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Test Code SSCP Systemic Sclerosis Criteria Panel, 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: 0.7 mL

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


Useful For

Evaluating patients with antinuclear antibody-associated connective tissue disease, specifically systemic sclerosis

Profile Information

Test ID Reporting Name Available Separately Always Performed
NAIFA Antinuclear Ab, HEp-2 Substrate, S Yes Yes
SCL70 Scl 70 Ab, IgG, S Yes Yes
RNAP RNA Polymerase III Ab, IgG, S Yes Yes

Method Name

NAIFA: Indirect Immunofluorescence

SCL70: Multiplex Flow Immunoassay

RNAP: Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

Systemic Sclerosis Panel, S

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

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

Reject Due To

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

Reference Values

ANTINUCLEAR ANTIBODIES, HEp-2 SUBSTRATE, IgG

<1:80 (Negative)

 

Scl 70 ANTIBODIES, IgG

<1.0 U (negative)

≥ 1.0 U (Positive)

 

RNA POLYMERASE III ANTIBODIES, IgG

<20.0 U (Negative)

20.0-39.9 U (Weak positive)

40.0-80.0 U (Moderate positive)

>80.0 U (Strong positive)

Interpretation

Presence of anti-cellular antibody (also known as antinuclear antibody) is a characteristic feature of systemic autoimmune rheumatic diseases such as systemic lupus erythematosus, mixed connective tissue disease, Sjogren syndrome and systemic sclerosis (SSc), and inflammatory myopathies (dermatomyositis, anti-synthetase syndrome and necrotizing autoimmune myopathy). It may also be of diagnostic relevance in patients with autoimmune liver diseases.

 

Patients' sera are screened at 1:80. The following nuclear patterns and their titers are reported: centromere, homogeneous, nuclear dots, nucleolar, speckled, fine dense speckled (also referred to as DFS70), and proliferating cell nuclear antigen (PCNA). If observed, the following cytoplasmic patterns are reported: reticular/AMA (antimitochondrial antibody), cytoplasmic speckled, fibrillar, polar/Golgi-like, or rods and rings. The spindle fiber and centrosome mitotic patterns are also reported if observed. Reported patterns may help guide differential diagnosis, although they may not be specific for individual antibodies or diseases. Negative results do not necessarily rule out systemic autoimmune rheumatic disease.

 

The antinuclear antibody test lacks diagnostic specificity and is associated with some cancers, infectious, and inflammatory conditions, with variable prevalence in healthy individuals. The lack of diagnostic specificity requires confirmation of positive results using associated antibody tests such as those targeting extractable nuclear antigens.

 

A positive test result for Scl-70 antibodies may be consistent with a diagnosis of systemic sclerosis in the appropriate clinical context.

 

A positive result for RNA polymerase III antibody may support a diagnosis of 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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

86039

86235

83516

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SSCP Systemic Sclerosis Panel, S In Process

 

Result ID Test Result Name Result LOINC Value
SCL70 Scl 70 Ab, IgG, S 47322-3
RNAP RNA Polymerase III Ab, IgG, S 79182-2
ANAH Antinuclear Ab, HEp-2 Substrate, S 59069-5
1TANA ANA Titer: 33253-6
1PANA ANA Pattern: 49311-4
2TANA ANA Titer 2: 33253-6
2PANA ANA Pattern 2: 49311-4
CYTQL Cytoplasmic Pattern: 55171-3
LCOM Lab Comment: 77202-0