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Comparison of commercially available serologic kits for the detection of celiac disease.
J Clin Gastroenterol 2009; 43(3):225-32JC

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 (alpha-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 (alpha-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 alpha-DGP assays, E: alpha-DGP-IgA, F: alpha-DGP-IgG, and G: alpha-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 alpha-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.

Authors+Show Affiliations

Department of Medicine and Pathology, Columbia University, New York, NY 10032, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18724250

Citation

Naiyer, Afzal J., et al. "Comparison of Commercially Available Serologic Kits for the Detection of Celiac Disease." Journal of Clinical Gastroenterology, vol. 43, no. 3, 2009, pp. 225-32.
Naiyer AJ, Hernandez L, Ciaccio EJ, et al. Comparison of commercially available serologic kits for the detection of celiac disease. J Clin Gastroenterol. 2009;43(3):225-32.
Naiyer, A. J., Hernandez, L., Ciaccio, E. J., Papadakis, K., Manavalan, J. S., Bhagat, G., & Green, P. H. (2009). Comparison of commercially available serologic kits for the detection of celiac disease. Journal of Clinical Gastroenterology, 43(3), pp. 225-32. doi:10.1097/MCG.0b013e31816200e5.
Naiyer AJ, et al. Comparison of Commercially Available Serologic Kits for the Detection of Celiac Disease. J Clin Gastroenterol. 2009;43(3):225-32. PubMed PMID: 18724250.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of commercially available serologic kits for the detection of celiac disease. AU - Naiyer,Afzal J, AU - Hernandez,Lincoln, AU - Ciaccio,Edward J, AU - Papadakis,Konstantinos, AU - Manavalan,John S, AU - Bhagat,Govind, AU - Green,Peter H R, PY - 2008/8/30/pubmed PY - 2009/9/2/medline PY - 2008/8/30/entrez SP - 225 EP - 32 JF - Journal of clinical gastroenterology JO - J. Clin. Gastroenterol. VL - 43 IS - 3 N2 - 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 (alpha-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 (alpha-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 alpha-DGP assays, E: alpha-DGP-IgA, F: alpha-DGP-IgG, and G: alpha-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 alpha-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. SN - 1539-2031 UR - https://www.unboundmedicine.com/medline/citation/18724250/Comparison_of_commercially_available_serologic_kits_for_the_detection_of_celiac_disease_ L2 - http://Insights.ovid.com/pubmed?pmid=18724250 DB - PRIME DP - Unbound Medicine ER -