More Related Content Similar to AugurixDiagnostic_public profile Similar to AugurixDiagnostic_public profile (20) 2. Our mission is to shorten the pathway to
wellness by facilitating early diagnosis of
Celiac disease.
Our value proposition is to provide
screening, diagnosis and monitoring of
therapy compliance for Gluten
intolerance.
Our vision is to empower patient’s
choices for an effective management of
their gluten-free journey.
3. • All related to food habits
• High consumer/patient concerns
• Very emotional
• Chronic diseases
STRICTLY CONFIDENTIAL 3
Gluten intollerance: Various Clinical Conditions
Celiac disease
1 out of 100 persons
Gluten sensitivity
5 out of 100 persons
Wheat allergy
0.2 out of 100 persons
Problem"
4. 4
What is Celiac Disease?
• It is a food intolerance to Gluten
– A protein found in Wheat, Barley
and Rye
• It is an autoimmune disease
• It is a hereditary condition
– 30% of the general population is
genetically predisposed
• It is associated with a number of
serious clinical conditions
• Treatment consist of strict, life-long
adherence to a gluten-free diet
5. • Celiac Disease (CD) is one of the most under
diagnosed illness.
• Up to 90% of the people affected are not aware of
their medical condition (*).
• Its incidence is 1% of the general population
worldwide and doubled in the past 10 years.
• CD is today recognized as an epidemic social
disease for its health and economical impact on the
individual, the family and the society.
• Today the path to diagnosis can take up to 8
years
(*) All references available on request
STRICTLY CONFIDENTIAL 5
…as a consequence
6. 6
Why is it clinically relevant?
Undiagnosed (untreated) Celiac Disease leads to
increased risk life-threatening problems due to
malabsorption of key nutrients
Anemia
20% celiac
suffer from
Anemia:
10 times more
35% celiac have
established
Osteoporosis:
3 times more
Osteoporosis
Infertility &
Malformation
8x risk
of abortion
and
malformation
Autoimmune
Diseases
Intestinal
Lymphoma
30% celiac suffer
from other auto-
Immune diseases:
60 times more
9x risk
lymphoma
with high
mortality
7. About Augurix
Key Facts
◆ Founded in 2007
◆ 2 IP in in vitro and in vivo diagnostics
◆ Simtomax® - CE marked,
◆ Fully integrated – R&D, QA, Production
◆ ISO13485, ISO 9001 certified
◆ Labs and Office in Monthey, Switzerland
◆ Scientific & Medical Board lead by
Dr Cecile Besson Duvanel, co-founder of Augurix
◆ More than 3.5 M chf obtained in three different funds rising rounds (Vc’s,
Private investors)
Debiopharm award 2011
CTI startup label 2008
Frost & Sullivan
Product Differentiation Award 2010
Swiss top 100 startup 2011&2012
DeVigier 2008
STRICTLY CONFIDENTIAL 7
Augurix
SOLUTION"
8. (*) Benkebil et al, 2013, World J Gastroenterol
8
ü Non invasive
§ 25µl capillary blood
ü Easy to use
§ All accessories included
§ No skills or equipment
ü Rapid, clear results
§ 10 minutes
§ Visual interpretation
ü Robust
§ 30 months shelf-life
§ Storage at room temperature
ü Flexibility
§ Whole blood, serum or plasma
ü Measures 3 parameters
§ Total IgA
§ IgA-DGP
§ IgG-DGP
ü Performant (*)
§ Specificity: 93.1%
§ Sensitivity: 100%
§ NPV: 100%
"
Features § First line screening of Celiac
Disease and IgA deficiency
§ Monitoring of GFD compliance
11. Ruling out Celiac Disease
w First rapid test matching lab performance
w Obtained CE mark, TGA registration,
w Market tested in Switzerland
w Distribution contract in 14 EU countries
w Distribution contract in Australia/NZealand in
2014/2015
w Listed in more than 1,000 pharmacies
w Approved for purchase from different hospitals
in the UK in August 2016
11
TRACTION / STAGE OF DEVELOPMENT"
12. • 6 studies were published. More than 2,000 patients
• Manuscript in preparation for 2 prospective studies
• One study is ongoing (prospective)
Evaluation of a point-of-care test based on deamidated
gliadin peptides for celiac disease screening in a large
pediatric population
Franc¸oise Bienvenua
, Ce´cile Besson Duvanelc
, Camille Seignoverta
,
Paul Rouzairea
, Alain Lachauxb
and Jacques Bienvenua
Objectives Celiac disease (CD) is nowadays known to be
a common chronic enteropathy that is becoming a growing
public health concern. Yet, it is estimated that more than
90% of patients remain undiagnosed. A point-of-care
diagnostic test can be a rapid and cost-effective solution in
the first-line screening of CD. The aim of this study is to
evaluate the performance of a novel point-of-care
screening test in a large pediatric population.
