International Journal of Medical Laboratory Research (IJMLR)

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

 

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

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