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Received: 05 Oct, 2020/Revision: 22 Oct, 2020 /Accepted: 12 Nov, 2020 ABSTRACT: The prevalence of diagnosed autoimmune conditions in 2019 shows that the leading countries are the United States (7% of adult population), followed by the EU (6%) and China (5%).There are more than 100different ADs (autoimmune diseases) and they are the third most common diseases worldwide. The difficulty in diagnosis, based on the clinical heterogeneity of the different types of AD and furthermorethe generated autoantibodies are often not specific for a single disease. In fact, there is a need to increase the clinical efficiency in the autoimmune diagnostic field. Therefore we tested and compared the CLIA-test-based HOB BioCLIA 6500® in both, handling and performance,to the FEIA-based Phadia 250® system. 23 selected autoimmune parameters (e.g. in ANA, celiac disease or anti-phospholipids syndrome) and altogether 6401 measurements are done in our high-throughput lab. For the performance, the non-compliance and the κ–values are calculated to describe the effect of discrepant results. For 16 of 21 compared parameters we found a good compliance. Notwithstanding for some of the parameters, e.g. celiac and rheumatoid parameters, a discrepancy is observed. In an additional “celiac project” we bought characterized sera from the in.vent Diagnostica GmbH and repeated the measurement on the systems together with IFT on endomysium slides. In this second part of the study a very good agreement was found.

CONCORDANCE OF THE ANALYTICAL PERFORMANCE OF AUTOIMMUNE ANTIBODIES ON THE HOB BIOCLIA® 1200 AUTOMATED IMMUNOASSAY ANALYZER TO THE PHADIA 250® SYSTEM