@misc{SowaGrossmannKnuetteretal., author = {Sowa, Mandy and Großmann, Kai and Kn{\"u}tter, Ilka and Hiemann, Rico and R{\"o}ber, Nadja and Anderer, Ursula and Csernok, Elena and Bogdanos, Dimitrios Petrou and Borghi, Maria Orietta and Meroni, Pier Luigi and Schierack, Peter and Reinhold, Dirk and Conrad, Karsten and Roggenbuck, Dirk}, title = {Simultaneous automated screening and confirmatory testing for vasculitis-specific ANCA}, series = {PLoS ONE}, volume = {9}, journal = {PLoS ONE}, number = {9}, issn = {1932-6203}, doi = {10.1371/journal.pone.0107743}, pages = {11}, language = {en} } @misc{RoeiBorisYehudaetal., author = {Roei, Tulchinsky and Boris, Gilburd and Yehuda, Shovman and Milena, Tocut and Eleanor, Zeruya and Ariel, Binyaminov and Tima, Davidson and B{\"u}ttner, Thomas and Nasser, Abdullah and Michel, Juliane and R{\"o}diger, Stefan and Schierack, Peter and Howard, Amital and Roggenbuck, Dirk and Yehuda, Shoenfeld and Ora, Shovman}, title = {CytoBead ANA 2 assay : a novel method for the detection of antinuclear antibodies}, series = {Scientific reports}, volume = {15}, journal = {Scientific reports}, number = {1}, publisher = {Nature Publishing Group UK}, address = {London}, issn = {2045-2322}, doi = {10.1038/s41598-025-04583-3}, pages = {1 -- 11}, abstract = {Detection of anti-nuclear autoantibodies (ANA) is based on a two-step algorithm including indirect immunofluorescence (IIF) on HEp2 cells and subsequent reflex/confirmatory testing for specific autoantibodies. Simultaneous cell- and microbead-based autoantibody detection by IIF may be utilized for the evaluation of systemic autoimmune rheumatic diseases (SARDs). In the present study, we assessed the performance of CytoBead ANA 2 in the detection of ANA and ANA-specific autoantibodies, compared to ANA IIF and BioPlex™ 2200. We also tested the ability of CytoBead ANA DFS-70 to identify dense-fine speckled (DFS) pattern associated with anti-DFS70 antibodies in non-SARDs patients. Hundred-twelve routine sera samples were assessed by manual CytoBead ANA 2 for the presence of ANA and specific autoantibodies. In parallel, these samples were analyzed by HEp2 ANA IIF test and a subsequent multiplexed assay BioPlex™ 2200 ANA. Twenty-nine ANA-positive samples obtained from non-SARDs patients and exhibiting DFS pattern by ANA IIF were further tested by CytoBead ANA DFS-70. A substantial agreement was observed between classical ANA IIF and manual CytoBead ANA 2 for the detection of ANA (k = 0.74). Discordant results were mainly associated with the presence of anti-SSA/Ro antibodies detected by CytoBead ANA 2 in ANA IIF negative patients. A good to almost perfect agreement was found between CytoBead ANA 2 and BioPlex™ 2200 for detection of specific antibodies with kappa values ranging from 0.70 to 0.90. Twenty samples (68.9\%) obtained from 29 ANA IIF positive without SARDs patients exhibited DFS pattern in CytoBead ANA DFS-70, which confirmed the presence of anti-DFS70 antibodies. The diagnostic performance of manual CytoBead ANA 2 for ANA screening and detection of ANA specific antibodies is comparable to the diagnostic performance of ANA IIF followed by BioPlex™ 2200. This novel one-step assay enables simultaneous ANA screening and confirmation and represents a promising alternative approach to the time-consuming and costly two-tier ANA analysis.}, language = {en} }