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.
 On behalf of Medicel network in the
study participated:
• Italy – Sicily
• Slovenia
• Turkey
• (Greece, Tunisia)
Slovenia data
 Setting
A. 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 among university students
Positive results
Unvalid results
First test – mild positive
Repeated test - negative
Positive results
t-TG > 100 U/ml
EMA positive
Marsh 3b
HLA-DQ2/DQ5
t-TG > 100 U/ml
EMA positive
Marsh 3c
•
•
•
21y girl
DM in family
Completely
asymptomatic
• 20y boy
• Intermitent chronic
diarrhea and
obstipation
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.
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
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
Tunisia data
Immunol Invest 2013; 42: 356–368
In 54 PoCT neg. tested
with Elisa tTG NPV 100%
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
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
In Sicily
 At the Family Pediatrician office (39)
Population in charge 31.287
Case finding for 6 months 24356
Suspected 790 (3.2%) Not suspected 23566
Offered PoC 3642 Refused 83 (2.3%)
Enrolled 678 Refusal 112 (14%)
Performed PoC 3559 Neg 3448
I tTG + 34
II tTG + 21
Pos 111
To Centre
Refusal 2
Neg 89 Pos 20
CD confirmed 15
13 Ist.
2 no Ist DSG
1 lost F.U.
3 Marsh 0
1 Marsh 1
1 F.U. tTG 11
IgA Def. 9 N IgA 35
Ist o EMA + 17
FU 3
No line 45
tTG-G
pos. 3c
Lost FU 1
tTG-A 42 EMA
N- In F.U.
tTG-A 122, EMA
+ Marsh 3c
In Sicily
 At the Celiac Centre
Sens
Spec
PPV
NPV
LR +
97.1
(93-100)
94.1
(90-98)
89.58
(81-94)
98.5
(94-99)
16.5
(8-32)
Results
PoCT PPV and rate for 1000 for PoCT and CD
RATE PER
THOUSAND
POCT +
CD
COUNTRY
Persons (and No.)
performing test
SUBJECTS
TESTED
POCT
+
(PPV)
CD
ITALY
Family (39)
pediatricians
3559
111
(16%)
17
31.18
4.77
SLOVENIA
Nurse (1)
Student (2)
Pediatrician(1)
Nurse (1)
Pediatrician(1)
1480
18
(33%)
6
12.16
4.05
771
2*
(N.A.)
1
2.59
1.30
TURKEY
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.