Ordering Recommendation

Comprehensive evaluation for systemic sclerosis (SSc) when suspicion for SSc is high and patient presents with features of overlap syndrome. For patients with distinct features of SSc, order Criteria Systemic Sclerosis Panel (3000479).

Mnemonic

SCL COMPRE

Methodology

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

Performed

Thu

Reported

1-8 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: 1.5 mL)

Storage/Transport Temperature

Refrigerated. Also acceptable: Room temperature or frozen.

Unacceptable Conditions

Hemolyzed, hyperlipemic, icteric, heat-treated or contaminated specimens

Remarks
Stability

Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month

Reference Interval

Test Number
Components
Reference Interval
  Smith/RNP (ENA) Ab, IgG 19 Units or less

  Scleroderma (Scl-70) (ENA) Antibody, IgG 40 AU/mL or less
  RNA Polymerase III Antibody, IgG 19 Units or less
  PM/Scl 100 Antibody, IgG Negative
  Fibrillarin (U3 RNP) Ab, IgG Negative
  Antinuclear Antibody (ANA), HEp-2, IgG Less than 1:80

Interpretive Data

Refer to report.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.


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
Smith/RNP (ENA) Antibody, IgG 19 Units or less  Negative
20-39 Units  Weak Positive
40-80 Units  Moderate Positive
81 Units or greater  Strong 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

Laboratory Developed Test (LDT)

Note

Panel includes: Antinuclear Antibody (ANA) with HEp-2 Substrate, IgG by IFA, Scleroderma (Scl-70) (ENA) Antibody, IgG, RNA Polymerase III Antibody, IgG, Smith/RNP (ENA) Antibody, IgG, Fibrillarin (U3 RNP) Antibody, IgG, PM/Scl-100 Antibody, IgG by Immunoblot.

Hotline History

N/A

CPT Codes

86039; 86235 x4; 83516

Components

Component Test Code* Component Chart Name LOINC
0050470 Smith/RNP (ENA) Ab, IgG 33983-8
0050599 Scleroderma (Scl-70) (ENA) Antibody, IgG 47322-3
2001602 RNA Polymerase III Antibody, IgG 79182-2
2003041 PM/Scl 100 Antibody, IgG 81732-0
2012174 Fibrillarin (U3 RNP) Ab, IgG 49963-2
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

Comprehensive Systemic Sclerosis Panel