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Clinical and Vaccine Immunology, November 2009, p. 1576-1582, Vol. 16, No. 11
1071-412X/09/$08.00+0     doi:10.1128/CVI.00205-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Performance of Serology Assays for Diagnosing Celiac Disease in a Clinical Setting{triangledown}

Miriam Parizade,1* Yoram Bujanover,2 Batya Weiss,2 Vered Nachmias,2 and Bracha Shainberg1

Maccabi Health Services, Central Laboratory, 9 Hamada St., Tamar Industrial Park, Rechovot 76302, Israel,1 Pediatric Gastroenterology, The Edmond & Lily Safra Children's Hospital, Sheba Medical Center, Tel Hashomer 52621, Israel2

Received 21 May 2009/ Returned for modification 24 June 2009/ Accepted 16 September 2009

Diagnosis of celiac disease frequently depends upon serology assays. We set out to prospectively assess the diagnostic value of five serology tests: an enzyme-linked immunosorbent assay (ELISA) for tissue transglutaminase (tTG)-immunoglobulin A (IgA) and tTG-IgG, a chemiluminescence assay for tTG-IgA, an ELISA for deamidated gliadin peptide (DGP) IgG and IgA screening, and detection of endomysial antibodies (Abs) by indirect immunofluorescence. One hundred sixteen children at high risk for developing celiac disease were evaluated clinically and underwent small bowel biopsies and blood serology tests. We examined differences between younger and older children in terms of clinical presentation, test performance, and the ability of high Ab levels to correctly predict diagnosis of celiac disease. Celiac disease was diagnosed for 85 (73%) children. No significant clinical differences were observed between the biopsy-positive and biopsy-negative groups. Children ≤3 years of age revealed higher concentrations of tTG-IgA and DGP Abs than children >3 years old (P = 0.017 and 0.007, respectively). High Ab concentrations were predictive of villous atrophies, with sensitivities ranging from 92.8% to 97.9%, depending on the assay and the cutoff points applied. Sensitivities, specificities, positive predictive values, and negative predictive values varied among assays and improved after correction for best cutoff points. Assay specificities obtained in the clinical setting were lower than expected. The new tTG-IgA chemiluminescence assay demonstrated high throughput but low specificity (74.2%). The tTG-IgA ELISA exhibited the highest test efficiency, and the tTG-IgA chemiluminescence assay was suitable for large-scale screening, with reduced specificity. High concentrations of celiac disease-specific Abs bring into question the need for performance of biopsies on children at high risk.

* Corresponding author. Mailing address: Maccabi Health Services, Central Laboratory, 9 Hamada St., Tamar Industrial Park, Rechovot 76302, Israel. Phone: 972-8-9311559. Fax: 972-8-9311380. E-mail: parizade_m{at}mac.org.il

{triangledown} Published ahead of print on 23 September 2009.

Clinical and Vaccine Immunology, November 2009, p. 1576-1582, Vol. 16, No. 11
1071-412X/09/$08.00+0     doi:10.1128/CVI.00205-09
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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