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Antinuclear Antibodies (ANA), IgG by ELISA with Reflex to ANA HEp-2 Substrate, IgG by IFA and ENA Confirmation
0050317
Ordering Recommendation

Aids in initial diagnosis of connective tissue disease.

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
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
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 May 18, 2015 
Test Number
Components
Reference Interval
Antinuclear Antibodies (ANA), IgG by ELISANone Detected
3000082Antinuclear Antibody (ANA) with HEp-2 Substrate, IgG by IFALess than 1:80
Double-Stranded DNA (dsDNA) Antibody, IgG by ELISANone Detected
2002693Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidia luciliae)Less than 1:10
0050470RNP (U1) (Ribonucleic Protein) (ENA) Antibody, IgG
29 AU/mL or lessNegative
30-40 AU/mLEquivocal
41 AU/mL or greaterPositive

0050085Smith (ENA) Antibody, IgG
29 AU/mL or lessNegative
30-40 AU/mLEquivocal
41 AU/mL or greaterPositive

2012074SSA 52 and 60 (Ro) (ENA) Antibodies, IgG
Test Number
Components
Reference Interval
SSA-52 (Ro52) (ENA) Antibody, IgG29 AU/mL or Less: Negative
30-40 AU/mL: Equivocal
41 AU/mL or greater: Positive
SSA-60 (Ro60) (ENA) Antibody, IgG29 AU/mL or Less: Negative
30-40 AU/mL: Equivocal
41 AU/mL or greater: Positive

0050692SSB (La) (ENA) Antibody, IgG
29 AU/mL or lessNegative
30-40 AU/mLEquivocal
41 AU/mL or greaterPositive

0099592Jo-1 Antibody, IgG
29 AU/mL or lessNegative
30-40 AU/mLEquivocal
41 AU/mL or greaterPositive

0050599Scleroderma (Scl-70) (ENA) Antibody, IgG
29 AU/mL or lessNegative
30-40 AU/mLEquivocal
41 AU/mL or greaterPositive


Interpretive Data
Antinuclear 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 than ANA IFA for systemic autoimmune rheumatic diseases (SARD).

Negative results do not necessarily rule out SARD.

Note
ANA lacks diagnostic specificity, and is associated with in variety diseases (cancers, autoimmune, infectious, and inflammatory conditions) and occurs in healthy individuals in varying prevalence. The lack of diagnostic specificity requires confirmation of positive ANA by more-specific serologic tests, which may be guided by the pattern(s) observed.

Specimens are screened for ANA using ELISA. If ANA IgG is detected by ELISA, then Antinuclear Antibody (ANA), HEp-2, IgG by IFA will be added. If ANA, IgG by IFA is confirmed positive with a titer of 1:80 or greater, then a titer and pattern will be reported. In addition, samples positive for ANA, IgG by IFA will reflex to Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA, Jo-1 Antibody, IgG, RNP (U1) (Ribonucleic Protein) (ENA) Antibody, IgG, Scleroderma (Scl-70) (ENA) Antibody, IgG, Smith (ENA) Antibody, IgG, SSA 52 and 60 (Ro) (ENA) Antibodies, IgG, and SSB (La) (ENA) Antibody, IgG. If Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA is detected, then Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidia luciliae) will be added. Additional charges apply.

ANA determined by indirect fluorescence assay (IFA) use HEp-2 substrate and IgG-specific conjugate at a screening dilution of 1:80. If positive, patterns reported include homogeneous, speckled, centromere, nucleolar, nuclear dots, or cytoplasmic. All positive results are reported with endpoint titers.
Hotline History
View Hotline History
CPT Code(s)
86038; if reflexed, add 86039; if reflexed, add 86235 x7 and 86225; if reflexed, add 86256
Components
Component Test Code*Component Chart NameLOINC
0050080Anti-Nuclear Ab (ANA), IgG by ELISA29950-3
* 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
  • 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