International Journal of Medical Laboratory Research (IJMLR)

CONCORDANCE OF THE ANALYTICAL PERFORMANCE OF AUTOIMMUNE ANTIBODIES ON THE HOB BIOCLIA® 6500 AUTOMATED IMMUNOASSAY ANALYZER TO THE PHADIA® 250 SYSTEM

​

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

 

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.

 

KEY WORDS: Chemiluminescentimmuno assay (CLIA); Automated autoimmune analyser; Autoimmune diseases (AD); HOB BioCLIA® 6500; Cohen’s Kappa (κ) test; indirect fluorescence test (IFT); celiac disease

​

REFERENCES:

1. https://www.statista.com/statistics/418328/diagnosed-autoimmune-conditions-prevalence-in-selected-countries/

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

3. Website:http://www.europarl.europa.eu/ cmsdata/133620/ENVI%202017-09%20WS%20Autoimmune%20diseases%20%20PE% 20614.174%20(Publication).pdf 

4. Jeong S, Hwang H, Roh J, Shim J E, Kim J, Kim G-T, Tag H-S, Kim H-S. 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;2018:1-12.

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

6. Solomon 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

7. 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.

8. 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.

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

10. Website:http://www.phadia.com/en/ Products/Phadia-Laboratory-Systems/Phadia-250/

11. Website:http://www.phadia.com/en-GB/5/Autoimmunity-Tests/Test-Principle-ImmunoCAP-Specific-IgA/

12. Watson P F, Petrie A. Method agreement analysis: A rewiev of correct methodology. Theriogenology 2010;73,9:1167-1179

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

14. Bentow C, Lakos G, Martis P, Wahl E, Garcia M, Viñas O, Espinosa G, Cervera R, Sjöwall C, Carmona-Fernandes D, Santos M J, Hanly J G, Mahler M. International Multi-Center Evaluation of a Novel Chemiluminescence Assay for the Detection of Anti-dsDNA Antibodies. Lupus 2016;25,8:864-872.

15. http://www.phadia.com/Global/A%20Document%20Library/Autoimmunity/Promotion%20Material/Product%20%20Peformance%20%20Detailer%20Info/Performance_Folder_EliA_ANA_Diff.pdf

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

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

 To cite this article:

Knies C, Olivo M ,Tönnies R, von Landenberg P. Concordance of the analytical performance of autoimmune antibodies on the hob bioclia® 6500 automated immunoassay analyzer to the phadia® 250 system. Int. J. Med. Lab. Res. 2020; 5,3:1-11.  http://doi.org/10.35503/IJMLR.2020.5301