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Test ID RO52 Ro52 Antibody, IgG, Serum


Ordering Guidance


This test detects antibodies to Ro52 only. For testing antibodies to both Ro 52 and Ro60, order ROPAN / Ro52 and Ro60 Antibodies, IgG, Serum.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial


Useful For

Detecting anti-SSA 52 (Ro52) antibodies in serum

 

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

Highlights

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

Method Name

Chemiluminescent Immunoassay

Reporting Name

Ro52 Antibody, IgG, S

Specimen Type

Serum

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  21 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK

Clinical Information

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

<20 CU (negative)

≥20 CU (positive)

Reference values apply to all ages

Interpretation

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's 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.

Cautions

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’s syndrome (SS), systemic sclerosis, or idiopathic inflammatory myopathy (IIM).

 

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

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

Paramagnetic beads are coated with purified recombinant Ro52 protein. The serum sample is diluted in assay buffer and incubated with the beads. Antibodies to Ro52 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 are reported in chemiluminescent units as derived from the relative light units measured from each sample.(Package insert: QUANTA Flash Ro52 Reagents, Inova Diagnostics; 06/2019)

Day(s) Performed

Wednesday

Report Available

2 to 3 days

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
RO52 Ro52 Antibody, IgG, S 53017-0

 

Result ID Test Result Name Result LOINC Value
RO52 Ro52 Antibody, IgG, S 53017-0