TY - JOUR
TI - Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries
AU - Smarrazzo, A.
AU - Stellato, P.
AU - Arcidiaco, C.
AU - Greco, L.
AU - Magazzù, G.
AU - Ben-Hariz, M.
AU - Tamara, M.L.
AU - Velmishi, V.
AU - Roma, E.
AU - Kansu, A.
AU - Mičetić-Turk, D.
AU - Bravi, E.
JO - World Journal of Gastroenterology
PY - 2017
VL - 23
TODO - 24
SP - 4437-4443
PB - Baishideng Publishing Group Co
SN - 1007-9327
TODO - 10.3748/wjg.v23.i24.4437
TODO - 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
TODO - 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.
ER -