Materials and methods Serum samples were collected
from a cohort of 250 children presenting either an
increased risk or a clinical suspicion of CD. All sera were
tested using the point-of-care test detecting IgA and IgG
antibodies against a combination of three different
deamidated gliadin peptides as well as total IgA. The
results of the screening test were compared with an
enzyme-linked tissue transglutaminase immunosorbent
assay and with histology resulting from intestinal biopsies
performed in patients with elevated titers of antitissue
transglutaminase antibodies.
Results The point-of-care test showed highly concordant
results with the laboratory immunoassay, yielding a
sensitivity of 93.1 (78–98.1%) and a specificity of 95%
(91.2–97.2%), with a diagnostic accuracy of 94.8%
(91.3–96.9%) and a negative predictive value of
99.1% (96.6–99.7%). The screening test identified
all patients with celiac-type histology findings on
biopsy, as well as all patients with concomitant
IgA deficiency.
Conclusion With a high diagnostic accuracy, this novel
point-of-care approach is an efficient tool for CD case
finding in pediatric populations. It has the potential to
improve the management of celiac patients in primary care
by providing faster counseling and treatment. Eur J
Gastroenterol Hepatol 24:1418–1423
c 2012 Wolters
Kluwer Health | Lippincott Williams & Wilkins.
European Journal of Gastroenterology & Hepatology 2012, 24:1418–1423
Keywords: celiac disease, deamidated gliadin peptides, point-of-care
diagnostic test
a
Immunology Laboratory, Lyon-Sud University Hospital, Pierre-Be´nite,
b
Department of Gastroenterology, Hepatology and Nutrition, Paediatric
Hospital, Bron, France and c
Augurix SA, Monthey, Switzerland
Correspondence to Franc¸oise Bienvenu, PhD, Immunology Laboratory,
Lyon-Sud University Hospital, 69495 Pierre-Be´nite, France
Tel: + 33 478 864 161; fax: + 33 478 863 344;
e-mail: francoise.bienvenu@chu-lyon.fr
Received 10 April 2012 Accepted 14 July 2012
Introduction
Celiac disease (CD) is a T-cell mediated gluten-sensitive
chronic enteropathy, defined by characteristic changes
observed on intestinal biopsy. Recent epidemiological
studies have reported that CD is a very common disease
affecting approximately 1% of the population not only in
Europe and North America but also in many other parts of
the world, and is becoming a widespread public health
concern [1]. In some countries such as Finland, this figure
has more than doubled to up to 2.7% in the last two
decades [2,3]. Different environmental factors such as
cereal consumption, breast-feeding, and early infections
have been suggested to play a role in this increasing
prevalence [4].
Current diagnosis relies on CD-related serology before
confirmation through a small intestinal biopsy histopatho-
logic examination. Serology markers have evolved over the
years with the identification of more specific antibodies.
Endomysial and antitissue transglutaminase (tTG) IgA
autoantibodies are considered nowadays to be among the
most reliable [5]. Although these markers show a high
sensitivity and specificity, their accuracy remains contro-
versial for young children, for adult patients with a minor
degree of mucosal damage, and for the follow-up of CD
patients on a gluten-free diet [6,7]. Very recently, a new
generation of assays on the basis of the detection of
antibodies against deamidated gliadin peptides (DGP) has
shown very high sensitivity, with a diagnostic accuracy for
CD that is at least equivalent to established assays [8,9].
tTG and DGP are important functionally related antigens
that play a crucial role in the pathogenesis of CD. Indeed,
tTG was found to catalyze deamidation of specific native
gliadin residues, enhancing T-cell reactivity [10].
Left untreated, CD can lead to long-term health issues
such as infertility, osteoporosis, and cancers of the
digestive tract [11]. Yet, it is estimated that more than
90% of patients remain undiagnosed [12]. Increasing the
diagnosis rate of CD can be quite challenging for
physicians, as the clinical presentation is often highly
variable, with patients being either asymptomatic or
1418 Original article
0954-691X
c 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI: 10.1097/MEG.0b013e3283582d95
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
1. Introduction
2. What POCTs are currently
available?
