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 language | English |
|---|---|
| Pages (from-to) | 1004-1008 |
| Number of pages | 5 |
| Journal | Archives of Disease in Childhood |
| Volume | 99 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 1 2014 |
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ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Medicine(all)
Cite this
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 journal › Article
}
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
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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 -