A Point-of-Care test for facing the burden of undiagnosed celiac disease in the Mediterranean area: a pragmatic design study

BMC Gastroenterology

Research Article

Giovanni Currò¹  Stefano Costa¹  Salvatore Pellegrino¹  Giuseppe Magazzu’¹  Stefania Marvaso¹  Pasqualino Rossi²  Luca Astarita³  Andrea Smarrazzo³  Francesca Tucci³  Carmela Arcidiaco³  Luigi Greco⁴  Aydan Kansu⁵  Giuseppe Primavera⁶  Mongi Ben-Hariz⁷  Jernej Dolinsek⁸  Dusanka Micetic-Turku⁸ 

[1] Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy;Directorate General for European and International Relations, Ministry of Health, Rome, Italy;European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy;European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy;Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy;Faculty of Medicine, Department of Pediatric Gastroenterology, Ankara University, Ankara, Turkey;National Health System, Azienda Sanitaria Locale 6, Associazione Culturale Pediatri, Palermo, Italy;Pediatric Unit, Mongi SLIM’s Hospital of Tunis, Marsa, Tunisia;University Medical Centre Pediatric Department, Ljubljanska, Maribor, Slovenia;

关键词: Celiac disease;    Diagnosis;    Mediterranean area;    Point-of-care test;    Rapid test;   

DOI  :  10.1186/s12876-014-0219-5

 received in 2014-09-14, accepted in 2014-12-11,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundWe aimed at assessing the factors that can influence results of the dissemination of an already validated, new generation commercial Point-of-Care Test (POCT) for detecting celiac disease (CD), in the Mediterranean area, when used in settings where it was designed to be administered, especially in countries with poor resources.MethodsPragmatic study design. Family pediatricians at their offices in Italy, nurses and pediatricians in Slovenia and Turkey at pediatricians’, schools and university primary care centers looked for CD in 3,559 (1-14 yrs), 1,480 (14-23 yrs) and 771 (1-18 yrs) asymptomatic subjects, respectively. A new generation POCT detecting IgA-tissue antitransglutaminase antibodies and IgA deficiency in a finger-tip blood drop was used. Subjects who tested positive and those suspected of having CD were referred to a Celiac Centre to undergo further investigations in order to confirm CD diagnosis. POCT Positive Predictive Value (PPV) at tertiary care (with Negative Predictive Value) and in primary care settings, and POCT and CD rates per thousand in primary care were estimated.ResultsAt tertiary care setting, PPV of the POCT and 95% CI were 89.5 (81.3-94.3) and 90 (56-98.5) with Negative Predictive Value 98.5 (94.2-99.6) and 98.7% (92-99.8) in children and adults, respectively. In primary care settings of different countries where POCT was performed by a different number of personnel, PPV ranged from 16 to 33% and the CD and POCT rates per thousand ranged from 4.77 to 1.3 and from 31.18 to 2.59, respectively.ConclusionsInterpretation of POCT results by different personnel may influence the performance of POC but dissemination of POCT is an urgent priority to be implemented among people of countries with limited resources, such as rural populations and school children.

【 授权许可】

Unknown   
© Costa et al.; licensee BioMed Central. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.