Population screening for coeliac disease in primary care by district nurses using a rapid antibody test: diagnostic accuracy and feasibility studyBMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39405.472975.80 (Published 13 December 2007) Cite this as: BMJ 2007;335:1244
All rapid responses
This recent paper represents a follow-up after the initial paper by
Maki et al in 2006 (Aliment Pharmacol Ther 24, 147-154), where they
demonstrated 96.7% sensitivity and 93.5% specificity in a wide age range
(1.6 to 68 yrs) and suggested that it may be useful in monitoring dietary
lapses in follow-up in addition to its comparable utility for intial
diagnosis. That initial study also suggested that the test was good for a
sub-group of patients with subsequently very subtle biopsy findings. In
this study, District nurses did the testing, (apparently untrained but in
any case should have got better as they used it) and reveals a
disappointing 78.1% sensitivity but excellent specificity of 100% in a 6
year old population (not recommended under this age, despite it being used
in under 6 year olds in the initial study). Like Endomysial testing, the
result is truly in the eye of the beholder!
A screening test like this needs to be Sensitive , that is, to pick
up cases and ideally not miss any - this study does not reassure me that
in over the counter practice(that is the general public, self-testing)
this is as valuable as previously reported and enthusiasm for its general
population use needs to be tempered. I am also sure that some patients
would not then seek further advice despite this being given by the
companies selling it. It may well lead to false reassurance, even in the
face of symptoms. In addition, the majority of my new cases per year are
below age 6 so for childhood use it's not helpful (i have many children
sent for advice and testing when a parent is Coeliac).
We used some of the Biocard kits in an informal study: in a girl age
6, undergoing a gluten challenge (and symptomatic), this kit was negative,
when our laboratory test (same sample) was positive, AutoDELFIA IgA tTG
33.2 AU (normal <7.9), the biopsy confirming partial villous atrophy.
The marketing of this test is very reasonable and on one site has a
rider that it isn't recommended under 5 years of age. It is easy enough to
use, but certainly isnt cheap in the UK (at £19.99) and this recent study
does not make me want to recommend it to anyone (child or parent)for self-
diagnosis when rapid access to blood testing in a validated lab is part of
the UK system.
I agree completely with Sanders et al that our aim should be far
better case finding in conjunction with patient (and Healthcare provider)
education through interested individuals, Coeliac UK (and Government)and
easy access to NHS lab testing that has better sensitivity than this test
appears to have in practice. I am also sceptical about population
screening, even though Coeliac disease does push that button. I agree that
in a large number of screening diagnosed cases (Type I diabetic children
are a prime example) adherence to diet is not great and many would not
thank you for the second diagnosis, however well intentioned that may have
Counselling of concerned patients, families,quantifying risk and
offering formal NHS testing for those who remain worried should be our
goal in the UK.
Competing interests: No competing interests
We read with interest this excellent paper pertaining to screening
children using point of care testing for coeliac disease.1 Although the
authors suggest that these children had clinical problems found in
untreated coeliac disease and benefited from the diagnosis (after 6 months
on a GFD) – despite this we would still advocate caution. It is fair to
say that coeliac disease fulfils the tenets of any screening programme,
however, we do not know the natural history of screen-detected patients
with coeliac disease. It may be that the individuals recognised through
screening have a more indolent clinical manifestation of the disease and
that untreated coeliac disease may even confer a biological advantage in
adulthood (lower cholesterol or blood pressure).2
Although the investigational process for population screening and case-
finding maybe the same, there is an important ethical difference between
them. If a patient seeks medical help then the physician is attempting to
diagnose the underlying condition (for example: patients with coeliac
disease who present with symptoms of irritable bowel syndrome). This would
be classified as case-finding and clearly it is the patient who has
initiated the consultation and in some sense is consenting for
investigation. Conversely, individuals (who are not patients) found to
have coeliac disease through screening programmes, may have considered
themselves as ‘well’ and it is the physician or healthcare system that is
identifying them as potentially ill.
