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Fully-automated, chemiluminescence IgA and IgG anti-tissue transglutaminase (tTG) antibodies serum assays for the screening of celiac disease.
J Immunol Methods 2016; 429:57-9JI

Abstract

AIM

Celiac disease (CD) is a systemic immune-mediated enteropathy sustained by gluten ingestion in genetically susceptible subjects. The European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has recently revised the diagnostic criteria, emphasizing the crucial role of serological testing in the diagnosis of this condition. This study was hence aimed to evaluate a new chemiluminescence assay for measuring anti-transglutaminase (tTG) and anti-endomysium (EMA) antibodies in a general population of unselected outpatients.

MATERIALS AND METHODS

The IgA and IgG anti-tissue transglutaminase (tTG) antibodies (Quanta Flash® IgA and Quanta Flash® IgG tTG, Inova Diagnostics, San Diego, CA, USA) were measured with the fully-automated BIO-FLASH® analyzer (Inova Diagnostics) in serum samples of 727 consecutive patients without a diagnosis of CD. Data were compared with those of anti-endomysium antibody (EmA) obtained in the same population.

RESULTS

A total of 96.4% samples display a negative concordance (anti-tTG negative and EMA negative), O% were positive for EMA and negative for anti-tTG IgA and IgG, 3.6% were both positive for tTG IgA and EMA, whereas 0.6% displayed discordant results (positive for anti-tTG and negative for EMA). The concordance (99%) and inter-rater agreement (Kappa Statistics, 0.943; p<0.001) between anti-tTG IgA and EmA antibodies were excellent, with sensitivity and specificity of 99% and 100%, respectively.

CONCLUSION

The results of this study show that Quanta Flash® IgA assay alone may be regarded as a reliable approach for screening of CD, with no need to perform EMA detection.

Authors+Show Affiliations

Clinical Pathology Laboratory, Hospital of Merano, Italy. Electronic address: massimo.daves@asbmeran-o.it.Cardiology Division, Hospital of Bolzano, Italy.Clinical Pathology Laboratory, Hospital of Merano, Italy.Clinical Pathology Laboratory, Hospital of Merano, Italy.Clinical Pathology Laboratory, Hospital of Merano, Italy.Clinical Pathology Laboratory, Hospital of Merano, Italy.Laboratory of Clinical Chemistry and Hematology, University Hospital of Parma, Italy.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

26773454

Citation

Daves, Massimo, et al. "Fully-automated, Chemiluminescence IgA and IgG Anti-tissue Transglutaminase (tTG) Antibodies Serum Assays for the Screening of Celiac Disease." Journal of Immunological Methods, vol. 429, 2016, pp. 57-9.
Daves M, Cemin R, Perkmann V, et al. Fully-automated, chemiluminescence IgA and IgG anti-tissue transglutaminase (tTG) antibodies serum assays for the screening of celiac disease. J Immunol Methods. 2016;429:57-9.
Daves, M., Cemin, R., Perkmann, V., Bernard, P., Caprioli, G., Platzgummer, S., & Lippi, G. (2016). Fully-automated, chemiluminescence IgA and IgG anti-tissue transglutaminase (tTG) antibodies serum assays for the screening of celiac disease. Journal of Immunological Methods, 429, pp. 57-9. doi:10.1016/j.jim.2016.01.002.
Daves M, et al. Fully-automated, Chemiluminescence IgA and IgG Anti-tissue Transglutaminase (tTG) Antibodies Serum Assays for the Screening of Celiac Disease. J Immunol Methods. 2016;429:57-9. PubMed PMID: 26773454.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fully-automated, chemiluminescence IgA and IgG anti-tissue transglutaminase (tTG) antibodies serum assays for the screening of celiac disease. AU - Daves,Massimo, AU - Cemin,Roberto, AU - Perkmann,Valentin, AU - Bernard,Patrick, AU - Caprioli,Giulia, AU - Platzgummer,Stefan, AU - Lippi,Giuseppe, Y1 - 2016/01/07/ PY - 2015/10/27/received PY - 2016/01/04/accepted PY - 2016/1/17/entrez PY - 2016/1/17/pubmed PY - 2016/6/21/medline KW - Anti-endomysium antibody KW - Anti-tissue transglutaminase antibodies KW - Celiac disease KW - Chemiluminescent immunoassay SP - 57 EP - 9 JF - Journal of immunological methods JO - J. Immunol. Methods VL - 429 N2 - AIM: Celiac disease (CD) is a systemic immune-mediated enteropathy sustained by gluten ingestion in genetically susceptible subjects. The European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) has recently revised the diagnostic criteria, emphasizing the crucial role of serological testing in the diagnosis of this condition. This study was hence aimed to evaluate a new chemiluminescence assay for measuring anti-transglutaminase (tTG) and anti-endomysium (EMA) antibodies in a general population of unselected outpatients. MATERIALS AND METHODS: The IgA and IgG anti-tissue transglutaminase (tTG) antibodies (Quanta Flash® IgA and Quanta Flash® IgG tTG, Inova Diagnostics, San Diego, CA, USA) were measured with the fully-automated BIO-FLASH® analyzer (Inova Diagnostics) in serum samples of 727 consecutive patients without a diagnosis of CD. Data were compared with those of anti-endomysium antibody (EmA) obtained in the same population. RESULTS: A total of 96.4% samples display a negative concordance (anti-tTG negative and EMA negative), O% were positive for EMA and negative for anti-tTG IgA and IgG, 3.6% were both positive for tTG IgA and EMA, whereas 0.6% displayed discordant results (positive for anti-tTG and negative for EMA). The concordance (99%) and inter-rater agreement (Kappa Statistics, 0.943; p<0.001) between anti-tTG IgA and EmA antibodies were excellent, with sensitivity and specificity of 99% and 100%, respectively. CONCLUSION: The results of this study show that Quanta Flash® IgA assay alone may be regarded as a reliable approach for screening of CD, with no need to perform EMA detection. SN - 1872-7905 UR - https://www.unboundmedicine.com/medline/citation/26773454/Fully_automated_chemiluminescence_IgA_and_IgG_anti_tissue_transglutaminase__tTG__antibodies_serum_assays_for_the_screening_of_celiac_disease_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-1759(16)30003-5 DB - PRIME DP - Unbound Medicine ER -