Celiac disease is an autoimmune disorder in which the body attacks itself and damages the small intestine. It can develop when a person with a genetic risk for celiac disease eats gluten (a protein found in wheat, rye, and barley). The GlutenID Celiac Genetic Health Risk test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from saliva collected for the purpose of reporting and interpreting Genetic Health Risks (GHR).
Qualitative tests will provide you with a detected or not detected result, indicating whether or not you have a genetic risk for celiac disease. It does this by looking at two genes called HLA-DQA1 and HLA-DQB1 and checking if those genes’ variants that are associated with celiac disease risk are present or absent. This test cannot tell you if you have celiac disease or if you will develop it. If your test result is “detected,” that indicates that you may have a higher risk of developing celiac disease in the future because you have one of the genetic variants associated with celiac disease.
Please note: This test was developed by Targeted Genomics, LLC and is performed at PacificDx laboratory; Targeted Genomics will provide you with your results. Quest Diagnostics does not provide laboratory testing services for this item. Your test results will not be shared with or available from Quest, and PWNHealth services and fees do not apply to this offering. For more information, please see Targeted Genomics’s Terms & Conditions and Privacy Policy.
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No doctor visit is required for purchase. Once your kit is delivered, activate it.
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Follow instructions provided to collect and return your sample.
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Access results online as soon as they’re available. You will be emailed when they are ready.
No. GlutenID™ tests DNA, so it is accurate if you are on a gluten-free or a gluten-containing diet.
Yes. GlutenID™ tests DNA which is unaffected by what you have eaten before the test. However, do not eat, drink, smoke, chew gum, brush your teeth, or use mouthwash for at least 30 minutes prior to providing your sample.
Positive results for specific genetic variants are reported within a gradient of Low Elevated Disease Risk for the following specific variant/disease pairs:
If a symptomatic individual on a gluten containing diet tests positive for celiac-associated genes, the best confirmatory test is tissue transglutanimase (tTG) antibody testing. However, this test will only be positive if adequate gluten has been consumed prior to testing; do not go on a gluten-free diet until after your antibodies are tested.
Quest offers the Celiac (Gluten) Disease Panel that tests tTg-IgA and IgA antibodies.
Genetic Health Risk reports are intended to provide you with genetic information to inform conversations with a healthcare professional. These reports should not be used to make medical decisions. Always consult with a healthcare professional before taking any medical action.
To help identify if a person has genes that are linked to an increased risk of developing celiac disease. Officially, the intended use is as follows:
The GlutenID Celiac Genetic Health Risk (GHR) Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human buccal (cheek) cells collected by Users 18 years of age or older for the purpose of reporting and interpreting celiac GHR. The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLADQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype. The GlutenID report describes if a person has variants linked to a haplotype associated with an increased risk for developing celiac disease, but it does not describe a person’s overall risk of developing celiac disease. This report is most relevant for people of European descent.
Yes, there are limitations, warnings, and precautions:
Relevant races/ethnicities:
The variants included in this test are common in many ethnicities including White, African American, Asian, and Others but are best studied in people of European descent. The relevance of each report and how your genetic health risk results are interpreted may differ depending on your ethnicity. Each genetic health report indicates if a person has variants associated with an increased risk of developing a disease, but it does not indicate their overall risk.
Warnings:
Special Conditions for Use
Other Warnings and Limitations
Precautions:
PacificDx, a College of American Pathologists (CAP) accredited laboratory in Irvine, CA is the only laboratory certified to run the GlutenID™ test.
If you need help with making a purchase on questhealth.com, with shipping, or with the delivery of your kit, please contact Quest at 1.844.738.3787 Mon–Fri between 9 AM – 5 PM EST.
If you need help with registering your kit, with sample collection, with your test results, or anything else, please contact Targeted Genomics by emailing their support: CustomerSupport@Targeted-Genomics.com or calling 1.800.971.5938.
