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Research Articles






Knies C, Olivo M, Tönnies R, von Landenberg P


ABSTRACT: With more than 80 ADs (autoimmune diseases), e.g. Lupus or Rheumatoid arthritis, they are the third most common diseases worldwide.The diagnosis is difficult, because the generated autoantibodies are often not specific for a single disease. In fact, there is a need to increase the clinical efficiency inautoimmune diagnosis. Therefore, we tested and compared the CLIA-based HOB BioCLIA 1200®to the FEIA-based Phadia 250® systemin both, handling and performance. 23selected autoimmune parameters(e.g. in ANA, celiac disease or anti-phospholipids syndrome) and altogether 5982 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 17 of 21 calculated parameters we found a good compliance, just fourparameters, e.g.the Rheumatoid arthritis parameter anti-RF-M and the celiac parameter anti-DGP-A, just substantial κ-values are shown. A reason for the anti-DGP-Acould be that celiac disease is not a relevant but rare disease in China. Thus the assay is far too sensitive or needs a higher reference range for a Caucasian patient poolas discussed with the manufacturers. The handling showed a stable running, random access system with an overall performance that makes it well usable in a medium sized laboratory.


KEY WORDS: Chemiluminescentimmuno assay (CLIA); Automated autoimmune analyser; Autoimmune diseases (AD); HOB BioCLIA 1200®; Cohen’s Kappa (κ) test


  1. Fenger M, Wiik A, Høier-Madsen M, Lykkegaard J J, Rozenfeld T, Hansen M S et al. Detection of Antinuclear Antibodies by Solid-Phase Immunoassays and Immunofluorescence Analysis. ClinChem 2004;50(11):2141-2147.

  2. Lohi S, Mustalahti K, Kaukinen K, Laurila K, Collin P, Rissanen H et al. Increasing Prevalence of Coeliac Disease Over Time. Aliment -

  3. Lerner A, Jeremias P, Matthias T. The World Incidence and Prevalence of Autoimmune Disease is Increasing. Internat J Celiac Dis 2015;3(4):151-155.

  4. Bach J F. The Effect of Infections on Susceptibility to Autoimmune and Allergic Diseases. N Engl J Med 2002;347(12):911-920.

  5. Davis J M, Matteson E L.My Treatment Approach to Rheumatoid Arthritis. Mayo ClinProc 2012;87(7):659-673.

  6. Jeong S, Hwang H, Roh J, Shim J E, Kim J, Kim G-T et al. Evaluation of an Automated Screening Assay, Compared to Indirect Immunofluorescence, an Extractable Nuclear Antigen Assay, and a Line Immunoassay in a Large Cohort of Asian Patients with Antinuclear Antibody-Associated Rheumatoid Disease: A Multicenter Retrospective Study. J Immunol Res 2018;2018:9094217.

  7. Sridhar S, Vasanthy N, Evaluation of indirect immunofluorescence assay in patients with autoimmune disease. Afr J Microbiol Res 2012;6(22):4634-38.

  8. olomon D H, Kavanaugh A J, Schur P H, American College of Rheumatology Ad Hoc Committee on Immunologic Testing Guidelines. Evidence-based guidelines for the use of immunologic tests: antinuclear antibody testing. Arthritis Rheum 2002;47(4):434-444.

  9. Website:

  10. Website:

  11. Website:

  12. Website:

  13. Watson P F, Petrie A. Method agreement analysis: A rewiev of correct methodology. Theriogenology 73 2010; 1167-1179.

  14. Holmberg A, Blomstergren A, Nord O, Lukacs M, Lundeberg J, Uhlén M. The Biotin Streptavidin can be Reversibly Rroken Using Water at Elevated Temperatures. Electrophoresis 2005;26(3):501-510.

  15. Chivers C E, Koner A L, Lowe E D, Howarth M. How the Biotin Streptavidin Interaction was made even Stronger: Investigation via Crystallography and a Chimaeric Tetramer. Biochem J 2011;435(1):55-63.

  16. Cinquanta L, Fontana D E, Bizzaro N. Chemiluminescent Immunoassay Technology: What does it Change in Autoantibody Detection?. Auto Immun Highlights 2017;8(1):9.

  17. Liu L, Qin F, Wang J et al. Development and Evaluation of 4G Autoimmune ANA Panel on the Automated Immunoassay BIOCLIA®-1200 Analyzer.10th INTERNATIONAL CONGRESS ON AUTOIMMUNITY, April 2016, Leipzig, Germany.

  18. chuursA H, van Weemen B K. Enzyme-Immunoassay: a Powerful Analytical Tool. J Immunoassay 1980;1(2):229–249.

  19. Saloga J, Klimek L, Buhl R, Mann Wolf, Knop J. Allergologie-Handbuch: Grundlagen und klinische Praxis. Schattauer 2006;213-15.

  20. Watson P F, Petrie A. Method agreement analysis: A rewiev of correct methodology. Theriogenology 73 2010; 1167-1179.

  21. Landis J R, Koch G G. The Measurement of Observer Agreement for Categorial Data. Biometrics 1977; 33(1):159-174.


  23. Bentow C, Lakos G, Martis P, Wahl E, Garcia M, Viñas O et al. International Multi-Center Evaluation of a Novel Chemiluminescence Assay for the Detection of Anti-dsDNA Antibodies. Lupus 2016;25(8):864-872.

  24. Gujral N, Freeman H J, Thomson A BR. Celiac disease: Prevalence, diagnosis, pathogenesis and treatment. World J Gastroenterol 2012;18(42):6036-6059.

  25. Schulte-Pelkum J, Radice A, Norman G L, Hoyos M L, Lakos G, Buchner C et al. Novel Clinical and Diagnostic Aspects of Antineutrophil Cytoplasmic Antibodies. J Immunol Res 2014;2014:185416.


  27. Data form ThermoFisher Scientific, Phadia AB, Rapsatan 7P, P.O. Box 6460, SE-751 37 Uppsala, Sweden

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