You have options
Celiac disease and non-celiac gluten sensitivity are best diagnosed by a physician for many reasons. However, if your doctor refuses to test you or a family member for celiac disease, you need confidentiality, or you are avoiding the doctor’s office due to cost or other reasons, you still have options to get tested. Here’s a guide to help you understand the options and choose scientifically validated tests.
For general information about what tests are used to diagnose celiac disease, the University of Chicago Celiac Disease Center has a helpful page on screening tests, and for diagnosing non-celiac gluten sensitivity, MassGeneral Hospital for Children has a useful FAQs page.
Online testing for celiac disease
A number of online labs offer celiac disease tests that patients can order themselves. This is called direct access testing (DAT) and is governed by state regulation. Direct access online labs generally have a contract with LabCorp or Quest and use their patient service centers and processing. Our foundation does not have a financial relationship with or endorse any labs.
Direct access testing is legal in most, but not all, states. Most direct access labs indicate they cannot perform tests in NY, NJ, RI, MD and in some cases MA. Quest has developed its own direct access testing, QuestDirect, where a celiac panel is one of the options. QuestDirect offers testing in all states except AZ, IN, OK, AK, and HI, as well as Puerto Rico.
Advantages: Confidentiality, potential for lower cost (prices vary widely – compare to check), and avoiding the cost of a visit to the doctor.
Disadvantages: They generally do not accept health insurance, they cannot give you medical advice, and you are not under a doctor’s care and guidance. (Some, like QuestDirect, offer the opportunity to speak with a physician about your test results). These are significant disadvantages, as choosing the correct tests and understanding the results in the context of your complete medical profile can be complex.
For more, read up on the “Pros and Cons of Consumer-Driven Testing.”
Unvalidated lab tests
Some online labs and home use kits offer unvalidated tests or have a mix of validated and unvalidated tests. It can be difficult for a consumer to tell the difference. Unvalidated tests are those for which accuracy and clinical usefulness have not been scientifically established. Some online labs or home use kits offering unvalidated tests have scientific-looking websites, a description of their CLIA-certified lab and an impressive list of medical advisors. It is not illegal as long as they comply with all regulations. However, the research and validation may not be published in peer-reviewed medical journals, the system the medical profession has developed over centuries to protect patients.
Online testing for non-celiac gluten sensitivity
Currently, there is no scientifically valid test to diagnose non-celiac gluten sensitivity. Celiac disease experts warn consumers against buying tests from online labs that claim to offer tests for “gluten sensitivity,” “gluten allergy,” “gluten intolerance,” “gluten cross reactivity” and similar terms that do not have an established medical basis.
For more information about non-celiac gluten sensitivity and how to diagnose it, we recommend these resources: MassGeneral Hospital for Children Center for Celiac Research and FAQs on the University of Chicago Celiac Disease Center website. Celiac disease and gluten sensitivity experts generally recommend first ruling out celiac disease, IBS and wheat allergy and then eliminating gluten from the diet to see if symptoms are resolved. Diagnosis of gluten sensitivity should be carried out under the care of a knowledgable physician. Self-diagnosis is not recommended.
Online genetic tests
Genetic testing can rule out celiac disease (definitively state that you don’t have the genes to develop it), but it cannot diagnose celiac disease. It can only indicate whether you are at risk for developing it. There are a variety of diagnostic scenarios where genetic testing using a blood draw can be useful in conjunction with other testing. (See the University of Chicago Celiac Disease Center’s screening page for more detail. Scroll down for genetic testing.)
Online tests based on saliva may have additional limitations. For example, 23andMe currently only tests for 95% of the celiac haplotypes, specifically those most relevant for people of European descent.
Home use tests, over-the-counter tests, lab developed tests
Most people are surprised to learn that the FDA does not review or regulate all lab tests with the same rigor. As the FDA states, “Some direct-to-consumer tests are reviewed by the FDA while others are not.”
The FDA advises caution when consumers purchase home use tests and offers a database where one can search for a test to see if it is FDA approved or cleared.
Furthermore, FDA states that lab developed tests (LDT), which are those developed and offered by a single lab, “typically do not have the FDA’s independent assurance of the analytical validity, clinical validity, or clear communication of test results.”
If your doctor refuses to test for celiac disease
If your doctor refuses to test for celiac disease, there are ways you can advocate for your own or your family member’s care.
Talk to your doctor and do your research
It’s best to use lab tests ordered by or discussed with your doctor. When that’s not possible and you are shopping online for tests, contact the lab companies directly for the most accurate and current information about their products and services. Keep in mind that the information and tests may not have been reviewed or approved by the FDA.
Last updated: December 2018