Evaluation of a point-of-care test based on deamidated gliadin peptides for celiac disease screening in a large pediatric population

aImmunology Laboratory, Lyon-Sud University Hospital, Pierre-Bénite bDepartment of Gastroenterology, Hepatology and Nutrition, Paediatric Hospital, Bron, France cAugurix SA, Monthey, Switzerland.
European journal of gastroenterology & hepatology (Impact Factor: 2.25). 09/2012; 24(12). DOI: 10.1097/MEG.0b013e3283582d95
Source: PubMed


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.

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.

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.

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    • "Some laboratories produce semi-quantitative data, increasing the uncertainty of the assessment. One of the objectives of the MEDICEL network is to support the upgrading of local diagnostic resources: hence we are now running ad hoc procedure to standardize the method of antibody assay and to increase the availability of HLA haplotyping by exploiting the new technologies that attempt to bring the test to the point of care [17,18]. "
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