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Application of a new generation rapid test for diagnosing celiac disease in the Mediterranean area. Aim of PoCT study. To assess which are the factors that can influence results of an already validated second generation commercial PoCT for detecting CD in the Mediterranean area.
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Application of a new generation rapid test for diagnosing celiac disease in the Mediterranean area
Aim of PoCT study • To assess which are the factors that can influence results of an already validated second generation commercial PoCT for detecting CD in the Mediterranean area.
On behalf of Medicel network in the study participated: • Italy – Sicily • Slovenia • Turkey • (Greece, Tunisia)
Screening study using PoCT tests in secondary school children and students in NE Slovenia • Setting • screeningwithinsecondaryschoolstudentsmostly in rural area of NE Slovenia • studentsfromMedicalfacultyandFacultyofhealthsciencesUniversityof Maribor
Personnel performing PoCT • Trained nurse, student and pediatrician + pediatric gastroenterologist – as supervisor • Trained nurse, 2 trained students, pediatric gastroenterologist - as supervisor
Subjects tested • 1000 (14-18y) secondaryschoolstudents • 480 (18-23y) Universitystudents • Biocard II generationIgA t-TG on wholeblood test + IgAdeficiencydetection • NationalMedicalEthicsComiteeapprovedresearch 28. 4. 2012 (No 44/04/12)
Results • NoofpositivePoCT: • 15 positive – 4 confirmed CD • 3 positive – 2 confirmed CD (+ 5 previouslydiagnosed CD) • With no line: • 3 – confirmedIgAdeficiency • 3 – confirmedIgAdeficiency
Results among university students Positive results Unvalid results First test – mild positive Repeated test - negative
Positive results • 21y girl • DM in family • Completely asymptomatic t-TG > 100 U/ml EMA positive Marsh 3b HLA-DQ2/DQ5 • 20y boy • Intermitent chronic diarrhea and obstipation t-TG > 100 U/ml EMA positive Marsh 3c Positive PoCT was the only criterion to perform further serological tests (EMA, t-TG).
Results • Among medical and nursing students 5 students had previously diagnosed CD. With PoCT screening 2 new cases were discovered. • The prevalence of CD between students was estimated 1.49 % (which is higher than in general population). • Among 1000 secondary school children 4 new cases were diagnosed.
Results among secondary school children • Between 1000 secondary school children: • 15 positive – 4 confirmed CD • 3 – confirmed IgA deficiency • In all 4 confirmed CD: t-TG > 100 ml, EMA+, Marsh 3b or 3c, HLA-DQ2/DQ5, DQ2/DQ2 All 4 children asymptomatic
Results PoCT PPV and rate for 1000 for PoCT and CD
Conclusion The strategy of case finding should be encouraged at the primary care level.