Methodology of Testing for Antinuclear Antibodies (ACR Position Statement)

ACR position statement supporting immunofluorescence ANA on HEp-2 as the gold standard, requiring labs using solid-phase alternatives to demonstrate comparable/improved sensitivity, and advising against indiscriminate ANA subserology panels. Candidate notes: ACR supports immunofluorescence ANA using HEp-2 substrate as the gold standard for ANA testing. Labs using bead-based multiplex or other solid-phase ANA assays must provide data that the alternative has the same or improved sensitivity compared with IF ANA. Laboratories should specify the methods used when reporting ANA results. IF ANA with history/physical identifies almost all SLE patients (sensitivity over 95%) but specificity vs related rheumatic disorders is only about 57% (cited). Document cites IF ANA sensitivities for SSc (~85%), PM/DM (~61%), primary Sjogren (~48%), JIA (~57%), drug-induced lupus (~100%), MCTD (~100%). Providers should avoid ordering panels of ANA subserologies when not indicated; select specific subserologies based on signs/symptoms and high pretest suspicion. Limits noted in the record: Hosted PDF mirror of ACR statement (approved 2009-2015 revisions); official rheumatology.org PDF fetch returned non-PDF HTML in this run. A positive ANA is not a diagnosis. Claims in this record are not verified.

A positive ANA is not a diagnosis. Claims in this record are not verified.

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