@article{3108577, title = "Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries", author = "Smarrazzo, A. and Stellato, P. and Arcidiaco, C. and Greco, L. and Magazzù, G. and Ben-Hariz, M. and Tamara, M.L. and Velmishi, V. and Roma, E. and Kansu, A. and Mičetić-Turk, D. and Bravi, E.", journal = "World Journal of Gastroenterology", year = "2017", volume = "23", number = "24", pages = "4437-4443", publisher = "Baishideng Publishing Group Co", issn = "1007-9327", doi = "10.3748/wjg.v23.i24.4437", keywords = "protein glutamine gamma glutamyltransferase antibody; immunoglobulin A; protein glutamine gamma glutamyltransferase, Albania; antibody titer; Article; celiac disease; controlled study; diagnostic accuracy; diagnostic test accuracy study; diagnostic value; Greece; human; immunoassay; Italy; multicenter study; randomized controlled trial; Slovenia; Spain; Tunisia; Turkey (republic); blood; celiac disease; clinical trial; enzyme linked immunosorbent assay; immunology; measurement accuracy; randomization; sensitivity and specificity; Southern Europe; validation study, Celiac Disease; Data Accuracy; Enzyme-Linked Immunosorbent Assay; Humans; Immunoglobulin A; Mediterranean Region; Random Allocation; Sensitivity and Specificity; Transglutaminases", abstract = "AIM To verify the precision and accuracy of transglutaminase antibodies (TGA) assays across Mediterranean countries. METHODS This study involved 8 referral centres for celiac disease (CD) in 7 Mediterranean countries. A central laboratory prepared 8 kits of 7 blinded and randomized serum samples, with a titrated amount of Human TGA IgA. Each sample was analysed three times on three different days, with each centre running a total of 21 tests. The results were included in a blindly coded report form, which was sent to the coordinator centre. The coordinator estimated the mean coefficient of Variation (CoVar = σ/μ), the mean accuracy (Accur = Vobserved -Vreal) and the mean percent variation (Var% = [(Vobserved -Vreal)/Vreal] × 100). RESULTS The analysis showed that 79.17% of the mean variation fell between -25% and +25% of the expected value, with the accuracy and precision progressively increasing with higher titres of TGA. From values 1.25 times greater than the normal cut-off, the measurements were highly reliable. CONCLUSION TGA estimation is a crucial step for the diagnosis of CD; given its accuracy and precision, clinicians could be confident in establishing a diagnosis. © The Author(s) 2017." }