The role of near-patient coeliac serology testing in the follow-up of patients with coeliac disease.

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.