Test Code RNAPSO RNA Polymerase III Antibodies, IgG, Serum
Additional Codes
Mayo Test Code: RNAP
Reporting Name
RNA Polymerase III Ab, IgG, SUseful 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
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumSpecimen 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 Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 21 days |
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)
Day(s) Performed
Tuesday, Thursday
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 |
Cautions
A positive result indicates detectable anti-RNA polymerase III above assay cutoff and does not unequivocally establish a diagnosis of systemic sclerosis.(6,7)
Enzyme immunoassay to detect anti-RNA polymerase III antibody uses an immunodominant epitope as antigen. Negative result does not also rule out the presence of antibodies targeting other epitopes in the RNA polymerase I/III antigens.
The level of RNA polymerase III autoantibodies does not indicate the severity of disease in patients with systemic sclerosis (SSc). However, patients with high positive anti-RNA polymerase III antibody titers are more likely to have SSc compared to those with low antibodies.(7)
Anti-RNA polymerase III antibodies may occur prior to clinical onset of SSc.(7)
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.
Report Available
2 to 7 daysSpecimen Retention Time
14 daysReject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | OK |
| Heat-treated specimen | Reject |
Method Name
Enzyme-Linked Immunosorbent Assay (ELISA)