title: Comparison of a novel whole blood transglutaminase-based ELISA with a whole blood rapid antibody test and established conventional serological celiac disease assays.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Paediatric Research Centre, University of Tampere, Finland.
authors.forename: Tiina
authors.initials: T
authors.lastname: Raivio
authors.forename: Ilma R
authors.initials: IR
authors.lastname: Korponay-Szabó
authors.forename: Tuula
authors.initials: T
authors.lastname: Paajanen
authors.forename: Merja
authors.initials: M
authors.lastname: Ashorn
authors.forename: Sari
authors.initials: S
authors.lastname: Iltanen
authors.forename: Pekka
authors.initials: P
authors.lastname: Collin
authors.forename: Kaija
authors.initials: K
authors.lastname: Laurila
authors.forename: Eva
authors.initials: E
authors.lastname: Nemes
authors.forename: Judit B
authors.initials: JB
authors.lastname: Kovács
authors.forename: Géraldine
authors.initials: G
authors.lastname: Carrard
authors.forename: Mika
authors.initials: M
authors.lastname: Saramäki
authors.forename: Markku
authors.initials: M
authors.lastname: Mäki
authors.forename: Katri
authors.initials: K
authors.lastname: Kaukinen
mesh_terms: D000293:Adolescent; D000328:Adult; D001323:Autoantibodies / Q000097:blood; D002446:Celiac Disease / Q000097:blood / Q000175:diagnosis* / Q000201:enzymology* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D004912:Erythrocytes / Q000201:enzymology*; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D012016:Reference Values; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D011503:Transglutaminases / Q000097:blood* / Q000276:immunology; D055815:Young Adult
chemical_list: D001323:Autoantibodies; D007070:Immunoglobulin A; D011503:Transglutaminases