Celiac Disease Self-Test (berkeleyhealth)

CELIAC DISEASE
Celiac disease (CD), also known as "celiac sprue," is a chronic inflammatory disorder of the small intestine caused by the ingestion of gluten-containing food products in susceptible individuals. It is a multifactorial disease involving both genetic and environmental factors. The environmental trigger is gluten, while the genetic predisposition is associated with the presence of specific genes in the major histocompatibility complex, which cause the production of specific antibodies against gluten and its components.
Celiac disease is more common than previously thought, with a global prevalence of approximately 1%. Underdiagnosis occurs because about half of those affected do not present classic gastrointestinal symptoms, but rather nonspecific manifestations of nutritional deficiency or even no symptoms at all.

GLUTEN, GLIADIN, AND DGP: Gluten is a protein found in wheat, composed of glutenin and gliadin, which acts as a "glue" to hold food together. Gliadin is a water-soluble peptide, part of gluten, and is responsible for celiac disease. Deaminated gliadin peptides (DGP) are formed by the action of the transglutaminase enzyme, and their detection is useful for increasing sensitivity and specificity in celiac disease screening.

RECOMMENDED USERS: Patients with symptoms (abdominal bloating, pain, chronic diarrhea, vomiting, constipation, weight loss, fatigue, irritability); People with first-degree relatives with celiac disease; People with type 1 diabetes. WHY - BENEFITS: Celiac disease is often underdiagnosed, and the impact of symptoms on quality of life can be severe. Checking for the presence of specific antibodies against DGP is a useful tool for detecting the disease.

TEST PRINCIPLE: The CELIAC test is based on an immunochromatographic reaction. If antibodies (IgA and IgG) are present in the sample, they will react with deaminated gliadin. A positive result indicates that the antibody concentration is close to 20 U/mL.

TECHNICAL SPECIFICATIONSDetection limit (cut-off): 20 AU/mLSensitivity: >90%Specificity: 94.1%Overall accuracy: 81.25%Performance data were obtained through two clinical studies with200 participants. Reference methods: ImmunoCap Thermofisher DGPIgG/IgA (ELISA) and Zenit RA Menarini DGP IgG/IgA (chemiluminescent IA).

KIT CONTENTS: 1 sealed aluminum bag containing: 1 test device and 1 desiccant sachet; 1 transparent plastic bag with pipette for blood collection; 1 bottle with dropper containing the diluent; 2 sterile lancets for blood samples; 1 alcohol wipe; 1 leaflet with instructions for use.