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EVALUATION OF A WHOLE BLOOD-BASED RAPID TEST FOR TRANSGLUTAMINASE DETECTION IN CELIAC DISEASE
L de Chaisemartin, L Gedah, G Malamut, J Coulloc’h, W-H Fridman, C Cellier, M-A Dragon-Durey
Immunology Department and Gastroenterology Department, Georges Pompidou Hospital, Paris, France
BACKGROUND: Recent serological screening studies have found that celiac disease is more prevalent than previously described (1% of North America and Europe populations). Indeed, celiac disease is frequently underdiagnosed, probably because of atypical and silent forms. A rapid test available at a doctor’s office may considerably improve celiac disease screening and verification of gluten-free diet compliance.
AIM: To assess : (1) the validity of the Biocard Celiac Test, a new, rapid test for IgA anti-transglutaminase antibodies (TGA) on capillary whole blood samples, and (2) the detectability of IgA TGA in a selected population of treated celiac patients in whom TGA are rare or at low levels.
METHODS: Whole-blood and serum samples were simultaneously collected from 90 patients in a center specializing in celiac disease. Out of the 90 patients tested, 81% were biopsy-proven celiac disease patients. Of these, 96% were on a gluten-free diet. No patient was IgA deficient. All subjects were tested for IgA anti-transglutaminase by ELISA (Eurospital) and by the Biocard Celiac Test. In the latter, the antigen used was the patient’s own transglutaminase. Test results became available within 5 minutes.
RESULTS: The rapid test was positive in 30 (33%) patients. All celiac patients not following a strict gluten-free diet tested positive. All non-celiac patients but one tested negative. Sensitivity and specificity of the rapid test for the presence of IgA TGA were 94% and 83%, respectively. Moreover, a negative result was able to predict the absence of IgA TGA with 98.4% efficiency (negative predictive value). A positive result was associated with the presence of serum IgA TGA in 60% of cases (positive predictive value).
CONCLUSIONS: The Biocard Celiac Test efficiently excluded the patients without anti-transglutaminase antibodies, suggesting that the test is well-adapted for celiac disease screening and verification of gluten-free diet compliance.