Reference Interval:
Effective November 19, 2012
| Test Number
| Components
| Reference Interval
| | | Anti-Nuclear Antibodies (ANA), IgG by ELISA
| None Detected
| | 0050639
| Nuclear Antibody (ANA) by IFA, IgG
| <1:40
| | | Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA
| None Detected
| | 2002693
| Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidia luciliae)
| Less than 1:10
| | 0050470
| RNP (U1) (Ribonucleic Protein) (ENA) Antibody, IgG
| 29 AU/mL or less: Negative
30-40 AU/mL: Equivocal
41 AU/mL or greater: Positive
| | 0050085
| Smith (ENA) Antibody, IgG
| 29 AU/mL or less: Negative
30-40 AU/mL: Equivocal
41 AU/mL or greater: Positive
| | 0050691
| SSA (Ro) (ENA) Antibody, IgG
| 29 AU/mL or less: Negative
30-40 AU/mL: Equivocal
41 AU/mL or greater: Positive
| | 0050692
| SSB (La) (ENA) Antibody, IgG
| 29 AU/mL or less: Negative
30-40 AU/mL: Equivocal
41 AU/mL or greater: Positive
|
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| Interpretive Data: |
Anti-Nuclear Antibodies (ANA), IgG by ELISA: ANA specimens are screened using enzyme-linked immunosorbent assay (ELISA) methodology. All ELISA results reported as Detected are further tested by indirect fluorescent assay (IFA) using HEp-2 substrate with an IgG-specific conjugate. The ANA ELISA screen is designed to detect antibodies against dsDNA, histone, SS-A (Ro), SS-B (La), Smith, snRNP/Sm, Scl-70, Jo-1, centromere, and an extract of lysed HEp-2 cells. ANA ELISA assays have been reported to have lower sensitivities for antibodies associated with nucleolar and speckled ANA-IFA patterns.
|
| Note: |
ANA are not specific for systemic lupus erythematosus (SLE) but are found in a variety of rheumatic or connective tissue diseases. When cell culture substrates (HEp-2 cells) are used, the ANA incidence is greater than 90 percent in systemic lupus erythematosus (SLE), 80 percent in Sjogren syndrome and scleroderma, and 40 percent in juvenile idiopathic arthritis.
ARUP uses anti-human IgG-specific conjugate since many (20-77 percent) normal individuals have low levels (1:10 to 1:80) of ANA-IgM. Conversion of ANAs from IgM to IgG generally precedes the onset of autoimmune disease states. If clinical presentation is inconsistent with the ANA IFA result, consult ARUP for alternative testing.
If ANA IgG is Detected by ELISA, then ANA IgG by IFA (using HEp-2 substrate) will be added. If ANA, IgG by IFA is 1:40 or greater, then a titer and pattern will be reported and dsDNA, IgG by ELISA, RNP, Smith, SSA, and SSB antibodies, IgG will be added. If dsDNA, IgG by ELISA is Detected, then dsDNA by IFA titer (using Crithidia luciliae) will be added. Additional charges apply.
Specimens are screened for ANA using ELISA. If the ELISA screen is positive, then an IFA using HEp-2 substrate will be added. If confirmed by IFA, then a titer and pattern will be reported and testing for dsDNA antibody and ENA (RNP, Smith, SSA, and SSB) antibodies will be added. Additional charges apply.
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| CPT Code(s): |
86038; if reflexed, add 86039; if reflexed, add 86235 x4 and 86225; if reflexed, add 86256
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Cross References: |
ANA Reflexive Profile (Anti-Nuclear Antibodies (ANA), IgG by ELISA with Reflexes to ANA, IgG by IFA and to dsDNA, RNP, Smith, SSA, and SSB Antibodies, IgG)
, Connective Tissue Disease (Anti-Nuclear Antibodies (ANA), IgG by ELISA with Reflexes to ANA, IgG by IFA and to dsDNA, RNP, Smith, SSA, and SSB Antibodies, IgG)
, Rheumatic Disease (Anti-Nuclear Antibodies (ANA), IgG by ELISA with Reflexes to ANA, IgG by IFA and to dsDNA, RNP, Smith, SSA, and SSB Antibodies, IgG)
, Systemic Lupus Erythematosus (SLE) (Anti-Nuclear Antibodies (ANA), IgG by ELISA with Reflexes to ANA, IgG by IFA and to dsDNA, RNP, Smith, SSA, and SSB Antibodies, IgG)
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