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Test Code ENAP or LAB2165 Extractable Nuclear Antibody (ENA) Panel w/reflex if indicated, Serum

Important Note

Please note:

  • For initial screening, the Connective Tissue Disease Cascade is recommended. 
  • For monitoring of previously positive tests within this panel, it is recommended to order the individual test and not this panel.
  • This ENA panel does not include a dsDNA. Please order DSDNA separately if this test is desired.
  • This test panel includes an automated algorithmic interpretation based upon the individual tests in this panel and the dsDNA result.  If all of the non dsDNA test results are negative, but the interpretation is positive (abnormal), a dsDNA will be reflex ordered to better understand the interpretation. 

Profile Information

Test ID Reporting Name Available Separately? Always Performed?
ACHROM Chromatin Antibody Y Y
ARIBOP Ribosomal P Antibody Y Y
ROSSA RO (SSA) Antibody Y Y
LASSB LA (SSB) Antibody Y Y
ACEN Centromere B Antibody Y Y
SMITH SM (SMITH) Antibody Y Y
ASMRNP Smith RNP Antibody Y Y
ARNP RNP Antibody Y Y
SCL70 SCL-70 Antibody Y Y
JO1 JO-1 Antibody Y Y

Specimen Requirements

Container Type:

Optimal: Gold

Acceptable: Red 

 

Optimal Collection Volume: 

4.5mL; full tube

Minimum Volume:

2 mL

Collection Instructions:

Gently invert the sample 5-6 times after collection.

Specimen Transport:

Refrigerate

Processing Instructions: 

1. Allow the specimen to clot for 30 minutes.

2. Centrifuge specimen within 2 hours of collection.

3. After centrifugation, specimen tubes without a gel barrier should have the serum aliquoted to a false bottom container.

4. Keep serum refrigerated until testing can be performed.

Specimen Stability

Specimen Type Temperature Time
Serum Refrigerated 7 days
Room Temperature 8 hours

Specimen Rejection Criteria

Hemolysis Mild OK; Moderate OK; Gross Reject
Lipemia Mild OK; Moderate OK; Gross Reject
Icterus Mild OK; Moderate OK; Gross Reject
Other Quantity not sufficient

Useful For

Evaluating patients for systemic autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren’s Syndrome (SS), Scleroderma (Systemic Sclerosis), and Polymyositis.

Methodology

Bio-Rad BioPlex 2200: Multiplex flow immunoassay

Reference Ranges

Test ID Reference Range and Reporting Units
ACHROM Negative: < 1.0 AI
ARIBOP Negative: < 1.0 AI
ROSSA Negative: < 1.0 AI
LASSB Negative: < 1.0 AI
ACEN Negative: < 1.0 AI
SMITH Negative: < 1.0 AI
ASMRNP Negative: < 1.0 AI
ARNP Negative: < 1.0 AI
SCL70 Negative: < 1.0 AI
JO1 Negative: < 1.0 AI

AI = Antibody Index

 

The ENA Panel also includes an interpretative comment generated by the BioPlex 2200 Medical Decision Support Software (MDSS) that associates patient antibody results with predefined MDSS profiles correlated with the following systemic autoimmune diseases: Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren’s Syndrome (SS), Scleroderma (Systemic Sclerosis) and Polymyositis.

Interpretive

Connective tissue diseases (CTDs) are a heterogeneous group of systemic autoimmune diseases characterized by abnormal structure or function of 1 or more connective tissue elements (ie, collagen, elastin, or mucopolysaccharides). Differential diagnosis of CTDs is mainly based on clinical findings but is complicated by the similarity of their symptoms. Therefore, antibodies to extractable nuclear antigens are useful markers for diagnosing or excluding CTDs.

 

The most prominent CTDs are systemic lupus erythematosus (SLE)—potentially affecting all organs; Sjogren’s Syndrome (SS)—characterized by diminished lacrimal and salivary gland secretions; scleroderma (systemic sclerosis [SSc])—a chronic, progressive dermatosis; limited systemic sclerosis—scleroderma also known as CREST syndrome with a more benign disease course; poly-dermatomyositis (PM/DM)—an acute or chronic inflammatory disease of muscle and skin; and mixed connective tissue disease (MCTD)—a syndrome with features of scleroderma, rheumatoid arthritis, SLE, and PM/DM.

 

Additional information can be found by clicking on the Connect Tissue Disease Cascade Algorithm link, found under the Resources section on the left-hand side of this page.

 

In the rare occurence when an ENA panel screen results as positive with all ENA panel analytes resulting as negative, a DSDNA is reflex ordered. The DSDNA is a part of the ANA panel within the analyzer, which is what causes the ENA panel screen to be resulted as positive. This is included for additional diagnostic purposes only. 

Day(s) Performed

Monday through Friday

Expected TAT

Same day or 1-2 days

Performing Laboratory

Bronson Laboratory, Chemistry - Kalamazoo

Sample Retention Time

7 days

CPT Code

86235