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ISSN 2063-5346
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VALIDATION OF THE RAPID TEST “POINTOF-CARE TEST” FOR THE DIAGNOSIS OF CELIAC DISEASE COMPARED TO THE STANDARD DIAGNOSTICS

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Ayman Emil Eskander, Noha Musa, Hend El Sherbini, Mona AbuZekry, Marwa Abdalaleem
» doi: 10.31838/ecb/2023.12.s3.193

Abstract

Background and aim: The worldwide prevalence of celiac disease (CD) of 1 % results in a global burden which necessitates rapid diagnosis and treatment. The aim of this study was to verify the efficacy of the Pointof-Care Test (POCT); BIOCARDTM Celiac Test for the diagnosis of CD. Methods: 500 children with symptoms suggestive of CD were included in this study and all of them underwent testing for CD using the BIOCARDTM Celiac Test and those with positive or query test results underwent serological testing for CD by anti-tissue transglutaminase immunoglobulin A (anti-tTG IgA) antibodies and upper gastrointestinal endoscopy along with small intestinal biopsies for histopathological examination for features suggestive of CD to confirm the diagnosis. Results: The BIOCARDTM Celiac Test results were positive for CD in 16 children (3.2 %), query in 3 (0.6 %) and were negative in 481 children (96.2 %). Out of the 16 positive POCT results, 14 children were confirmed by both biopsy histopathological results and serum anti-tTG IgA antibodies test to have CD, one of them had negative anti-tTG IgA antibodies test but had biopsy-confirmed CD and the last one had positive anti-tTG IgA antibodies test but the biopsy result was not suggestive of CD. The sensitivity of the POCT; BIOCARDTM Celiac Test in detecting CD in our study was 93.75 % when confirmed by histopathological examination of biopsy samples and serum anti-tTG IgA antibodies test as reference standard diagnostic tests. Conclusion: The POCT; BIOCARDTM Celiac Test was successfully validated as a rapid, simple and cheap biomarker for early detection and diagnosis of CD, and hence it can be applied for CD case-finding in primary care settings.

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