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Antinuclear Antibodies (ANA) with Reflex

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Updated Test Information:

Test Description
Antinuclear Antibodies (ANA) with Reflex
Synonym(s)

dsDNA, Connective Tissue Disease
Test ID
ANA
General Information

Antinuclear antibodies (ANA) are specific serological markers for the diagnosis and disease management of patients with connective tissue diseases (CTD). Smith antibodies are highly specific, although insensitive, clinical markers for systemic lupus erythematosus (SLE). U1-RNP antibodies are used to diagnosis SLE and mixed connective tissue disease (MCTD). RNP 70 antibodies are more specific for MCTD. U1RNP antibodies in the absence of RNP 70 may indicate SLE. SS-A/Ro antibodies can be a marker for SLE and Sjögren’s syndrome. SS-B/La antibodies are highly specific clinical markers for Sjögren’s syndrome, but a small proportion of patients can remain SS-B/La negative. CENP antibodies are found in patients with CREST Syndrome. Scl-70 antibodies are characteristic and specific for scleroderma. Jo-1 antibodies can be found as markers in polymyositis, dermatomyositis and intestinal pneumonitis. Assay results should be used in conjunction with clinical findings and other serological tests. In accordance with the ACR classification, the EliA ANA screen correlates with alternative methods for detection and contains these antigens; U1RNP (RNP 70, A, C), SSA/Ro (60 kDa, 52 kDa), SSB/La, Centromere B, Scl-70, Jo-1 proteins, and native purified Sm proteins.
Specimen Type

Serum
Alternate Specimen Type

Plasma (EDTA or Citrate)
Specimen Requirements

Tiger
Minimum Sample Volume

2 mL
Pediatric Min. Volume (if applicable)

1 mL
Additional Processing Details

Heparin interferes with the measurement of Smith antibodies.
Caution: Serum/plasma samples are not to be repeatedly frozen and thawed, since this can cause analyte deterioration. They are to be thawed only once.
Stability

Stored at 22˚C: 8 hrs
Stored at 2-8˚C: 48 hrs
If assays are not completed within 48 hrs or the specimen is to be stored beyond 48 hrs, the serum/plasma should be frozen at or below -20˚C.
Unacceptable Specimen Conditions

Lipemic, hemolyzed or microbially contaminated samples.
Methodology

Fluorescent enzyme immunoassay (FEIA)
Estimated TAT

2-5 days
Testing Schedule

Monday-Saturday, alternating days
Test Includes

ANA Screen
dsDNA IgG
CPT Code(s)

86038
86225
Reference Range
  Negative Equivocal Positive               
ANA IgG <0.70 0.7-1.0 >1.0    Ratio
dsDNA  IgG <10 10-15 >15     IU/ml
Reflex Conditions

If Antinuclear Antibodies (ANA) is positive, an ENA Reflex Panel will be performed. The ENA Reflex Panel includes: SmDp IgG, U1RNP IgG, RNP 70 IgG, Scl-70s IgG, Jo-1 IgG, CENPB IgG, SSA/Ro IgG, and SSB/La IgG.
Performing Lab

Incyte Diagnostics
LOINC Code(s)

5047-6