3. How Simtomax works
4. Clinical data
5. Alternative technologies
6. Conclusion
7. Expert opinion
Diagnostic Evaluation
Simtomax, a novel point of care
test for coeliac disease
Peter D Mooney, Matthew Kurien & David S Sanders†
University of Sheffield, Royal Hallamshire Hospital, Gastroenterology & Liver Unit, Sheffield, UK
Introduction: Coeliac disease is an autoimmune condition resulting from an
abnormal reaction to dietary gluten leading to small bowel villous atrophy.
International prevalence studies suggest that coeliac disease affects 1% of
the adult population. However, despite its high prevalence, large numbers
of patients go undiagnosed. One method of increasing detection rates would
be to introduce a quick screening test in the form of a finger-prick blood test.
Areas covered: There are currently four available point-of-care tests (POCTs)
available for use by health professionals. This diagnostic evaluation will
review the evidence for the use of POCTs in coeliac disease including Simto-
max a novel test for deamidated gliadin peptides and total IgA level.
Expert opinion: An accurate POCT has the potential to increase the rates of
diagnosis of coeliac disease if used effectively as part of a case finding
approach in primary or secondary care. Evidence for the use of Simtomax is
currently fairly limited only drawing comparison with laboratory serology
rather than the gold standard of histology and it has only been trialled in
high-risk populations. However, results to date are encouraging and further
research into this area is required.
Keywords: coeliac, point of care, serology, simtomax
Expert Opin. Med. Diagn. [Early Online]
1. Introduction
Coeliac disease (CD) is an autoimmune disease characterised by a heightened
immunological response to ingested gluten (from wheat, barley or rye) in genetically
susceptible individuals carrying either the HLA DQ2 or DQ8 genotype [1]. Histor-
ically, CD was felt to be an uncommon condition, but recent studies have demon-
strated higher prevalence rates in society of 1% [2,3]. Most frequently, the clinical
presentation of CD includes gastrointestinal symptoms such as diarrhoea, weight
loss and abdominal bloating. However, nongastrointestinal presentations of CD
do occur including conditions such as osteoporosis, subfertility, liver disease,
peripheral neuropathy and ataxia. Further, CD is more common in patients with
other autoimmune diseases such as type 1 diabetes and thyroid disease. Despite
the high prevalence of this condition, frequently delays are encountered in establish-
ing a correct diagnosis. A recent study evaluating 2,000 symptomatic patients dem-
onstrated a mean duration of 13.2 years prior to correct diagnosis of CD [4]. In
addition, in the same study the average number of prediagnosis visits to general
practitioners about symptoms was 7.0 amongst those diagnosed after the year
2000 (approximately when serological tests became routinely available) compared
to 17.4 amongst those diagnosed before 2000, which led to a prolonged and sub-
stantial decrement in quality of life. Interestingly, these patients who present to pri-
mary care may only represent a fraction of the total coeliac patients within the
community, with a recent metaanalysis suggesting that the ratio of known to undi-
agnosed cases of CD being 1 to 7 [5]. Delays in diagnosis can cause a significant
impact on a patient’s health and quality of life. As a result methods of increasing
coeliac diagnosis are to be actively encouraged. Currently, the vast majority of
10.1517/17530059.2013.836179 © 2013 Informa UK, Ltd. ISSN 1753-0059, e-ISSN 1753-0067 1
All rights reserved: reproduction in whole or in part not permitted
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Practice Nursing 2012,Vol 23, No 3 1
T
here is increasing interest in point-of-
care tests and the role they may have
in improving the detection of coeliac
disease. The aim of this article is to review the
assessment and diagnosis of patients with
suspected coeliac disease in general practice,
considering the potential implications a
missed diagnosis may have on patients and
health professionals. The emerging point-of-
care tests will be evaluated as diagnostic tools
and their potential relevance to practice
nurses discussed.
Coeliac disease: epidemiology
Coeliac disease is an autoimmune disease
characterized by a heightened immunological
response to ingested gluten (from wheat, bar-
ley or rye) in genetically susceptible individu-
als carrying either the HLA DQ2 or DQ8
genotype (Schuppan, 2000). Historically coe-
liac disease was considered an uncommon
condition, but in the last 10 years European
studies have demonstrated higher prevalence
rates at about 1% (Sanders et al, 2003; West
et al, 2003).
