Test Id : SSA
SS-A/Ro Antibodies, IgG, Serum
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Evaluating patients at-risk for connective tissue disease with or without interstitial lung disease
Detection of both anti-SS-A 52 (Ro52) and SS-A 60 (Ro60) antibodies in serum
    
        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.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        Aliases
            
                
                
                    
                    Lists additional common names for a test, as an aid in searching
                
            
    
    Anti-Ro
Anti-Sjogren's Syndrome
Anti-SSA (Anti-Sjogren's Syndrome A)
Autoantibodies to SSA (Ro)
Ro (Anti-SSA)
Ro Autoantibodies
Sjogren's Syndrome
SSA (Anti-SSA)
SSA Autoantibodies
    
        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: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Information: Centrifuge and aliquot serum into 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 specimen | 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 at-risk for connective tissue disease with or without interstitial lung disease
Detection of both anti-SS-A 52 (Ro52) and SS-A 60 (Ro60) antibodies in serum
    
        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
                
            
    
    SS-A/Ro is an extractable nuclear antigen composed of two distinct antigens of 52 kDa (Ro52) and 60 kDa (Ro60) combined with cytoplasmic RNA species.(1,2) SS-A/Ro (Ro52 and/or Ro60) antibodies occur in patients with several different connective tissue diseases including Sjogren syndrome (SjS), an autoimmune disease that involves primarily the salivary and lachrymal glands,systemic lupus erythematosus (SLE), rheumatoid arthritis, systemic sclerosis (SSc) and idiopathic inflammatory myopathies (IIM).(1-5) SS-A/Ro antibodies are associated with childhood SLE, neonatal SLE, and with congenital heart block in infants born to mothers with SLE.(3-5) 
Traditionally, anti-SS-A/Ro antibodies were detected by indirect immunofluorescence assay on HEp-2 substrates and confirmed by immunodiffusion, immunoblot or ELISA, mostly using a mixture of both Ro52 and Ro60 as the antigens.(1) With technological advances in the expression and purification of recombinant proteins, solid-phase immunoassays such as ELISA, CLIA, LIA, ALBIA or autoantigen arrays became available that allow the separate detection of anti-Ro52 and anti-Ro60 antibodies.(2,3) Based on separate determination of Ro52 and Ro60 antibodies, there is substantial evidence that differential associations of these autoantibodies in patients may corelate with specific phenotypes in SLE (neonatal lupus, and fetal atrioventricular blockade), SjS, SSc, IIM, or primary biliary cholangitis.(1-4, 6) SjS patients with antibodies to both Ro52 and Ro60 are characterized by higher prevalence of markers of B-cell hyperactivity and glandular inflammation compared to those with single positivity.(4,6) Although these antibodies are often found together, both autoantibodies have important and distinct diagnostic and predictive attributes and should be distinguished when SS-A/Ro antibody is positive or tested singly.(6)
 
For more information see Connective Tissue Disease Cascade.
    
        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.
                
            
    
    <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 result for SS-A/Ro antibodies may be suggestive of connective tissue disease (CTD) such as Sjogren syndrome, systemic lupus erythematosus (SLE), systemic sclerosis (SSc), inflammatory myopathies especially in patients with anti-synthetase syndrome, CTD-associated with interstitial lung diseases (CTD-ILD), or rheumatoid arthritis.
A positive result for SS-A/Ro antibodies in a woman with SLE prior to delivery may suggest an increased risk of congenital heart block in the neonate.
Differential testing for Ro52 and Ro60 antibodies in SS-A/Ro positive patients may be useful in the diagnosis of specific CTD clinical subset, disease stratification, and prognosis. Consider testing for Ro52 and Ro60 antibodies (ROPAN / Ro52 and Ro60 Antibodies, IgG, Serum) if the patient is positive for SS-A/Ro.
    
        Cautions
            
                
                
                    
                    Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
                
            
    
    
            
            
    
        Clinical Reference
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Lee AYS, Reed JH, Gordon TP: Anti-Ro60 and anti-Ro52/TRIM21: Two distinct autoantibodies in systemic autoimmune diseases. J Autoimmun. 2021 Nov;124:102724. doi: 10.1016/j.jaut.2021.102724
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). 2021 Mar 20;10.1002/acr.24597. Epub ahead of print.
3. Homburger H, Larsen S: Detection of specific antibodies. In: Rich R, Fleisher T, Schwartz B, et al, eds. Clinical Immunology: Principles and Practice. 1st ed. Mosby-Year Book; 1996:2096-2109
4. Kotzin B, West S: Systemic lupus erythematosus. In: Rich R, Fleisher T, Shearer W, et al, eds. Clinical Immunology Principles and Practice. 2nd ed. Mosby-Year Book; 2001:60.1-60.24
    
        Method Description
            
                
                
                    
                    Describes how the test is performed and provides a method-specific reference
                
            
    
    Recombinant SS-A/Ro 52 kD and affinity-purified SS-A/Ro 60 kD antigens are coupled covalently to polystyrene microspheres, which are impregnated with fluorescent dyes to create a unique fluorescent signature. SS-A/Ro antibodies, if present in diluted serum, bind to the SS-A/Ro antigens on the microspheres. The microspheres are washed to remove extraneous serum proteins. Phycoerythrin (PE)-conjugated antihuman IgG antibody is then added to detect IgG anti-SS-A/Ro 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 SS-A/Ro 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
                
            
    
    
    
        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 Friday, Sunday
    
        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.
                
            
    
    
    
        Specimen Retention Time
            
                
                
                    
                    Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        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.
                
            
    
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        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.
                
            
    
    CPT codes are provided by the performing laboratory.
86235
    
        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 | 
|---|---|---|
| SSA | SS-A/Ro Ab, 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.
                                     | 
|---|---|---|
| SSA | SS-A/Ro Ab, IgG, S | 33610-7 |