiagnosis
By S. Lori Brown, Ph.D., M.P.H., Sharon L. Hansen, Ph.D., John J.
Langone, Ph.D., Nancy Lowe, M.A., and Nancy Pressly, B.S. Engr., Center
for Devices and Radiological Health

The Food and Drug Administration (FDA) is concerned about the potential
for misdiagnosis of Lyme disease based on the results of commonly
marketed tests for detecting antibodies to Borrelia burgdorferi, the
organism that causes Lyme disease. It is important that clinicians
understand that a positive test result does not necessarily indicate
current infection with B. burgdorferi, and a patient with active Lyme
disease may have a negative test result. (1-5)

The tests should be used only to support a clinical diagnosis of Lyme
disease and should never be the primary basis for making diagnostic or
treatment decisions. Diagnosis should be based on a patient history,
which includes symptoms and exposure to the tick vector and physical
findings. The most definitive diagnostic procedure is biopsy and
isolation of B. burgdorferi in culture.

Assays for anti-Borrelia burgdorferi (anti-Bb) can provide evidence of
previous or current infection, but to improve reliability FDA supports
the Centers for Disease Control and Prevention (CDC) recommendation for
two-step testing and interpretation of results (1).

The first step is to perform an assay that detects either total or
class-specific antibodies (IgM or IgG) by using enzyme-linked
immunosorbent technology ("ELISA" or "EIA") or indirect
immunofluorescence microscopy ("IFA"). IgM levels usually peak 3 to 6
weeks after infection. IgG antibodies begin to be detectable several
weeks after infection and may continue to develop for several months
and generally persist for years.

A negative result indicates only that there was no serologic evidence
of infection with B. burgdorferi. It should not be used as the basis
for excluding B. burgdorferi as the cause of illness, especially if the
blood was collected within 2 weeks of when symptoms began.
A positive or equivocal result is presumptive evidence of the presence
of anti-Bb. It should always be followed by second-step testing and
should not be reported until the second step testing is completed.

The second step is to perform a Western-blot (immunoblot) assay, a more
specific assay than that used for the first step

A negative result indicates that no reliable serologic evidence of B.
burgdorferi infection was present. A negative result should not be used
as the sole basis for excluding B. burgdorferi as the cause of illness.
If Lyme disease is suspected, a second specimen collected 2 to 4 weeks
after the first specimen should be tested. If retesting, do the first
step and if the result is positive or equivocal, do the second step.
A positive result provides serologic evidence of past or current
infection with B. burgdorferi. Because the presence of even specific
antibodies to B. burgdorferi does not always indicate current
infection, a positive result can support, but not establish, a clinical
diagnosis of Lyme disease.
Even using the two-step approach, the sensitivity and specificity of
the combined test results are inadequate. Because assays for anti-Bb
should be used only for supporting a clinical diagnosis of Lyme disease
and not for "screening" asymptomatic individuals, the result of the
first-step assay is best described as "initial" rather than
"screening." Likewise, the second-step Western-blot assay is best
described as "supplemental" rather than "confirmatory", because of the
low specificity for detecting IgM anti-Bb. Thus, a positive IgM anti-Bb
result alone is not adequate for supporting a diagnosis of Lyme disease
in persons with illness of greater than one-month duration.

Several factors contribute to the limitations of using ELISA, IFA, or
Western blot tests for supporting a diagnosis of Lyme disease. The
stage of disease in which the specimen was taken is critical. Many
patients with active or recent infections do not have detectable
anti-Bb in a single specimen. This happens because such antibodies
often develop after manifestations of early infection or because
detectable anti-Bb may diminish or never develop in patients treated
with antibiotics. Further, a positive test result can be true evidence
of previous infection with B. burgdorferi and unrelated to a current
illness. Assays for anti-Bb may yield false-positive results, because
antibodies to B. burgdorferiantigens may cross react with antigens
associated with autoimmune diseases or from infection with other
spirochetes, rickettsia, ehrlichia, or other bacteria such as
Helicobacter pylori. (6,7)

In summary, serologic testing is not useful early in the course of Lyme
disease, because of the low sensitivity of tests in early disease.
Serologic testing may be more useful in later disease at which time
sensitivity and specificity of the test is improved.

References

Center for Disease Control and Prevention. Recommendations for test
performance and interpretation from the second national conference on
serologic diagnosis of Lyme Disease. MMWR 1995; 44:590-591.
Association of State and Territorial Public Health Laboratory Directors
and the Centers for Disease Control and Prevention. Recommendations.
In: Proceedings of the Second National Conference on Serologic
Diagnosis of Lyme Disease (Dearborn, Michigan). Washington, DC:
Association of State and Territorial Public Health Laboratory Directors
1995; 1-5.
Craven RB, Quan TJ, Bailey RE, Dattwyler RJ, Ryan RW, Sigal LH, Steere
AC, Sullivan B, Johnson BJB, Dennis DT, Gubler DJ. Improved
serodiagnostic testing for Lyme disease; results of a multi center
serologic evaluation. Emerging Infect Dis 1996; 136-140.
Bakken LL, Callister SM, Wand PJ, Schell RF. Interlaboratory comparison
of test results for detection of Lyme disease by 516 participants in
the Wisconsin State Laboratory of Hygiene/College of American
Pathologists proficiency testing program. J Clin Microbiol 1997;
35:537-543.
Johnson RC, Johnson BJB. Lyme disease: serodiagnosis of Borrelia
burgdorferi sensu lato infection. In: Rose NR, Macario EC, Fahey JL,
Freidman H, Penn GM, eds. Manual of Clinical Laboratory Immunology, 5th
ed. Washington, DC: American Society for Microbiology, 1997: 526-533.
Magnarelli LA, Miller JN, Anderson JF, Riviere GR. Cross-reactivity of
nonspecific treponemal antibody in serologic tests for Lyme disease. J
Clin Microbiol 1990;28:1276-1279.
Schwan TG, Burgdorfer W, Rosa PA. Borrelia. In: Murray PR, Baron EJ,
Pfaller MA, Tenover FC, Yolken RH, eds. Manual of Clinical
Microbiology, 6th ed. Washington, DC: American Society for
Microbiology, 1995:626-635.

--------------------------------------------------------------------------------

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> See, I would say that the criteria are "serodiagnostic standards" for
> research and surveillance purposes.

I know you would and have been saying it.

But it is still wrong. And no matter how many times you say it, it
remains factually incorrect.

> They have, however, been adopted as a diagnostic tool in determining
> antibody responses in individual cases...but this is by reason of
> practice and custom.

NO absolutely not. The purpose of the Deaborn standard WAS for
diagnosis NOT for "research and surveillance."

Where on earth did you even come up with that?

> Whether a Western Blot is "confirmatory" of a positive ELISA or not
is
> usually...(NOT always)...determined by applying the surveillance
> criteria to the results.

No. No. No. No.

You're just continuing to make this more complicated. Continuing to
conflate various seperate and distinct things into one.

In fact the above statement is SO confused that it is hard to know
where to begin.

A WB is or is not positive according to the Deaborn criteria.

Always (*except as far as Igenex and perhaps ILADS is concerned).

If you have a positive ELISA, the next step is to perform a WB. This is
a "de novo" test--the ELISA now is meaningless except that it triggered
step 2, the WB. You preform the WB. It is read according to the Deaborn
criteria. It is positive or negative according to those criteria,
ALWAYS.

.

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