title: Evaluation of a point-of-care test based on deamidated gliadin peptides for celiac disease screening in a large pediatric population.
abstract: OBJECTIVE
  Celiac disease (CD) is nowadays known to be a common chronic enteropathy that is becoming a growing public health concern. Yet, it is estimated that more than 90% of patients remain undiagnosed. A point-of-care diagnostic test can be a rapid and cost-effective solution in the first-line screening of CD. The aim of this study is to evaluate the performance of a novel point-of-care screening test in a large pediatric population.
  
  
  METHODS
  Serum samples were collected from a cohort of 250 children presenting either an increased risk or a clinical suspicion of CD. All sera were tested using the point-of-care test detecting IgA and IgG antibodies against a combination of three different deamidated gliadin peptides as well as total IgA. The results of the screening test were compared with an enzyme-linked tissue transglutaminase immunosorbent assay and with histology resulting from intestinal biopsies performed in patients with elevated titers of antitissue transglutaminase antibodies.
  
  
  RESULTS
  The point-of-care test showed highly concordant results with the laboratory immunoassay, yielding a sensitivity of 93.1 (78-98.1%) and a specificity of 95% (91.2-97.2%), with a diagnostic accuracy of 94.8% (91.3-96.9%) and a negative predictive value of 99.1% (96.6-99.7%). The screening test identified all patients with celiac-type histology findings on biopsy, as well as all patients with concomitant IgA deficiency.
  
  
  CONCLUSIONS
  With a high diagnostic accuracy, this novel point-of-care approach is an efficient tool for CD case finding in pediatric populations. It has the potential to improve the management of celiac patients in primary care by providing faster counseling and treatment.
authors.affiliation: Immunology Laboratory, Lyon-Sud University Hospital, Pierre-Bénite, France. francoise.bienvenu@chu-lyon.fr
authors.forename: Françoise
authors.initials: F
authors.lastname: Bienvenu
authors.forename: Cécile
authors.initials: C
authors.lastname: Besson Duvanel
authors.forename: Camille
authors.initials: C
authors.lastname: Seignovert
authors.forename: Paul
authors.initials: P
authors.lastname: Rouzaire
authors.forename: Alain
authors.initials: A
authors.lastname: Lachaux
authors.forename: Jacques
authors.initials: J
authors.lastname: Bienvenu
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001323:Autoantibodies / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D002446:Celiac Disease / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D019204:GTP-Binding Proteins; D005903:Gliadin / Q000276:immunology*; D006801:Humans; D017098:IgA Deficiency / Q000097:blood / Q000175:diagnosis / Q000276:immunology; D007070:Immunoglobulin A / Q000097:blood*; D007074:Immunoglobulin G / Q000097:blood*; D007223:Infant; D008297:Male; D008403:Mass Screening / Q000295:instrumentation*; D010446:Peptide Fragments / Q000276:immunology*; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D012680:Sensitivity and Specificity; D011503:Transglutaminases / Q000276:immunology; D055815:Young Adult
chemical_list: D001323:Autoantibodies; D015415:Biomarkers; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D010446:Peptide Fragments; D005903:Gliadin; D000091345:Protein Glutamine gamma Glutamyltransferase 2; D011503:Transglutaminases; D019204:GTP-Binding Proteins