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Test Code FACN1 Anti-cN-1A (NT5c1A) IBM


Specimen Required


Collection Container/Tube: Red

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Acceptable: SST

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube is acceptable. Spin down and send 2 mL of serum refrigerated in a plastic vial.


Method Name

Enzyme-linked immunosorbent assay (ELISA)

Reporting Name

Anti-cN-1A (NT5c1A) IBM

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL (volume does NOT allow for repeat testing)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  60 days
  Ambient  7 days

Reject Due To

Gross hemolysis: Reject
Thawing: Warm OK; Cold OK
Gross lipemia: Reject
Gross icterus Reject
Other: Anything other than serum ; bacterial contamination

Clinical Information

Anti-cN-1A autoantibodies in idiopathic inflammatory myopathy (IIM) patients appear to be disease-specific for sporadic Inclusion Body Myositis (sIBM) and are rarely detected in other autoimmune conditions. Anti-cN-1A autoantibodies have a moderate sensitivity, but their high specificity for sIBM may be helpful in the diagnosis of this infrequent and difficult-to-diagnose myopathy. This assay can augment and accelerate the suspected diagnosis of sIBM using sera where muscle biopsy is delayed and/or unfeasible.

Reference Values

Reference Range:          <20

 

Interpretation: 

Negative:                      <20 units

Weak Positive:              20 - 39 units

Moderate Positive:        40 - 80 units

Strong Positive:            >80 units

Performing Laboratory

Esoterix Endocrinology

Test Classification

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.

CPT Code Information

83516

Day(s) Performed

Varies; 1-2 days per week

Report Available

9-14 days