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HLA-B*15:02 Determination
Test Code12341
CPT Codes
81381
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) tube, EDTA (royal blue-top) tube, or sodium citrate (light blue-top) tube
Instructions
If submitted with any other tests, please submit separate tube for this test. Do not open tube or split sample.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Refrigerated: 7 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen • Clotted
Methodology
Polymerase Chain Reaction Amplification • Sequence Specific Oligonucleotide Probes
Setup Schedule
Set up: Daily; Report available: 8 days
Reference Range
See Laboratory Report
Clinical Significance
The presence of HLA-B*15:02 increases risk for Carbamazepine (CBZ) induced Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). HLA-B*15:02 allele frequency varies by ethnicity, it as high as 10% in Asians, 0.1-1% in African Americans and less than 0.1 percent in Caucasians. FDA-approved labeling recommends screening for HLA-B*15:02 prior to treatment with CBZ in patients of Asian ancestry. Carbamazepine is an antiepileptic drug, approved for the treatment of epilepsy, trigeminal neuralgia, and bipolar disorder.
References:
1. Phillips, EJ., Clin Pharmacol Ther. 2018 Apr;103(4): 574-581
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf. Accessed Dec 16, 2021.
References:
1. Phillips, EJ., Clin Pharmacol Ther. 2018 Apr;103(4): 574-581
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021710s11s012lbl.pdf. Accessed Dec 16, 2021.
