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).

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

New York DOH Approval Status

This test is New York DOH 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 year (avoid repeated freeze/thaw cycles)

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