ArticleFrontiers in immunology2025
Is there an alternative to the indirect immunofluorescence ANA HEp-2 assay for the diagnosis of connective tissue diseases?
Article in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Anti-nuclear antibodies (ANA) are serological hallmarks in the diagnosis of ANA-associated rheumatic diseases (AARD). For many years, indirect immunofluorescence (IIF) on HEp-2 cell substrate has been regarded as the gold standard method for ANA detection. Nowadays, several solid phase immunoassays (SPA) have been developed for ANA screening. The aim of this study was to evaluate three automated assays as potential alternatives to the IIF HEp-2 assay for ANA detection in the diagnosis of AARD. Patients and methods: This study included 271 patients referred to our department for routine ANA testing: 94 patients with confirmed AARD, 144 in whom AARD was excluded and 33 with an uncertain AARD diagnosis. For all sera, ANA detection was initially performed using an IIF HEp-2 assay (EUROIMMUN Results: The highest positivity rate was found with the MAGLUMI in the AARD group, with the highest concordance rate with IIF (77.9% Conclusion: These findings suggest that SPA can serve as a complementary approach to IIF for ANA screening in the diagnosis of AARD. The MAGLUMI assay could be used for initial screening alongside IIF, depending on the clinical context. A proper adjustment of the threshold of the MAGLUMI ANA Screen assay may improve its specificity and limit false positive results.
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