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.
