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Related Experiment Videos

Multicenter evaluation study on a new HEp2 ANA screening enzyme immune assay.

P M Bayer1, S Bauerfeind, J Bienvenu

  • 1Zentrallabor Wilhelminenspital, Vienna, Austria.

Journal of Autoimmunity
|August 11, 1999
PubMed
Summary

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The COBAS Core HEp2 ANA enzyme immune assay (EIA) shows good precision for detecting antinuclear antibodies (ANA). While it agrees well with indirect immunofluorescence assay (IFA) in many autoimmune diseases, it may miss some antibodies detected by IFA.

Area of Science:

  • Immunology
  • Clinical Chemistry
  • Autoimmune Diseases

Background:

  • Antinuclear antibodies (ANA) are key biomarkers for autoimmune diseases.
  • Indirect immunofluorescence assay (IFA) is a standard method for ANA detection.
  • Enzyme immune assays (EIAs) offer potential for standardized ANA testing.

Purpose of the Study:

  • To evaluate the performance of the COBAS Core HEp2 ANA enzyme immune assay (EIA).
  • To compare the COBAS Core EIA with the indirect immunofluorescence assay (IFA) for ANA detection.
  • To assess the clinical utility of the COBAS Core EIA in various autoimmune conditions.

Main Methods:

  • Precision study evaluating intra-assay and inter-assay coefficients of variation (CVs) for the COBAS Core EIA.
  • Clinical sample study comparing COBAS Core EIA results against HEp2-cell IFA.

Related Experiment Videos

  • Evaluation of sera from patients with systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and dermato/polymyositis.

    • Main Results:

    • COBAS Core EIA demonstrated good precision with intra-assay CVs mostly below 9% and inter-assay CVs between 4.7% and 10.4%.
    • Good agreement between COBAS Core EIA and IFA was observed in healthy subjects and patients with systemic lupus erythematosus, mixed connective tissue disease, and rheumatoid arthritis.
    • Lower positive rates were observed with COBAS Core EIA in Sjögren's syndrome and scleroderma patients compared to IFA, potentially due to differences in detectable autoantibodies.
    • Discrepancies in dermato/polymyositis were linked to the EIA's focus on nuclear antigens and limited detection of cytoplasmic antibodies like Jo1.

    Conclusions:

    • The COBAS Core HEp2 ANA EIA exhibits acceptable precision and good agreement with IFA for certain autoimmune diseases.
    • The EIA may underdetect specific autoantibodies identifiable by IFA, particularly in conditions like Sjögren's syndrome and scleroderma.
    • Clinical performance varied between reference centers and unselected populations, highlighting the need for careful interpretation in diverse patient groups.