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The role of near-patient coeliac serology testing in the follow-up of patients with coeliac disease
  1. D A George1,
  2. L L Hui2,
  3. D Rattehalli1,
  4. T Lovatt1,
  5. I Perry1,
  6. M Green1,
  7. K Robinson1,
  8. J R F Walters2,
  9. M J Brookes1
  1. 1Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
  2. 2Department of Gastroenterology, Imperial College London, London, UK
  1. Correspondence to Dr Matthew Brookes, Department of Gastroenterology, New Cross Hospital, Wolverhampton Road, Wolverhampton WV10 0QP, UK; m.j.brookes{at}bham.ac.uk

Abstract

Objective This pilot study was undertaken to assess the validity and effectiveness of near-patient coeliac immunological testing, compared to standard laboratory immunological techniques, used in the context of dietician-led coeliac disease follow-up clinics.

Design The study was designed in two phases, each assessing the near-patient test and standard laboratory immunological techniques. Phase 1 analysed stored serum samples; Phase 2 analysed whole blood from patients attending the dietician-led coeliac disease clinics.

Setting Patients were recruited from New Cross Hospital, Wolverhampton (n=50), and Imperial College London (n=30), between March 2010 and February 2011.

Patients Those with a diagnosis of coeliac disease for greater than 12 months attending dietician-led coeliac disease clinics.

Interventions In addition to whole blood taken for routine analysis, patients required a capillary finger-prick blood sample.

Main outcome measure To determine if the whole blood and serum near-patient test results were in correlation with outcomes of standard laboratory evaluation.

Results Phase 1 demonstrated that the near-patient serum test had a sensitivity of 93.5% (95% CI 0.79% to 0.98%), specificity of 94.9% (0.83% to 0.99%), when compared to standard laboratory ELISA. Phase 2, involving patients whole blood, had a sensitivity of 77.8% (0.45% to 0.93%), and specificity of 100% (0.94% to 1%).

Conclusions This pilot study has demonstrated that there appears to be a role for near-patient testing in coeliac disease, but further studies are recommended.

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