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Test ID: SSAB
SS-A and SS-B Antibodies, IgG, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

82403

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

Yes

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

Evaluating patients with signs and symptoms of a connective tissue disease in whom the test for antinuclear antibodies is positive, especially those with signs and symptoms consistent with Sjogren's syndrome or lupus erythematosus

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 IDReporting NameAvailable SeparatelyAlways Performed
SSASS-A/Ro Ab, IgG, SYesYes
SSBSS-B/La Ab, IgG, SYesYes

Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.

See Connective Tissue Disease Cascade (CTDC) in Special Instructions.

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

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

Multiplex Flow Immunoassay

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

SSA/SSB

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

Anti-La
Anti-Ro
Anti-Sjogren's Syndrome
Anti-SSA (Anti-Sjogren's Syndrome A)
Anti-SSB (Anti-Sjogren's Syndrome B)
Autoantibodies to SS-B/LA, Serum
Autoantibodies to SSA (Ro)
Autoantibodies to SSB (La)
La (Anti-SSB)
Ro (Anti-SSA)
Ro Autoantibodies
Sjogren's Syndrome
SSA (Anti-SSA)
SSA Autoantibodies
SSB (Anti-SSB)
SSB Autoantibodies

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.5 mL

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.35 mL

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

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross OK

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)21 days
 Frozen 21 days

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

SS-A/Ro, SS-B/La, RNP, and Sm are autoantigens commonly referred to as extractable nuclear antigens (ENAs). Antibodies to ENAs are common in patients with connective tissue diseases (systemic rheumatic diseases).

 

SS-A/Ro is composed of protein antigens of 52kD and 60 kD combined with cytoplasmic RNA species. SS-A/Ro antibodies occur in patients with several different connective tissue diseases including Sjogren's syndrome, an autoimmune disease that involves primarily the salivary and lachrymal glands (up to 90% of cases); lupus erythematosus (LE) (40%-60% of cases); and rheumatoid arthritis. SS-A/Ro antibodies are associated with childhood LE, neonatal LE, and with congenital heart block in infants born to mothers with LE.(1,2) SS-A/Ro antibodies have also been reported to be associated with features of extraglandular inflammation in patients with LE including vasculitis, purpura, cytopenias, and adenopathy.

 

SS-B/La is composed of a 48-kD protein combined with RNA species. SS-B/La antibodies are found primarily in patients with Sjogren's syndrome or LE, where they occur with frequencies of approximately 60% and 15%, respectively.(1,2) SS-B/La antibodies occur only infrequently in the absence of SS-A/Ro antibodies.

 

See Connective Tissue Disease Cascade (CTDC) in Special Instructions and Optimized Laboratory Testing for Connective Tissue Diseases in Primary Care: The Mayo Connective Tissue Diseases Cascade in Publications.

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 (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 or SS-B/La antibodies is consistent with connective tissue disease, including Sjogren's syndrome, lupus erythematosus (LE), or rheumatoid arthritis.

 

A positive result for SS-A/Ro antibodies in a woman with LE prior to delivery indicates an increased risk of congenital heart block in the neonate.

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

Testing for SS-A/Ro and SS-B/La antibodies is not useful in patients without demonstrable antinuclear antibodies.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Homburger H, Larsen S: Detection of specific antibodies. In Clinical Immunology: Principles and Practice. 1st edition. Edited by R Rich, T Fleisher, B Schwartz, et al. St. Louis, Mosby-Year Book, 1996, pp 2096-2109

2. Kotzin B, West S: Systemic lupus erythematosus. In Clinical Immunology Principles and Practice. 2nd edition. Edited by R Rich, T Fleisher, W Shearer, et al. St. Louis, Mosby-Year Book 2001, pp 60.1-60.24

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

Recombinant SS-A/Ro 52 kD, affinity-purified SS-A/Ro 60 kD, and affinity-purified SS-B antigen are coupled covalently to polystyrene microspheres that 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, and SS-B/La antibodies, if present, bind to the SS-B 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 anti-SS-A/Ro or anti-SS-B/La 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 and SS-B/La microspheres to a 4-point calibration curve. (Package insert: Bioplex 2200 ANA Screen. Bio-Rad Laboratories, Hercules, CA)

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

Monday through Saturday; 4p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

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

7 days

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

Rochester

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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86235 x 2

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
SSASS-A/Ro Ab, IgG, S33610-7
SSBSS-B/La Ab, IgG, S33613-1