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
622521Useful 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
SerumSpecimen 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 daysSpecimen Retention Time
14 daysPerforming 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 |