<<Disclaimer: Verify this information before applying it to your situation.>>

I wrote:

> "Does anybody know of a diagnostic lab that regularly screens blood and
> tissue biopsies for celiac disease in the northwest?  I have family
> members ready to be tested, but I want to make sure that the lab they
> choose is used to screening for the disease."

Here are all of the responses I received:

I am not sure about labs in the NW, but the blood samples can be drawn
and sent to Dr. Fassano at University of Maryland I believe for free.
You can access his website and  their are detailed instructions on how
to get the blood draw kit and what to do after it is drawn.

****************************************************************************
****

Our daughter had hers drawn when one of the support groups in the area
had a blood draw and her screening was done by University of Maryland.
The only drawback is that it takes about 6-8 weeks to get the results if
you are feeling ill and need the info right away.  I think that she made
a donation when she signed up for the screening, but that was just a
voluntary donation.

****************************************************************************
****

Be sure and check out Enterolab, by Dr. Fine before you choose a local
lab.  His website at www.finerhealth.com is very good at describing the
pitfalls of ordinary testing.  He has a simple stool test that shows wheat,
yeast allergies at the gut level, that are far more accurate than what is
currently being used.

************************************************************************

They can still use the Baltimore Lab of Dr.Fasano even if they live out
West.  If they would rather use a lab out there I suggest they call
Dr.Fasano's lab and speak to the techs.  I'm sure they can give you a name
of a Northwest lab.  Dr. Fasano's phone number is (410)706-1997.

************************************************************************

Any doc can send your tests to the proper lab, Susan. If they won't, go to
another doc.

There are only a handful of labs in the US that are competent
to evaluate the tests for celiac -- this includes both the
blood tests and the biopsy. Tests done at other labs
are likely to return from 20 to 50 percent false negative
readings.

Below is a list, that I gleaned and put together off the list,
of reliable labs in the US and an explanation of the various
blood tests. -vance

In the scheme of medical expenses, the gluten antibody tests
are relatively inexpensive, coming in at under $200.00 for
the entire panel. Currently, these tests are performed at
five or six locations in the US (call for information on how
to prepare the blood sample)."

For an excellent in depth explanation of the tests and what
they mean, try this website:
http://www.enabling.org/ia/celiac/diag-tst.html#US
RELIABLE LABS FOR EVALUATING TESTS FOR CELIAC

1) IMMCO Diagnostics, 963 Kenmore Avenue, Buffalo, NY 14223
716-876-5672, 1-800-537-TEST (8378), [log in to unmask]

2) Immunopathology Laboratory, Dept. of Pathology, 5233 RCP,
University of Iowa Hospitals and Clinics, 200 Hawkins Drive,
Iowa City, IA 52242, phone (319/356-2688/8470)

3) U. of Maryland at Baltimore (Baltimore, MD) 1-410-706-1997:
Pediatric Gastroenterology & Nutrition Laboratory,
UMAB/Bressler Research Building, Room 10-047, 655 West
Baltimore Street, Baltimore, MD, 21201, Attention:
Karoly Horvath, MD, or Athba Hammed, Research Assistance.
Phone (410) 706-1997 or Fax (410) 328-1072. Baltimore is where
the 3-year blood study is being done for celiac disease and
their first degree relatives. Dr. Fasano and Dr. Horvath are
very involved with celiac research there.

4) Specialty Laboratories, 2211 Michigan Avenue, Santa Monica,
CA 90404, phone (800) 421-7110, HTTP://WWW.SPECIALTYLABS.COM

5) Mayo clinic has only recently admitted that any normal foods
you eat can make you sick, but since making that step they have
become very expert at celiac: Joe Murry has a book on celiac
and is perhaps the best known authority on the disease. Mayo
Clinic: Dr. Joe Murray now works there.

 >http://www.mayohealth.org/mayo/common/htm/index.htm

6) Prometheus, Inc. 5739 Pacific Center Boulevard - San Diego,
California 92121, Tel: (619) 824-0895 / Toll Free (888) 423-5227 / Fax:
(619) 824-0896:

The president of Prometheus wrote the following to me: "The
company is completely focused on gastrointestinal diseases,
with particular expertise in Inflammatory Bowel Disease and
Celiac Disease. We have, in my humble opinion, the best option
for Celiac testing. In fact, at the recent International Celiac
Disease Meeting held in Marina Del Rey, CA, Dr. Peter Green
from NY described a case where a specimen was sent to one lab,
and came back negative. Due to his suspicion, he then had the
specimen sent specifically to Prometheus, which he uses regularly.

Result: Positive. And now, correlated with biopsy.

