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Test Code LAB2056 RNA Polymerase III Antibodies, IgG, Serum

Additional Codes

RNAP

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


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 Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days
Medical University of South Carolina Note:

On-campus collections: Tube to 99 or deliver to University Extension Hospital Room EH318 
 
Off-campus collections: Centrifuge and aliquot within 2 hours. Specimen to be stored/transported Refrigerated.

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

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

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)

Method Description

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; 05/2019)

Report Available

2 to 7 days

Specimen Retention Time

14 days

Reject Due To

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

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Secondary ID

83397