Ordering Recommendation

Indicated for patients with distinct features of systemic scleroderma/sclerosis (SSc). For a more comprehensive panel that includes U3 RNP (fibrillarin), PM/Scl-100, and U1RNP, refer to Systemic Sclerosis, Comprehensive Panel (3000480).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube (SST).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 3 mL serum to an ARUP standard transport tube. (Min: 0.25 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Contaminated, hemolyzed, or severely lipemic specimens.

Remarks
Stability

Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Indirect Fluorescent Antibody/Semi-Quantitative Multiplex Bead Assay/Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun, Tue, Thu

Reported

1-4 days

Reference Interval

Test Number
Components
Reference Interval
  Scleroderma (Scl-70) (ENA) Antibody, IgG 40 AU/mL or less
  RNA Polymerase III Antibody, IgG 19 Units or less
  Antinuclear Antibody (ANA), HEp-2, IgG Less than 1:80

Interpretive Data




Component Interpretation
Scleroderma (Scl-70) (ENA) Antibody, IgG 29 AU/mL or less  Negative
30-40 AU/mL  Equivocal
41 AU/mL or greater  Positive
RNA Polymerase III Antibody, IgG 19 Units or less  Negative
20-39 Units  Weak Positive
40-80 Units  Moderate Positive
81 Units or greater Strong Positive

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86039; 86235; 83516

Components

Component Test Code* Component Chart Name LOINC
0050599 Scleroderma (Scl-70) (ENA) Antibody, IgG 47322-3
2001602 RNA Polymerase III Antibody, IgG 79182-2
3000090 Antinuclear Antibody (ANA), HEp-2, IgG 21424-7
3000096 ANA Interpretive Comment 49311-4
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • ANA
  • Antinuclear Antibodies
  • Antinuclear Antibody
  • FANA
  • Fluorescent Antinuclear Antibodies
  • Sclerosis
  • Systemic Sclerosis
Criteria Systemic Sclerosis Panel