title: Coeliac disease case finding and diet monitoring by point-of-care testing.
abstract: BACKGROUND
  Immunoglobulin A class transglutaminase autoantibodies are highly predictive markers of active coeliac disease, a disorder difficult to recognize solely on clinical grounds.
  
  
  OBJECTIVE
  To develop and evaluate a simple rapid test for point-of-care detection of coeliac autoantibodies.
  
  
  METHODS
  The novel whole blood test utilizes the patient's endogenous transglutaminase in red blood cells for detection of transglutaminase-specific immunoglobulin A antibodies present in the blood sample, with normal plasma immunoglobulin A detection as positive test control. We evaluated 284 patients under suspicion of coeliac disease and undergoing jejunal biopsy, and 263 coeliac patients on a gluten-free diet, 383 being tested prospectively in a point-of-care setting. Results were compared with histology, conventional serum autoantibody results and dietary adherence.
  
  
  RESULTS
  The rapid test showed 97% sensitivity and 97% specificity for untreated coeliac disease, and identified all immunoglobulin A-deficient samples. Point-of-care testing found new coeliac cases as efficiently as antibody tests in laboratory. Coeliac autoantibodies were detected onsite in 21% of treated patients, while endomysial and transglutaminase antibodies were positive in 20% and 19%, respectively. The positivity rate correlated with dietary lapses and decreased on intensified dietary advice given upon positive point-of-care test results.
  
  
  CONCLUSIONS
  Point-of-care testing was accurate in finding new coeliac cases and helped to identify and decrease dietary non-compliance.
authors.affiliation: Paediatric Research Centre, Medical School, University of Tampere and Tampere University Hospital, Tampere, Finland.
authors.forename: I R
authors.initials: IR
authors.lastname: Korponay-Szabó
authors.forename: T
authors.initials: T
authors.lastname: Raivio
authors.forename: K
authors.initials: K
authors.lastname: Laurila
authors.forename: J
authors.initials: J
authors.lastname: Opre
authors.forename: R
authors.initials: R
authors.lastname: Király
authors.forename: J B
authors.initials: JB
authors.lastname: Kovács
authors.forename: K
authors.initials: K
authors.lastname: Kaukinen
authors.forename: L
authors.initials: L
authors.lastname: Fésüs
authors.forename: M
authors.initials: M
authors.lastname: Mäki
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001323:Autoantibodies / Q000097:blood; D002446:Celiac Disease / Q000175:diagnosis* / Q000178:diet therapy*; D002648:Child; D002675:Child, Preschool; D005983:Glutens / Q000008:administration & dosage; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008875:Middle Aged; D010349:Patient Compliance; D019095:Point-of-Care Systems; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D011503:Transglutaminases / Q000276:immunology
chemical_list: D001323:Autoantibodies; D007070:Immunoglobulin A; D011933:Reagent Kits, Diagnostic; D005983:Glutens; D011503:Transglutaminases