Scleroderma (Scl-70) (ENA) Antibody, IgG

0050599
copy
 

Copy Utility


emailprint
Example Reports
Negative
Positive

Icon

Additional Technical Information

Ordering Recommendation

Aids in the diagnosis of systemic scleroderma/sclerosis (SSc). Negative results do not rule out SSc. Preferred test is Comprehensive Systemic Sclerosis Panel (3000480).

Mnemonic

SCLER

Methodology

Semi-Quantitative Multiplex Bead Assay

Performed

Sun-Sat

Reported

1-3 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.2 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma or other body fluids. Contaminated, hemolyzed, or severely lipemic specimens.

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Reference Interval

29 AU/mL or less Negative
30-40 AU/mL Equivocal
41 AU/mL or greater Positive

Interpretive Data

The presence of Scl-70 antibodies (also referred to as topoisomerase I, topo-I or ATA) is considered diagnostic for systemic sclerosis (SSc). Scl-70 antibodies alone are detected in about 20 percent of SSc patients and are associated with the diffuse form of the disease, which may include specific organ involvement and poor prognosis. Scl-70 antibodies have also been reported in a varying percentage of patients with systemic lupus erythematosus (SLE). Scl-70 (topo-1) is a DNA binding protein and anti-DNA/DNA complexes in the sera of SLE patients may bind to topo-I, leading to a false-positive result. The presence of Scl-70 antibody in sera may also be due to contamination of recombinant Scl-70 with DNA derived from cellular material used in immunoassays. Strong clinical correlation is recommended if both Scl-70 and dsDNA antibodies are detected.

Negative results do not necessarily rule out the presence of SSc. If clinical suspicion remains, consider further testing for centromere, RNA polymerase III and U3-RNP, PM/Scl, or Th/To antibodies.

Compliance Category

FDA

Note

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
02/21/2023
X
N/A

CPT Codes

86235

Are you an ARUP Client? Click here for your pricing.

Components

Component Test Code* Component Chart Name LOINC
0050599 Scleroderma (Scl-70) (ENA) Antibody, IgG 47322-3
* 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

  • Anti-Scleroderma (Scl-70) (ENA) Antibody
  • Autoantibodies to Scl 70 Antigen
  • Scl70
  • Scleroderma Antibodies
  • Topo 1
  • Topoisomerase 1 Antibody
  • Topoisomerase I Antibody
Scleroderma (Scl-70) (ENA) Antibody, IgG