Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries

Autor: Smarrazzo, A. Stellato, P. Arcidiaco, C. Greco, L. Magazzù, G. Ben-Hariz, M. Tamara, M.L. Velmishi, V. Roma, E. Kansu, A. Mičetić-Turk, D. Bravi, E.
Jazyk: angličtina
Rok vydání: 2017
Popis: 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.
Databáze: OpenAIRE