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.