- Ilma R Korponay-Szabó, associate professor in paediatrics12,
- Katalin Szabados, consultant paediatric gastroenterologist3,
- Jánosné Pusztai, district nurse4,
- Katalin Uhrin, consultant pathologist5,
- Éva Ludmány, consultant pathologist5,
- Éva Nemes, senior lecturer in paediatrics1,
- Katri Kaukinen, senior lecturer in gastroenterology6,
- Anikó Kapitány, PhD student7,
- Lotta Koskinen, PhD student8,
- Sándor Sipka, professor of immunology7,
- Anikó Imre, director of the health officer service4,
- Markku Mäki, professor of paediatrics9
- 1Department of Paediatrics, Medical and Health Science Centre, University of Debrecen, 4032 Debrecen, Hungary
- 2Coeliac Disease Centre, Heim Pál Children’s Hospital, 1089 Budapest, Hungary
- 3Department of Infectology, Hetényi Géza County Hospital, 5000 Szolnok, Hungary
- 4County Institute of Public Health and Health Officer Service, 5000 Szolnok, Hungary
- 5Department of Pathology, Hetényi Géza County Hospital, 5000 Szolnok, Hungary
- 6Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital and Medical School, 33014 Tampere, Finland
- 7Regional Immunology Laboratory, Third Department of Internal Medicine, Medical and Health Science Centre, University of Debrecen, 4032 Debrecen, Hungary
- 8Department of Medical Genetics, Biomedicum Helsinki, University of Helsinki, 00014 Helsinki, Finland
- 9Paediatric Research Centre, Tampere University Hospital and Medical School, 33014 Tampere, Finland
- Correspondence to: M Mäki
- Accepted 8 October 2007
Objective To evaluate the feasibility and diagnostic accuracy of screening for coeliac disease by rapid detection of IgA antibodies to tissue transglutaminase performed in primary care.
Design District nurses screened 6 year old children using rapid antibody testing of finger prick blood. They also collected capillary blood samples for laboratory determination of IgA and IgG antibodies to endomysium and IgA antibodies to tissue transglutaminase. Children with positive rapid test results were directly sent for biopsy of the small intestine.
Setting Primary care in Jász-Nagykun-Szolnok county, Hungary.
Participants 2690 children (77% of 6 year olds living in the county) and 120 nurses.
Main outcome measures Positivity for antibodies to endomysium or transglutaminase in the laboratory and coeliac disease confirmed at biopsy.
Results 37 children (1.4%, 95% confidence interval 0.9% to 1.8%) had biopsy confirmed coeliac disease. Only five of these children had been diagnosed clinically before screening. Rapid testing had a 78.1% sensitivity (70.0% to 89.3%) and 100% specificity (88.4% to 100%) for a final diagnosis of coeliac disease by biopsy. Sensitivity was 65.1% (50.2% to 77.6%) and specificity was 100% (99.8% to 100%) compared with combined results of IgA and IgG laboratory tests. Trained laboratory workers detected 30 of the 31 newly diagnosed IgA competent patients with the rapid test kit used blindly. Median time to biopsy after a positive rapid test result was significantly shorter (20 days, range 4-148) than after a positive laboratory result (142 days, 70-256; P<0.001). Children with coeliac disease detected at screening were smaller and had worse health status than their peers but they improved on a gluten-free diet.
Conclusions A simple rapid antibody test enabled primary care nurses to detect patients with coeliac disease in the community who were not picked up in clinical care. Extra training is needed to improve sensitivity.
Thanks to all participating nurses, families, and primary care doctors. Thanks also to Andrásné Jordán, Hajnalka Bata, Erzsébet Nagy, Lászlóné Nagy, and Beatrix Barabás for technical help.
Contributors: IRK-S designed the study, evaluated serological results, and wrote the manuscript with the help of the other authors. KS performed the biopsies, the clinical evaluation, and follow-up of patients identified by screening. JP and AI organised the screening and collected the data from the nurses. KU and ÉL performed the histological evaluation of the biopsies. ÉN evaluated the clinical data and helped in the statistical analysis. KK performed the immunohistochemistry. AK, SS, and LK helped with HLA testing. MM helped design the study, evaluate the data, and prepare the manuscript. IKR-S is guarantor.
Funding: The Hungarian Scientific Research Fund (OTKA K61868), the Hungarian Ministry of Health (ETT518/2003), the Research Fund of Tampere University Hospital, and an EU Marie Curie mobility grant (MRTN-CT-2006-036032; TRACKS). Ani-Biotech, Vantaa, Finland provided the rapid test kits free of charge but did not sponsor the study in any other ways.
Competing interests: MM and IRK-S are the inventors of the patent application “Methods and means for detecting gluten-induced disease” (PCT/FIO2/00340, international publication number W002/086509 A19). Finn Medi Research (owned by Tampere University and Tampere University Hospital, Finland) has commercialised the innovation and licensed it to Ani Biotech, which used it to develop the Biocard coeliac test. FinnMedi Research and Ani Biotech were not involved in this study.
Ethical approval: Ethical committee of Heim Pál Children’s Hospital (permission IKEB 30/2005).
- Accepted 8 October 2007