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

BMC Gastroenterology

Luigi Greco²  Carmela Arcidiaco¹  Francesca Tucci¹  Andrea Smarrazzo¹  Pasqualino Rossi⁶  Giuseppe Primavera⁴  Salvatore Pellegrino⁸  Dusanka Micetic-Turku⁵  Stefania Marvaso⁸  Giuseppe Magazzu’⁸  Aydan Kansu⁷  Jernej Dolinsek⁵  Giovanni Currò⁸  Mongi Ben-Hariz³  Luca Astarita¹  Stefano Costa⁸ 

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

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

Others  :  1121731
DOI  :  10.1186/s12876-014-0219-5

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

【 摘 要 】

Background

We 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.

Methods

Pragmatic 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.

Results

At 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.

Conclusions

Interpretation 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】

   
2014 Costa et al.; licensee BioMed Central.

【 图 表 】

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