Frequently Asked Questions (FAQ's)
Is the APA Assay the first laboratory test for fibromyalgia?
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.
What does the APA Assay detect?
The APA (Anti-Polymer Antibody) Assay detects IgG anti-polymer antibodies in human
What are anti-polymer antibodies?
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.
Why do anti-polymer antibodies occur in fibromyalgia patients?
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.
If my physician has already told me that I have fibromyalgia, could this test be
of any use for me?
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.
Are there other examples of lab tests for factors that are not completely
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.
What about using other lab tests for fibromyalgia patients?
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
Is a lab test useful even if it doesn't detect something in every patient?
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
If I don't have the antibodies that the APA Assay detects, does that mean I
don't have fibromyalgia?
Answer: 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
Has the APA Assay been approved by the U.S. Food and Drug Administration for use
as a diagnostic test?
Answer: 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.
How long do clinical trials take?
Unlike drug trials, clinical trials of a non-invasive blood test like the APA
Assay can be done Questionuickly, 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.
Can I have my blood tested for anti-polymer antibodies?
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.
Cambridgeshire, UK PE1 1SY
Telephone: +(44) 01733 296800
Fax: +(44) 01733 296809
Does my physician know about this test?
Answer: 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.
Click here to print out a copy of Science Summary of The Anti-Polymer
Antibody Assay (APA Assay) and Fibromyalgia Syndrome" (PDF format).