Test Description

The ANA test is performed using specialized HEp-2 cells to detect autoantibodies associated with SLE, mixed connective tissue disorders, rheumatoid arthritis, progressive systemic sclerosis, Sjögren’s syndrome, dermatopolymyositis and chronic active immune hepatitis. These autoantibodies are primarily directed against the components of the nucleus. Specific staining patterns are identified and antibody titers are then determined. The pattern and titer of the antibody binding to these cells in conjunction with other symptoms provide help in rheumatic and other autoimmune disease diagnosis.

When should this test be ordered?
The ANA test is ordered for a variety of connective tissue disorders including lupus. Depending on the pattern of antibody binding it is possible to identify which is the likely antigen and also the autoimmune disease leading to the condition with significant specificity when used in conjunction with further ENA testing.
High Risk · Positive
Speckled Pattern: Associated with systemic lupus erythematosus (SLE), Sjögren syndrome, scleroderma, polymyositis, rheumatoid arthritis, and mixed connective tissue disease.
Nucleolar Pattern: Associated with scleroderma and systemic sclerosis (SSc), polymyositis, and dermatomyositis.
Homogeneous Pattern: Associated with systemic lupus erythematosus (SLE) and drug-induced lupus erythematosus.
Centromere Pattern: Associated with scleroderma and CREST (calcinosis, Raynaud syndrome, esophogeal dysmotility, sclerodactyly, and telangiectasia).
Speckled and Nucleolar Pattern: Associated with progressive systemic sclerosis.
Homogeneous and Speckled Pattern: Associated withsystemic lupus erythematosus (SLE), Sjögren syndrome, scleroderma, polymyositis, rheumatoid arthritis, and mixed connective tissue disease.
Peripheral Pattern: Associated with systemic lupus erythematosus (SLE) and drug-induced lupus erythematosus.
Peripheral and Centromere Pattern: Associated with systemic lupus erythematosus (SLE), Drug-induced lupus erythematosus, scleroderma and CREST.
Homogeneous and Nucleolar Pattern: Associated with systemic lupus erythematosus (SLE), drug-induced lupus erythematosus, scleroderma and systemic sclerosis (SSc), polymyositis, and dermatomyositis.
Borderline Risk ·
None determined for this test.
Low Risk · Negative
Within Range.
Testing Method Used
Immunofluorescence assay.

Sample is stable for 7 days at 2-8°C.

Please ship samples daily.
Improvements and Prevention
Physicians may select and prescribe medications specific to your diagnosis.
Symptoms can be alleviated by maintaining a healthy weight, physical therapy or strength enhancing exercises, reduce fatigue by getting adequate rest and sleep, and consuming an anti-inflammatory diet.
Specimen Type
Serum
Fasting Required
No, but may be ordered with tests that require fasting
Drawing and Processing
  1. Draw from a vein into a SST tubetube1
  2. Invert tube (do not shake) 1-2 times to mix adequately
  3. Let stand upright in tube rack for 30 minutes
  4. Centrifuge for 15 minutes at 3300rpm
  5. Do not leave at room temperature for more than 1 hour
  6. Keep cold in a refrigerator to maintain stability, until ready to ship
Shipping Instructions
  1. Freeze ice packs 24 hours prior to use
  2. Place ice packs inside the Styrofoam insulated kit
  3. Place processed tubes inside biohazard bag, place inside kit
  4. Seal box, print airbill and adhere to box and wait for courier to pick up
Rejection Criteria
QNS; temperature out of range upon receipt; grossly lipemic or hemolyzed; wrong specimen type; sample stability exceeded for this analyte; unlabeled or mislabeled specimen.
References

1. Scofield, RH (May 8, 2004). “Autoantibodies as predictors of disease”. Lancet 363 (9420): 1544–6.

2. Richardson, B; Epstein, WV (September 1981). “Utility of the fluorescent antinuclear antibody test in a single patient”. Annals of internal medicine 95 (3): 333–8

The information provided here is intended for educational purposes only and should not be used or substituted as medical advice. You should consult a healthcare practitioner regarding medical diagnosis or treatment.

* Vibrant™ Tests have been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.