title: A point-of-care test for facing the burden of undiagnosed celiac disease in the Mediterranean area: a pragmatic design study.
abstract: 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.
authors.affiliation: Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy. stefan.costa@gmail.com.
authors.forename: Stefano
authors.initials: S
authors.lastname: Costa
authors.affiliation: European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy. luca_astarita@hotmail.com.
authors.forename: Luca
authors.initials: L
authors.lastname: Astarita
authors.affiliation: Pediatric Unit, Mongi SLIM's Hospital of Tunis, Marsa, Tunisia. mongi.benhariz@rns.tn.
authors.forename: Mongi
authors.initials: M
authors.lastname: Ben-Hariz
authors.affiliation: Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy. giovanni.curro75@gmail.com.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Currò
authors.affiliation: University Medical Centre Pediatric Department, Ljubljanska, Maribor, Slovenia. jernej.dolinsek@ukc-mb.si.
authors.forename: Jernej
authors.initials: J
authors.lastname: Dolinsek
authors.affiliation: Faculty of Medicine, Department of Pediatric Gastroenterology, Ankara University, Ankara, Turkey. aydankansu@gmail.com.
authors.forename: Aydan
authors.initials: A
authors.lastname: Kansu
authors.affiliation: Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy. magazzug@unime.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Magazzu'
authors.affiliation: Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy. stefaniamarvaso@tiscali.it.
authors.forename: Stefania
authors.initials: S
authors.lastname: Marvaso
authors.affiliation: University Medical Centre Pediatric Department, Ljubljanska, Maribor, Slovenia. dusanka.turk13@gmail.com.
authors.forename: Dusanka
authors.initials: D
authors.lastname: Micetic-Turku
authors.affiliation: Celiac Regional Center, Pediatric Gastroenterology and Cystic Fibrosis Unit, University of Messina, Via Consolare Valeria 1, 98125, Messina, Italy. salvatorepellegrino2014@gmail.com.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pellegrino
authors.affiliation: National Health System, Azienda Sanitaria Locale 6, Associazione Culturale Pediatri, Palermo, Italy. beppeprimavera@virgilio.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Primavera
authors.affiliation: Directorate General for European and International Relations, Ministry of Health, Rome, Italy. p.rossi@sanita.it.
authors.forename: Pasqualino
authors.initials: P
authors.lastname: Rossi
authors.affiliation: European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy. and1_mlk@hotmail.it.
authors.forename: Andrea
authors.initials: A
authors.lastname: Smarrazzo
authors.affiliation: European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy. ftucci84@gmail.com.
authors.forename: Francesca
authors.initials: F
authors.lastname: Tucci
authors.affiliation: European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy. margherita@unina.it.
authors.forename: Carmela
authors.initials: C
authors.lastname: Arcidiaco
authors.affiliation: European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy. ydongre@unina.it.|Department of Translational Medical Science, Section of Pediatrics, University of Naples Federico II, Naples, Italy. ydongre@unina.it.
authors.forename: Luigi
authors.initials: L
authors.lastname: Greco
mesh_terms: D002446:Celiac Disease / Q000175:diagnosis*; D002846:Chromatography, Affinity; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood*; D007558:Italy; D019095:Point-of-Care Systems; D017524:Slovenia; D011503:Transglutaminases / Q000276:immunology*; D014421:Turkey
chemical_list: D007070:Immunoglobulin A; D011503:Transglutaminases