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Updated: Aug 8, 2026

Anti-Nuclear Antibody Screening Using HEp-2 Cells
Published on: June 24, 2014
[An immunoenzymatic technique for the detection of antinuclear antibodies]
H Meriche1, S Meriche-Gadiri, M Ghaffor
1Service d'immunologie, Institut Pasteur, 2, rue du Docteur-Laveran, Alger, Algérie.
Insights
A new immunoenzymatic assay (ANA-EIA) effectively screens for anti-nuclear antibodies (ANA). This test demonstrates high sensitivity and specificity, comparable to the indirect immunofluorescent assay (IFA).
Area of Science:
- Immunology
- Clinical Chemistry
- Diagnostic Assays
Background:
- Anti-nuclear antibodies (ANA) are critical biomarkers for diagnosing autoimmune rheumatic diseases.
- The indirect immunofluorescent assay (IFA) is a standard method for ANA detection but can be labor-intensive.
- There is a need for efficient and reliable ANA screening methods in clinical laboratories.
Purpose of the Study:
- To develop and evaluate a novel immunoenzymatic assay (ANA-EIA) for detecting anti-nuclear antibodies (ANA).
- To compare the performance of the ANA-EIA test against the established indirect immunofluorescent assay (IFA).
Main Methods:
- Development of a simple sandwich-format, heterogeneous-phase immunoenzymatic assay (ANA-EIA).
- Testing of 292 sera from patients with rheumatic diseases and 40 sera from healthy individuals.
- Comparative analysis of ANA-EIA results with those obtained from IFA.
Main Results:
- The ANA-EIA test achieved a sensitivity of 97% and a specificity of 96%.
- Global concordance between ANA-EIA and IFA was 96.6%, with a discordance rate of 3.4%.
- Excellent agreement was observed for homogeneous, speckled, and nucleolar ANA patterns; cytoplasmic patterns require further investigation.
Conclusions:
- The ANA-EIA test is a highly sensitive and specific method for ANA screening.
- Its ease of use and analytical performance make it suitable for routine application in immunopathology laboratories.
- ANA-EIA offers a reliable alternative to IFA for ANA detection in clinical settings.
Abstract:
In the present work, we propose, for the detection of the anti-nuclear antibodies (ANA) an immunoenzymatic test in simple sandwich in heterogeneous phase (ANA-EIA) allowing the screening of the antinuclear antibodies, and its assessment in comparison with the indirect immunofluorescent assay (IFA) for 292 sera of patients affected by rheumatic diseases and 40 sera of individuals presenting no pathology. The ANA-EIA test proved to have a sensitivity of 97% and a specificity of 96%. Moreover, it gives a global concordance of 96.6% and a discordance of 3.4% compared to IFA. Also, the analysis of correlation between this test and IFA for the positive individual gives a very good concordance according to homogeneous, speckled and nucleolar aspects. On the other hand, the results obtained for cytoplasmic aspect (74%), although acceptable, needs to be confirmed a second time with a more important sampling. According to the results obtained, this test could have an interesting routine application in laboratory of immunopathology given its analytic characteristics similar to those of IFA, and its great easiness of realisation.
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