Many people with rheumatoid arthritis (RA) experience difficulties in getting a diagnosis. The lag between first appearance of symptoms and the time of diagnosis ranges from a few months to more than 10 years, which can lead to permanent joint damage. A new at-home blood test aims to help people with RA get diagnosed as quickly as possible, but is it a reliable method?
The co-founder of the company that sells the only direct-to-consumer at-home test currently on the market explains how the test works, while a rheumatologist weighs in on the benefits and drawbacks of using it.
“We wanted to help the next generation” of people with RA, said Jani Tuomi during a phone interview with HealthCentral. Tuomi is the co-founder of imaware™, the company behind the at-home RA screening test, as well as a test for celiac disease. Tuomi explained that a person interested in purchasing the test would first be interviewed over the phone regarding possible RA symptoms, then they would send a few drops of blood to the company for analysis. The results would be accompanied by a report for both the individual and their doctor. There is also follow-up from the company.
The imaware™ test checks for three biomarkers that may indicate RA: CCP-IgG (also known as anti-CCP), and RF-IgA and RF-IgM — both part of rheumatoid factor. (A biomarker is a substance, structure, or process that indicates a medical condition or its outcome.) These are involved in someone having a positive blood test for RA. Tuomi pointed out that “the CCP biomarker acts as a view into people who may have developed rheumatoid arthritis.” The anti-CCP test is highly specific and can be positive several years before someone develops symptoms of RA.
Robert G. Hylland, M.D., fellow of the American College of Rheumatology, and assistant clinical professor at the Michigan State University college of osteopathic medicine, says early treatment of RA is key, as it “can prevent or delay joint damage and provide a much less painful and more productive life for our patients.”
A diagnosis delay can result from a lack of access to medical care Dr. Hylland said in an email interview with HealthCentral, or there may be a delay in receiving a diagnosis even after seeing a doctor. Those with positive rheumatoid factor and progressive symptoms usually get diagnosed sooner. If you do not have obvious symptoms or test negative for rheumatoid factor, your family doctor may not be aware that RA is a possibility. In either case, an at-home test could speed up the diagnosis prossess.
But, Dr. Hylland says, the lack of certainty in blood tests makes it important to go beyond taking an at-home test and take the additional step to see a rheumatologist for more in-depth assessment.
It is important to keep in mind that an RA diagnosis is made by taking an accurate history from the patient and performing a quality physical examination, according to Dr. Hylland, whereas “blood tests provide confirmation and prognostic data to help with counselling and treatment.”
Of people who have RA, 30 percent are seronegative, which means they do not have a positive blood test. Dr. Hylland is concerned that a negative result to an at-home test might discourage someone from seeking help. This could be particularly problematic in those who have another form of autoimmune arthritis, such as lupus, psoriatic arthritis, arthritis associated with inflammatory bowel diseases, and more.
Tuomi mentioned that in the case of a negative result, the report provided by imaware™ recommends a follow-up with their doctor.
If you are experiencing symptoms that you think may be RA, such as joint swelling and pain, morning stiffness that lasts longer than 30 minutes, and fatigue, it’s a good idea to see your family doctor. In such cases, they may order blood tests, some of which are similar to the at-home test. If your results are positive, your family doctor will most likely refer you to a rheumatologist for further assessment and a possible diagnosis. If, however, your results are negative and your doctor does not take further action, you may need something more.
Although a blood test can have limitations in identifying RA, Dr. Hylland said an at-home test “could encourage an earlier visit to the doctor and thereby to diagnosis and treatment.”
As well, many of the people who have purchased the test “have been family members getting their daughters tested,” Tuomi said. This test may help relatives of someone with RA have a faster road to diagnosis and treatment.
The at-home RA test costs $99 and is currently only available in the United States. This cost covers the initial online conversation about your symptoms, the test and analysis, the results reviewed by a physician, as well as a report for you and one for your doctor. There will also be follow-up via an internet portal. If you need a doctor’s order to get the test, imaware™ will provide that at no extra cost.
Tuomi explained that imaware™ destroys all samples after analysis and does not sell data. In the future, it may be shared to support research, but “anonymously and with your positive opt-in,” that is, with your permission. That said, Dr. Hylland cautions patients to “carefully read what you are giving away.”