We are often told that there is no one test that can detect if we have fibromyalgia. Last year, I read about the FM/a test that supposedly can detect if a person has fibromyalgia or not. I do not think this blood test is readily available world wide and is costly. However, is it a reliable test? Does this test create false positives or false negatives?

According to the official website of the FM/a test, they state that the test gives you a definite diagnosis of fibromyalgia. However, I am not sure how much I trust this statement as the test itself does not seem to be FDA approved. They state the test is FDA approved, however it is not listed on the FDA site when I search for the FM/a test. This has left me a little confused. Is it or is it not FDA approved?!?

Advertisements

“FM/a is a cytokine assay of in vitro stimulated peripheral blood mononuclear cells. Production of cytokines by stimulated immune cells in patients with fibromyalgia has been shown to be significantly different from that of healthy control patients. Based on the concentrations of four cytokines, a cytokine/chemokine composite score, calculated as 1 / (1 + e^−x) * 100, on a scale of 0 to 100 was developed. A score greater than 50 is considered positive for fibromyalgia.”

The site that there is a 99% accuracy rate, however in another article I read stated the test showed a higher false positive for people with RA –rheumatoid arthritis (29%) and lupus ( 31%). From speaking to many people with fibromyalgia over the internet many also have RA or lupus alongside their fibromyalgia. Why is their site reporting a 99% accuracy while the other study reveals false positives were detected ? You can read about the study here.

Their website also goes on to list twelve symptoms of fibromyalgia. These include chronic pain/tender areas, chronic fatigue, brain fog, anxiety/nervousness, feeling depressed, trouble concentrating, headaches, restless legs when sleeping, poor sleep, joint pain, leg cramps and areas of numbness /tingling. The site states you must have at least four of the listed symptoms to qualify for the FM/a test. I agree that these can be symptoms of fibromyalgia, but they can also be symptoms of many other conditions. I personally think having four of these symptoms alone is not enough evidence that it could be fibromyalgia. I can’t justify spending $1080 for the blood test. Yes!! You read that right. The test costs $1080 per pop! Most insurance companies will not pay for the blood test to be completed, but on the FM/a website states it is covered by insurance. The people I have conversed with who did have the test done, all states it was not covered and they had to pay out of pocket. Maybe some insurance companies will pay, but I also think it depends on the company and where you reside. I have just learned in the last week many countries do not even accept fibromyalgia as a diagnoses or even a disability!

Downsides to the test

1. Patients must stop taking ALL medications that may alter their immune system for two weeks prior to taking the FM/a blood test.

2. High percentage of false positives are detected.

3. The cost of the test is $1080!

To have a positive diagnosis the FM/a test must be at least 50/100. Any lower they state it can’t be confirmable. If your test comes back positive for fibromyalgia and you are 18 years of age, you can qualify to enter into a clinical trial for treatment – which includes BCG. I had no idea what was meant for BCG, so I googled it. The search returned BCG as being a vaccine used years ago for TB (tuberculosus). I could not find any other uses for BCG. According to canada.ca, the routine use of BCG is not recommended. Maybe being used in a clinical trial to treat another condition may be different. I do not have the answers.

I have seen discussions online from people who have had the FM/a test completed and got a positive diagnosis of fibromyalgia. It would be interesting to have an in depth discussion with these individuals to acquire more information about the experience. For those of you who have gotten the test, please know I do not judge your decision as each of us have to do what we feel is right. For myself, there are just so many unanswered questions about this specific test and why is it not mentioned by doctors we see?

Conclusion: If this blood test is so accurate, why is it not FDA approved ( or listed on the FDA website) ? Why do the doctors in the states who have fibromyalgia themselves and run fibromyalgia clinics, not speak of this test? If the blood test is 99% accurate why isn’t this test being used worldwide to help diagnose fibromyalgia at a faster rate?!? As of right now, it can take years to get a solid diagnosis for fibromyalgia. If you are like me, every health care provider I have seen, including specialists have told me there is not a test to diagnose fibromyalgia and that it becomes a rule out kind of diagnosis. Are doctors unaware of this test ? I do not have the answers to my own questions.

The FM/a test could be a step in the right direction. It would be great to have a blood test be able to detect fibromyalgia. However, I personally will not be spending $1080 for a blood test at this point. I feel like there needs to be a wider study done on the blood test to verify its accuracy. I fear jumping straight to getting the test completed, could possibly lead to many possible misdiagnoses due to false positives and negatives.