Serum levels of immunoglobulin A-tissue transglutaminase antibodies (IgA-tTG) by commercially available enzyme-linked immunosorbent technique (ELISA) are accepted as the best serology screening tool for celiac disease. ELISA based IgA-tTG tests are available only in centralised laboratories, and testing requires expert personnel in ideal conditions and therefore a long testing time. ‘Celiac card’ is recently developed rapid and sensitive one step immunoassay test based on detection of IgA. The objective of the study was to validate the diagnostic performance of immunoassay based ‘celiac card’ and compare it with human anti-tissue.Methods
This diagnostic accuracy study was carried out in Indian tertiary care hospital. Children aged between 1 to 12 years and considered to be high risk for celiac disease (recurrent diarrhoea/chronic diarrhoea/or recurrent abdominal pain along with poor weight gain or abdominal distension/or moderate to severe iron deficiency anaemia/or short stature) were recruited. Those with chronic gastrointestinal diseases like inflammatory bowel disease or already diagnosed celiac disease were excluded. Eligible participants were screened for IgA anti tTG antibodies by ‘celiac card’ and ELISA based ‘Euroimmun kit’. Patients screened positive by either of the two diagnostic methods underwent upper gastrointestinal endoscopy and biopsy and diagnosis of celiac disease made as per Marsh grading.Results
Sensitivity and specificity of ‘Celiac card’ were calculated in 250 enrolled children and found out to be 92.31% and 98.28% respectively, which was similar to the ELISA based ‘Euroimmun’ kit.Conclusions
The diagnostic accuracy of the rapid ‘Celiac card’ test is high and similar to the sensitivity and specificity of the existing ELISA based ‘Euroimmun’ kit, which makes it an excellent screening test for celiac disease.