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

World Journal of Gastroenterology 2017年第24期23卷 4437-4443页

作者： Andrea Smarrazzo Giuseppe Magazzù Mongi Ben-Hariz Maria Legarda Tamara virtut velmishi Elefhteria Roma Aydan Kansu Dusanka Micetic-Turk Enzo Bravi Pio Stellato Carmela Arcidiaco Luigi Greco Department of Translational Medical Sciences School of MedicineSection of PediatricsUniversity of Naples“Federico II” European Laboratory for Food Induced Diseases Celiac Regional Centre Pediatric Gastroenterology and Cystic Fibrosis UnitUniversity of Messina Pediatric Unit Mongi SLIM’s Hospital of Tunis Paediatric Gastroenterology Unit Cruces University Hospital Service of Pediatric Gastroenterology"Mother Teresa"Hospital First Department of Pediatrics University of Athens Department of Pediatric Gastroenterology School of MedicineAnkara University University Medical Centre Paediatric Department Eurospital SpA

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 Ig A.Each sample was analysed three times on three different days,with each centre running a total of 21tests.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(Co Var=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.

关键词：腹的疾病面筋 Transglutaminase 非侵略的测试精确性精确

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