Re: More on Klempner's deceptiveness




derdrittemann2...@xxxxxxxxx wrote:
> a_weisman@xxxxxxxxx wrote:
> >>
> > "This is really frustrating. I don't think that this should be so
> > difficult for someone as intelligent as you to get".
>
>
> To your knowledge, are Western Blots USUALLY interpreted according to
> the same criteria (2 of 3 IgM...5 of 10 IgG) as per the CDC
> surveillance CRITERIA?

The CDC surveillance criteria provide as follows for for laboratory
confirmation:

EXCERPT (full text below):

Laboratory criteria for diagnosis:

Isolation of Borrelia burgdorferi from a clinical specimen or
Demonstration of diagnostic immunoglobulin M or immunoglobulin G
antibodies to B. burgdorferi in serum or cerebrospinal fluid (CSF). A
two-test approach using a sensitive enzyme immunoassay or
immunofluorescence antibody followed by Western blot is recommended
(7).

Footnote 7:

CDC. Recommendations for test performance and interpretation from the
Second National Conference on Serologic Diagnosis of Lyme Disease. MMWR
1995;44:590-1.

_______________________________________________________________________

So the answer is YES, they are ALWAYS interpreted that way. (*except
for Igenex and ILADS).

However, the Dearborn criteria ARE for serodiagnosis. They are NOT for
"research and surveillance." They are USED as part of the surveillance
case definition criteria for laboratory confirmation.

NOTE: TO meet the CDC surveillance case defintion and to thus be a "CDC
positive case" (meaning that your case would be one of the 15, 0r 20 or
last year I think it was 22,000 cases reported annually, you need:

EM Rash (as defined by CDC, meaning physician diagnosed and at least 5
by 5 cm)

OR

BOTH of the following:

At least ONE "late manfistation" (as they define them)

AND Laboratory confirmation (as defined by them)



______________________________________________________________________

Division of Public Health Surveillance and Informatics
http://www.cdc.gov/epo/dphsi/casedef/lyme_disease_current.htm

Lyme Disease (Borrelia burgdorferi)

1996 Case Definition
Clinical description
A systemic, tickborne disease with protean manifestations, including
dermatologic, rheumatologic, neurologic, and cardiac abnormalities. The
best clinical marker for the disease is the initial skin lesion (i.e.,
erythema migrans [EM]) that occurs in 60%-80% of patients.

Laboratory criteria for diagnosis
Isolation of Borrelia burgdorferi from a clinical specimen or
Demonstration of diagnostic immunoglobulin M or immunoglobulin G
antibodies to B. burgdorferi in serum or cerebrospinal fluid (CSF). A
two-test approach using a sensitive enzyme immunoassay or
immunofluorescence antibody followed by Western blot is recommended
(7).
Case classification
Confirmed: a) a case with EM or b) a case with at least one late
manifestation (as defined below) that is laboratory confirmed.

Comment
This surveillance case definition was developed for national reporting
of Lyme disease; it is not intended to be used in clinical diagnosis.

Definition of terms used in the clinical description and case
definition:

Erythema migrans. For purposes of surveillance, EM is defined as a skin
lesion that typically begins as a red macule or papule and expands over
a period of days to weeks to form a large round lesion, often with
partial central clearing. A single primary lesion must reach greater
than or equal to 5 cm in size. Secondary lesions also may occur.
Annular erythematous lesions occurring within several hours of a tick
bite represent hypersensitivity reactions and do not qualify as EM. For
most patients, the expanding EM lesion is accompanied by other acute
symptoms, particularly fatigue, fever, headache, mildly stiff neck,
arthralgia, or myalgia. These symptoms are typically intermittent. The
diagnosis of EM must be made by a physician. Laboratory confirmation is
recommended for persons with no known exposure.
Late manifestations. Late manifestations include any of the following
when an alternate explanation is not found:
Musculoskeletal system. Recurrent, brief attacks (weeks or months) of
objective joint swelling in one or a few joints, sometimes followed by
chronic arthritis in one or a few joints. Manifestations not considered
as criteria for diagnosis include chronic progressive arthritis not
preceded by brief attacks and chronic symmetrical polyarthritis.
Additionally, arthralgia, myalgia, or fibromyalgia syndromes alone are
not criteria for musculoskeletal involvement.
Nervous system. Any of the following, alone or in combination:
lymphocytic meningitis; cranial neuritis, particularly facial palsy
(may be bilateral); radiculoneuropathy; or, rarely, encephalomyelitis.
Encephalomyelitis must be confirmed by demonstration of antibody
production against B. burgdorferi in the CSF, evidenced by a higher
titer of antibody in CSF than in serum. Headache, fatigue, paresthesia,
or mildly stiff neck alone are not criteria for neurologic involvement.

