title: Celiac disease screening by immunochromatographic visual assays: results of a multicenter study.
abstract: OBJECTIVE
  To assay the efficiency for celiac disease (CD) screening of 2 immunochromatographic visual stick assays based on human recombinant tissue transglutaminase (tTG). One was the antitissue transglutaminase antibodies (AtTGA) stick for IgA/G antibodies to tTG detection, the other was the AtTGA/antigliadin antibodies (AGA) stick for IgA antibodies for tTG and/or gliadins.
  
  
  METHODS
  In a prospective multicenter study, 4 pediatric gastroenterology units from Spain and 2 from Latin America enrolled 72 control children with a normal small bowel mucosa and 113 untreated patients with CD with Marsh type 3 lesions.
  
  
  RESULTS
  Evaluation of results by the gastroenterologists and by 2 independent observers at the coordination center showed a remarkably low interobserver variability. For the AtTGA stick, sensitivity was 96.5% and specificity was 98.6%. The AtTGA/AGA stick displayed a sensitivity of 94.5% and a specificity of 98.6% for AtTGA and a sensitivity of 63.1% and a specificity of 95.2% for AGA. The highest efficiency and positive likelihood ratio was obtained for the AtTGA stick, higher than for IgA AtTGA by enzyme-linked immunosorbent assay. One additional advantage was that previous investigation of total serum IgA levels could be eluded. The IgA AtTGA/AGA stick, with an efficiency of 95.1%, compared with 89.2% when the combined results of the 2 enzyme-linked immunosorbent assays were considered, turned out to be an excellent diagnostic tool for infants with no IgA deficiency.
  
  
  CONCLUSIONS
  These 2 assays are extremely efficient for CD screening, by combining a high diagnostic accuracy with the simplicity and rapidity of visual methods.
authors.affiliation: Pediatric Gastroenterology Unit, La Fe Children's Hospital, Valencia, Spain. lcblesa@ono.com
authors.forename: Luis Carlos Blesa
authors.initials: LC
authors.lastname: Baviera
authors.forename: Ester Donat
authors.initials: ED
authors.lastname: Aliaga
authors.forename: Luis
authors.initials: L
authors.lastname: Ortigosa
authors.forename: Néstor
authors.initials: N
authors.lastname: Litwin
authors.forename: Luis
authors.initials: L
authors.lastname: Peña-Quintana
authors.forename: Virginia
authors.initials: V
authors.lastname: Méndez
authors.forename: Ma Victoria
authors.initials: MV
authors.lastname: González
authors.forename: Javier Manzanares
authors.initials: JM
authors.lastname: López-Manzanares
authors.forename: Enrique
authors.initials: E
authors.lastname: Méndez
authors.forename: Carmen Ribes
authors.initials: CR
authors.lastname: Koninckx
mesh_terms: D000293:Adolescent; D000888:Antibodies, Anti-Idiotypic / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D002446:Celiac Disease / Q000175:diagnosis* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D002845:Chromatography / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay; D005903:Gliadin / Q000097:blood / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007070:Immunoglobulin A / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D007223:Infant; D007843:Latin America; D008403:Mass Screening / Q000379:methods*; D015588:Observer Variation; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013030:Spain; D011503:Transglutaminases / Q000097:blood / Q000276:immunology
chemical_list: D000888:Antibodies, Anti-Idiotypic; D015415:Biomarkers; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D005903:Gliadin; D011503:Transglutaminases