We recently performed a primary care based cross-sectional study using
serological markers (endomysial and gliadin antibodies) to initially
recognise coeliac disease.3 1200 adult volunteers were recruited from
January 1999 to June 2001 from 5 General Practices in South Yorkshire,
United Kingdom. Any participant with a positive serological result was
offered a small bowel biopsy to confirm the diagnosis of coeliac disease.
Twelve new cases of coeliac disease were diagnosed from 1200 samples. The
prevalence of coeliac disease in this primary care population sample is 1%
(95% CI 0.4-1.3%).1 In this screening study, 9/12 diagnosed cases of
coeliac disease ultimately had subtle symptoms which could be attributed
to coeliac disease (for example, anaemia or subtle gastrointestinal
symptoms). Five years later 5/12 screen detected patients are no longer
complying with the gluten-free diet.
We, and others have demonstrated a delay in the diagnosis of coeliac
disease – surely the important change in our clinical practice (both in
primary and secondary care) is to have a low threshold for case-finding.
Now that point of care testing is here we must be cautious about how we
advocate its use – if this test is available over the counter there is a
risk that individuals will test and treat themselves without ever seeking
healthcare professionals’ advice or even a duodenal biopsy. With excellent
technology comes the burden of increased responsibility.
1. Korponay-Szabó IR, Szabados K, Pusztai J, Uhrin K, Ludmány E, Nemes E
et al. Population screening for coeliac disease in primary care by
district nurses using a rapid antibody test: diagnostic accuracy and
feasibility study. BMJ 2007;335:1244-1247.
2. West J, Logan RF, Card TR, Smith C, Hubbard R. Risk of vascular disease
in adults with diagnosed coeliac disease: a population-based study.
Aliment Pharmacol Ther 2004;20:73-9.
3. Sanders DS, Patel D, Stephenson TJ, Milford-Ward A, McCloskey EV,
Hadjivassiliou M, Lobo AJ. A primary care cross-sectional study of
undiagnosed adult coeliac disease. Eur J Gastroenterol Hepatol 2003
Competing interests: No competing interests
The paper of Korponay-Szabó et al. (1) highlights once more (2) (3)
the importance of a population screening program to early detect celiac
patients. Although celiac disease (CD) satisfies 5 out of 5 major WHO
criteria for mass screening, only a case finding approach for symptoms
and/or conditions known to be associated with CD is the currently "best
buy" recommendation mainly because of economical and ethical reasons.
However, under diagnosis of CD disease is still common because of low
awareness of CD in general practice and often results in protracted and
unnecessary morbidity. At least one clinical sign of CD was present in 23
out of 28 children diagnosed with CD at screening (1) but investigation
for CD had not been previously performed in these subjects. In the last
years the tissue transglutaminase antibodies showed both sensitivity and
specificity of more than 93% and have been recently considered as the
optimal test for screening CD (4). Nowadays the finger prick blood test
offers a simple, fast, cheap and accurate serological test for CD (1) and,
hopefully, would permit an easier screening for CD in pediatric ages. In
Italy, fast tests for urine, Streptococcus and Rotavirus infection and
serum glucose and CRP are already available in the office of family
paediatricians speeding up the diagnostic and therapeutic process. It is
auspicious that this fast test for CD could both improve their
consciousness about CD and be also part of their diagnostic armamentarium
in the next future.
1. Korponay-Szabó IR, Szabados K, Pusztai J, Uhrin K, et al.
Population screening for coeliac disease in primary care by district
nurses using a rapid antibody test: diagnostic accuracy and feasibility
study. BMJ published online 6 Dec 2007; doi:10.1136/bmj.39405.472975.80
2. Bingley PJ, Williams AJK, Norcross AJ, Unsworth DJ, et al. Undiagnosed
coeliac disease at age seven: population based prospective birth cohort
study. BMJ 2004;328;322-323
3. Hin H, Bird G, Fisher P, Mahy N, Jewell D. Coeliac disease in primary
care: case finding study. BMJ 1999;318;164-167
4. Gomez JC, Selvaggio G, Pizarro B, et al. Value of a screening algorithm
for celiac disease using tissue transglutaminase antibodies as first level
in a population-based study. Am J Gastroenterol 2002;97:2785–90.
Competing interests: No competing interests