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Human Recombinant Tissue Transglutaminase Elisa: An Innovative Diagnostic Assay for Celiac Disease

Sblattero, D, PhD1; Berti, I, MD1,2; Trevisiol, C, MD1; Marzari, R, PhD3; Tommasini, A, MD1; Bradbury, A, MD, PhD4; Fasano, A, MD2; Ventura, A, MD1; Not, T, MD1

American Journal of Gastroenterology: May 2000 - Volume 95 - Issue 5 - p 1253–1257
doi: 10.1111/j.1572-0241.2000.02018.x

OBJECTIVE: Tissue transglutaminase is the autoantigen recognized by the sera of celiac patients. An enzyme-linked immunosorbent assay (ELISA) based on guinea-pig tissue transglutaminase was recently used to measure serum tissue transglutaminase antibodies for the diagnosis of celiac disease. We determine the sensitivity and specificity of an ELISA test based on the use of human recombinant transglutaminase, compared with the guinea pig transglutaminase ELISA and IgA antiendomysium antibodies.

METHODS: Serum samples were tested from 65 patients with intestinal biopsy proven celiac disease, from 10 patients with Crohn's disease, and from 150 healthy blood donors.

RESULTS: Human transglutaminase ELISA identified 64 of 65 celiac patients, whereas the guinea pig transglutaminase ELISA and IgA antiendomysium antibodies identified 58 of 65 and 60 of 65 subjects, respectively. The three tests showed comparable specificity.

CONCLUSIONS: These results proved that the human tissue transglutaminase-based ELISA represents a cost-effective strategy for identifying both symptomatic and atypical forms of celiac disease and could mean that intestinal biopsy need no longer be the gold standard for diagnosing this clinical condition. Furthermore, early identification and treatment of patients with celiac disease in an outpatient setting could have significant implications for reducing long-term morbidity and can produce major savings in future health care costs.

1Department of Pediatrics, IRCCS “Burlo Garofolo,” Trieste, Italy

2Division of Pediatric Gastroenterology and Nutrition, University of Maryland at Baltimore, Baltimore, Maryland, USA

3Department of Biology, University of Trieste, Trieste, Italy

4International School for Advanced Studies (SISSA), Trieste, Italy

Reprint requests and correspondence: Tarcisio Not, MD, Clinica Pediatrica, Istituto per l'Infanzia I.R.C.C.S. “Burlo Garofolo,” Via dell'Istria 65/1, 34100 Trieste, Italy.

Received August. 17, 1999; accepted January. 6, 2000

© The American College of Gastroenterology 2000. All Rights Reserved.
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