Detection of Anti-Extractable Nuclear Antigens in Patients with Systemic Rheumatic Disease via Fluorescence Enzyme Immunoassay and Its Clinical Utility
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Purpose: Testing for autoantibodies to extractable nuclear antigens (ENAs) plays an important role in the diagnosis and managementof systemic rheumatic disease. Currently, no gold standard tests are available for detecting anti-ENAs. To address this gap, weaimed to identify an assay that exhibits satisfactory diagnostic performance in the detection of five common anti-ENAs by comparingtwo 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 microplateELISA to detect anti-ENAs. Statistical analyses were performed to check the agreement rate between the two platformsusing 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 coefficientsof the two assays were in the range of 0.44 to 0.82. Between the two assays, a significant difference in sensitivity and specificitywas seen only for anti-Sm and anti-RNP, respectively. Conclusion: In this study, FEIA and ELISA showed comparable efficiency for detecting anti-ENAs.
Abstract
Purpose: Testing for autoantibodies to extractable nuclear antigens (ENAs) plays an important role in the diagnosis and managementof systemic rheumatic disease. Currently, no gold standard tests are available for detecting anti-ENAs. To address this gap, weaimed to identify an assay that exhibits satisfactory diagnostic performance in the detection of five common anti-ENAs by comparingtwo 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 microplateELISA to detect anti-ENAs. Statistical analyses were performed to check the agreement rate between the two platformsusing 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 coefficientsof the two assays were in the range of 0.44 to 0.82. Between the two assays, a significant difference in sensitivity and specificitywas seen only for anti-Sm and anti-RNP, respectively. Conclusion: In this study, FEIA and ELISA showed comparable efficiency for detecting anti-ENAs.
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