Significant variability in autoantibody tests

Autoantibody testing is a key step in the diagnosis of many autoimmune diseases, including myositis. Against this backdrop, an international consortium of laboratories responsible for these tests has compared its practices and issued recommendations:

  • 15 laboratories (in Europe, North America, Australia and Japan) took part in this comparative study and tested 24 reference sera from quality control,
  • assay techniques may have been developed by the laboratory itself or may have used commercial kits,
  • there is considerable variability in results, even among laboratories using the same diagnostic kits,
  • discrepancies between laboratories exist for both myositis-specific antibodies (MSA) and myositis-associated antibodies (MAA).

The authors emphasise the urgent and pressing need to achieve the harmonisation sought by all stakeholders (clinicians, manufacturers of diagnostic kits and diagnostic laboratories).

 

Interlaboratory variability in laboratory testing and reporting of myositis autoantibodies. Harvey GR, Ashur I, Bossuyt X et al. J Autoimmun. 2026 Mar 20;160:103548.