Τίτλος:
Variability of anti-human transglutaminase testing in celiac disease across Mediterranean countries
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
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.
Περιοδικό:
World Journal of Gastroenterology
Εκδότης:
Baishideng Publishing Group Co
Λέξεις-κλειδιά:
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
DOI:
10.3748/wjg.v23.i24.4437
