Anti-Nuclear Antibodies (ANA), IgG by ELISA with Reflexes to ANA, IgG by IFA and to dsDNA, RNP, Smith, SSA, and SSB Antibodies, IgG
0050317
Ordering Recommendation
Aids in initial diagnosis of connective tissue disease.
Submit With Order
Mnemonic
ANA REF
Methodology
Qualitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody/Semi-Quantitative Multiplex Bead Assay
Performed
Sun-Sat
Reported
1-5 days
N/A
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 1.0 mL serum to an ARUP Standard Transport Tube. (Min: 0.6 mL)  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
Non-serum specimens. Contaminated, grossly hemolyzed, heat-inactivated, severely lipemic, specimens or inclusion of fibrin clots.  
Remarks
 
Stability
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)  
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
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.
CPT Code(s)
86038; if reflexed, add 86039; if reflexed, add 86235 x4 and 86225; if reflexed, add 86256
Components
Component Test Code*Component Chart Name
0050080Anti-Nuclear Ab (ANA), IgG by ELISA
* 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.
Cross References
  • ANA IgG panel
  • ANA IgG reflex
  • ANA panel
  • ANA reflex
  • ANA Reflexive Profile
  • ANA, dsDNA, RNP, Smith, SSA, SSB IgG
  • Antinuclear Antibody
  • FANA
  • Fluorescent Antinuclear Antibody