The 2012 recommendations of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) allowed for the first time a non biopsy approach to celiac disease detection (CD). The goal of this study was to evaluate four tissue-transglutaminase (tTg) IgA tests from four random-access analyzers for their accuracy in identifying CD without a biopsy. The study included 186 children who had been referred for upper endoscopy and intestinal biopsy. One group consisted of 109 individuals who had positive tTg and were referred for suspected CD. Another group comprised 77 individuals with negative tTg who were referred for other reasons. At the time of the endoscopy, all participants had a blood sample taken. 4 tTg IgA tests on automated analyzers and 1 Elisa kit were used to evaluate the samples. When complete consensus was obtained, CD was diagnosed. The tests’ analytical performance included accuracy with controls and samples, lot to lot variance, and carryover. All evaluated tTg IgA-automated tests in our cohort had sensitivities more than 98 percent and specificities greater than 99 percent. ROC analysis revealed that the AUC for all four analyzers was more than 0.99. Positive predictive values (PPV) were all greater than 0.99, while negative predictive values (NPV) were greater than 0.97.
Using the four high-volume random-access analyzers utilised in our investigation, CD can be reliably identified without a biopsy based on tTg IgA levels at least ten times the ULN.
