Performance Assessment of a Novel Multianalyte Methodology for Celiac Disease Biomarker Detection and Evaluation of the Serology-Alone Criteria for Biopsy-Free Diagnosis

Abstract

Context.— Serology plays a vital role in celiac disease (CD) diagnosis, and the latest European guidelines advocate for biopsy-free diagnoses in patients with ≥10× the upper limit of normal (ULN) of anti–tissue transglutaminase (tTG) immunoglobulin A (IgA) antibodies. Objective.— To assess performance characteristics of a novel automated particle-based multianalyte technology (Aptiva) for anti-tTG and anti–deamidated gliadin peptide (DGP) antibody detection as compared to the traditional enzyme-linked immunosorbent assay (QUANTA Lite). Performance characteristics of the ≥10× ULN anti–tTG IgA criteria for serologic diagnosis of CD were also evaluated. Design.— Sera samples from 703 patients were tested for anti–tTG IgA, anti–tTG immunoglobulin G (IgG), anti–DGP IgA, and anti–DGP IgG antibodies on both platforms. In total, 127 patients had medical information and were classified as CD-positive (n = 58) and CD-negative (n = 69) based on biopsy results. Clinical performance characteristics were evaluated. Results.— Anti–tTG IgA detection showed equal clinical sensitivity and specificity of 91% sensitivity and 99% specificity on both platforms. Anti–tTG IgG resulted in moderate sensitivity of 69% and 72%, but high specificity of 100% and 94% on Aptiva and QUANTA Lite, respectively. Anti–DGP IgG displayed comparable sensitivity of 90% and 81%, and a specificity of 94% and 99%, on Aptiva and QUANTA Lite, respectively. Anti–DGP IgA demonstrated greater sensitivity on QUANTA Lite (83%) than Aptiva (69%) and similar specificities of 97% and 98% on QUANTA Lite and Aptiva, respectively. At ≥10× ULN levels for anti–tTG IgA, Aptiva displayed a sensitivity of 72% and a specificity of 100%, and QUANTA Lite showed a sensitivity of 69% and a specificity of 100%. Conclusions.— Aptiva is a reliable method to measure CD biomarkers with reduced hands-on necessity and high-throughput capabilities. This study supports the use of a ≥10× ULN anti–tTG IgA biopsy-free approach for serologic diagnosis of CD.