Test Catalog

Test Id : ENAE

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Antibody to Extractable Nuclear Antigen Evaluation, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Connective Tissue Disease Cascade.

Method Name
A short description of the method used to perform the test

Multiplex Flow Immunoassay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Ab to Extractable Nuclear Ag Eval,S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-ENA (Antibodies to Extractable Nuclear Antigens)

Anti-La

Anti-Ribonuclear Protein

Anti-RNP (Anti-Ribonucleoprotein)

Anti-Ro

Anti-Sjogren's Syndrome

Anti-Sm (Smith)

Anti-Smith (SM) Antigen

Antibodies to Extractable Nuclear Antigens

Autoantibodies to Jo 1 Antigen

Autoantibodies to Sm (Smith)

Connective Tissue Disease Autoantibody Panel (2 tests)

DNA Topoisomerase 1 Antibodies

ENA (Extractable Nuclear Antigens), Anti

ENA/ADNA

Extractable Nuclear Antigens, Anti

Histidyl-tRNA Synthetase Antibodies

Immunology Profile (ENA)

Jo 1 Antibodies

Ribonucleoprotein (RNP) Autoantibodies

RNP (Anti-RNP)

Scl 70 Antibodies

Scleroderma Antibodies (? FOR SPECIFIC TEST)

Sjogren's Syndrome

Sm (Anti-Sm) (Smith)

Sm (Smith) Autoantibodies

Smith Antigen, Anti

SmRNP Autoantibodies

Topoisomerase 1 Antibodies

Autoantibodies to Scl 70 Antigen

Anti-SS-A (Anti-Sjogren's Syndrome A)

Anti-SS-B (Anti-Sjogren's Syndrome B)

Autoantibodies to SS-A (Ro)

Autoantibodies to SS-B (La)

La (Anti-SS-B/La)

Myositis

Ro (Anti-SS-A/Ro)

U1RNP (Ribonucleoprotein) Autoantibodies

Anti-U1RNP (Anti-Ribonucleoprotein)

Autoantibodies to U1RNP

SS-B (Anti-SSB)

SS-A (Anti-SSA)

Anti-synthetase syndrome

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Connective Tissue Disease Cascade.

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.35 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

For more information see Connective Tissue Disease Cascade.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

SS-A/Ro ANTIBODIES, IgG

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

 

SS-B/La ANTIBODIES, IgG

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

 

Sm ANTIBODIES, IgG

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

 

RNP ANTIBODIES, IgG

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

 

Scl 70 ANTIBODIES, IgG

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

 

Jo 1 ANTIBODIES, IgG

<1.0 U (negative)

> or =1.0 U (positive)

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

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

 

For more information, see the individual test codes.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Negative results to do not rule out the presence of connective tissue disease.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Method Description
Describes how the test is performed and provides a method-specific reference

Antigen is coupled covalently to polystyrene microspheres, which are impregnated with fluorescent dyes to create a unique fluorescent signature. Antibodies, if present in diluted serum, bind to the antigen on the microspheres. The microspheres are washed to remove extraneous serum proteins. Phycoerythrin (PE)-conjugated antihuman IgG antibody is then added to detect IgG antibodies bound to the microspheres. The microspheres are washed to remove unbound conjugate, and bound conjugate is detected by laser photometry. A primary laser reveals the fluorescent signature of each microsphere to distinguish it from microspheres that are labeled with other antigens, and a secondary laser reveals the level of PE fluorescence associated with each microsphere. Results are calculated by comparing the median fluorescence response for microspheres to a 4-point calibration curve.(Package insert: Bioplex 2200 ANA Screen. Bio-Rad Laboratories; 02/2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86235 x 6

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports