Variation in antinuclear antibody detection: need for clear expectations and additional studies

Antinuclear antibodies by indirect immunofluorescence and solid phase assays

“…Pisetsky et al recently reported substantial variability between two antinuclear antibodies (ANA) indirect immunofluorescence (IIF) assays as well as one solid-phase assay (SPA) from different manufacturers in a study of a cross-sectional cohort of systemic lupus erythematosus (SLE) patients 1. This publication triggered several responses related to the performance of IIF for ANA detection 2–6. Bizzaro questioned whether ANA testing by IIF can be replaced by SPAs for the diagnosis of ANA-associated rheumatic disorders (AARD) 7.…”

ANA testing in ‘real life’

“…The recent article by Pisetsky et al 1 showing data derived from a comparison of different antinuclear antibody (ANA) assays in a cohort of patients with established systemic lupus erythematosus highlighted the critical issue of ANA detection. With great interest, we read the correspondence by van Hoovels et al 2 describing variation in ANA detection by automated indirect immunofluorescence (IIF) analysis and the following letter from Mahler and Auza on the strong need for ANA testing standardisation 3. Nowadays, the IIF on human epithelial cells (HEp-2) is considered the gold standard for ANA testing, but biological and non-biological issues limiting the IIF test are not currently adequately clarified in study literature.…”