May 16 is International Celiac Disease Awareness Day. Therefore, it is time to explore how this autoimmune condition affecting millions worldwide often remains undetected and how smarter testing tools can help both patients and healthcare professionals.  

The global burden of celiac disease

Celiac disease is a well-known but underdiagnosed autoimmune disease, with a prevalence of nearly one in a hundred in Europe. Yet, the real burden of the condition may be even greater as more than 80% of those affected remain undiagnosed. (1)

Facts about celiac disease

• Celiac disease is an autoimmune condition where gluten, a protein found in wheat, rye, and barley, induces damage to the small intestinal mucosa in patients with a genetic predisposition. (2)
• An estimated 83–95% of celiac patients in developed countries remain undiagnosed. This figure is likely higher in developing countries. (1)
• Typical symptoms of celiac disease include steatorrhea, diarrhea, anemia and weight loss. Some patients can be asymptomatic or present with non-classical symptoms, such as dyspepsia, fatigue, and dermatological disorders. (2)
• After a celiac diagnosis, a strict gluten-free diet is the most effective treatment, as even small traces of gluten can trigger an immune reaction, leading to symptoms. (3)
• Celiac disease, non-celiac gluten/wheat sensitivity, and wheat allergy are three main categories of wheat-related disorders. Despite overlapping symptoms, they are distinct conditions with different underlying mechanisms – autoimmune, non-autoimmune, and allergic, respectively. (4)

There is a great need for reliable, cost-effective diagnostic tools that conserve limited healthcare resources and do not place an unnecessary burden on patients seeking a diagnosis. Modern quick tests offer an accurate solution to the challenge of celiac diagnosis.

“More effective and faster celiac disease diagnosis demands solutions that are both clinically reliable and easy to implement at the point of care.”

The traditional path to celiac diagnosis is often slow and invasive

The standard diagnostic pathway for celiac disease begins with serological testing. This typically involves measuring tissue transglutaminase IgA (tTG-IgA) antibodies, often supplemented with endomysial antibody (EMA) testing. (3)

Celiac disease can be diagnosed without an endoscopy if tTG-IgA levels are very high (≥10 times the upper limit of normal) and EMA is positive, particularly in children (5). In other cases, the diagnosis is confirmed with a duodenal biopsy obtained during endoscopy (3, 5).

However, a selective IgA deficiency makes IgA-based tests less accurate and therefore less reliable. This is a major challenge for the accuracy of a celiac diagnosis in IgA-deficient individuals.

Selective IgA deficiency is 10 to 15 times more common in patients with celiac disease than in the general population, affecting an estimated 2–3% of celiac patients. (3, 6) To address this diagnostic challenge, testing can be done with IgG-based antibody tests, although their accuracy can vary.

Endoscopy remains the standard diagnostic method when serological findings are inconclusive or there is a good reason to suspect a positive diagnosis despite negative test results. However, endoscopies are invasive as well as physically and psychologically demanding for patients. Furthermore, endoscopies demand heavy healthcare resources.

While diagnostic criteria have become less invasive, traditional methods are not without limitations, especially as the incidence of celiac disease grows.

Towards more effective celiac diagnostics

Celiac disease can present at any age and manifest with diverse symptom profiles. The condition may remain symptomless in some individuals with a predisposition.

Delayed diagnosis may result from limitations in the aforementioned serological tests or from IgA deficiencies. Furthermore, patients may not seek testing in time due to atypical symptoms that are not identified as those of celiac disease.

The BIOHIT Celiac quick test was developed to address these challenges. It is a qualitative immunochromatographic in vitro test that aids in the diagnosis of celiac disease by detecting tissue transglutaminase antibodies (IgA/IgG/IgM) in whole blood, plasma, or serum samples, including fingertip whole blood samples.

Patients with IgA deficiency are often missed by conventional testing. By measuring a combination of antibody classes simultaneously, the quick test improves the sensitivity of celiac testing and makes it a reliable first-line tool when there is a reason to suspect celiac disease.

Key benefits of the BIOHIT Celiac quick test:

• Results in 10 minutes.
• Highly accurate and versatile: tTG-IgA, IgG, and IgM antibodies in a single test.
• Detects antibodies from whole blood, plasma, or serum samples, including fingertip whole blood samples.
• Patient-friendly, non-invasive method.
• Suitable for use by healthcare professionals in GP practices, outpatient clinics, and pharmacies.

A celiac quick test supports diagnosis in different clinical pathways, either as a primary testing tool or as a part of a broader diagnostics process. Although quick tests make diagnosis faster, the test results should be interpreted within the full clinical context. Therefore, the final diagnosis should be made by a medical professional.

”The test aids patient care, makes getting a diagnosis faster and reduces costs. The quick test is an excellent solution for celiac disease triage: it provides an accurate result in 10 minutes.”

Get to know the BIOHIT Celiac quick test →

Strengthen your diagnostics with Biohit’s solutions

Want to discuss celiac diagnostic tools with a specialist? Contact our team. Our solutions are available internationally for medical centers, private clinics, and primary care facilities.

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References

1. Singh P, Arora A, Strand TA, et al. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018;16(6):823–836. doi:10.1016/j.cgh.2017.06.037
2. Al-Toma A, Zingone F, Branchi F, et al. European Society for the Study of Coeliac Disease 2025 Updated Guidelines on the Diagnosis and Management of Coeliac Disease in Adults. Part 1: Diagnostic Approach. United European Gastroenterol J. 2025;13(10):1855–1886. doi:10.1002/ueg2.70119
3. Rubio-Tapia A, Hill ID, Semrad C, et al. American College of Gastroenterology Guidelines Update: Diagnosis and Management of Celiac Disease. Am J Gastroenterol. 2023;118(1):59–76. doi:10.14309/ajg.0000000000002075
4. Størdal K, Kurppa K. Celiac disease, non-celiac wheat sensitivity, wheat allergy — clinical and diagnostic aspects. Semin Immunol. 2025;77:101930. doi:10.1016/j.smim.2025.101930
5. Husby S, Koletzko S, Korponay-Szabó IR, et al. European Society for Paediatric Gastroenterology, Hepatology and Nutrition Guidelines for Diagnosing Coeliac Disease 2020. J Pediatr Gastroenterol Nutr. 2020;70(1):141–156. doi:10.1097/MPG.0000000000002497
6. Kumar V, Jarzabek-Chorzelska M, Sulej J, et al. Celiac Disease and Immunoglobulin A Deficiency: How Effective Are the Serological Methods of Diagnosis? Clinical and diagnostic laboratory immunology. 2002;9(6):1295–1300. https://doi.org/10.1128/CDLI.9.6.1295-1300.2002