BMJ, doi: 10.1136/bmj.39405.472975.80, (Published 6 December 2007)

Research

Population screening for coeliac disease in primary care by district nurses using a rapid antibody test: diagnostic accuracy and feasibility study

¹ Department of Paediatrics, Medical and Health Science Centre, University of Debrecen, 4032 Debrecen, Hungary, ² Coeliac Disease Centre, Heim Pál Children’s Hospital, 1089 Budapest, Hungary, ³ Department of Infectology, Hetényi Géza County Hospital, 5000 Szolnok, Hungary, ⁴ County Institute of Public Health and Health Officer Service, 5000 Szolnok, Hungary, ⁵ Department of Pathology, Hetényi Géza County Hospital, 5000 Szolnok, Hungary, ⁶ Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital and Medical School, 33014 Tampere, Finland, ⁷ Regional Immunology Laboratory, Third Department of Internal Medicine, Medical and Health Science Centre, University of Debrecen, 4032 Debrecen, Hungary, ⁸ Department of Medical Genetics, Biomedicum Helsinki, University of Helsinki, 00014 Helsinki, Finland, ⁹ Paediatric Research Centre, Tampere University Hospital and Medical School, 33014 Tampere, Finland

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.

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