The most frequent age of presentation of
coeliac disease is between the fourth and
sixth decade of life. While coeliac disease is
twice as common in females as in males, the
greatest risk factor for developing coeliac
disease is having a first-degree relative with
the condition.
Most frequently the clinical presentation of
coeliac disease includes gastrointestinal
symptoms such as diarrhoea, weight loss and
abdominal bloating. Non-gastrointestinal
presentations of coeliac disease also occur
including conditions such as osteoporosis,
subfertility, liver disease, peripheral neuropa-
thy and ataxia. Furthermore, coeliac disease
is more common in patients with other
autoimmune diseases such as type 1 diabetes
(2–10%) and thyroid disease (3–7%)
(National Institute for Health and Clinical
Excellence (NICE), 2009).
Challenges
The diagnosis and management of coeliac
disease presents important challenges to
patients and health professionals. Despite the
high prevalence of coeliac disease, delays are
often encountered in establishing a correct
diagnosis. A study evaluating 2000 sympto-
matic patients by Gray and Papanicolas,
(2010) demonstrated that patients wait a
mean duration of 13.2 years before receiving
a correct diagnosis. The same study found
that patients made an average of seven visits
to general practice for their coeliac symptoms
before their diagnosis after the year 2000
(approximately when serological tests became
routinely available) compared to 17.4 pre-
diagnosis visits for those diagnosed before
2000. Delays in diagnosis lead to a prolonged
and substantial decrement in quality of life.
Such findings emphasize the importance of
accurate diagnosis and effective management
of coeliac disease in primary care.Interestingly,
patients who present to general practice may
only represent a fraction of the total coeliac
patients within the community. One meta-
analysis found that the ratio of diagnosed to
undiagnosed cases of coeliac disease was 1:7
(Fasano et al, 2003).
Diagnosing coeliac disease
An understanding of the diverse presenta-
tions of coeliac disease, an early diagnosis
and establishment on a gluten-free diet are
essential to minimize the potential long-term
complications of coeliac disease such as mal-
nutrition, osteoporosis and malignancy. This
approach also reduces the significant morbid-
ity and mortality associated with untreated
coeliac disease (Logan et al, 1989).
The coeliac iceberg is a tool that may help
health professionals improve the detection of
coeliac disease (Figure 1). This concept high-
lights the clinical variability of coeliac disease
and helps to understand its systemic nature.
The highest level of the iceberg (above the
waterline) describes patients with typical gas-
trointestinal symptoms. The next level (just
under the water) represents patients consid-
ered to have atypical presentations of coeliac
disease (no gastrointestinal symptoms) such
as iron deficiency anaemia, osteoporosis,
abnormal liver function tests or subfertility.
The lower levels of the iceberg represent
other patients who may have coeliac disease,
Point-of-care testing for
coeliac disease
The presentation of
coeliac disease in
general practice can
be varied, and delay
in diagnosis reduces
patients’ quality of
life. Matthew Kurien
and David Sanders
look at the evidence
for point-of-care
tests, which may
help speed up
diagnostic times
Product Focus SIMTOMAX
Matthew Kurien is clinical research
fellow in gastroenterology, Royal Hallamshire
Hospital, Sheffield Teaching Hospitals Trust
and David Sanders is professor of
gastroenterology, Royal Hallamshire Hospital,
Sheffield Teaching Hospitals Trust
Submitted 5 February 2012;
accepted for publication following peer
review 10 February 2012
Key words: Coeliac, simtomax, serology,
point of care
BRIEF ARTICLE
Diagnostic accuracy of a new point-of-care screening assay
for celiac disease
Faiza Benkebil, Christophe Combescure, Silvia I Anghel, Cécile Besson Duvanel, Michela G Schäppi
Faiza Benkebil, Vidymed, 1007 Lausanne, Switzerland
Christophe Combescure, CRC and Division of Clinical Epi-
demiology, Department of Health and Community Medicine,
University of Geneva and University Hospitals of Geneva, 1007
Geneva, Switzerland
Silvia I Anghel, R and D Department, Augurix, BioArk, 1870
Monthey, Switzerland
Cecile Besson Duvanel, Scientific Officer, Augurix, BioArk,
1870 Monthey, Switzerland
Michela G Schäppi, Pediatric Gastroenterology Unit, Pediat-
rics Department, Geneva University Hospitals, 1211 Geneva,
Switzerland
Author contributions: Benkebil F designed the study and
performed the research; Combescure C performed the statisti-
cal analysis and wrote the paper; Anghel SI performed the data
analysis and wrote the paper; Besson Duvanel C designed the
study and wrote the paper; Schäppi MG designed the study, per-
formed the research, and wrote the paper.