In a nutshell, not all labs or all tests are the same. Prometheus
worked very closely with the leading clinical research specialists
and pediatric gastroenterologists to optimize their testing system,
and then validated it with their clinical specimen banks. Elaine
Monarch of the Celiac Disease Foundation can confirm our focused
efforts in this area, as can the clinicians, like Dr. Green, who
rely on Prometheus for the absolute best in Celiac Disease
serological assessment.

Editor at fault: [log in to unmask] I will add here, that if you choose to
have a biopsy done, you should have from 12 to 20 samples taken -- not
just the 2 or 3 that many docs want to get by with.

************************************************************************

The following detailed explanation of celiac tests is from Tom Ryan,
Technical Service Specialist, INOVA Diagnostics, Inc.

There has been a lot of discussion about serological testing for celiac
disease recently, specifically regarding tTG (tissue Transglutaminase)
testing.  I will try to answer some of the many questions that have
appeared on this list about all of the tests.  First, and this applies
to any of the blood tests, you must currently be on a gluten containing
diet for the tests to be accurate.  Antibodies are produced by the
immune system in response to substances that the body perceives as
threatening.  The immune response that your body produces is it's
response to being exposed to gluten in the diet and it's subsequent
effect on the intestinal mucosa.  If there is no gluten in the diet,
then there is no response that we can measure.  A brief change in diet
will not have a noticeable effect.  If you have been gluten free for a
week or so, it won't make any great difference.  The response might be
marginally less but the difference is insignificant because the body has
not had time to respond to the change.  Conversely, if you have been
gluten free for a protracted period of time and decide to be tested, a
brief challenge of a couple of weeks is not enough to elicit a response
and get an accurate test.  There are several steps that take place to
generate an immune response and it takes time both for the positive
reaction when gluten is present and to clear the antibodies when gluten
is eliminated.  There has been a great deal of discussion about how much
and how long a challenge should be and there is no consensus.  Talk with
your Doctor.  My personal feeling is that the minimum is 2 slices of
bread per day for 6 weeks to get an accurate test but I would not try to
second guess the Doctor.  There are basically four tests that can be
performed to aid in diagnosing celiac disease.  Notice that I say they
will "aid" in diagnosing celiac disease.  Immunology is fairly accurate
but it is far from being an exact science.  All of the lab tests,
regardless of the type or source, are presented as aids to diagnosis.
They should not be used alone as a basis for diagnosis but rather are
intended to be considered in conjunction with the physical examination
of the patient as well as the reported symptoms, etc.  by a trained
physician.  There has been a great deal of confusion about what the
tests are and I hope to alleviate some of the misunderstandings.  There
are many terms that we hear.  tTG, IgA, IgG, ELISA, etc.  What are all
of these?  Some contributors to the list make reference to the "IgA" or
"IgG" test or to the "ELISA" test.  These labels are incomplete for our
purposes and could be referring to any number of different tests.

We all have, within our bodies, a family of closely related although
not identical proteins that are capable of acting as antibodies.
These are collectively referred to as "immunoglobulins". Five major
types of immunoglobulins are normally present in the human adult. They
are IgG, IgA, IgM, IgE and IgD. Each of these is a shorthand way of
writing "immunoglobulin gamma G" (or A or M, etc.) and they each
perform a different function in our systems. IgG is the principal
immunoglobulin in human serum. It is important in providing immunity
in a developing fetus because it will pass across the placental
barrier. IgA is the principal immunoglobulin in secretions from
respiratory and intestinal mucosa. IgE is a gamma globulin produced
by cells lining the intestinal and respiratory tracts. It produces
the antibodies associated with most hypersensitivity (allergic)
responses. It is associated with asthma, hay fever, etc. IgM is a
globulin formed in almost every immune response in the early part
of the reaction. IgD is a rare protein present in normal sera in a
tiny amount. These designations refer to the type of protein that
is carrying the antibody in question. Both IgG and IgA subtypes of
anti-gliadin antibody are produced, hence we refer to them as "IgG
gliadin" or "IgA gliadin". Collectively they are anti-gliadin
antibodies.

ANTI-GLIADIN ANTIBODIES:

Both IgA and IgG anti-gliadin antibodies (AGA) are detected in sera of
patients with gluten sensitive enteropathy (celiac disease). IgG anti-
gliadin antibodies are more sensitive but are less specific markers for
disease compared with IgA class antibodies. IgA anti-gliadin antibodies
are less sensitive but are more specific. In clinical trials, the IgA
antibodies have a specificity of 97% but the sensitivity is only 71%.
That means that, if a patient is IgA positive, there is a 97%
probability that they have CD. Conversely, if the patient is IgA
negative, there is only a 71% probability that the patient is truly
negative for CD. Therefore, a positive result is a strong indication
that the patient has the disease but a negative result doesn't
necessarily mean that they don't have it.  False positive results are
rather uncommon but false negative results can occur.

