Comparison of Commercially Available Serologic Kits for the ... : Journal of Clinical Gastroenterology (original) (raw)

ALIMENTARY TRACT: Clinical Research

Comparison of Commercially Available Serologic Kits for the Detection of Celiac Disease

Naiyer, Afzal J. MD; Hernandez, Lincoln MD; Ciaccio, Edward J. PhD; Papadakis, Konstantinos MD; Manavalan, John S. MD; Bhagat, Govind MD; Green, Peter H. R. MD

Department of Medicine and Pathology, Columbia University, New York, NY.

No conflicts of interest exist

This study has been self funded by us, The Celiac Disease Center at Columbia University.

Reprints: Dr Peter H. R. Green, MD, Department of Medicine, College of Physicians and Surgeons, Columbia University, 180 Ft Washington Av (Room 956), New York, NY 10032 (e-mail: [email protected]).

Received for publication June 12, 2007; accepted November 10, 2007

Abstract

Background

The sensitivity and specificity of current antihuman tissue transglutaminase (tTG) IgA assays used to detect celiac disease reportedly approach 100%. In addition, the sensitivity of new generation deamidated gliadin peptide (α-DGP) antibody assays has also been reported to be similar to the tTG IgA assays. In routine clinical practice, however, the sensitivities and specificities of these tests for diagnosing celiac disease seem to be lower.

Aim

We analyzed sensitivities and specificities of 4 IgA tTG and 3 deamidated gliadin peptide (α-DGP) kits.

Methods

The performance of 4 tTG IgA assays, A: Inova (Hu red blood cell), B: Binding site (rHu Ag), C: Eurospital (rHu Ag), D: Immco (rHu Ag) and 3 Inova α-DGP assays, E: α-DGP-IgA, F: α-DGP-IgG, and G: α-DGP-IgA+G was evaluated using sera from different subsets of celiac disease patients and controls; group 1: active celiac disease n=28, group 2: gluten-free diet n=54, group 3: healthy controls n=40, group 4: disease controls n=57(Crohn's disease n=17, chronic hepatitis n=40).

Results

Using the manufacturer's cut-off values, the sensitivities and specificities of different kits ranged from 71.4% to 96.4% and 87.5% to 100%, respectively. When group 1 was compared with disease controls, sensitivities remained the same but specificities decreased. Receiver operating characteristic plot derived cut-off values modified decision thresholds in all assays except kit (G). Kappa analysis demonstrated variable degrees of agreement. All assays demonstrated higher sensitivities for patients with higher grades of villous atrophy.

Conclusions

Overall sensitivity was at or below 90%, which is lower than that reported in the literature. Performance of the recombinant and red blood cell antigen-based tTG assays was similar, whereas the α-DGP assays demonstrated lower values. Receiver operating characteristic plot derived cut-off values altered test results. Many factors affect the results of these tests and clinicians should be aware of their limitations.