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
SettingA. screening within secondary school
students mostly in rural area of NE Slovenia
B. students from Medical faculty and Faculty of health sciences University of Maribor
Personnel performing PoCT
A. Trained nurse, student and pediatrician + pediatric gastroenterologist – as supervisor
B. Trained nurse, 2 trained students, pediatric gastroenterologist - as supervisor
Subjects tested
A. 1000 (14-18y) secondary school students
B. 480 (18-23y) University students
Biocard II generation IgA t-TG on whole blood test + IgA deficiency detection
National Medical Ethics Comitee approved research 28. 4. 2012 (No 44/04/12)
Results
No of positive PoCT:A. 15 positive – 4 confirmed CDB. 3 positive – 2 confirmed CD (+ 5
previously diagnosed CD) With no line:A. 3 – confirmed IgA deficiencyB. 3 – confirmed IgA deficiency
Results among university students
Positive results
Unvalid results
First test – mild positive
Repeated test - negative
Positive results• 21y girl• DM in family• Completely
asymptomatict-TG > 100 U/mlEMA positiveMarsh 3bHLA-DQ2/DQ5
• 20y boy• Intermitent chronic
diarrhea and obstipation
t-TG > 100 U/mlEMA positiveMarsh 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
RATE PER THOUSAND
COUNTRY Persons (and No.) performing
test
SUBJECTS TESTED
POCT +
(PPV)
CD POCT +
CD
ITALY Family (39) pediatricians
3559 111(16%)
17 31.18 4.77
SLOVENIA Nurse (1)Student (2)
Pediatrician(1)
1480 18(33%)
6 12.16 4.05
TURKEY Nurse (1) Pediatrician(1)
771 2* (N.A.)
1 2.59 1.30
PoCT PPV and rate for 1000 for PoCT and CD
Conclusion
The strategy of case finding should be encouraged at the primary care level.