title: Analytical and clinical comparison of two fully automated immunoassay systems for the diagnosis of celiac disease.
abstract: OBJECTIVE
  Here we compared analytical and clinical performance characteristics of two novel automated assay systems for the detection of celiac disease (CD) specific antibodies: QUANTA Flash (INOVA Diagnostics, Inc.) and EliA (Thermo Scientific).
  
  
  METHODS
  A total of 74 biopsy-proven CD patients (2 with IgA deficiency) and 138 controls were tested by both methods.
  
  
  RESULTS
  Sensitivities of QUANTA Flash assays ranged from 35.1% to 90.5% and specificities from 96.4% to 99.3%, while sensitivities for EliA assays ranged from 37.8% to 90.5% (equivocal considered positive) and specificities from 97.1% to 100.0%. Good qualitative agreement was found between all assays. Thirty-four (50.0%) of the 68 QUANTA Flash h-tTG IgA positive results were higher than 10 times the upper limit of normal (ULN). In contrast, only 22.8% of the EliA tTG IgA positive samples were >10x ULN. Seventy-three (98.6%) biopsy-proven CD patients were correctly identified with the QUANTA Flash h-tTG IgA+DGP IgG combination, while 64 (86.5%) and 72 (97.3%) (depending on equivocal range) were identified with the same combination of EliA assays.
  
  
  CONCLUSIONS
  The QUANTA Flash CD assays have outstanding clinical performance. Of particular clinical significance, in light of proposals to decrease the absolute necessity of biopsy, was the demonstration that 50% of the QUANTA Flash h-tTG IgA results were >10x ULN.
authors.affiliation: INOVA Diagnostics, Inc., 9900 Old Grove Road, San Diego, CA 92131-1638, USA.
authors.forename: Gabriella
authors.identifier: 0000-0003-2856-3617
authors.initials: G
authors.lastname: Lakos
authors.affiliation: INOVA Diagnostics, Inc., 9900 Old Grove Road, San Diego, CA 92131-1638, USA.
authors.forename: Gary L
authors.initials: GL
authors.lastname: Norman
authors.affiliation: INOVA Diagnostics, Inc., 9900 Old Grove Road, San Diego, CA 92131-1638, USA.
authors.forename: Michael
authors.identifier: 0000-0002-7919-0948
authors.initials: M
authors.lastname: Mahler
authors.affiliation: INOVA Diagnostics, Inc., 9900 Old Grove Road, San Diego, CA 92131-1638, USA.
authors.forename: Peter
authors.identifier: 0000-0003-1143-0068
authors.initials: P
authors.lastname: Martis
authors.affiliation: INOVA Diagnostics, Inc., 9900 Old Grove Road, San Diego, CA 92131-1638, USA.
authors.forename: Chelsea
authors.identifier: 0000-0002-7836-4336
authors.initials: C
authors.lastname: Bentow
authors.affiliation: University of Maryland, Baltimore, MD 21201, USA.
authors.forename: Debby
authors.initials: D
authors.lastname: Santora
authors.affiliation: Center for Celiac Research, Massachusetts Hospital for Children, Boston, MA 02114, USA.
authors.forename: Alessio
authors.initials: A
authors.lastname: Fasano
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057205:Automation, Laboratory; D001706:Biopsy; D016022:Case-Control Studies; D002446:Celiac Disease / Q000097:blood / Q000175:diagnosis*; D004386:Duodenum / Q000473:pathology; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007070:Immunoglobulin A / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D007070:Immunoglobulin A; D007074:Immunoglobulin G
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