Celiac.com 02/13/2014 - A team of researchers recently set out to assess the validity and effectiveness of near-patient celiac immunological testing in dietician-led celiac disease follow-up clinics, and to compare the results against standard laboratory immunological techniques.
Each of the two phases of the study assessed the near-patient test and standard laboratory immunological techniques. In Phase 1, the team analyzed stored serum samples, while in Phase 2 they analyzed whole blood from patients attending the dietician-led celiac disease clinics. Between March 2010 and February 2011, the team recruited 50 patients from New Cross Hospital, Wolverhampton, and 30 from Imperial College London.
All patients had a diagnosis of celiac disease for greater than 12 months, and attended dietician-led celiac disease clinics. During the study, the team took whole blood samples for routine analysis, along with regular capillary finger-prick blood samples. The team wanted to determine if the whole blood and serum near-patient test results correlated with outcomes of standard laboratory evaluation.
The first phase of the study showed that the near-patient serum test had a sensitivity of 93.5% (95% CI 0.79% to 0.98%), and a specificity of 94.9% (0.83% to 0.99%), when compared with the standard laboratory ELISA.
The second phase showed that whole blood measurements had a sensitivity of 77.8% (0.45% to 0.93%), and specificity of 100% (0.94% to 1%).
The team concludes that the study results suggest a possible role for near-patient testing in celiac disease, but they suggest additional studies to corroborate and refine such a role.
Disclosure: The team noted the receipt of a £2250 (approximately $3,750.00) bursary award from Dr. Falk Pharma and Core.