Looking for celiac disease: diagnostic accuracy of two rapid commercial assays

Am J Gastroenterol. 2006 Jul;101(7):1597-600. doi: 10.1111/j.1572-0241.2006.00597.x.


Background: Early diagnosis and treatment with gluten-free diet reduces mortality and the prevalence of associated disorders in celiac disease (CD). A simple "in the office" test of anti-transglutaminase antibodies might be of great help in first-line screening for CD.

Aims: We evaluated the sensitivity and specificity of two commercial kits based, respectively, on rapid detection of IgA-IgG anti-human-transglutaminase antibodies (anti-h-tTG) in serum and IgA anti-h-tTG antibody in one drop of whole blood. These assays were compared to a well-established enzyme-linked immunosorbent assay technique.

Methods: Serum samples were analyzed from 114 biopsy-confirmed celiacs, 120 healthy controls, 20 first-degree relatives of celiacs, and 75 diseased controls. The whole blood samples were analyzed from 51 biopsy-confirmed celiacs and 100 controls.

Results: The serum-based test was positive in all 114 celiacs (sensitivity 100%). Among the controls there were seven healthy blood donors, one first-degree relative, and three diseased controls who tested positive (specificity 94.9%). The blood drop-based assay testing IgA antibodies was positive in 46 of 51 (sensitivity 90.2%), and since three of the five patients testing negative had total IgA deficiency, the sensitivity value can be increased to 95.8%. All 100 controls tested negative (specificity 100%).

Conclusions: The commercial kits described here produce high values of sensitivity and specificity, offering the general practitioner who suspects a possible case of CD the real possibility to look for anti-h-tTG antibodies in his own medical office during a standard visit at a satisfyingly low cost.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Celiac Disease / blood
  • Celiac Disease / diagnosis*
  • Early Diagnosis
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Immunoglobulin A / blood
  • Immunoglobulin G / blood
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Transglutaminases


  • Immunoglobulin A
  • Immunoglobulin G
  • Reagent Kits, Diagnostic
  • Transglutaminases