Q: Is the APA Assay the first
laboratory test for fibromyalgia?
A: Yes. Until now there has not
been a lab test that is specific for
fibromyalgia. Research studies to date
have shown that the APA Assay can identify
between one-half and two-thirds of
fibromyalgia patients tested.
Q: What does the APA Assay
detect?
A: The APA (Anti-Polymer Antibody)
Assay detects IgG anti-polymer antibodies
in human serum.
Q: What are anti-polymer
antibodies?
A: Researchers are still in the
process of trying to fully understand the
nature of these antibodies. However,
published studies have recently reported
that fibromyalgia patients with a higher
level of anti-polymer antibodies in their
blood have more severe fibromyalgia
symptoms than patients with lower antibody
levels. This makes the APA Assay a
valuable fibromyalgia test even though the
circumstances surrounding antibody
production are not yet completely
understood.
Q: Why do anti-polymer antibodies
occur in fibromyalgia patients?
A: Why anti-polymer antibodies
occur is also not fully understood yet.
However, this is not unusual, because it
is also not fully understood why other
abnormal antibodies occur in diseases like
rheumatoid arthritis (RA) and systemic
lupus erythematosus (SLE). Nevertheless,
detecting the presence of the other
antibodies in RA and SLE patients is
useful in aiding in the diagnosis, and
sometimes the treatment, of those
illnesses.
Q: If my physician has already told
me that I have fibromyalgia, could this
test be of any use for me?
A: Yes it could. The test could
objectively confirm your physician's
diagnosis, and it might also help in
determining your treatment. A positive
result on the APA Assay means that a
fibromyalgia patient's immune system is
producing anti-polymer antibodies. This is
the first evidence that an immune response
is associated with fibromyalgia as it is
with rheumatoid arthritis and lupus.
Immune-modulating drugs have not been
thought to be appropriate for fibromyalgia
in the past, but now the APA Assay could
lend considerable support to a physician's
decision to prescribe these drugs for a
fibromyalgia patient.
Q: Are there other examples of lab
tests for factors that are not completely
understood?
A: Yes. One good example is the
anti-nuclear antibody test, or ANA test,
which is the most commonly used autoimmune
screening test. Physicians order the ANA
test approximately 25 million times per
year worldwide and use the results to help
diagnose and monitor their patients, yet
researchers still don't fully understand
why anti-nuclear antibodies are produced
or what their significance is.
Q: What about using other lab tests
for fibromyalgia patients?
A: There are dozens of lab tests
that physicians can order when they are in
the process of examining a patient
suspected of having fibromyalgia. However,
these tests are not specific for
fibromyalgia and they are usually ordered
to help rule out other immune disorders.
Many fibromyalgia patients have completely
normal results on all of these other
tests.
Q: Is a lab test useful even if it
doesn't detect something in every
patient?
A: Yes, both positive and negative
test results can supply valuable
information, and many diagnostic tests
don't operate in the 95% to 100% detection
range. For example, the discovery of
proteins called rheumatoid factors helped
convince physicians that rheumatoid
arthritis was a real disease instead of a
psychological disorder, yet only about 70%
of patients who receive a diagnosis of
rheumatoid arthritis test positive for
rheumatoid factors.
Q: If I don't have the antibodies
that the APA Assay detects, does that mean
I don't have fibromyalgia?
A: No, people without anti-polymer
antibodies can still have fibromyalgia. In
research studies to date, up to two thirds
of fibromyalgia patients tested positive
on the APA Assay but the other
fibromyalgia patients did not. This and
other research indicates that there are
several distinct subgroups of fibromyalgia
patients, and fibromyalgia patients
without anti-polymer antibodies probably
belong to one of the smaller patient
subgroups.
Q: Has the APA Assay been approved
by the U.S. Food and Drug Administration
for use as a diagnostic test?
A: No, but the test is undergoing
the clinical trials necessary to support a
regulatory filing for FDA approval. For
diagnostic tests, the FDA requires that
tests be produced in kit form, and the kit
is what the FDA approves and regulates. An
APA Assay kit, in the Enzyme Linked
ImmunoSorbent Assay (ELISA) microtiter
plate format, has been developed for
Autoimmune Technologies by Corgenix, Inc.,
and this kit is now being used in the U.S.
clinical trials. The data obtained from
these trials will then be submitted to the
FDA in what is called a Pre-Market
Approval, or PMA, application.
Q: How long do clinical trials
take?
A: Unlike drug trials, clinical
trials of a non-invasive blood test like
the APA Assay can be done quickly, and the
clinical trials of the APA ELISA Kit will
probably take between six and nine months
to complete. After that, the PMA
application to the FDA will be submitted.
If the FDA decides to approve the PMA,
approval could come within six months to a
year after the date of submission.
Q: Can I have my blood tested for
anti-polymer antibodies?
A: The APA ELISA Kit is designed to
be distributed to the clinical labs which
run the test when it is ordered by a
physician. FDA regulations prohibit the
use of a test kit in the U.S. while it is
undergoing clinical trials and approval,
but the kit is available to labs in other
countries through the Corgenix
international sales office in
Peterborough, UK. For more information,
contact:
Corgenix UK Ltd.
75 Broadway
Peterborough
Cambridgeshire, UK PE1 1SY
www.corgenix.co.uk
Telephone: +(44) 01733 296800
Fax: +(44) 01733 296809
Q: Does my physician know about this
test?
A: Your physician may not know about the APA
Assay, and you may want to give him or her a printed
copy of the APA Assay Science
Summary that is available on the Autoimmune
Technologies Web site, www.autoimmune.com.
Reprints of published articles are available from Autoimmune
Technologies, and representatives are also available
to discuss the material with a physician over the telephone.
Go to the Fibromyalgia Syndrome
Research Page
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