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Anti-ENA6 Plus DFS70Ab Profile

CPT: 83516; 86235(x6)
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Synonyms

  • Anti-Extractable Nuclear Antigens (ENA) 6 Plus Anti-Dense Fine Speckled 70 Antibodies Profile

Test Includes

Anti-DFS70; Anti-Sm; Anti-U1 RNP; Anti-Ro (SS-A); Anti-La (SS-B); Anti-Scl-70; Anti-Jo-1


Expected Turnaround Time

10 - 12 days



Specimen Requirements


Specimen

Serum


Volume

3 mL


Minimum Volume

1.5 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or gel-barrier tube


Collection

Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping.


Storage Instructions

Refrigerate.


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

14 days

Frozen

60 days

Freeze/thaw cycles

Stable x1


Causes for Rejection

Grossly hemolyzed; bacterial contamination; lipemic, icteric, non-serum specimen types


Test Details


Use

Anti-ENA6 Plus DFS70 is designed to facilitate the proper triage of patients with positive Anti-Nuclear Antibodies (ANA) by identifying those most likely to benefit from a rheumatology specialist. It detects the novel Anti-DFS70 along with 6 other clinically useful autoantibodies to ENA, which may help identify systemic lupus erythematous (SLE), mixed connective tissue disease (MCTD), Sjogren's, systemic sclerosis, and idiopathic inflammatory myopathy (IIM). Positive Anti-DFS70 antibodies in isolation may help identify individuals who do not have an AARD (ANA-associated rheumatic disease), especially in the absence of significant clinical findings.

Anti-DFS70 Abs confer a likelihood ratio for the absence of systemic autoimmune rheumatic disease of 10.9 and are detectable in 2% to 22% of healthy individuals and in less than 1% of patients with AARD.


Limitations

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


Methodology

See individual test components.


References

Conrad K, Röber N, Andrade LE, Mahler M. The Clinical Relevance of Anti-DFS70 Autoantibodies. Clin Rev Allergy Immunol. 2017 Apr;52(2):202-216.27350273
Fitch-Rogalsky C, Steber W, Mahler M, et al. Clinical and Serological Features of Patients Referred through a Rheumatology Triage System because of Positive Antinuclear Antibodies. PLoS One. 2014 Apr 4;9(4):e93812.24705829

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
520301 Anti-ENA6 Plus DFS70Ab Profile 520316 Anti-DFS70 Ab Units 95129-3
520301 Anti-ENA6 Plus DFS70Ab Profile 520216 Anti-Sm Ab (RDL) Units 11090-8
520301 Anti-ENA6 Plus DFS70Ab Profile 520217 Anti-U1 RNP Ab (RDL) Units 57662-9
520301 Anti-ENA6 Plus DFS70Ab Profile 520218 Anti-Ro (SS-A) Ab (RDL) Units 33569-5
520301 Anti-ENA6 Plus DFS70Ab Profile 520225 Anti-La (SS-B) Ab (RDL) Units 45142-7
520301 Anti-ENA6 Plus DFS70Ab Profile 520221 Anti-Scl-70 Ab (RDL) Units 26975-3
520301 Anti-ENA6 Plus DFS70Ab Profile 520259 Anti-Jo-1 Ab (RDL) Units 35333-4
Reflex Table for Anti-Scl-70 Ab (RDL)
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 520043 Confirmatory Anti Scl-70 520043 Confirmatory Anti Scl-70 8092-9

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