B-072 Analytical Evaluation of a Novel Fully Automated Multiplexed Microarray Immunoassay for the Simultaneous Detection of Eleven Autoantibodies Associated with Connective Tissue Diseases in a Spanish Reference Laboratory

Abstract

Abstract Background Detection of different autoantibodies is key in the identification of autoimmune diseases; however, most available devices are either individual tests and/or manual/semi-automated. Development of fully-automated multiplexed devices for autoantibody testing is needed. We evaluated the analytical performance of the novel MosaiQ® AiPlex CTD (AiPlex-CTD) microarray, used with the fully-automated MosaiQ system, for simultaneous qualitative detection of eleven autoantibodies associated with connective tissue diseases (CTD), compared with selected CE-marked devices. Methods AiPlex-CTD microarrays (AliveDx, Switzerland) were prepared by printing antigens onto functionalized glass chips. Microarrays consisting of 2 separate sides (1 side was printed, leaving the other side available for future addition of antigens) were assembled into magazines (containing 250 microarrays) for processing on the MosaiQ 125 instrument. Serum samples from a Spanish refence laboratory, characterized as reactive to ≥1 autoantibodies using Quanta Flash® CTD Screen (Werfen, Spain) or as non-reactive by FIDISTM Connective Profile (Theradiag, France). All samples were tested with AiPlex-CTD. Positive percent agreement (PPA) and negative percent agreement (NPA), overall and for individual analytes were calculated. Results Compared with Quanta Flash® CTD Screen, AiPlex-CTD showed PPA ranging from 80% for Sm to 100% for SS-A 60, TRIM21, U1RNP, Jo-1 and Scl-70. No reactive samples were available for Sm/RNP and Ribosomal P. Compared with FIDIS, NPA ranged from 95% for dsDNA, Scl-70 and CENP-B and 100% for SS-A 60, TRIM21, SS-B, Sm, Sm/RNP, U1RNP, Jo-1 and Ribosomal P. Performance details for individual analytes are shown in the Table. Conclusions In this sample cohort, AiPlex-CTD demonstrated high concordance with the compared CE-marked devices for the automated qualitative detection of the autoantibodies included in the assay, which is line with previous observations in a larger cohort using FIDIS and other CE-marked devices. This high throughput multiplexed platform has the potential to help optimize CTD testing by simplifying complex testing pathways.