Supported by the Swiss Celiac Association, Association Ro-
mande de Coeliakie, No. ME 8309 awarded to Schäppi MG
Correspondence to: Michela G Schäppi, MD, PhD, Cli-
nique des Grangettes 7, Chemin des Grangettes, 1224 Chêne-
Bougeries, Switzerland. michela.tempia@grangettes.ch
Telephone: +41-22-3050578 Fax: +41-22-3050579
Received: January 29, 2013 Revised: April 23, 2013
Accepted: May 8, 2013
Published online: August 21, 2013
Abstract
AIM: To determine the diagnostic accuracy of a new
point-of-care assay detecting anti-deamidated gliadin
peptides in celiac disease (CD) patients.
METHODS: One-hundred-and-twelve patients (age
range: 1.8-79.2 years old) with clinical symptoms sug-
gestive of CD and/or first-degree relatives (FDR) of CD
patients (n = 66), and confirmed CD on a gluten-free
diet (GFD) (n = 46), were prospectively enrolled in the
study at Gastroenterology outpatient clinics for adult
patients and from the Gastroenterology Consultation
Ward at the Pediatric Department of the University
Hospital of Geneva. Written informed consent was ob-
tained from all subjects enrolled. The study received
approval from the local ethics committee. The original
CD diagnosis had been based on serum-positive IgA
anti-tissue transglutaminase enzyme-linked immo-
sorbent assay (ELISA) (QuantaLite™, Inova Diag-
nostics, San Diego, CA, United States) and on biopsy
results. Serum samples from all study participants
were tested by the new CD lateral flow immunochro-
matographic assay (CD-LFIA) device, Simtomax®
Blood
Drop (Augurix SA, BioArk, Monthey, Switzerland) to de-
tect immunoglobulin (Ig)A and IgG antibodies against
deamidated gliadin peptides. The diagnostic perfor-
mance was evaluated using receiver operating charac-
teristic curves with 95%CIs. A cut-off of 2 on the Rann
colorimetric scale was used to calculate the device’s
sensitivity and specificity.
RESULTS: CD-LFIA was highly accurate in detect-
ing untreated celiac patients. In the group of patients
with CD symptoms and/or FDR, eight new cases of CD
were detected by ELISA and biopsy. All of these new
cases were also correctly identified by CD-LFIA. The
test yielded four false positive and four false nega-
tive results. The false positive results were all within
the groups with clinical symptoms suggestive of CD
and/or FDR, wherears the false negative results were
all within the GFD group. The test yeld a sensitivy of
78.9% (95%CI: 54.4-93.9) and specificity of 95.7%
(95%CI: 89.4-98.8), and the area under the curve
reached 0.893 (95%CI: 0.798-0.988). The Kappa coef-
ficient, calculated according to the values obtained by
two readers from the same device, was of 0.96 (SE:
0.06). When the GFD patients were excluded from
the analysis, the area under the curve reached 0.989
(95%CI: 0.971-1.000) and the Kappa coefficient, cal-
culated according to the values obtained by two read-
ers from the same device, became 0.96 (SE: 0.07).
Furthermore, using the Rann scale cut-off of 2 without
5111
World J Gastroenterol 2013 August 21; 19(31): 5111-5117
ISSN 1007-9327 (print) ISSN 2219-2840 (online)
© 2013 Baishideng. All rights reserved.
