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HLA-B*1502 Genotyping (Carbamazepine) Test

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HLA-B*1502 Genotyping (Carbamazepine) Test

Short Name: HLA-B*1502 Genotyping

Also known as: HLA-B*1502 Testing, Carbamazepine Hypersensitivity Genotyping, HLA-B*1502 Pharmacogenomic Test, SJS/TEN Risk Genotyping, HLA-B*15:02 Allele Detection

HLA-B*1502 Genotyping (Carbamazepine) Test test available at DNA Labs India for ₹5,250. Uses Sanger Sequencing on Peripheral Blood samples. Results in Results are typically available within 10 working days from the date of sample collection.. Free home collection in 300+ cities across India.

Genetic🏠 Home Collection

🩺 Medically Reviewed By

Overview

The primary purpose of HLA-B*1502 genotyping is to identify individuals who carry the HLA-B*1502 allele before they are prescribed carbamazepine. Carriers of this allele have a significantly higher risk of developing Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), which are severe, potentially fatal skin reactions. By identifying at-risk individuals through this genetic test, healthcare providers can make informed decisions to prescribe alternative medications, thereby preventing life-threatening adverse drug reactions. This test is a cornerstone of personalized medicine and pharmacogenomic-guided prescribing.

Test Code
3050
CPT Code
81381
ICD Code
Z13.89
Price
₹5,250
Sample Type
Peripheral Blood
Result Time
Results are typically available within 10 working days from the date of sample collection.
Fasting Required
No
Method
Sanger Sequencing
Step 1

Sample Collection

No special preparation or fasting is required for this test. A valid doctor's prescription may be needed. Please carry a government-issued photo ID and the prescription to the sample collection center. Inform the phlebotomist about any blood-thinning medications you are currently taking.

Method: Venipuncture

Step 2

Laboratory Analysis

A trained phlebotomist will clean the puncture site on your arm with an antiseptic. A sterile needle will be used to draw approximately 2 mL of blood from a vein, which will be collected into an EDTA vacutainer. The procedure typically takes less than 5 minutes.

Step 3

Report Delivery

After the blood draw, gentle pressure will be applied to the puncture site with a sterile cotton ball or bandage. You may resume normal activities immediately. If you experience prolonged bleeding, excessive bruising, or signs of infection at the puncture site, contact your healthcare provider.

Timeline: Results are typically available within 10 working days from the date of sample collection.

Patient Instructions

1
Before the Test:No special preparation is required. A doctor's prescription may be needed. Carry a valid photo ID and inform the collection center about any medications you are taking, especially blood thinners.
2
During the Test:A small blood sample (approximately 2 mL) will be collected from a vein in your arm into an EDTA vacutainer. The procedure is quick and typically takes less than 5 minutes.
3
After the Test:After blood collection, a bandage will be applied to the puncture site. You can resume normal activities immediately. Results will be available within 10 days via the online portal, email, or WhatsApp.

About This Test

Who Should Get This Test

The primary purpose of HLA-B*1502 genotyping is to identify individuals who carry the HLA-B*1502 allele before they are prescribed carbamazepine. Carriers of this allele have a significantly higher risk of developing Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), which are severe, potentially fatal skin reactions. By identifying at-risk individuals through this genetic test, healthcare providers can make informed decisions to prescribe alternative medications, thereby preventing life-threatening adverse drug reactions. This test is a cornerstone of personalized medicine and pharmacogenomic-guided prescribing.

How to Prepare

  • No fasting is required before sample collection
  • Carry a valid doctor's prescription and government-issued photo ID
  • Inform the phlebotomist of any blood-thinning medications (e.g., warfarin, aspirin)
  • Stay well hydrated before the blood draw
  • Wear loose-fitting sleeves to allow easy access to the arm
  • Avoid strenuous exercise immediately before the blood draw

Doctor's Notes

Reviewed by — MBBS, MD (Medical Genetics) · Reg. No. 8532

"As a neurologist, I routinely prescribe carbamazepine for epilepsy, trigeminal neuralgia, and certain neuropathic pain conditions. HLA-B*1502 genotyping has become an indispensable pre-treatment screening tool, particularly for patients of Indian and South Asian descent where the allele prevalence ranges from 2% to 15% depending on the region and ethnic group. A positive test result guides me to select alternative anticonvulsant medications, potentially preventing a life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis event. I strongly recommend this pharmacogenomic test for all patients before initiating carbamazepine therapy, in accordance with international CPIC and FDA guidelines."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypePeripheral Blood
Sample Volume2 mL
ContainerEDTA Vacutainer (2 mL)
Collection MethodVenipuncture

