Test Catalog

Test Id : ROPAN

Ro52 and Ro60 Antibodies, IgG, Serum

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

Detection of anti-SSA 52 (Ro52) or SSA 60 (Ro60) antibodies in serum

 

Evaluating patients at-risk for connective tissue disease with or without interstitial lung disease

 

Differentiation of antibodies to Ro52 and Ro60 in patients known to be positive for anti- SS-A (Ro) antibodies

Highlights

For the differentiation of Sjogren syndrome (SS)A (Ro52 or Ro60) antibodies in patients at-risk for autoimmune connective tissue disease with or without lung involvement.

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
RO52 Ro52 Antibody, IgG, S Yes Yes
RO60 Ro60 Antibody, IgG, S Yes Yes

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

Chemiluminescent 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

Ro52 and Ro60 Antibodies, IgG, S

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

TRIM21

SSA/Ro

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

Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.8 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

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) 14 days
Frozen 21 days

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

Detection of anti-SSA 52 (Ro52) or SSA 60 (Ro60) antibodies in serum

 

Evaluating patients at-risk for connective tissue disease with or without interstitial lung disease

 

Differentiation of antibodies to Ro52 and Ro60 in patients known to be positive for anti- SS-A (Ro) antibodies

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

Anti- SS-A (Ro) antibodies can occur in patients with a variety of connective tissue diseases including Sjogren syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathy (IIM).(1) In addition, children born to mothers positive for anti-SS-A/Ro antibodies are at increased risk for congenital heart block.(2)

 

Anti-SS-A/Ro antibodies can be specific for protein antigens of 52 kDa (Ro52) or 60 kDa (Ro60); these antigens arise from different genes and have unique biological features. The Ro52 antigen is also known as TRIM21; this protein has E3 ligase activity and functions in the process of ubiquitination. The Ro60 antigen is a 60-kDa RNA-binding protein, known to have repair functions for misfolded RNA.(2)

 

Individuals may display antibody reactivity to either Ro52, Ro60, or both. Patients with only anti-Ro52 antibodies display a higher incidence of IIM and SSc. Anti-Ro52 antibodies in conjunction with antisynthetase antibodies such Jo-1 (others include PL-7, PL-12, EJ, and OJ) are highly associated with interstitial lung disease in patients with IIM. In contrast, isolated anti-Ro60 antibodies are associated with increased risk for SLE and, to a lesser degree, for SS. Positivity for both anti-Ro52 and anti-Ro60 antibodies are most strongly associated with SS; this association is even stronger if anti-SS-B/La antibodies are also detected. The presence of anti-Ro52 and anti-Ro60 antibodies may also be observed in patients with SLE.(3,4)

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.

Ro52 ANTIBODY, IgG

<20 CU (negative)

> or =20 CU (positive)

Reference values apply to all ages

 

Ro60 ANTIBODY, IgG

<20 CU (negative)

> or =20 CU (positive)

Reference values apply to all ages

Interpretation
Provides information to assist in interpretation of the test results

The presence of antibodies to both SSA 52 (Ro52) or SSA 60 (Ro60) is highly suggestive of a diagnosis of Sjogren syndrome (SS) with positivity for R060 alone more likely to be associated with systemic lupus erythematosus (SLE).

 

Antibodies to Ro52 may be present in patients with idiopathic inflammatory myopathy (IIM), systemic sclerosis (SSc) or overlap connective tissue disease (CTD). In CTD, antibodies to Ro52 alone or in association with other specific autoantibodies may be associated with interstitial lung diseases.

 

Negative results for antibodies to Ro52 and Ro60 does not exclude the possibility of any CTD, including SS, SLE, SSc, and IIM.

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

Results from this testing should be interpreted in the context of clinical findings and other laboratory testing. Tests cannot be exclusively relied upon to establish a diagnosis for any connective tissue disease or related disorder, including systemic lupus erythematosus, Sjogren syndrome (SS), systemic sclerosis, or idiopathic inflammatory myopathy.

 

When assessed by standard SS-A (Ro) solid phase immunoassays such as enzyme immunoassays using combined antigens, some antibodies specific for either SSA 52 (Ro52) or SSA 60 (Ro60) may not be detected, due to masking of target epitopes. In addition, multiplex bead assays with Ro52 or Ro60 antigens may simply be reported as SS-A/Ro positive without differentiation of the specific positive antibody.

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

1. Fayyaz A, Kurien BT, Scofield H: Autoantibodies in Sjogren’s syndrome. Rheum Dis Clin North Am. 2016;42(3):419-434

2. Defendenti C, Atzeni F, Spina MF, et al: Clinical and laboratory aspects of Ro/SSA-52 autoantibodies. Autoimmun Rev. 2010;10(3):150-154

3. Robbins A, Hentzien M, Toquet S, et al: Diagnostic utility of separate anti-Ro60 and anti-Ro52/TRIM21 antibody detection in autoimmune diseases. Front Immunol. 2019 Mar 12;10:444

4. Schulte-Pelkum J, Fritzler M, Mahler M: Latest update on the Ro/SS-A autoantibody system. Autoimmun Rev. 2009;8(7):632-637

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

Paramagnetic beads are coated with purified recombinant Ro52 protein or purified recombinant Ro60 protein. The serum sample is diluted in assay buffer and incubated with the beads. Antibodies to Ro52 or Ro60 bind to their respective beads and are detected by anti-human IgG antibody conjugated with isoluminol. With addition of trigger reagents, a luminescent reaction is produced by the isoluminol conjugate. The light produced by the reaction is measured by a photomultiplier, proportional to the amount of antibodies that are bound to the beads. The antibodies are quantified according to the working curve on the instrument. Anti-Ro52 and anti-Ro60 are reported in Chemiluminescent Units (CU) as derived from the relative light units measured from each sample.(Package insert: QUANTA Flash Ro52 Reagents, Inova Diagnostics; 06/2019; QUANTA Flash Ro60 Reagents, Inova Diagnostics; 06/2019)

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, Wednesday, Friday

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.

1 to 3 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 Regional Manager. 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 2

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
ROPAN Ro52 and Ro60 Antibodies, IgG, S 33610-7
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.
RO52 Ro52 Antibody, IgG, S 53017-0
RO60 Ro60 Antibody, IgG, S 53019-6

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 | Create a 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