On the other hand, the IgG anti-gliadin antibodies are 91% specific and
have an 87% sensitivity. This means that they will show positive results
more readily but there isn't as strong a correlation with CD. It is
less specific. Patients with other conditions but not afflicted with
CD will occasionally show positive results. IgG anti-gliadin antibodies
are detectable in approximately 21% of patients with other gastrointestinal
disorders. This test might yield false positive results but is less
likely to yield false negative results.

A sensitive testing protocol includes testing for both IgA and IgG
anti-gliadin antibodies since a significant portion of celiac patients
(approx. 2-5%) are IgA deficient. This combined IgA and IgG
anti-gliadin antibody assay has an overall sensitivity of 95% with a
specificity of 90%.

The type of test used to detect the anti-gliadin antibodies is called
an ELISA. This is an acronym and it stands for Enzyme Linked Immuno-
Sorbent Assay. "ELISA" is not a test in itself. It is a method of
testing and it is a relatively simple test to perform. It involves
putting a measured amount of diluted patient serum into the wells of a
specially constructed and prepared plate and incubating it for a
period of time with various chemicals. The end result is a color
change, the intensity of which is dependent upon the concentration of
anti-gliadin antibody (or other protein being measured) in the patient
serum. The ability of this colored solution to absorb light at a
particular wavelength can be measured on a laboratory instrument
and mathematically compared with solutions that contain a known amount
of anti-gliadin antibody to arrive at a number for the amount of
antibody present. The sample can then be classified as negative,
(0-20 units); weak positive, (21-30 units); or moderate to strong
positive if greater than 30 units.

The purpose of testing for anti-gliadin antibodies includes, in
addition to diagnosis of gluten sensitive enteropathy, monitoring
for compliance to a gluten free diet. IgA gliadin antibodies
increase rapidly in response to gluten in the diet and decrease
rapidly when gluten is absent from the diet. The IgA anti-gliadin
antibodies can totally disappear in 2-6 months on a gluten free
diet, so they are useful as a diet control. By contrast, IgG
anti-gliadin antibodies need a long time, sometimes more than a
year, to become negative. The reverse is also true. That is, a
patient with CD who has been on a gluten free diet and tests
negative for IgA anti-gliadin antibodies, will show a rapid
increase in antibody production when challenged by gluten in
the diet. Approximately 90% of challenged patients will yield
a positive IgA anti-gliadin result within 14-35 days after being
challenged. The IgG antibodies are somewhat slower.

ENDOMYSIAL ANTIBODIES:

IgA class anti-endomysial antibodies (AEA) are very specific, occurring
only in CD and DH. These antibodies are found in approximately 80% of
patients with DH and in essentially 100% of patients with active CD.
IgA endomysial antibodies are more sensitive and specific than gliadin
antibodies for diagnosis of CD. Antibody titers (dilutions) are found
to parallel morphological changes in the jejunum and can also be used to
reflect compliance with gluten-free diets. Titers decrease or become
negative in patients on gluten free diets and reappear upon gluten
challenge.

The test for anti-endomysial antibodies is more subjective and more
complicated for the lab to perform than the anti-gliadin assays. It
involves serially diluting some of the patients serum, that is, diluting
it by 1/2 then 1/4, 1/8, 1/16, etc. and putting these dilutions on a
glass slide that has some sort of tissue affixed to it. The slide is
then processed with various solutions and examined under a fluorescent
microscope to determine if any of that serum binds to any of the
proteins in the tissue. If so, then that patient is confirmed as having
antibodies to that particular protein. This method of testing is called
an IFA or sometimes IIFA. It stands for Indirect Immuno-Fluorescent
Assay.

The selection of which tissue slide to use is determined by what
specific protein, hence which antibody, you are specifically looking
for. Endomysial antibodies react with the endomysium, which is a sheath
of reticular fibrils that surround each muscle fiber. Therefore, to
detect endomysial antibodies, you would want to use a tissue substrate
that contains a lot of muscle tissue. The substrate used most often for
this assay is distal sections of the esophagus. These are very thinly
sliced and fixed to the slide. They contain muscle fibers and not much
else so there is a lot of endomysium available to react with the
anti-endomysial antibodies.

