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Test Code SCL70 Scl 70 Antibodies, IgG, Serum

Additional Codes

Mayo Test ID
SCL70

Reporting Name

Scl 70 Ab, IgG, S

Useful For

Evaluating patients with clinical features of systemic sclerosis and in the differential evaluation of individuals at-risk for connective tissue disease with Hep-2 substrate antinuclear antibody positive result, preferably using

antinuclear antibodies

 

Testing for Scl70 antibodies is not useful who test negative for antinuclear antibody using Hep-2 substrate by IFA.

Testing Algorithm

For more information see Connective Tissue Disease Cascade.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

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: 0.5 mL

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


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Special Instructions

Reference Values

<1.0 U (negative)

≥1.0 U (positive)

Reference values apply to all ages.

Day(s) Performed

Monday through Saturday

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

86235

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SCL70 Scl 70 Ab, IgG, S 47322-3

 

Result ID Test Result Name Result LOINC Value
SCL70 Scl 70 Ab, IgG, S 47322-3

Interpretation

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

Clinical Reference

1. Dellavance A, Gallindo C, Soares MG, et al. Redefining the Scl-70 indirect immunofluorescence pattern: autoantibodies to DNA topoisomerase I yield a specific compound immunofluorescence pattern. Rheumatology(Oxford). 2009;48(6):632-637

2. Andrade LEC, Klotz W, Herold M, et al. International consensus on antinuclear antibody patterns: definition of the ac-29 pattern associated with antibodies to DNA topoisomerase I. Clin Chem Lab Med. 2018;56(10):1783-1788

3. van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of rheumatology/European League against rheumatism collaborative initiative. Ann Rheum Dis. 2013;72(11):1747-1755

4. Walker UA, Tyndall A, Czirják L,et al. Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group database. Ann Rheum Dis. 2007;66(6):754-763

5. Nihtyanova SI, Sari A, Harvey JC, et al. Using autoantibodies and cutaneous subset to develop outcome-based disease classification in systemic sclerosis. Arthritis Rheumatol. 2020;72(3):465-476

6. Nandiwada SL, Peterson LK, Mayes MD, et al. Ethnic differences in autoantibody diversity and hierarchy: More clues from a US cohort of patients with systemic sclerosis. J Rheumatol. 2016;43(10):1816-1824

7. Homer KL, Warren J, Karayev D, et al. Performance of anti-topoisomerase I antibody testing by multiple-bead, enzyme-linked immunosorbent assay and immunodiffusion in a university setting. J Clin Rheumatol. 2020;26(3):115-118

8. Lam BH, Assassi S, Charles J, et al. False positive anti-Topoisomerase I (Scl-70) antibody results in clinical practice: A case series from a scleroderma referral center. Semin Arthritis Rheum. 2022;56:152052

9. Jandali B, Salazar GA, Hudson M, et al. The Effect of anti-Scl-70 antibody determination method on its predictive significance for interstitial lung disease progression in systemic sclerosis. ACR Open Rheumatol. 2022;4(4):345-351

10. Mahler M, Silverman ED, Schulte-Pelkum J, Fritzler MJ. Anti-Scl-70 (topo-I) antibodies in SLE: Myth or reality? Autoimmun Rev. 2010 Sep;9(11):756-60.

Report Available

1 to 3 days

Method Name

Multiplex Flow Immunoassay