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Test Code RAIFA Antinuclear Antibodies, HEp-2 Substrate, IgG, with Reflex, Serum


Ordering Guidance


This algorithm is recommended for the initial evaluation of patients at risk for systemic lupus erythematosus, mixed connective tissue disease, and Sjogren syndrome.



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: 0.7 mL

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


Secondary ID

622521

Useful For

Evaluation of patients suspected of having systemic autoimmune rheumatic disease (antinuclear antibody-associated rheumatic diseases or connective tissue diseases), especially systemic lupus erythematosus, mixed connective tissue disease and Sjogren syndrome

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
ADNA1 dsDNA Ab, IgG, S Yes No
RNP RNP Ab, IgG, S Yes No
SCL70 Scl 70 Ab, IgG, S Yes No
SM Sm Ab, IgG, S Yes No
SSA SS-A/Ro Ab, IgG, S Yes No
SSB SS-B/La Ab, IgG, S Yes No

Testing Algorithm

If human epithelial type 2 (HEp-2) indirect immunofluorescence assay (IFA) result is positive with a titer of 1:80 or greater, then a titer and pattern will be reported.

 

If positive for a homogeneous, speckled, or dense fine speckled pattern, then reflex confirmatory testing for double-stranded DNA antibodies (Ab), ribonucleoprotein Ab, Scl-70 Ab, Sm Ab, SS-A/Ro Ab, or SS-B/La Ab will be performed at an additional charge. If confirmatory tests are negative, consideration for other ANA-associated antibodies may be required for evaluation. Other confirmatory autoantibodies may be performed based on reported patterns or clinical suspicion.

Method Name

Indirect Immunofluorescence Assay (IFA)

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat-treated specimen Reject

Reference Values

<1:80 (negative)

Interpretation

Presence of anti-cellular antibody (also known as antinuclear antibody) is a feature of systemic autoimmune rheumatic diseases such as systemic lupus erythematosus, mixed connective tissue disease, Sjogren syndrome, and systemic sclerosis and some inflammatory myopathies (dermatomyositis, anti-synthetase syndrome and necrotizing autoimmune myopathy). It may also be of diagnostic relevance in patients with autoimmune liver diseases.

 

Patients' sera are screened at 1:80. The following nuclear patterns and their titers are reported: centromere, homogeneous, nuclear dots, nucleolar, speckled, fine dense speckled (also referred to as DFS70), and proliferating cell nuclear antigen (PCNA). If observed, the following cytoplasmic patterns are reported: reticular/AMA (antimitochondrial antibody), cytoplasmic speckled, fibrillar, polar/Golgi-like, or rods and rings. The spindle fiber and centrosome mitotic patterns are also reported if observed. Reported patterns may help guide differential diagnosis, although they may not be specific for individual antibodies or diseases. Negative results do not necessarily rule out systemic autoimmune rheumatic disease.

 

The anti-cellular antibody test lacks diagnostic specificity and is associated with some cancers, infectious, and inflammatory conditions, with variable prevalence in healthy individuals. The lack of diagnostic specificity requires confirmation of positive results using associated antibody tests such as those targeting extractable nuclear antigens.

Method Description

Antibodies to nuclear antigens in a human epithelial type 2 (HEp-2) cell line by an indirect immunofluorescent technique. Commercial slides prepared from HEp-2 cells are used as a substrate. IgG antibodies in serum specimens are detected after incubation of serum with the commercial slides by the addition of a fluorescein isothiocyante (FITC)-labeled antihuman-IgG reagent. All patient specimens are initially screened at 1:80.(Package insert: NOVA Lite DAPI ANA. Inova Diagnostics; 06/2018)

Day(s) Performed

Monday through Saturday

Report Available

3 to 4 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86039

LOINC Code Information

Test ID Test Order Name Order LOINC Value
RAIFA Antinuclear Ab, HEp-2,with reflex,S 59069-5

 

Result ID Test Result Name Result LOINC Value
ANAH Antinuclear Ab, HEp-2 Substrate, S 59069-5
1TANA ANA Titer: 33253-6
1PANA ANA Pattern: 49311-4
2TANA ANA Titer 2: 33253-6
2PANA ANA Pattern 2: 49311-4
CYTQL Cytoplasmic Pattern: 55171-3
LCOM Lab Comment: 77202-0
IM_04 Antinuclear Ab,HEp-2,reflex Comment 77202-0