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.