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

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 

作者机构：Department of Translational Medical SciencesSchool of MedicineSection of PediatricsUniversity of Naples“Federico II” European Laboratory for Food Induced Diseases Celiac Regional CentrePediatric Gastroenterology and Cystic Fibrosis UnitUniversity of Messina Pediatric UnitMongi SLIM’s Hospital of Tunis Paediatric Gastroenterology UnitCruces University Hospital Service of Pediatric Gastroenterology"Mother Teresa"Hospital First Department of PediatricsUniversity of Athens Department of Pediatric GastroenterologySchool of MedicineAnkara University University Medical CentrePaediatric Department Eurospital SpA 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2017年第23卷第24期

页      面：4437-4443页

核心收录：

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：Supported by Italian Department of Health,Direction of International Affairs Euromed action.Project:MEDICEL-Mediterranean Network for Celiac Disease-Phase II(CUP No.E61J11000450001) European Laboratory for Food Induced Disease,Federico II University,Naples 

主　　题：Coeliac disease Gluten Transglutaminase Non-invasive testing Accuracy Precision 

摘      要：To verify the precision and accuracy of transglutaminase antibodies (TGA) assays across Mediterranean countries. METHODSThis 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). RESULTSThe 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. CONCLUSIONTGA estimation is a crucial step for the diagnosis of CD; given its accuracy and precision, clinicians could be confident in establishing a diagnosis.