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The paper by Pisetsky et al 1 has stimulated a timely and interesting debate on a focal point in the diagnosis of autoimmune rheumatic diseases, that is, the accuracy of the antinuclear antibody (ANA) test and the reliability of the results provided by this test. The data produced by Pisetsky et al once more demonstrate the poor standardisation of the ANA assay when performed by the indirect immunofluorescence (IIF) method and the enormous difference that exists between different ANA-IIF kits. However, issues are related to intermethods variability and to the intrinsic limitations of the IIF method. Whatever title is chosen, it entails either a relevant loss of diagnostic specificity or sensitivity. This raises the question of whether IIF on HEp-2 cell substrates should be still considered the gold standard for ANA detection as stated almost 10 years ago by the American College of Rheumatology (ACR). The reasons that led the ACR to take this position were related to the insufficient diagnostic sensitivity of emerging alternative methods to IIF. These alternative methods, which were then almost exclusively made up of immunoenzymatic assays (ELISA), were spreading in clinical laboratories as substitutes of the manual IIF method to overcome known IIF limitations and for their higher throughput. …
Handling editor Josef S Smolen
Contributors NB is the sole author of the article.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests The author has received speaker honoraria from Thermo Fisher and Werfen.
Patient consent Not required.
Provenance and peer review Not commissioned; internally peer reviewed.
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