title: Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India.
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.
  
  
  METHODS
  Cross-sectional study.
  
  
  METHODS
  Tertiary care centre in north India.
  
  
  METHODS
  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.
authors.affiliation: Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Prashant
authors.initials: P
authors.lastname: Singh
authors.affiliation: Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Nitya
authors.initials: N
authors.lastname: Wadhwa
authors.affiliation: Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Mona K
authors.initials: MK
authors.lastname: Chaturvedi
authors.affiliation: Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Vidyut
authors.initials: V
authors.lastname: Bhatia
authors.affiliation: Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Savita
authors.initials: S
authors.lastname: Saini
authors.affiliation: Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Nikhil
authors.initials: N
authors.lastname: Tandon
authors.affiliation: Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Govind K
authors.initials: GK
authors.lastname: Makharia
authors.affiliation: Tampere Center for Child Health Research, University of Tampere and Tampere University Hospital, Tampere, Finland.
authors.forename: Markku
authors.initials: M
authors.lastname: Maki
authors.affiliation: Institute for Maternal and Child Health-IRCCS Burlo Garofolo, Trieste, and University of Trieste, Trieste, Italy.
authors.forename: Tarcisio
authors.initials: T
authors.lastname: Not
authors.affiliation: UCL Institute of Child Health, London, UK.
authors.forename: Alan
authors.initials: A
authors.lastname: Phillips
authors.affiliation: Department of Pediatrics, Center for Diarrheal Research, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Shinjini
authors.initials: S
authors.lastname: Bhatnagar
mesh_terms: D000293:Adolescent; D002446:Celiac Disease / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D062606:Tertiary Care Centers
keywords: Gastroenterology; Nutrition