Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      The investigators will perform prospective observational multicenter study which includes
      children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study
      group) and children without suspicion of CD who underwent gastroscopy for other reasons. The
      investigators will compare sensitivity, specificity and predictive values of several
      serological kits of TG2 (tissue transglutaminase) (Bioplex 2200, Bioflash, Phadia 250,
      Liason-XL, Orgentec Alergia and Eurospital) compared with definitive diagnosis of CD
      according to histological findings.
    

Detailed description: 
      Small bowel biopsies have so far been considered as the reference standard for the diagnosis
      of Celiac disease (CD). However, during the last decades evidence has accumulated on the
      diagnostic value of specific CD antibodies and has increasingly been used for diagnostic
      purposes. At the same time, the leading role of histology for the diagnosis of CD has been
      questioned for several reasons: histological findings are not specific for CD, lesions may be
      patchy and can occur in the duodenal bulb only and interpretation depends on preparation of
      the tissue and is prone to a high inter-observer variability. The diagnosis of CD may then
      depend not only on the results of small bowel biopsies, but also on information from clinical
      data and on results from specific CD antibody testing. ESPGHAN (European Society of
      Gastroenterology, Hepatology and Nutrition) guidelines for the diagnosis of CD which was
      recently published enabled diagnosis of CD based on classical symptoms and high titre levels
      (>10 times upper limit of normal) of tissue transglutaminase (TG2) and positive Endomysial
      Anti bodies (EMA) in separate blood samples.

      Due to these facts, it is important to use serological kit for TG2 with high specificity and
      sensitivity. The aim of this study is to assess in a prospective study the kit with the
      highest sensitivity and specificity among patients with suspected CD.

      The investigators will perform prospective observational multicenter study which includes
      children with suspicion of CD who referred to gastroscopy and intestinal biopsies (study
      group) and children without suspicion of CD who underwent gastroscopy for other reasons. The
      investigators will compare sensitivity, specificity and predictive values of several
      serological kits of TG2 (Bioplex 2200, Bioflash, Phadia 250, Liason-XL, Orgentec Alergia and
      Eurospital) compared with definitive diagnosis of CD according to histological findings.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study group: 100 children with suspicion of CD based on positive serology (TG2 >2 times
        upper limit of normal) and classical clinical manifestations or belonging to high risk
        groups, who underwent gastroscopy with intestinal biopsies.

        Control group: 100 children without suspicion of CD who underwent gastroscopy for other
        reasons (abdominal pain, failure to thrive, vomiting, eg)
      
Biospecimen description: 
      10 cc of blood samples (for celiac serology kits assessment)
    
Keywords: Celiac disease; Tissue transglutaminase; Histology