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Test Code CRITH DNA Double-Stranded (dsDNA) Antibodies by Crithidia luciliae IFA, IgG, Serum

Reporting Name

dsDNA Ab by Crithidia IFA, IgG, S

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: 0.3 mL

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


Specimen Stability Information

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

Reference Values

Negative

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

86255

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CRITH dsDNA Ab by Crithidia IFA, IgG, S 58466-4

 

Result ID Test Result Name Result LOINC Value
62925 dsDNA Ab by Crithidia IFA, IgG, S In Process
37268 Crithidia Interpretation 69048-7

Method Name

Indirect Immunofluorescence

Useful For

Confirmation testing for dsDNA IgG antibodies in patients with clinical features of systemic lupus erythematosus or at-risk for disease

 

This test should not be used independently for monitoring treatment response or establishing remission.

Clinical Information

Double-stranded DNA (dsDNA) antibodies are systemic lupus erythematosus (SLE)-specific antibodies and are part of the immunology domain of the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (1) as well as a previous guidance on SLE diagnosis.(2) The Crithidia luciliae indirect immunofluorescence test (CLIFT) is widely used as a confirmatory test following a positive dsDNA IgG result obtained by a solid-phase immunoassay due to its structural or analytical specificity.(3-5)

 

The CLIFT (dsDNA) test is indicated in patients who are positive for anti-cellular antibody (also known as antinuclear antibody [ANA]) homogeneous pattern (6) using HEp-2 substrate by indirect immunofluorescence assay (IFA) following a positive result for dsDNA IgG using a solid-phase immunoassay (eg, enzyme-linked immunosorbent assay or multiplex bead assay).(3,4) A positive CLIFT result is usually associated with the presence of moderate-to-high affinity dsDNA IgG antibodies. The CLIFT result may be negative and the immunoassay positive for dsDNA IgG in SLE patients with inactive (remission) disease or in patients with early disease.(3,4,7) Discordant results between CLIFT and solid-phase immunoassays may also be due to differences in the structural specificities of DNA analytes as well as the absence reliable reagents to harmonize available clinical tests.(3,5,8)

 

A minority of SLE patients may test negative using HEp-2 by IFA for nuclear antibodies.(9) Testing antibodies associated with the HEp-2 IFA cytoplasmic pattern such as ribosomal P IgG autoantibodies may be useful if features of neuropsychiatric disease are present.(9) Alternatively, patients may be tested for Smith, ribonuclear protein (RNP), SSA-52 and SSA-60 antibodies.(6,9)

Interpretation

A positive result for double-stranded DNA (dsDNA) IgG antibodies in the appropriate clinical context is highly suggestive of systemic lupus erythematosus (SLE). The presence of dsDNA IgG antibodies detected using the Crithidia luciliae indirect immunofluorescence test is highly specific for SLE with moderate sensitivity.

 

A negative result does not exclude a diagnosis of SLE.

Day(s) Performed

Monday through Friday

Report Available

2 to 4 days

Specimen Minimum Volume

See Specimen Required

Specimen Retention Time

14 days