Evaluation of the automated indirect immunofluorescence test for anti-dsDNA antibodies

Clin Chim Acta. 2019 Nov:498:143-147. doi: 10.1016/j.cca.2019.08.018. Epub 2019 Aug 20.

Abstract

Background: Anti-dsDNA antibody is a specific antibody in systemic lupus erythematosus (SLE). Indirect immunofluorescence test (IIFT) is a highly specific method in detecting anti-dsDNA antibody. The application of automated system has gained better consistency than manual operation. This study detected anti-dsDNA antibodies using EUROPattern Computer-aided immunofluorescence microscopy (EPA), and evaluated the performance of the automated system.

Methods: The sera of 96 patients with suspected SLE and 102 control patients were examined using IIFT. The consistency between the EPA and manual reading was analyzed.

Results: Analysis of 198 samples showed that the overall consistency of the negative/positive results between the EPA and manual reading was 94.95%. Based on the manual reading results, the sensitivity and specificity of EPA were 95.70% and 94.29%, respectively. The analysis of 57 samples with non-specific fluorescence showed that the overall consistency of the negative/positive results was 96.49%. The analysis of the antibody titer of 89 positive samples showed that the consistency between the EPA and manual reading was 97.75%.

Conclusion: EPA was consistent with the manual reading with regard to qualitative reading and antibody titer. With low-exposure function, EPA could read samples with non-specific fluorescence. EPA was superior to manual reading in automation and standardization.

Keywords: Computer-aided immunofluorescence microscopy; EUROPattern suite; Indirect immunofluorescence test; dsDNA.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Antinuclear / blood*
  • Automation
  • Case-Control Studies
  • Fluorescent Antibody Technique, Indirect / methods*
  • Fluorescent Antibody Technique, Indirect / standards
  • Humans
  • Lupus Erythematosus, Systemic / diagnosis*
  • Microscopy, Fluorescence / methods*
  • Microscopy, Fluorescence / standards
  • Reference Standards
  • Sensitivity and Specificity

Substances

  • Antibodies, Antinuclear