HLA-A*31:01, HLA-B*15:02, HLA-B*57:01 rs2395029 (LD), and HLA-B*58:01 Genotyping

HLA-A and HLA-B (major histocompatibility complex, class I, A and B) are closely related proteins in the human leukocyteantigen (HLA) complex. They play major roles in the immune system and are found on nearly every cell. Carriers of certain polymorphisms, such as HLA-A*31:01, HLA-B*15:02, HLA-B*57:01 rs2395029 (LD), and HLA-B*58:01, are at risk for severe hypersensitivity when given certain medications, including abacavir, allopurinol, phenytoin and carbamazepine.


Indications for Testing

Testing prior to initiating commonly impacted drugs to identify patients at high risk for severe drug-induced hypersensitivity reactions should be considered for individuals with a personal or family history of adverse drug effects to carbamazepine, abacavir or allopurinol. Confirm the presence of genotypes that affect the sensitivity to specific medications.

Patients initiating carbamazepine therapy may benefit from HLA-A*3101 testing. All patients of Asian ethnicity should be tested for the HLA-B*15:02 allele prior to carbamazepine, phenytoin and fosphenytoin administration. Patients of all ethnicities should be tested for HLA-B*57:01 rs2395029 (LD) prior to abacavir administration due to incidence of hypersensitivity. All patients should be tested for HLA-B*58:01 prior to allopurinol therapy due to severe cutaneous reactions. Assessment of medical necessity for testing is up to the provider’s clinical judgment.


Insurance Coverage

HLA-A*31:01, HLA-B*15:02, HLA-B*57:01 rs2395029 (LD) and HLA-B*58:01 testing are covered by Medicare and most private insurance providers. The CPT codes for HLA-A*31:01, HLA-B*15:02, HLA-B*57:01 and HLA-B*58;01 Mutation DNA Analysis are 81370-81383 (provided  as guidance only).


Specimen Collection

Click here to order testing supplies or call Client Services at 800-837–8362. 

  • Buccal Swabs: 4 sterile buccal swabs
  • Blood: 5-10cc whole blood lavender-top EDTA or yellow-top ACD-A tubes

Turnaround Time: 7 business days, faster turnaround available for clinical trials