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Use of nonbiopsy ESPGHAN criteria depends on celiac serology test performance
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A recent guideline published by the European Society of Paediatric Gastroenterology, Hepatology and Nutrition, or ESPGHAN, which established criteria for omitting a diagnostic biopsy for pediatric celiac disease, has a high positive predicted value dependent on the performance of celiac serology tests, according to research data.
“Clinicians who may wish to apply the nonbiopsy protocol to their patients must be aware of how their antibody test performs, as there are many kits available and not all tests perform equally,” Dominica Gidrewicz, MSc, MD, FRCPC, pediatric gastroenterologist at Alberta Children's Hospital in Canada, told Healio Gastroenterology. “Secondly, in our study, even when we applied the ESPGHAN nonbiopsy criteria we had a few false positives who were all either HLA DQ2- or DQ8-positive. Thus the HLA testing was not very helpful in this situation.”
Gidrewicz and colleagues performed a single-center retrospective study of a large North American pediatric population to evaluate the performance of the ESPGHAN criteria for nonbiopsy diagnosis of celiac disease, which require a patient to be symptomatic with a tissue transglutaminase (TTG) at least 10 times the upper limit of normal, a positive endomysial antibody (EMA) collected on a second blood sample and a positive human leukocyte antigen (HLA) DQ2 and/or DQ8 status, family permission and response to a gluten-free diet. EMA testing for predicting likelihood of biopsy-proven celiac disease and whether duodenal bulb biopsies can be limited to a patient subgroup also were evaluated.
The researchers identified 17,505 patients younger than 18 years who had celiac serology performed from July 2008 to December 2011, and corresponding results from intestinal biopsies performed between July 2008 and April 2012 were obtained. Overall, 775 with positive TTG (56% biopsied), 574 with negative TTG (all biopsied), and 25 who were immunoglobulin A-deficient were included in the final analysis.
Among patients who had TTG 10 times the upper limit of normal, 97.3% (95% CI, 95-99) of EMA-positive patients had a biopsy diagnostic of celiac disease compared with 42.9% (95% CI, 16-75) of EMA-negative patients (P < .001). Four HLA DQ2- and/or DQ8-positive patients who met the ESPGHAN criteria did not have biopsies diagnostic of celiac disease.
Among patients who had TTG three to 10 times the upper limit of normal, 75.7% (95% CI, 65-84) of EMA-positive patients had a biopsy diagnostic of celiac disease compared with 40% (95% CI, 26-55) of EMA-negative patients (P < .001).
Among patients who had TTG one to three times the upper limit of normal, 52.2% (95% CI, 33-71) of EMA-positive patients had a biopsy diagnostic of celiac disease compared with 13.3% (95% CI, 5-30) of EMA-negative patients (P < .01).
Among patients who underwent bulbar and duodenal biopsy, 9.8% (95% CI, 6-14) had celiac disease confined to the bulb, particularly those with a low titer TTG (P < .01).
Overall prevalence of celiac disease was 34.6% (95% CI, 32-38). TTG performed with 98.7% sensitivity, 86.4% specificity and 79.4% positive predictive value.
“There were no false positives when the EMA was greater than 1:80, thus we have chosen in our center to apply the criteria more strictly to patients with not only a positive EMA but rather an EMA greater or equal to 1:80,” Gidrewicz said. “When celiac disease is diagnosed without a biospy, as when it is with biopsy, the patient must be followed for symptomatic resolution and normalization of the celiac serology. Finally, we found that the additional EMA results were very helpful in improving the positive predictive value of the TTG, especially at low titer TTGs.” – by Adam Leitenberger
Disclosure: The researchers report no relevant financial disclosures.
Editor’s Note: This article was updated on April 15 to reflect additional information.
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