Sample Stability

EDTA whole blood: Stable at 2–8°C for up to 7 days
Room temperature (15–25°C): Stable for up to 24 hours
Do not freeze whole blood samples
Sample Rejection Criteria:
  • Hemolyzed or clotted blood sample
  • Insufficient sample volume (less than 1 mL)
  • Unlabeled or mislabeled specimen
  • Sample received beyond the stability period
  • Leaking or damaged vacutainer
  • Sample collected in incorrect anticoagulant tube

Understanding Your Results

The HLA-B*1502 genotyping test reports whether the HLA-B*1502 allele is detected (positive) or not detected (negative) in the patient's DNA. The result helps clinicians assess the genetic risk of carbamazepine-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) before initiating therapy.
📊

Positive (HLA-B*1502 Detected)

The individual carries the HLA-B*1502 allele, which is associated with a significantly increased risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) when exposed to carbamazepine. Current clinical guidelines recommend that carbamazepine should generally not be used in HLA-B*1502-positive individuals unless the expected clinical benefit clearly outweighs the risk. The treating physician should consider alternative medications such as oxcarbazepine (with caution), valproate, lamotrigine (with its own HLA considerations), or other appropriate anticonvulsants.

📊

Negative (HLA-B*1502 Not Detected)

The individual does not carry the HLA-B*1502 allele. The risk of carbamazepine-induced SJS/TEN is significantly lower compared to HLA-B*1502 carriers. However, a negative result does not completely eliminate the risk of all cutaneous adverse reactions, as other HLA alleles (such as HLA-A*3101) and non-genetic factors may also contribute. Clinical monitoring during carbamazepine therapy is still recommended, and patients should be advised to report any skin rashes, blisters, or mucosal symptoms immediately.

⚠️ When to Consult a Doctor:

Consult your doctor if you test positive for HLA-B*1502 before starting or continuing carbamazepine therapy. If you are currently taking carbamazepine and develop any skin rash, blisters, peeling skin, sores in the mouth or eyes, or flu-like symptoms, seek immediate medical attention as these may be early signs of Stevens-Johnson syndrome or toxic epidermal necrolysis. Always discuss your test results with a qualified healthcare provider before making any changes to your medication.

Limitations

  • This test only detects the HLA-B*1502 allele and does not identify other genetic variants associated with carbamazepine hypersensitivity (e.g., HLA-A*3101)
  • A negative result does not completely eliminate the risk of SJS/TEN with carbamazepine use
  • Other HLA alleles and non-genetic factors may also contribute to carbamazepine-related adverse drug reactions
  • This test is not a diagnostic test for SJS/TEN; it is a risk-assessment pharmacogenomic test
  • Clinical correlation and physician judgment remain essential for all treatment decisions

Risks & Considerations

  • Minor pain or discomfort at the blood draw site
  • Small bruise or hematoma at the puncture site
  • Very rare risk of infection at the venipuncture site
  • Lightheadedness or dizziness during or after blood collection

Interfering Factors

  • Contaminated or degraded DNA sample may affect test accuracy
  • Recent blood transfusion (within the past few weeks) may interfere with genotyping results due to the presence of donor DNA
  • Improper sample storage or transport conditions may compromise DNA integrity
  • Hemolyzed or clotted blood samples may yield inconclusive results

Compare With Similar Tests

TestHLA-B*1502 Genotyping (Carbamazepine)HLA-A*3101 Genotyping (Carbamazepine)HLA-B*5801 Genotyping (Allopurinol)HLA-B*5701 Genotyping (Abacavir)Carbamazepine Serum Level Test
ComparisonHLA-B*1502 Genotyping (Carbamazepine)While HLA-B*1502 testing focuses on the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), HLA-A*3101 genotyping assesses the risk of other carbamazepine-related hypersensitivity reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and maculopexanthema. Both tests may be recommended before starting carbamazepine for comprehensive pharmacogenomic risk assessment.Similar to HLA-B*1502 testing for carbamazepine, HLA-B*5801 testing identifies individuals at risk of SJS/TEN when exposed to allopurinol, a medication used for gout. Both are pharmacogenomic tests that guide safer prescribing decisions and are recommended by international guidelines for at-risk populations.HLA-B*5701 testing identifies individuals at risk of hypersensitivity reactions to abacavir, an antiretroviral medication. Like HLA-B*1502 testing, it is a pre-treatment pharmacogenomic screening test recommended to prevent severe adverse drug reactions. All three tests (HLA-B*1502, HLA-B*5801, HLA-B*5701) represent the clinical application of pharmacogenomics in personalized medicine.While HLA-B*1502 genotyping assesses genetic predisposition to adverse reactions before starting carbamazepine, the carbamazepine serum level test measures the actual drug concentration in the blood during therapy. The genotyping test is a one-time pre-treatment assessment, whereas serum level monitoring is performed periodically during treatment to ensure therapeutic drug levels and avoid toxicity.

Frequently Asked Questions

What is HLA-B*1502 genotyping?
HLA-B*1502 genotyping is a pharmacogenomic blood test that detects the presence of the HLA-B*1502 genetic variant in your DNA. This variant is associated with a significantly increased risk of developing Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) when exposed to the medication carbamazepine. The test uses Sanger sequencing to accurately identify whether you carry this allele.
Why is HLA-B*1502 testing important before taking carbamazepine?
Carbamazepine is an effective medication for epilepsy, trigeminal neuralgia, and bipolar disorder, but it can cause severe and potentially life-threatening skin reactions (SJS/TEN) in individuals who carry the HLA-B*1502 allele. Testing before starting the medication allows your doctor to identify your risk level and choose a safer alternative if needed, potentially preventing a life-threatening adverse drug reaction.
Who should get tested for HLA-B*1502?
HLA-B*1502 testing is recommended for anyone who is about to start carbamazepine therapy, particularly individuals of South Asian, Southeast Asian, or East Asian descent, including Indian populations. The allele is found in approximately 2–15% of various Indian ethnic groups. Testing is also recommended for individuals with a family history of SJS/TEN or previous severe skin reactions to anticonvulsant medications.
How is the HLA-B*1502 genotyping test performed?
The test requires a simple blood draw of approximately 2 mL collected in an EDTA vacutainer. The blood sample is sent to the laboratory where DNA is extracted and analyzed using Sanger sequencing to detect the presence or absence of the HLA-B*1502 allele. The entire collection process takes less than 5 minutes.
What does a positive HLA-B*1502 test result mean?
A positive result means you carry the HLA-B*1502 allele, which is associated with a significantly increased risk of developing Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) if you take carbamazepine. Your doctor will likely recommend an alternative medication. A positive result does not mean you currently have SJS/TEN — it indicates a genetic predisposition to a severe drug reaction.
What does a negative HLA-B*1502 test result mean?
A negative result means the HLA-B*1502 allele was not detected in your DNA. This indicates that your risk of carbamazepine-induced SJS/TEN is significantly lower. However, a negative result does not completely eliminate all risk of adverse reactions, as other genetic and non-genetic factors may still contribute. Your doctor will still monitor you during carbamazepine therapy.
Is the HLA-B*1502 allele common in India?
Yes, the HLA-B*1502 allele is found at relatively higher frequencies in Indian populations compared to European populations. The prevalence varies by ethnic group and geographic region within India, generally ranging from approximately 2% to 15%. This makes HLA-B*1502 testing particularly relevant for Indian patients who are being considered for carbamazepine therapy.
Can I take carbamazepine if I test positive for HLA-B*1502?
Current clinical guidelines, including those from the FDA and CPIC, recommend that carbamazepine should generally not be prescribed to individuals who test positive for HLA-B*1502, unless the expected clinical benefit clearly outweighs the significant risk of SJS/TEN. Your doctor will discuss alternative medications such as valproate, levetiracetam, or other appropriate options based on your specific medical condition.
How long does it take to get the HLA-B*1502 test results?
Results for HLA-B*1502 genotyping are typically available within 10 working days from the date of sample collection. Results can be accessed through the online portal, received via email, or delivered through WhatsApp for your convenience.
Is fasting required for the HLA-B*1502 genotyping test?
No, fasting is not required for this test. Since it is a genetic test that analyzes DNA from your blood cells, food intake does not affect the results. You can eat and drink normally before the blood draw. However, staying well-hydrated is recommended to make the blood collection process smoother.
Is the HLA-B*1502 genotyping test covered by insurance or government health schemes?
Coverage for HLA-B*1502 genotyping varies depending on your insurance policy and the specific government health scheme. Currently, this test may not be explicitly covered under schemes like PMJAY, CGHS, ECHS, or ESIC. It is advisable to check directly with your insurance provider or the relevant health scheme authority for coverage eligibility. DNA Labs India offers the test at a competitive price of INR 5250.
Can the HLA-B*1502 genotyping test be done at home?
Yes, DNA Labs India offers free home sample collection for HLA-B*1502 genotyping across numerous cities in India, including Mumbai, Delhi, Bangalore, Hyderabad, Chennai, Kolkata, Pune, Ahmedabad, and many more. You can book the test online, and a trained phlebotomist will visit your home to collect the blood sample at a time convenient to you.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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