Test Catalog

Test Id : RNAP

RNA Polymerase III Antibodies, IgG, Serum

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

Evaluating patients suspected of having systemic sclerosis, when used in conjunction with centromere and Scl70 antibodies

 

Providing diagnostic and prognostic information in patients with systemic sclerosis

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

Enzyme-Linked Immunosorbent Assay (ELISA)

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

RNA Polymerase III Ab, IgG, S

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

RNA Polymerase III Ab, IgG, S

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

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

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

0.4 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) 21 days
Frozen 21 days

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

Evaluating patients suspected of having systemic sclerosis, when used in conjunction with centromere and Scl70 antibodies

 

Providing diagnostic and prognostic information in patients with systemic sclerosis

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

Systemic sclerosis is a multisystem connective tissue (systemic rheumatic) disease characterized by fibroblast dysfunction leading to fibrosis of the skin and internal organs, microvascular injury leading to tissue hypoxia, and an autoimmune response manifested by production of autoantibodies.(1,2) The severity of the disease is highly variable among individual patients. Limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis have been recognized as distinct subsets, with worse survival for those with the diffuse form.(2) Clinical features of CREST syndrome (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasias) can be seen in both limited cutaneous and diffuse cutaneous forms but, overall, are associated with a better prognosis.(2) Several disease-specific and mutually exclusive autoantibodies have been identified that are helpful in both diagnosis and disease classification. Centromere and topoisomerase I (Scl 70) autoantibodies are associated with limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis, respectively.(3)

 

RNA polymerase III is a complex, 16-subunit enzyme directing transcription of small, stable nontranslated RNA genes: tRNA, 5S rRNA, Alu RNA, U6 snRNA, and 7SK snRNA genes. The immunodominant epitope for autoantibodies with anti-RNA polymerase I/III specificity has been identified on the RNA polymerase-specific subunit RPC155.(4)

 

Autoantibodies to RNA polymerase III antigen are found in 11% to 23% of patients with systemic sclerosis.(1,4) Systemic sclerosis patients who are positive for RNA polymerase III antibodies form a distinct serologic subgroup and usually do not have any of the other antibodies typically found in systemic sclerosis patients such as anticentromere or anti-Scl70.(1) Numerous studies have shown that systemic sclerosis patients with anti-RNA polymerase III have an increased risk of the diffuse cutaneous form of scleroderma, with a high likelihood of skin involvement and hypertensive renal disease.(1,4)

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.

<20.0 U (negative)

20.0-39.9 U (weak positive)

40.0-80.0 U (moderate positive)

>80.0 U (strong positive)

Interpretation
Provides information to assist in interpretation of the test results

A positive result supports a possible diagnosis of systemic sclerosis (see Cautions). This autoantibody is strongly associated with diffuse cutaneous scleroderma and with an increased risk of acute renal crisis. 

 

A negative result indicates no detectable IgG antibodies to RNA polymerase III, but does not rule out the possibility of systemic sclerosis (11%-23% sensitivity).(1,4)

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

A positive result indicates the presence of measurable IgG antibodies to RNA polymerase III, but does not unequivocally establish the diagnosis of systemic sclerosis or other autoimmune disease.

 

The level of RNA polymerase III autoantibodies does not indicate the severity of disease in patients with systemic sclerosis.

 

The presence of immune complexes or other immunoglobulin aggregates in the patient specimen may cause an increased level of nonspecific binding and produce false-positive results with this assay.

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

1. Koenig M, Dieude M, Senecal, J-L: Predictive value of antinuclear antibodies: The lessons of the systemic sclerosis autoantibodies. Autoimmun Rev 2008;7(8):588-593

2. Wollheim FA: Classification of systemic sclerosis. Visions and reality. Rheumatology (Oxford) 2005 Oct;44(10):1212-1216

3. Cavazzana I, Ceribelli A, Paolo A, et al: Anti-RNA polymerase III antibodies: A marker of systemic sclerosis with rapid onset and skin thickening progression. Autoimmun Rev 2009;8(7):580-584

4. Kuwana M, Kimura K, Kawakami Y: Identification of an immunodominant epitope on RNA polymerase III recognized by systemic sclerosis sera: application to enzyme-linked immunosorbent assay. Arthritis Rheum 2002 Oct;46(10):2742-2747

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

The immunodominant fragment of RNA polymerase III antigen is derived from recombinant DNA technology. Purified RNA polymerase III antigen is adsorbed to the wells of a polystyrene microtiter plate under conditions that preserve the antigen in its antigenic state. Prediluted controls and diluted patient sera are added to separate wells. Unbound sample is washed away and an enzyme-labeled antihuman IgG conjugate is added to each well. After incubation and washing away of unbound enzyme-labeled antihuman IgG, the bound conjugate is measured by adding a chromogenic substrate. The intensity of the absorbance produced is measured with an automated microwell plate reader. Results are calculated by comparison to a single-point calibrator.(Package insert: QUANTA Lite RNA Pol III, INOVA Diagnostics, San Diego, CA. 1/2015)

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.

Wednesday

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 day - 7 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.

83516

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