HLA-B*5701 Typing

Test Code
19774


CPT Codes
81381

Includes
Additional testing by Sequence Based Typing (SBT) may be performed when necessary.


Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube


Minimum Volume
3 mL


Other Acceptable Specimens
Whole blood collected in: sodium heparin (green-top) tube, EDTA (pink-top), EDTA (royal blue-top), or sodium citrate (light blue-top) tube


Instructions
A separate EDTA (lavender-top) tube must be submitted for all HLA testing. If submitted with any other test requiring an EDTA tube, please submit a separate tube for this test. Do not open tube.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen • Clotted


Methodology
Polymerase Chain Reaction (PCR) • Sequence Specific Oligonucleotide Probes (SSO)

FDA Status
Typing performed by using AS-PCR with reflex to the FDA-cleared LABType® SSO Kit. The AS-PCR portion of the test was developed and its performance characteristics have been determined by Quest Diagnostics.

Setup Schedule

Set up: Daily; Report available: 6 days



Limitations
A negative result does not rule out the risk for ABC HSR and clinical vigilance should be maintained regardless of the result. The frequency of HLA/-B5701 is approximately 8% in Caucasians and 2% in African Americans.


Clinical Significance
Abacavir therapy for HIV treatment is associated with significant drug hypersensitivity in approximately 8% of recipients, with retrospective studies indicating a strong association with the HLA-B*5701 Allele. HLA-B*5701 typing can be used for genetic risk stratification prior to initiation of Abacavir therapy.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.