Author/Editor     Smarrazzo, Andrea; Magazzu, Giuseppe; Hariz, M. Ben; Legarda Tamara, Maria; Velmishi, Virtut; Roma, Elefhteria; Kansu, Aydan; Mičetić-Turk, Dušanka; Bravi, Enzo; Stellato, Pio; Arcidiaco, Carmela; Greco, Luigi
Title     Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries
Type     članek
Vol. and No.     Letnik 23, št. 24
Publication year     2017
Volume     str. 4437-4443
ISSN     2219-2840 - World journal of gastroenterology
Language     eng
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 = %/%), 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.
Descriptors     Coeliac disease
Keywords     accuracy
gluten
non-invasive testing
precision
transglutaminase