title: Fully-automated, chemiluminescence IgA and IgG anti-tissue transglutaminase (tTG) antibodies serum assays for the screening of celiac disease.
abstract: OBJECTIVE
  Celiac disease (CD) is a systemic immune-mediated enteropathy sustained by gluten ingestion in genetically susceptible subjects. The European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has recently revised the diagnostic criteria, emphasizing the crucial role of serological testing in the diagnosis of this condition. This study was hence aimed to evaluate a new chemiluminescence assay for measuring anti-transglutaminase (tTG) and anti-endomysium (EMA) antibodies in a general population of unselected outpatients.
  
  
  METHODS
  The IgA and IgG anti-tissue transglutaminase (tTG) antibodies (Quanta Flash® IgA and Quanta Flash® IgG tTG, Inova Diagnostics, San Diego, CA, USA) were measured with the fully-automated BIO-FLASH® analyzer (Inova Diagnostics) in serum samples of 727 consecutive patients without a diagnosis of CD. Data were compared with those of anti-endomysium antibody (EmA) obtained in the same population.
  
  
  RESULTS
  A total of 96.4% samples display a negative concordance (anti-tTG negative and EMA negative), O% were positive for EMA and negative for anti-tTG IgA and IgG, 3.6% were both positive for tTG IgA and EMA, whereas 0.6% displayed discordant results (positive for anti-tTG and negative for EMA). The concordance (99%) and inter-rater agreement (Kappa Statistics, 0.943; p<0.001) between anti-tTG IgA and EmA antibodies were excellent, with sensitivity and specificity of 99% and 100%, respectively.
  
  
  CONCLUSIONS
  The results of this study show that Quanta Flash® IgA assay alone may be regarded as a reliable approach for screening of CD, with no need to perform EMA detection.
authors.affiliation: Clinical Pathology Laboratory, Hospital of Merano, Italy. Electronic address: massimo.daves@asbmeran-o.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Daves
authors.affiliation: Cardiology Division, Hospital of Bolzano, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Cemin
authors.affiliation: Clinical Pathology Laboratory, Hospital of Merano, Italy.
authors.forename: Valentin
authors.initials: V
authors.lastname: Perkmann
authors.affiliation: Clinical Pathology Laboratory, Hospital of Merano, Italy.
authors.forename: Patrick
authors.initials: P
authors.lastname: Bernard
authors.affiliation: Clinical Pathology Laboratory, Hospital of Merano, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Caprioli
authors.affiliation: Clinical Pathology Laboratory, Hospital of Merano, Italy.
authors.forename: Stefan
authors.initials: S
authors.lastname: Platzgummer
authors.affiliation: Laboratory of Clinical Chemistry and Hematology, University Hospital of Parma, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lippi
mesh_terms: D000293:Adolescent; D000328:Adult; D001323:Autoantibodies / Q000097:blood* / Q000276:immunology*; D001331:Automation; D002446:Celiac Disease / Q000097:blood / Q000175:diagnosis* / Q000276:immunology*; D002648:Child; D005260:Female; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood* / Q000276:immunology; D007074:Immunoglobulin G / Q000097:blood* / Q000276:immunology; D049449:Luminescence; D008297:Male; D008875:Middle Aged; D011503:Transglutaminases / Q000276:immunology* / Q000378:metabolism; D055815:Young Adult
chemical_list: D001323:Autoantibodies; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D011503:Transglutaminases
keywords: Anti-endomysium antibody; Anti-tissue transglutaminase antibodies; Celiac disease; Chemiluminescent immunoassay