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Test Code ENAE Antibody to Extractable Nuclear Antigen Evaluation, Serum

Reporting Name

Ab to Extractable Nuclear Ag Eval,S

Useful For

Evaluating patients with clinical features suggestive of antinuclear antibody (ANA) associated connective tissue disease. May also be indicated in patients who test negative for ANA and have features of Sjogren syndrome and idiopathic inflammatory myopathies

Profile Information

Test ID Reporting Name Available Separately Always Performed
SSA SS-A/Ro Ab, IgG, S Yes Yes
SSB SS-B/La Ab, IgG, S Yes Yes
SM Sm Ab, IgG, S Yes Yes
RNP RNP Ab, IgG, S Yes Yes
SCL70 Scl 70 Ab, IgG, S Yes Yes
JO1 Jo 1 Ab, IgG, S Yes Yes

Testing Algorithm

For more information see Connective Tissue Disease Cascade.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.35 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Special Instructions

Reference Values

SS-A/Ro ANTIBODIES, IgG

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

 

SS-B/La ANTIBODIES, IgG

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

 

Sm ANTIBODIES, IgG

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

 

RNP ANTIBODIES, IgG

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

 

Scl 70 ANTIBODIES, IgG

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

 

Jo 1 ANTIBODIES, IgG

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

Day(s) Performed

Monday through Saturday

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86235 x 6

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ENAE Ab to Extractable Nuclear Ag Eval,S 90228-8

 

Result ID Test Result Name Result LOINC Value
JO1 Jo 1 Ab, IgG, S 33571-1
RNP RNP Ab, IgG, S 29958-6
SCL70 Scl 70 Ab, IgG, S 47322-3
SM Sm Ab, IgG, S 18323-6
SSA SS-A/Ro Ab, IgG, S 33610-7
SSB SS-B/La Ab, IgG, S 33613-1

Clinical Information

Antibodies to SS-A/Ro, SS-B/La, Smith (Sm), U1RNP (RNP68/A), Scl 70 and JO1 are associated with the presence of antinuclear antibodies (ANA) and useful in the evaluation of specific ANA-associated connective tissue diseases (CTD), ANA-CTD.(1) Due to their frequencies in ANA-CTD and the overlapping clinical presentations of these diseases, inclusion of these tests in a panel may be useful at initial evaluation of patients at-risk for certain CTD. The combined presence of antibodies to SS-A/Ro (Ro52 and Ro60) and anti-SS-B/La is highly suggestive of Sjogren syndrome.(2,3) Separate determination of anti-Ro52 and anti-Ro60 antibodies is preferred to combined SS-A/Ro in the evaluation of ANA-CTD as their differential presence maybe useful in risk stratification and prognosis of ANA-CTD patients.(4) The presence of anti-Sm antibodies are specific for systemic lupus erythematosus (SLE) and is included the classification criteria for disease.(5) Monospecific antibody reactivity to U1RNP may indicate a diagnosis of mixed connective tissue disease (MCTD).(6) However, anti-U1RNP antibodies may also be seen in patients with SLE, systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM).(6,7) In addition, there exists diverse analytes for the detection U1RNP with differential correlations with MCTD, SLE, SSc, and IIM.(8) Anti-Scl 70 (topoisomerase 1) antibody is one of three autoantibodies included in the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for SSc.(9). It is generally associated with diffuse cutaneous SSc clinical manifestations including interstitial lung disease with poor prognostic outcomes.(10) Lastly, antibodies to JO1, is a member of the amino acyl-tRNA synthetase family of enzymes is suggestive of diagnosis of IIM, specifically anti-synthetase syndrome and is included in the 2017 EULAR/ACR classification for IIM.(11)

 

For more information, see the individual test codes.

Interpretation

A positive antibody result in the appropriate clinical context maybe suggestive of connective tissue disease.

 

For more information, see the individual test codes.

Report Available

Same day/1 to 2 days

Specimen Retention Time

14 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat-Treated Reject

Method Name

Multiplex Flow Immunoassay