Jennifer Nibecker, United States of America
Inova Diagnostics Research and DevelopmentPresenter of 1 Presentation
CLINICAL EVALUATION AND METHOD COMPARISON OF NOVEL ASSAYS FOR THE DETECTION OF ANTIBODIES ASSOCIATED WITH CELIAC DISEASE
Abstract
Background and Aims
Antibodies to tissue transglutaminase (tTG) and deamidated gliadin peptide (DGP) are important factors in diagnosis of celiac disease (CD). This study aimed to compare the performance of novel tTG and DGP assays with reference methods using clinically characterized samples.
Methods
A total of 461 samples were included in the study, consisting of 161 samples from CD patients, and 290 samples from patients with various other diseases including other gastroenterological conditions. All samples were tested by a novel fully automated particle-based multi-analyte technology (PMAT, research use only, Inova Diagnostics, USA). Additionally, all samples were tested in parallel using chemiluminescent based assays currently on the market (QUANTA Flash, Inova Diagnostics, USA). Qualitative correlations were calculated, and clinical performance was assessed for each of the analytes.
Results
The results derived from the clinical evaluation and the method comparisons are summarized in the tables below.
Conclusions
Our data show good agreement between the results obtained using the novel PMAT assays and the reference methods. Additionally, all analytes in the Aptiva Celiac Disease IgA and IgG Reagents showed excellent clinical performance.