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Aim of PoCT study

Widespread 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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Aim of PoCT study

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  1. Widespread application of a new generation rapid test for diagnosing celiac disease in the Mediterranean area

  2. 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.

  3. On behalf of Medicel network in the study participated: • Italy – Sicily • Slovenia • Turkey • (Greece, Tunisia)

  4. Slovenia data • Setting • screeningwithinsecondaryschoolstudentsmostly in rural area of NE Slovenia • studentsfromMedicalfacultyandFacultyofhealthsciencesUniversityof Maribor

  5. Personnel performing PoCT • Trained nurse, student and pediatrician + pediatric gastroenterologist – as supervisor • Trained nurse, 2 trained students, pediatric gastroenterologist - as supervisor

  6. 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)

  7. Results among university students Positive results Unvalid results First test – mild positive Repeated test - negative

  8. 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

  9. 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.

  10. Turkey data • Setting: Primary care Pediatrician office • Personnel performing the PoCT: nurse and pediatrician • Subjects tested:771 (1-18 years) asymptomatic children at school (666) and at a primary care pediatrician office (105) • PoCT positive 2*, CD 1, PPV* • Rate per thousand: PoCT 2.59; CD 1.30 * 1 patient was not referred to Center to undergo conventional serology and histology

  11. Tunisia data Immunol Invest 2013; 42: 356–368 • Setting: Primary school screening • Personnel performing the PoCT: 3 doctors and a nurse • Subjects tested: 2064 • PoCT + 7, CD 7, PPV 100% • Rate per thousand: PoCT 3.39; CD 3.39

  12. Tunisia data Immunol Invest 2013; 42: 356–368 In 54 PoCT neg. tested with Elisa tTG NPV 100%

  13. Greece data Acta Pædiatr 2013;102:749–754 • Setting: nursing school • Personnel performing the test: properly trained nonmedical staff • Subjects tested: 1080 toddlers (2-6 yrs) • PoCT + 7, CD 7, PPV 100% • Rate per thousand: PoCT 6.48; CD 6.48

  14. Sicily data • Two settings: 1) Primary care Family pediatricians and 2) Celiac Center • Personnel performing test: 1(family pediatricians 2) Biologist or Physician • Subjets tested: 1) 3559 (1-14yrs) asymptomatic children 2) 206 (1-18 yrs) pediatric pts for suspected CD

  15. In Sicily • At the Family Pediatrician office (39)

  16. Population in charge 31.287 Case finding for 6 months 24356 Suspected 790 (3.2%) Not suspected 23566 Refused 83 (2.3%) Offered PoC 3642 Refusal 112 (14%) Enrolled 678 Performed PoC 3559 Neg 3448 No line 45 I tTG + 34 Pos 111 To Centre Refusal 2 II tTG + 21 Pos 20 Neg 89 IgA Def. 9 N IgA 35 CD confirmed 15 tTG-G pos. 3c Ist o EMA + 17 Lost FU 1 13 Ist. 2 no Ist DSG tTG-A 42 EMA N- In F.U. FU 3 1 lost F.U. 3 Marsh 0 1 Marsh 1 1 F.U. tTG 11 tTG-A 122, EMA + Marsh 3c

  17. In Sicily • At the Celiac Centre

  18. Results PoCT PPV and rate for 1000 for PoCT and CD

  19. Conclusions • Interpretation by different number of personnel of the doubt results and the test lecture time may influence the performance of PoCT • Dissemination of PoCT seems to be urgent to implement in people of countries with limited resources such as the rural population and school children • In general it may be cost/effective keeping into account excess cost of undiagnosed symptomatic CD.

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