Antiepileptic Drug Safety Panel (HLA-B*15:02 & HLA-A*31:01)

• Pre-treatment Risk AssessmentIdentifies genetically susceptible patients before exposure to Carbamazepine, Oxcarbazepine & PhenytoinPersonalised Drug SelectionProvides pharmacogenetic information that can support selection of appropriate therapy.Prevention-Focused Care

  Helps clinicians identify patients at increased risk of severe drug hypersensitivity before an adverse reaction occurs.

  Evidence-Based Prescribing

  HLA-guided Carbamazepine, Oxcarbazepine & Phenytoin prescribing is supported by international pharmacogenetic recommendations, including CPIC and FDA guidance.

Sample Collection:
A peripheral blood sample is collected in an EDTA tube.

DNA Extraction:
DNA is extracted from the patient’s blood sample.

Allele-Specific PCR:
Targeted PCR is performed to detect HLA-B*15:02 & HLA-A*31:01.

Genetic Analysis:
The amplified targets are analysed to determine the presence or absence of the clinically relevant alleles.

Result Interpretation:
The genotype is interpreted in the context of known drug–gene associations.

Reporting:
A comprehensive report is generated to provide the genetic findings for clinical consideration.

The test reports whether the clinically relevant HLA alleles are detected.

HLA-B*15:02 Not Detected

The patient does not carry the tested HLA-B*15:02 allele. This is associated with a lower genetic risk of Carbamazepine, Oxcarbazepine & Phenytoin induced SJS/TEN compared with carriers but does not eliminate the possibility of an adverse drug reaction.

HLA-A*31:01 Not Detected
The patient does not carry the tested HLA-A*31:01 allele. This is associated with a lower genetic risk of Carbamazepine-induced SJS/TEN, DRESS, MPE compared with carriers but does not eliminate the possibility of an adverse drug reaction.

HLA-B*15:02 Detected

The patient carries the HLA-B*15:02 allele and may have an increased risk of severe cutaneous reactions with Carbamazepine, Oxcarbazepine & Phenytoin. Alternative therapy should be considered according to applicable clinical guidelines and the patient’s individual circumstances.

HLA-A*31:01 Detected

The patient carries an allele associated with increased risk of several Carbamazepine-induced hypersensitivity reactions. CPIC recommends considering alternative therapy in Carbamazepine-naïve patients when appropriate alternatives are available.

Importance

Genetic results should always be interpreted by the treating clinician alongside the patient’s clinical history, ancestry, medications and other relevant factors.