Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India

Prashant Singh, Nitya Wadhwa, Mona K. Chaturvedi, Vidyut Bhatia, Savita Saini, Nikhil Tandon, Govind K. Makharia, Markku Maki, Tarcisio Not, Alan Phillips, Shinjini Bhatnagar

Research output: Contribution to journalArticle

11 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1004-1008
Number of pages5
JournalArchives of Disease in Childhood
Volume99
Issue number11
DOIs
Publication statusPublished - Nov 1 2014

Fingerprint

Celiac Disease
Tertiary Care Centers
India
Point-of-Care Systems
Antibodies
Biopsy
Developing Countries
Histology
Refractory Anemia
Point-of-Care Testing
Transglutaminases
Wetlands
Serologic Tests
Diarrhea
Cross-Sectional Studies
Sensitivity and Specificity

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Medicine(all)

Cite this

Singh, P., Wadhwa, N., Chaturvedi, M. K., Bhatia, V., Saini, S., Tandon, N., ... Bhatnagar, S. (2014). Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India. Archives of Disease in Childhood, 99(11), 1004-1008. https://doi.org/10.1136/archdischild-2013-305567

Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India. / Singh, Prashant; Wadhwa, Nitya; Chaturvedi, Mona K.; Bhatia, Vidyut; Saini, Savita; Tandon, Nikhil; Makharia, Govind K.; Maki, Markku; Not, Tarcisio; Phillips, Alan; Bhatnagar, Shinjini.

In: Archives of Disease in Childhood, Vol. 99, No. 11, 01.11.2014, p. 1004-1008.

Research output: Contribution to journalArticle

Singh, P, Wadhwa, N, Chaturvedi, MK, Bhatia, V, Saini, S, Tandon, N, Makharia, GK, Maki, M, Not, T, Phillips, A & Bhatnagar, S 2014, 'Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India', Archives of Disease in Childhood, vol. 99, no. 11, pp. 1004-1008. https://doi.org/10.1136/archdischild-2013-305567
Singh, Prashant ; Wadhwa, Nitya ; Chaturvedi, Mona K. ; Bhatia, Vidyut ; Saini, Savita ; Tandon, Nikhil ; Makharia, Govind K. ; Maki, Markku ; Not, Tarcisio ; Phillips, Alan ; Bhatnagar, Shinjini. / Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India. In: Archives of Disease in Childhood. 2014 ; Vol. 99, No. 11. pp. 1004-1008.
@article{9eae84ce7f934a07bdfcbb87eb2e590b,
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. 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.",
author = "Prashant Singh and Nitya Wadhwa and Chaturvedi, {Mona K.} and Vidyut Bhatia and Savita Saini and Nikhil Tandon and Makharia, {Govind K.} and Markku Maki and Tarcisio Not and Alan Phillips and Shinjini Bhatnagar",
year = "2014",
month = "11",
day = "1",
doi = "10.1136/archdischild-2013-305567",
language = "English",
volume = "99",
pages = "1004--1008",
journal = "Archives of Disease in Childhood",
issn = "0003-9888",
publisher = "BMJ Publishing Group",
number = "11",

}

TY - JOUR

T1 - Validation of point-of-care testing for coeliac disease in children in a tertiary hospital in north India

AU - Singh, Prashant

AU - Wadhwa, Nitya

AU - Chaturvedi, Mona K.

AU - Bhatia, Vidyut

AU - Saini, Savita

AU - Tandon, Nikhil

AU - Makharia, Govind K.

AU - Maki, Markku

AU - Not, Tarcisio

AU - Phillips, Alan

AU - Bhatnagar, Shinjini

PY - 2014/11/1

Y1 - 2014/11/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84907930206&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84907930206&partnerID=8YFLogxK

U2 - 10.1136/archdischild-2013-305567

DO - 10.1136/archdischild-2013-305567

M3 - Article

C2 - 24942708

AN - SCOPUS:84907930206

VL - 99

SP - 1004

EP - 1008

JO - Archives of Disease in Childhood

JF - Archives of Disease in Childhood

SN - 0003-9888

IS - 11

ER -