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Test Code Billings Clinic: 9127 Mayo: RNAP RNA Polymerase III Antibodies, IgG, Serum

Reporting Name

RNA Polymerase III Ab, IgG, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Evaluating patients suspected of having systemic sclerosis as part of systemic sclerosis criteria antibody tests

 

Providing diagnostic and prognostic information in patients with systemic sclerosis

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.3 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat-treated specimen Reject

Reference Values

<20.0 U (negative)

20.0-39.9 U (weak positive)

40.0-80.0 U (moderate positive)

>80.0 U (strong positive)

Interpretation

A positive result for RNA polymerase III antibody may support a diagnosis of systemic sclerosis (SSc) in the appropriate clinical context. Anti-RNA polymerase III autoantibody in patients with SSc is associated with the diffuse cutaneous form of disease and an increased risk of sclerodermal renal crisis.

 

A negative result indicates no detectable IgG antibodies to RNA polymerase III and does not rule out a diagnosis of SSc. The RNA polymerase III IgG enzyme-linked immunosorbent assay tests only for the RP155 dominant epitope, other epitopes in the antigenic complex are absent and cannot be detected.(6) The overall pooled prevalence of anti-RNA polymerase III antibody is reported to be 11%, 95% CI: 8 to 14, range of 0% to 41% in published studies.(4)

Day(s) Performed

Tuesday, Thursday

Report Available

2 to 7 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

83516

LOINC Code Information

Test ID Test Order Name Order LOINC Value
RNAP RNA Polymerase III Ab, IgG, S 79182-2

 

Result ID Test Result Name Result LOINC Value
RNAP RNA Polymerase III Ab, IgG, S 79182-2