Cardiovascular system. Acute onset of high-grade (2nd-degree or
3rd-degree) atrioventricular conduction defects that resolve in days to
weeks and are sometimes associated with myocarditis. Palpitations,
bradycardia, bundle branch block, or myocarditis alone are not criteria
for cardiovascular involvement.
Exposure. Exposure is defined as having been (less than or equal to 30
days before onset of EM) in wooded, brushy, or grassy areas (i.e.,
potential tick habitats) in a county in which Lyme disease is endemic.
A history of tick bite is not required.
Disease endemic to county. A county in which Lyme disease is endemic is
one in which at least two confirmed cases have been previously acquired
or in which established populations of a known tick vector are infected
with B. burgdorferi.
See also:
1995 Case Definition
http://www.cdc.gov/epo/dphsi/casedef/lyme_disease_1995.htm

Lyme Disease (Borrelia burgdorferi)

1995 Case Definition
Clinical description
A systemic, tick-borne disease with protean manifestations, including
dermatologic, rheumatologic, neurologic, and cardiac abnormalities. The
best clinical marker for the disease is the initial skin lesion,
erythema migrans, that occurs among 60%-80% of patients.

Clinical case definition
Erythema migrans, or
At least one late manifestation, as defined below, and laboratory
confirmation of infection
Laboratory criteria for diagnosis
Isolation of Borrelia burgdorferi from clinical specimen, or
Demonstration of diagnostic levels of IgM and IgG antibodies to the
spirochete in serum or CSF, or
Significant change in IgM or IgG antibody response to B. burgdorferi in
paired acute- and convalescent-phase serum samples
Case classification
Confirmed: a case that meets one of the clinical case definitions above

Comment
This surveillance case definition was developed for national reporting
of Lyme disease; it is NOT appropriate for clinical diagnosis.

Definition of terms used in the clinical description and case
definition:

A. Erythema migrans (EM)
For purposes of surveillance, EM is defined as a skin lesion that
typically begins as a red macule or papule and expands over a period of
days to weeks to form a large round lesion, often with partial central
clearing. A solitary lesion must reach at least 5 cm in size. Secondary
lesions may also occur. Annular erythematous lesions occurring within
several hours of a tick bite represent hypersensitivity reactions and
do not qualify as EM. For most patients, the expanding EM lesion is
accompanied by other acute symptoms, particularly fatigue, fever,
headache, mild stiff neck, arthralgia, or myalgia. These symptoms are
typically intermittent. The diagnosis of EM must be made by a
physician. Laboratory confirmation is recommended for persons with no
known exposure.

B. Late manifestations

Late manifestations include any of the following when an alternate
explanation is not found:
Musculoskeletal system
Recurrent, brief attacks (weeks or months) of objective joint swelling
in one or a few joints, sometimes followed by chronic arthritis in one
or a few joints. Manifestations not considered as criteria for
diagnosis include chronic progressive arthritis not preceded by brief
attacks and chronic symmetrical polyarthritis. Additionally,
arthralgia, myalgia, or fibromyalgia syndromes alone are not criteria
for musculoskeletal involvement.
Nervous system
Any of the following, alone or in combination: Lymphocytic meningitis;
cranial neuritis, particularly facial palsy (may be bilateral);
radiculoneuropathy; or, rarely, encephalomyelitis. Encephalomyelitis
must be confirmed by showing antibody production against B. burgdorferi
in the cerebrospinal fluid (CSF), demonstrated by a higher titer of
antibody in CSF than in serum. Headache, fatigue, paresthesia, or mild
stiff neck alone are not criteria for neurologic involvement.
Cardiovascular system
Acute onset, high-grade (2nd or 3rd degree) atrioventricular conduction
defects that resolve in days to weeks and are sometimes associated with
myocarditis. Palpitations, bradycardia, bundle branch block, or
myocarditis alone are not criteria for cardiovascular involvement.
C. Exposure

Exposure is defined as having been in wooded, brushy, or grassy areas
(potential tick habitats) in a county in which Lyme disease is endemic
no more than 30 days before onset of EM. A history of tick bite is NOT
required.

D. Disease endemic to county

A county in which Lyme disease is endemic is one in which at least two
definite cases have been previously acquired or in which a known tick
vector has been shown to be infected with B. burgdorferi

E. Laboratory confirmation

As noted above, laboratory confirmation of infection with B.
burgdorferi is established when a laboratory isolates the spirochete
from tissue or body fluid, detects diagnostic levels of IgM or IgG
antibodies to the spirochete in serum or CSF, or detects a significant
change in antibody levels in paired acute- and convalescent-phase serum
samples. States may determine the criteria for laboratory confirmation
and diagnostic levels of antibody. Syphilis and other known causes of
biologic false-positive serologic test results should be excluded when
laboratory confirmation has been based on serologic testing alone.
See also:
1996 Case Definition

.



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