Not a diagnostic test for ankylosing spondylitis, juvenile rheumatoid arthritis, or Reiter syndrome. May assist in the diagnosis of these conditions only if other clinical signs and symptoms are present.
Qualitative Flow Cytometry
Lavender Hemogard (EDTA), pink Hemogard (K2EDTA), or green Hemogard (sodium or lithium heparin). Hemogard tubes are preferred for laboratory safety.
Transport 4 mL whole blood. (Min: 0.5 mL)
CRITICAL ROOM TEMPERATURE.
Frozen or refrigerated specimens. Specimens older than 72 hours. Clotted or hemolyzed specimens.
New York State Clients: Frozen or refrigerated specimens. Heparin specimens older than 48 hours or EDTA specimens older than 30 hours. Clotted or hemolyzed specimens.
Specimens must be analyzed within 72 hours of collection.
New York State Clients: EDTA specimens must be analyzed within 30 hours of collection. Heparin specimens must be analyzed within 48 hours of collection.
Ambient: 72 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
New York State Clients: Ambient: 30 hours in EDTA, 48 hours in heparin; Refrigerated: Unacceptable; Frozen: Unacceptable
HLA-B27 is a serologically-defined allele of the human HLA-B locus. The presence of the HLA-B27 antigen is strongly associated with ankylosing spondylitis and related disorders.
The performance characteristics of this test were determined by ARUP Laboratories, Inc.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
Indeterminate Results: The Anti-HLA-B27 antibody (clone GS145.2) used in the HLA-B27 assay can cross-react with some other HLA-B locus antigens, creating false-positive results for HLA-B27 expression. Therefore, results falling within the established indeterminate zone will include a recommendation of genotype testing to confirm positive HLA-B27 expression. Order Ankylosing Spondylitis HLA-B27 Genotyping, (ARUP test code 0050392).
|Component Test Code*||Component Chart Name||LOINC|
- Ankylosing Spondylitis
- HLA Antigen B27
- HLA-B27 Antigen