Comparison of a Novel Whole Blood Transglutaminase‐based ELISA With a Whole Blood Rapid Antibody Test and Established Conventional Serological Celiac Disease Assays

ABSTRACT Objectives: Serum immunoglobulin A–class tissue transglutaminase (tTG‐ab) and endomysial antibody (EMA) tests play a key role in the diagnostic evaluation of celiac disease. Recently, a novel whole blood rapid test based on self‐tissue transglutaminase (tTG) was developed for celiac disease...

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Published inJournal of pediatric gastroenterology and nutrition Vol. 47; no. 5; pp. 562 - 567
Main Authors Raivio, Tiina, Korponay‐Szabó, Ilma R, Paajanen, Tuula, Ashorn, Merja, Iltanen, Sari, Collin, Pekka, Laurila, Kaija, Nemes, Éva, Kovács, Judit B, Carrard, Géraldine, Saramäki, Mika, Mäki, Markku, Kaukinen, Katri
Format Journal Article
LanguageEnglish
Published Hagerstown, MD Lippincott Williams & Wilkins, Inc 01.11.2008
Lippincott Williams & Wilkins
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Summary:ABSTRACT Objectives: Serum immunoglobulin A–class tissue transglutaminase (tTG‐ab) and endomysial antibody (EMA) tests play a key role in the diagnostic evaluation of celiac disease. Recently, a novel whole blood rapid test based on self‐tissue transglutaminase (tTG) was developed for celiac disease case finding. Based on the same principle, a whole blood self‐tTG enzyme‐linked immunosorbent assay (ELISA), especially applicable to large‐scale screening of celiac disease, has been produced. We assessed the value of this new test in celiac disease antibody detection. Patients and Methods: The new test uses endogenous tTG found in red blood cells of whole blood in IgA‐class tTG‐ab measurement by detecting tTG–tTG‐ab complexes formed after hemolysis of the whole blood sample. Stored whole blood samples from 150 untreated celiac disease patients and 107 control individuals without celiac disease were evaluated, and the test results were compared with those of the whole blood rapid test, 2 conventional serum‐based tTG‐ab ELISA tests, and 2 EMA tests. Results: A total of 15 whole blood samples were found to be clotted or dried after storage and were excluded from further evaluation. The whole blood ELISA test had a specificity (98%) comparable to that of the conventional serological tests, the sensitivity (91%) being slightly lower. The test was concordant with the whole blood rapid test in 92% of cases, with 2 serological ELISA tests in 91% and 94% of cases and with EMA tests in 94% and 93% of cases. Conclusions: Whole blood self‐tTG–based testing is accurate in celiac antibody detection, also when an ELISA method is applied. The testing requires no serum separation or external tTG.
Bibliography:Drs Korponay‐Szabó and Mäki report having a patent application licenced to Ani Biotech, Vantaa, Finland, via the Tampere University/University Hospital–owned company Finn‐Medi Research Ltd, Tampere, Finland. Géraldine Carrard is an employee of Ani Labsystems Ltd, Oy, Vantaa, Finland, and Mika Saramäki is an employee of Ani Biotech Oy. The other authors have nothing to declare. Ani Labsystems Ltd Oy and Ani Biotech Oy provided the whole blood self‐tissue transglutaminase antibody tests used in the study; however, the present study was prompted solely by academic interest. The companies did not have the right to influence the results and were not involved in the data analysis.
Supported by the Academy of Finland Research Council for Health, the Hungarian Scientific Research Fund (OTKA K61868), the Competitive Research Funding of the Pirkanmaa Hospital District, the Yrjö Jahnsson Foundation, the Finnish Medical Foundation, the Foundation for Paediatric Research, the Finnish Foundation of Gastroenterological Research, the Finnish Celiac Society, and EU Marie Curie Mobility Grant MRTN‐CT‐2006‐036032 (TRACKS).
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ISSN:0277-2116
1536-4801
DOI:10.1097/MPG.0b013e3181615cde