Lab Test for
Fibromyalgia
I got the following information from a newsletter
reader--
FREQUENTLY ASKED QUESTIONS
ABOUT THE APA ASSAY/bigger>/bigger>/fontfamily>
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/color>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/color> that is available
on the Autoimmune Technologies Web site,
www.autoimmune.com/color>. Reprints
of published articles are available from Autoimmune Technologies, and
representatives are also available to discuss the material with a physician over
the telephone.