Reading this test involves viewing the reacted slides with a fluorescent
microscope to make the determination. This requires a highly skilled and
trained eye and, of necessity, is somewhat subjective. You are looking
for a green fluorescence in the endomysium covering the muscle fibers.
The test is reported as the "titer" or final dilution in which the
fluorescence can still clearly be seen. As you can imagine, this is very
subjective. There are no standardized values and it is up to the
judgement of the particular technician what the endpoint titer is.
Recently, (1998) the endomysial antigen targeted by the anti-endomysial
antibodies was identified as the protein cross-linking enzyme known as
tissue transglutaminase (tTG). This has enabled the production of an
antigen specific ELISA assay incorporating tTG as a reliable and
objective alternative to the traditional and subjective
Immunofluorescence based assays. In clinical trials, the correlation
with the endomysial IFA assay has been shown to be close to 100%. This
is a test that has been very well received in the professional
community. It is an ELISA, like the anti-gliadin antibody test and, as
such, is not subject to interpretation like the IFA. That is the
greatest advantage to this new test! With this or any ELISA, the
response is measured on an instrument that calculates the amount of
light of a particular wavelength that is absorbed by the solution and
prints out a numerical result. There is no chance of human error skewing
the results because there is no judgement call involved. The ELISA
plate, regardless of what you are testing for, is processed with at
least three control sera (sometimes as many as eight) in addition to the
unknown sample being tested. There is a negative serum and at least two
positive sera containing different levels of the antibody being tested.
There are specific requirements for the absorption levels of these three
controls. That is, each of them has a minimum or maximum (or both)
number that must be seen by the instrument in order for it to be a valid
test. If there is any variance from these expected numbers, it is an
indication that something went wrong and the test results are discarded
and the test repeated. There is therefore no way the technician could
report inaccurate results, (assuming they diluted the sample correctly).
Either the test was valid, and you can rely upon the accuracy of the
result, or the test is invalid, and the entire result discarded. If any
error was made during the processing of the ELISA plate, it would result
in the control sera numbers being out of range and the entire test
result would be thrown out.

In summary, the tTG ELISA is measuring the same thing that the
endomysial IFA is measuring but with a method that is more sensitive and
specific and not subject to interpretation.

IgA class Reticulin antibodies are found only in Celiac disease and
dermatitis herpetiformis. These antibodies are found in approximately
60% of CD patients and 25% of DH patients. This test is falling into
disuse because of the limited utility and the availability of better
tests. It is an IFA performed on a tissue substrate with all the
attendant problems that go along with it.

The development of all of these serum assays has tremendously simplified
the diagnosis of CD and improved the accuracy as well. The original
criteria for diagnosis according to the European Society for Pediatric
Gastroenterology and Nutrition, (ESPGAN), involved a year of arduous
studies with: a) an initial positive gut biopsy, b) 6 months on a
gluten free diet, c) a second, negative gut biopsy, d) a gluten
challenge for 6 months and e) a third, positive gut biopsy. The revised
ESPGAN criteria call for positive results in two of the serological
tests confirmed by a single positive biopsy. In practice, many
gastroenterologists are utilizing the serologies in conjunction with a
controlled diet and the clinical presentation to form a basis for
diagnosis without the need for the invasive procedure.

Through the auspices of the Celiac Disease Foundation and others, a
professional symposium and workshop was organized earlier this year in
Marina Del Rey, California with participants from Europe as well as the
U.S. to establish standards for reporting test results. This should
improve testing and diagnosis even more. At the conclusion of this
conference a Celiac Disease Standardization Committee was formed to
investigate and make recommendations on a standardized method of
reporting results.

Due to the numerous requests I have received, I am publishing a list of
several labs throughout the country that offer tTG testing. It is part
two of this posting.

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The following section is from: Tania Gerarduzzi, Ph.D. at (410) 706-3734,
Her email: [log in to unmask]
Mailing address for testing facility:
UMAB, Building BRB, Room 10-049
655 W. Baltimore Street
Baltimore, MD 21201

From email I've received from list members, you can get the tTG
test (which requires being on gluten) by contacting the University of
Maryland research project that is using the tTG test, and asking to
participate. Ask to be sent the information, and they will assign you a
number. They are particularly interested in testing families.  Contact
information appears below. I was told that you must be on gluten to take
this test, for this study, if you are looking for a diagnosis.

The test involves getting your local doctor - or the nurse
with doctor's order - or technician - to draw 2 tubes of
blood. These tubes will be sent to you with instructions
when you call and stay you want to participate in the study.
One has a red top and requires 3 cc of blood, the other has
a yellow top and requires 7 cc of blood. The MUST be sent
overnight delivery - best to arrive the following a.m. - so you
would be wise to have the blood draw done Monday through
Thursday so it doesn't arrive on a Saturday or Sunday. Ship
by a method that pads and protects the tubes of blood, so they
won't break. Sending at room temperature is OK. Protect
in plastic bubbles - foam - styrofoam -etc.

The only charge is the blood draw at your doctor's or his lab,
any charge for packaging you or your doctor provide, and the
overnight delivery, since it is a research study.