Online Submissions: http://www.wjgnet.com/esps/
wjg@wjgnet.com
doi:10.3748/wjg.v19.i31.5111
August 21, 2013|Volume 19|Issue 31|WJG|www.wjgnet.com
International Journal of Celiac Disease, 2015, Vol. 3, No. 1, xx
Available online at http://pubs.sciepub.com/ijcd/3/1/8
© Science and Education Publishing
DOI:10.12691/ijcd-3-1-8
Evaluation of a DGP Point-of-care test for Celiac Disease
in a Pediatric Population
Claude-Olivier Marti1,2,‡),*
, Benoit Fellay1,‡)
, Annemarie Bürgin-Wolff3
, Jean-Luc Magnin1
, Peter Baehler1
1
Hôpital Cantonal Fribourg, Fribourg, Switzerland
2
Laboratoire Promed, Marly Switzerland
3
Coeliakie Institut, Liestal, Switzerland
‡)
Have contributed equally to this work
*Corresponding author: claude-olivier.marti@promed-lab.ch
Received January 12, 2015; revised January 22, 2015; accepted January 25, 2015
Abstract Celiac disease (CD) is a largely undiagnosed immune-mediated enteropathy. A point-of-care test
(POCT) could represent a rapid and cost-effective tool on ruling out CD. The objective of this study is to evaluate
retrospectively the performance of a POCT based on detection of IgA and IgG antibodies against deamidated
gliadins peptides (DGP). The study was performed on 53 children presenting clinical suspicions of CD, all being
investigated by intestinal biopsy and standard serology. The performance of POCT was compared to the diagnostic
result obtained from the gold standard of histology and serology. 10 children were diagnosed as CD positive by the
POCT. Among the 43 children identified as CD negatives, 37 were correctly identified by POCT and 6 were
considered as false positives. No false negative results were observed. The POCT yields a sensitivity and a negative
predictive value (NPV) of 100%, and a negative likelihood ratio (LR-) of 0 in this selected pediatric population. The
high NPV and low LR- ratio indicate that this POCT could be an useful and discriminative tool for excluding CD.
This study and the results published so far are promising but need to be confirmed in larger cohort.
Keywords: rule-out CD, rapid test, children
Cite This Article: Claude-Olivier Marti, Benoit Fellay, Annemarie Bürgin-Wolff, Jean-Luc Magnin, and
Peter Baehler, “Evaluation of a DGP Point-of-care test for Celiac Disease in a Pediatric Population.”
International Journal of Celiac Disease, vol. 3, no. 1 (2015): XX-XX. doi: 10.12691/ijcd-3-1-8.
1. Introduction
Celiac disease (CD) is defined as a systemic immune-
mediated enteropathy induced by dietary gluten (from
wheat, barley, rye) in genetically predisposed individuals
carrying the HLA-DQ2 and/or DQ8 haplotypes [1,2,3].
CD is characterized by a triggered autoimmune response
and subsequent modification of the intestinal integrity,
engendering a broad range of clinical presentations [4,5].
Its prevalence is approximately 1% among the European
population but shows wide regional differences for unclear
reasons (e.g. 0.3% in Germany, 0.8% in Switzerland and
2.4% in Finland) [6,7,8]. Different environmental factors
such as breast-feeding, cereal consumption or infection
have been proposed to influence the risk of developing the
disease [5,9,10].
The diagnosis of CD has relied for decades on duodenal
biopsy with characteristic histologic pathology as a gold
standard. Nowadays, serological markers are a useful
diagnostic tool [11]. They have improved substantially in
the last two decades and led to the identification of more
sensitive and specific antibodies. In parallel, the role of
the duodenal biopsy as the “gold standard” has been
questioned by a high variability in the histological
interpretation. These changes have led to the publication
of new guidelines by the European Society for Pediatric
Gastroenterology, Hepatology, and Nutrition (ESPGHAN,
[2]). The aim of the new guideline was to achieve high
diagnostic accuracy and to reduce burden for patients by
relying more on genetic and serological tests and therefore
decreasing the percentage of patients where biopsy is still
required.
IgA anti-tissue transglutaminase (tTG) and the related
endomysium antibodies (EMA) are today considered as
the most reliable serological markers. The anti-gliadin
antibodies (AGA) have been recently replaced by a new
generation of tests based on the detection of antibodies
against deaminated gliadin peptides (DGP). Recently,
serological tests based on detection of antibodies against
DGP showed a very good sensitivity and specificity in
pediatric populations [12,13,14] Moreover, several studies
have shown that IgG anti-DGP have a high specificity and
a better sensitivity than IgG anti-tTG in adults and children
[2,15,16].
Given that CD is a lifelong condition that can be treated
by strict gluten-free diet (GFD), early and rapid diagnosis
is mandatory as it allows for faster counselling and
treatment, avoiding progression of the condition, decreasing
development of comorbidities, and leading to better
patient comfort and a reduction in the use of healthcare
services in the long term [17].
12
Clinically Validated
