Synonyms

   ANA IFA, LE (Lupus Erythematosus) Prep

Clinical Significance

   It is useful for : Evaluation of patients suspected of having systemic autoimmune rheumatic disease (ANA-associated rheumatic diseases or connective tissue disease) or organ-specific autoimmune diseases such as autoimmune liver diseases.

Specimen

   Serum

Stability

   Refrigerated (preferred) : 21 days

   Frozen : 28 days

Reference Range

   Negative

Interpretation

   The diagnosis of ANA-associated rheumatic diseases is usually based on a set of criteria of which the presence on anticellular antibody or specific associated antibodies may be components. Of all ANA-associated rheumatic diseases, the presence of anticellular antibody is considered mandatory entry criterion by the 2019 European League Against Rheumatism and the American College of Rheumatology classification criteria for SLE.(7) Since cytoplasmic staining patterns may be reported as "ANA negative" or as a comment with no quantitative or titer result, some patients with clinicopathological symptoms consistent with neuropsychiatric SLE would not qualify for entry based on where testing is performed.(8-10) This limitation may therefore exclude patients who may meet the clinical and other laboratory criteria for disease but are not reported as "ANA positive" due to the use of the current terminology. In an international inception cohort of newly diagnosed SLE patients, 6.2% were anticellular antibody-negative with 1.5% testing positive for isolated cytoplasmic or mitotic pattern.

   Autoimmune disorders can be difficult to diagnose and patients may find it helpful to work with a rheumatologist in addition to their primary care physician when interpreting results from an ANA test. Rheumatologists are specialists that focus on autoimmune disorders and conditions of the muscles, joints, and bones. Rheumatologists are able to answer questions about autoimmune disorders and interpret ANA test results.

Limitation

   Some patients without clinical evidence of systemic autoimmune rheumatic disease (SARD) maybe positive for anticellular antibody. This occurs at variable prevalence depending on the patient demographics. A positive result may also precede clinical manifestation of SARD or be associated with some viral or chronic infections, cancers, or use of certain medications. All results must be reported in the appropriate clinical context as the performance of the test can be variable.