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Original article
Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India
  1. Prashant Singh1,
  2. Nitya Wadhwa1,
  3. Mona K Chaturvedi1,
  4. Vidyut Bhatia1,
  5. Savita Saini1,
  6. Nikhil Tandon2,
  7. Govind K Makharia3,
  8. Markku Maki4,
  9. Tarcisio Not5,
  10. Alan Phillips6,
  11. Shinjini Bhatnagar1
  1. 1Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India
  2. 2Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India
  3. 3Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India
  4. 4Tampere Center for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland
  5. 5Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, and University of Trieste, Trieste, Italy
  6. 6UCL Institute of Child Health, London, UK
  1. Correspondence to Dr Shinjini Bhatnagar, Professor and Head, Pediatric Biology Center, Translational Health Science and Technology Institute, 496, UdyogVihar, Phase III, Gurgaon Haryana 122 016, India; shinjini.bhatnagar{at}gmail.com

Abstract

Objective Some of the conventional serological tests for coeliac disease (CD) are expensive, time-consuming and not readily available in developing countries, leading to a delay in diagnosis. Recently, point-of-care tests (POCT) have been manufactured and tested in Europe but have not been validated in our setting. We therefore aimed to study the diagnostic accuracy of the POCT ‘Biocard’ test in diagnosing CD in Indian children.

Design Cross-sectional study.

Setting Tertiary care centre in north India.

Patients Children, aged 2–18 years, with chronic diarrhoea, short stature or refractory anaemia underwent serological testing for CD with antiendomysial antibodies (AEA), antitissue transglutaminase (tTG) antibodies and Biocard test followed by duodenal biopsy irrespective of serological results. CD was diagnosed with positive AEA and duodenal biopsy showing >grade 2 changes using modified Marsh criteria. Those who were both AEA negative and had normal histology were considered CD negative.

Results Of 319 children who underwent the serological testing, 170 agreed for biopsy. Of these, 110 were diagnosed with CD and 30 were found to be CD negative. Remaining 30 had discordant AEA and histology results and were not included in analysis. Biocard test agreed with 92/110 positive and 27/30 negative diagnoses based on reference tests (83.6% sensitivity and 90% specificity). tTG was found to be 93.8% sensitive and 96.4% specific.

Conclusions We successfully validated the POCT for CD in our setting. It could be used to increase case detection rates in developing countries with a large undiagnosed CD burden.

  • Gastroenterology
  • Nutrition

https://doi.org/10.1136/archdischild-2013-305567

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