Pin-Prick Blood Test for Non-Celiac Gluten Sensitivity Arrives

Researchers at the 2016 British Society of Gastroenterology Annual Meeting present evidence that a pin-prick blood test performed in a doctor’s office is able to identify patients with non-celiac gluten sensitivity. (1)

Among three point-of-care (POC) tests for celiac disease, Simtomax® (2) was the most accurate in distinguishing between celiac disease (CD) and non-celiac gluten sensitivity (NCGS).

Background

Because the clinical symptoms of CD and NCGS overlap, it is difficult to distinguish the two disorders on the basis of symptoms alone ie bloating • abdominal pain • diarrhea • symptoms mimicking irritable bowel syndrome • nausea • reflux • mouth ulcers • constipation • feeling generally unwell • fatigue • headaches • foggy mind • numbness • joint pains • skin rash • et al

How is CD Diagnosed? (3)

  • by the presence of  tissue transglutaminase antibody (TTG), endomysial antibody (EMA) and deamidated gliadin peptide (DGP) in screening blood tests
  • by small intestinal biopsy showing evidence of villous atrophy

How is NCGS Diagnosed?

  • currently, a diagnosis of NCGS depends upon ruling out CD
    • absence of biomarkers ie TTG, EMA and DGP antibodies
    • by small intestinal biopsy showing NO evidence of villous atrophy

Why does a proper diagnosis matter?

  • Celiac disease is a serious disorder with patients being at risk for nutritional deficiencies and development of other autoimmune disorders and rarely malignancies such as small intestinal lymphoma.

The Study 

Researchers from the Royal Hallamshire Hospital in the U.K. compared the accuracy of three POC tests:

  • Simtomax® (DGP)
  • Biocard® (TTG)
  • Celiac Quick Test® (EMA)

Researchers recruited three different patient groups, all of whom had undergone small intestinal biopsy.

  • A. 100 patients with a positive EMA
  • B. 667 patients from the general population with GI symptoms or ataxia (Patients with positive EMA, previous villous atrophy, known celiac disease, self-reported gluten sensitivity and those on a gluten-free diet were excluded from this group to reduce positive ascertainment bias.)
  • C. 35 patients with self-reported gluten sensitivity

The Results

  • Group A showed Simtomax® was superior to Biocard® and Celiac Quick Test® for detecting celiac disease (96.5% sensitivity; 85% celiac disease prevalence).
  • Group B showed Simtomax® had comparable sensitivity and negative predictive value to EMA and TTG.
  • Group C, showed that Simtomax® had 100% sensitivity (true positive rate) in identifying celiac disease (true positive rate) in patients with self-reported gluten sensitivity, and a 100% negative predictive value (true negative rate) for identifying patients with NCGS

Conclusion

Simtomax® proved as accurate in identifying those with and without CD as current diagnostic technology. The results suggest that medical care providers can positively identify patients with NCGS in their offices without having them first undergo extensive, invasive and expensive process of first ruling out CD.

References: Lau MS, et al. Abstract #OC-024. Presented at: British Society of Gastroenterology Annual Meeting; June 20-23, 2016; Liverpool, UK.

Disclosures: One of the researchers reports grant/research support from Tillotts Pharma.

Footnotes

  1. Helio Gastroenterology
  2. http://augurix.com/simtomax/
  3. http://www.celiac.ca/?page_id=883