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Journal of Immunology Research
Volume 2014, Article ID 371263, 9 pages
http://dx.doi.org/10.1155/2014/371263
Research Article

Analytical and Clinical Comparison of Two Fully Automated Immunoassay Systems for the Diagnosis of Celiac Disease

1INOVA Diagnostics, Inc., 9900 Old Grove Road, San Diego, CA 92131-1638, USA
2University of Maryland, Baltimore, MD 21201, USA
3Center for Celiac Research, Massachusetts Hospital for Children, Boston, MA 02114, USA

Received 13 December 2013; Revised 29 January 2014; Accepted 29 January 2014; Published 13 March 2014

Academic Editor: Marvin J. Fritzler

Copyright © 2014 Gabriella Lakos et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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. Conclusion. 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.