RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test
About RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test
| Field | Value |
|---|---|
| Also Known As | AML1-ETO Qualitative Test, t(8;21) Translocation Test, RUNX1-RUNX1T1 Fusion Gene Test, AML1/ETO Translocation Detection |
| Sample Type | Bone marrow aspirate (preferred) or peripheral blood |
| Fasting Required | No fasting required |
| Report Time | 5 days |
| Recommended For | Adults and children with suspected or confirmed acute myeloid leukemia (AML) |
| Price | Starting at ₹4,800 |
What is a RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test?
The RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative test is a specialised molecular test that detects a specific genetic abnormality linked to a type of blood cancer called acute myeloid leukemia (AML). It identifies whether the RUNX1-RUNX1T1 fusion gene, formed by a chromosomal swap between chromosomes 8 and 21, is present or absent in a patient's cells.
Also known as the AML1-ETO test and the RUNX1-RUNX1T1 Fusion Gene test, it is used for diagnosis, classification, and monitoring of AML. The test is performed using bone marrow or peripheral blood samples analysed by Real Time PCR.
What Does a RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test Measure?
The AML1-ETO test procedure uses Real Time PCR technology to examine a patient's genetic material for a specific abnormality. The table below explains what the test looks for.
| Component | What It Means |
|---|---|
| RUNX1-RUNX1T1 fusion gene (AML1-ETO) | An abnormal gene created when part of chromosome 8 swaps with part of chromosome 21. This disrupts normal blood cell development. |
| Qualitative result (Detected or Not Detected) | Confirms whether the fusion gene is present or absent in the sample. |
A positive finding means the t(8;21) translocation is present, which is directly associated with a specific subtype of AML. A negative result means this particular genetic change was not found.
Why is a RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test Done?
A hematologist or oncologist may order this test when a patient shows signs of a blood disorder or when initial blood tests suggest leukemia. The RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test plays a key role in confirming diagnosis and planning treatment.
Common Symptoms That May Require This Test
A doctor may recommend this test when a patient presents with the following symptoms:
- Persistent tiredness and weakness without a clear cause
- Easy bruising or unexplained skin discolouration
- Frequent or prolonged bleeding from gums or nose
- Recurring infections that do not resolve quickly
- Bone pain or tenderness
- Headaches alongside other blood-related symptoms
- Heavy menstrual bleeding in women of reproductive age
Conditions This Test Can Help Detect
This test helps identify the following conditions:
- Acute myeloid leukemia (AML) with t(8;21)(q22;q22)
- AML FAB type M2, the subtype most commonly linked to this translocation
- Core-binding factor AML (CBF-AML), a category of AML that includes t(8;21) cases
RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test for Chronic Disease Monitoring
This test is also used after an AML diagnosis to track how well treatment is working. The RUNX1-RUNX1T1 fusion transcript is a recognised marker for minimal residual disease (MRD), which refers to small numbers of leukemia cells that may remain after treatment. Monitoring MRD helps a doctor detect early signs of relapse. For ongoing MRD tracking, a quantitative version of this test is typically recommended.
How to Prepare and What to Expect
No special preparation is needed before this test. However, there are a few practical steps to keep in mind before your appointment.
Do You Need to Fast?
No, fasting is not required for this test. You may eat and drink normally before sample collection.
Practical Tips Before Your Test
Here are some steps to help your test go smoothly:
- Bring a detailed clinical history, including your symptoms, previous test results, and any relevant medical records, as this is required for the test
- Inform your doctor about all medications you are currently taking, particularly blood thinners
- