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Sequential testing with different tissue transglutaminase antibodies, a new approach for diagnosis of celiac disease

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Abstract

Background

The diagnosis of celiac disease (CeD) in clinical practice relies on serological testing for IgA antibodies to human tissue transglutaminase (anti-tTG) which diagnose CeD autoimmunity. We compared three kits for their performance in diagnosis of the disease and evaluated the point prevalence of CeD autoimmunity in a South Indian urban population.

Methods

In the first part of the study, sera from 90 patients with documented CeD and 92 healthy controls were tested for anti-tTG using three different kits. One thousand nine hundred and seventeen healthy adults residing in urban areas of Vellore and Kancheepuram districts were tested for CeD autoimmunity using a sequential two-test strategy.

Results

The sensitivity, specificity, false positivity, false negativity, positive predictive value, and negative predictive value for the three assays respectively were as follows: 95.5%, 82.6%, 17.3%, 4.4%, 84.3%, and 95% for the Aeskulisa New Generation Assay; 85.5%, 100%, 0%, 14.4%, 100%, and 87.6% for Quanta Lite; and 71.1%, 100%, 0%, 28.8%, 100%, and 71% for Celiac Microlisa. The ROC curves showed good discrimination for all three ELISAs with an AUC of 0.947, 0.950, and 0.886 for the Aeskulisa, Quanta Lite, and Celiac Microlisa, respectively. Of 1917 (males 908, females 1009) healthy adults, 113 (5.89%) were seropositive for IgA anti-htTG in the Aeskulisa test. Two of the latter tested positive in the Quanta Lite assay and/or the Celiac Microlisa assay. The CeD autoimmunity prevalence in this urban population was 1.0 per thousand (95% confidence interval 0.3 to 3.7 per thousand).

Conclusion

Sequential testing for anti-tTG using first a highly sensitive assay followed by a very specific assay is a new strategy for screening for CeD in clinical practice.

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Correspondence to Balakrishnan S. Ramakrishna.

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Conflict of interest

GV, JM, GM, AS, PS, RB, and BSR declare that they have no conflicts of interest.

Ethics statement

The authors declare that the study was performed in a manner to conform with the Helsinki Declaration of 1975, as revised in 2000 and 2008, concerning Human and Animal Rights. The protocol was approved by the Institutional Ethics Committee, and informed consent was obtained from the study subjects.

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Venugopal, G., Mechenro, J., Makharia, G. et al. Sequential testing with different tissue transglutaminase antibodies, a new approach for diagnosis of celiac disease. Indian J Gastroenterol 36, 481–486 (2017). https://doi.org/10.1007/s12664-017-0803-z

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  • DOI: https://doi.org/10.1007/s12664-017-0803-z

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