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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

Interpretation

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

 

For more information, see the individual test codes.

Clinical Reference

1. Bossuyt X, De Langhe E, Borghi MO, Meroni PL. Understanding and interpreting antinuclear antibody tests in systemic rheumatic diseases. Nat Rev Rheumatol. 2020;16(12):715-726

2. Armagan B, Robinson SA, Bazoberry A, et al. Antibodies to both Ro52 and Ro60 for identifying Sjogren's syndrome patients best Suited for clinical trials of disease-modifying therapies. Arthritis Care Res (Hoboken). 2022;74(9):1559-1565

3. Deroo L, Achten H, De Boeck K, et al. The value of separate detection of anti-Ro52, anti-Ro60 and anti-SSB/La reactivities in relation to diagnosis and phenotypes in primary Sjogren's syndrome. Clin Exp Rheumatol. 2022;40(12):2310-1317

4. Lee AYS, Reed JH, Gordon TP. Anti-Ro60 and anti-Ro52/TRIM21: Two distinct autoantibodies in systemic autoimmune diseases. J Autoimmun. 2021;124:102724

5. Aringer M, Costenbader K, Daikh D, et al. 2019 European League against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Arthritis Rheumatol. 2019;71(9):1400-1412

6. Alarcon-Segovia D, Cardiel MH. Comparison between 3 diagnostic criteria for mixed connective tissue disease. Study of 593 patients. J Rheumatol. 1989;16(3):328-334

7. Hoffmann-Vold AM, Gunnarsson R, Garen T, Midtvedt O, Molberg O. Performance of the 2013 American College of Rheumatology/European League against rheumatism classification criteria for systemic sclerosis (SSc) in large, well-defined cohorts of SSc and mixed connective tissue disease. J Rheumatol. 2015;42(1):60-63

8. Tebo AE, Peterson LK, Snyder MR, Lebiedz-Odrobina D. Clinical significance of anti-U1 ribonucleoprotein antibody is analyte dependent: implications for laboratory reporting, interpretation, and interassay correlations. Arch Pathol Lab Med. 2023;147(12):1461-1465

9. van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Ann Rheum Dis. 2013;72(11):1747-1755

10. Santos CS, Morales CM, Castro CA, Alvarez ED. Clinical phenotype in scleroderma patients based on autoantibodies. Rheumatol Adv Pract. 2023;7(Suppl 1):i26-i33

11. Lundberg IE, Tjärnlund A, Bottai M, et al. 2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major. Ann Rheum Dis. 2017;76(12):1955-1964

Report Available

Same day/1 to 2 days

Method Name

Multiplex Flow Immunoassay

Beebe Healthcare Laboratory Services Additional Information:

Aliases:

Anti Extractable Extractable Nuclear Ag

Anti-ENA