Antinuclear Antibody (ANA) with HEp-2 Substrate, IgG by IFA with Reflex by Pattern
Also known as: ANA AB PAT
Use
The Antinuclear Antibody (ANA) test is used as an initial screening for systemic autoimmune rheumatic diseases, which include conditions such as systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). It detects the presence of antinuclear antibodies that are a hallmark feature of these diseases. Positive results from ANA testing help guide further testing and diagnosis as ANAs are associated with a variety of autoimmune diseases and some healthy individuals. Reflexive tests are performed based on initial screening results to further narrow down specific antibody profiles linked to different rheumatic conditions.
Special Instructions
ANA testing begins with screening using IFA and IgG-specific conjugates. Depending on findings, tests may reflex automatically to analyze specific antibody patterns. The test is performed daily, with reporting ranging from 1 to 8 days.
Limitations
ANA lacks diagnostic specificity and is associated with a variety of conditions beyond autoimmune diseases, including cancers and infectious diseases. Negative results do not rule out systemic autoimmune rheumatic diseases. Positive patterns identified need specific serologic tests for confirmation. Variability in patterns observed in patients may not necessarily correlate with specific diseases or antibodies, thus emphasizing the need for clinical correlation and additional confirmatory tests.
FDA ApprovedNew York Approved
Methodology
Immunoassay (Multiplex Bead Assay)
Biomarkers
LOINC Codes
- 21424-7
- 49311-4
Result Turnaround Time
1-8 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2 mL
Minimum Volume
1.0 mL
Container
ARUP Standard Transport Tube
Collection Instructions
Separate from cells ASAP or within 2 hours of collection.
Storage Instructions
Refrigerated.
Causes for Rejection
Non-serum specimens. Contaminated, grossly hemolyzed, heat-inactivated, severely lipemic specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 48 hours |
| Refrigerated | 2 weeks |
| Frozen | 1 year (avoid repeated freeze/thaw cycles) |