Download - 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.
On behalf of Medicel network in the study participated:
• Italy – Sicily• Slovenia• Turkey• (Greece, Tunisia)
Slovenia data
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 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
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 andhistology
Tunisia data
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
Immunol Invest 2013; 42: 356–368
Tunisia data
In 54 PoCT neg. tested with Elisa tTG NPV 100%
Immunol Invest 2013; 42: 356–368
Greece data
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
Acta Pædiatr 2013;102:749–754
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%)Enrolled 678Refusal 112 (14%)
I tTG + 34
II tTG + 21
CD confirmed 15
13 Ist. 2 no Ist DSG
1 lost F.U.
3 Marsh 0
1 Marsh 1
1 F.U. tTG 11
Not suspected 23566
Performed PoC 3559
Pos 111
No line 45 To Centre
Ist o EMA + 17
N IgA 35
tTG-G pos. 3c
tTG-A 42 EMA N- In F.U.
Neg 89
Neg 3448
Pos 20 IgA Def. 9
Lost FU 1
FU 3
Refusal 2
tTG-A 122, EMA + Marsh 3c
Offered PoC 3642 Refused 83 (2.3%)
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
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
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.