Yonsei Med J.  2020 Jan;61(1):73-78. 10.3349/ymj.2020.61.1.73.

Detection of Anti-Extractable Nuclear Antigens in Patients with Systemic Rheumatic Disease via Fluorescence Enzyme Immunoassay and Its Clinical Utility

Affiliations
  • 1Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea. kimhs54@yuhs.ac

Abstract

PURPOSE
Testing for autoantibodies to extractable nuclear antigens (ENAs) plays an important role in the diagnosis and management of systemic rheumatic disease. Currently, no gold standard tests are available for detecting anti-ENAs. To address this gap, we aimed to identify an assay that exhibits satisfactory diagnostic performance in the detection of five common anti-ENAs by comparing two commonly used assays, an automated fluorescent enzyme immunoassay (FEIA) and a microplate ELISA assay.
MATERIALS AND METHODS
Sera from 100 patients with systemic rheumatic disease were collected and assayed with FEIA and microplate ELISA to detect anti-ENAs. Statistical analyses were performed to check the agreement rate between the two platforms using kappa coefficients. Analytical sensitivity and specificity for each assay were calculated.
RESULTS
The concordance rates between ELISA and FEIA ranged from 89% for anti-RNP to 97% for anti-Scl-70, and the kappa coefficients of the two assays were in the range of 0.44 to 0.82. Between the two assays, a significant difference in sensitivity and specificity was seen only for anti-Sm and anti-RNP, respectively.
CONCLUSION
In this study, FEIA and ELISA showed comparable efficiency for detecting anti-ENAs.

Keyword

Anti-ENA antibody; rheumatoid arthritis; systemic lupus erythematosus; enzyme-linked immunosorbent assay

MeSH Terms

Antigens, Nuclear*
Arthritis, Rheumatoid
Autoantibodies
Diagnosis
Enzyme-Linked Immunosorbent Assay
Fluorescence*
Humans
Immunoenzyme Techniques*
Lupus Erythematosus, Systemic
Rheumatic Diseases*
Sensitivity and Specificity
Antigens, Nuclear
Autoantibodies

Figure

  • Fig. 1 Spearman's correlation plots of results from INOVA and Phadia® 250 for the five anti-ENAs. (A) anti-SS-A/Ro, (B) anti-SS-B/La, (C) anti-RNP, (D) anti-Sm, and (E) anti-Scl-70. ENAs, extractable nuclear antigens.


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