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Epic Code LAB1230491 ANA Screen

Important Note

Ordering Recommendation:

Initial ANA screen for autoimmune connective tissue diseases.

Test Name Alias

ANA | Antinuclear Antibody | ANA Screen Double Reflex | ENA | Extractable Nuclear Antigens | ANA Screen Double Reflex | 184 | ANA (Antinuclear Antibodies) Screen, Double Reflex to ANA IFA Hep2 Titer and Pattern, and if positive to ANA antibodies | ANA Screen w/reflex

Interface Order Alias

1230491

Clinical Information

Initial ANA screen for autoimmune connective tissue diseases.

  1. The initial ANA screen if positive will reflex to a confirmatory ANA Hep2 IFA slide.
  2. The Hep2 slide patterns reported include Homogeneous, Speckled, Nucleolar, Centromere, and SSA Ro to a titer of 1:80 through 1:1280. All positive results are reported with endpoint titers.
  3. If the ANA Hep2 titer is ≥ 1:160 the following individual antinuclear antibodies will reflex.     *Antibodies to: dsDNA, Smith, RNP, SSA, SSB, Scl 70, Centromere and Jo 1.

*Individual ANA antibodies reflexed at a titer of 1:160 due to more clinical significance.

 

ANA (antinuclear antibodies) occur in patients with a variety of autoimmune diseases, both systemic and organ-specific. They are particularly common in systemic rheumatic diseases, which include lupus erythematosus (LE), discoid LE, drug-induced LE, mixed connective tissue disease, Sjogren syndrome, scleroderma (systemic sclerosis), CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, telangiectasia) syndrome, polymyositis/dermatomyositis, and rheumatoid arthritis. 

 

The diagnosis of a systemic rheumatic disease is based primarily on the presence of compatible clinical signs and symptoms. The results of tests for autoantibodies including ANA and specific autoantibodies are ancillary. Additional diagnostic criteria include consistent histopathology or specific radiographic findings.

 

Some patients without clinical evidence of an autoimmune disease or a systemic rheumatic disease may have a detectable level of antinuclear antibody (ANA). This finding is more common in women than men and the frequency of detectable ANA in healthy women over 40 years of age may approach 15% to 20%. ANA may also be detectable following viral illnesses, in chronic infections, or in patients treated with many different medications.

Collection Instructions

Specimen Collection: Blood

Container(s): Gold Top (Serum Separator-SST Gel)

Preferred Volume to Collect: 5.0 mL

Minimum Volume to Collect: 2.5 mL

Neonate Volume to Collect: 2.5 mL

Capillary collect ok: Yes

Microtainer acceptable: Yes

Collection Instructions:

  • After collection, gently invert tube 8-10 times.
  • Specimen should be processed within 2 hours – See Processing Instructions.

Processing Instructions (Laboratory, Outpatient or Off-site collection)

Processed Specimen: Serum

Centrifuge/Spin: Yes

Aliquot: No

Processing Instructions:

  • Allow blood to clot for 30 minutes in a vertical position and centrifuge within 2 hours.

Transport Temperature: Refrigerate

Rejection Criteria

Specimen not centrifuged within 2 hours

Quantity not sufficient

Specimen Stability

Ambient: 8 hours

Refrigerate: 7 days

Frozen: aliquot serum for longer storage

Laboratory Retention: 7 days

Reflex Information

Reflex approved by Medical Executive Committee. Please see link: Reflex Testing Document

Test Frequency

Available M-F, usual TAT 1-3 days

Reference Range

ANA Screen: Negative

ANA Hep2 IFA:  <1:80

Anti-dsDNA: <5 IU/ml

Antibodies to SSA, SSB, Sm, RNP, Scl 70, centromere, Jo 1: Negative

Performing Department

Immunochemistry

Performing Department Laboratory Location

Corewell Health Reference Laboratory, Grand Rapids, MI

Methodology

Multiplex flow immunoassay with reflex to indirect immunofluorescence (IFA), HE-p2000 substrate if positive

CPT

86038

CDM Code

3028603802

Epic Test ID

1230102113

Reviewed Date

12/13/2022

Updated Date

1/26/2024 - Reference Range and Methodology