title: New screening tests enrich anti-transglutaminase results and support a highly sensitive two-test based strategy for celiac disease diagnosis.
abstract: BACKGROUND
  The identification of specific serological algorithms allowing the diagnosis of celiac disease (CD) is a new challenge for both the clinic and the laboratory. We compared the diagnostic accuracy of three new tests proposed for CD screening with that of the well established IgA tTG, and ascertained whether any combination of these tools might enhance accuracy in diagnosing CD.
  
  
  METHODS
  In sera from 329 CD and 374 control children, the following were assayed: IgA tTG; IgA/IgG, which identify tTG-gliadin complexes (Aeskulisa Celi Check and CeliCheck IgGA); IgA/IgG, which identify deamidated gliadin peptides and tTG (QUANTA Lite(TM) h-tTG/DGP Screen).
  
  
  RESULTS
  When specificity was set at 100%, the most sensitive index of CD was IgA tTG (75.7%, cut-off=100U), followed by QUANTA Lite(TM) h-tTG/DGP Screen (65.3%, cut-off 145U), Aeskulisa Celi Check (62.6%, cut-off 909U/mL) and CeliCheck IgGA (59.6%, cut-off 977U/mL). Three algorithms were obtained by combining IgA tTG with each of the new tests. The algorithm obtained by measuring IgA tTG and QUANTA Lite(TM) h-tTG/DGP Screen allowed the correct identification of CD in 78.7% of cases (negative predictive value=97.3%).
  
  
  CONCLUSIONS
  The two-test based strategy could be used for the cost effective diagnosis of CD.
authors.affiliation: Department of Laboratory Medicine, University of Padova, Padova, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Basso
authors.forename: Graziella
authors.initials: G
authors.lastname: Guariso
authors.forename: Dania
authors.initials: D
authors.lastname: Bozzato
authors.forename: Elisa
authors.initials: E
authors.lastname: Rossi
authors.forename: Matilde
authors.initials: M
authors.lastname: Pescarin
authors.forename: Paola
authors.initials: P
authors.lastname: Fogar
authors.forename: Stefania
authors.initials: S
authors.lastname: Moz
authors.forename: Filippo
authors.initials: F
authors.lastname: Navaglia
authors.forename: Michela
authors.initials: M
authors.lastname: Pelloso
authors.forename: Marco
authors.initials: M
authors.lastname: Gasparetto
authors.forename: Carlo-Federico
authors.initials: CF
authors.lastname: Zambon
authors.forename: Andrea
authors.initials: A
authors.lastname: Padoan
authors.forename: Eliana
authors.initials: E
authors.lastname: Greco
authors.forename: Massimo
authors.initials: M
authors.lastname: Rugge
authors.forename: Mario
authors.initials: M
authors.lastname: Plebani
mesh_terms: D000293:Adolescent; D016022:Case-Control Studies; D002446:Celiac Disease / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D011503:Transglutaminases / Q000276:immunology*
chemical_list: D011503:Transglutaminases