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Variation in antinuclear antibody detection: need for clear expectations and additional studies
  1. Michael Mahler,
  2. Carolina Auza
  1. Inova Diagnostics Inc., San Diego, California, USA
  1. Correspondence to Dr Michael Mahler, Inova Diagnostics Inc., San Diego, CA 32131-1638, USA; mmahler{at}

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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 triggered significant discussions among experts in ANA testing. In this context, we read with interest the correspondence by van Hoovels et al 2 describing variation in ANA detection by automated indirect immunofluorescence (IIF) analysis. The data presented showed significant variation between manufacturers and also between laboratories and even within the same laboratory, which raised concerns. The majority of laboratories (n=12) used NOVA View (Inova Diagnostics), followed by G-Sight (Menarini, n=9; split into HEp-2 and HEp-2000) and Image Navigator (ImmunoConcepts, n=2).

A similar study has been conducted as part of the regulatory clearance of the NOVA View system, which showed significantly higher consistency. In addition, van Hoovels et al 2 had previously performed a similar study that also reported variability higher than expected.3 However, in this study, the variability could be improved by …

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  • Contributors Both authors contributed to content of the correspondence.

  • Competing interests MM and CA are employees of a diagnostic company. One of the products discussed in the article by van Hoovels is from Inova Diagnostics.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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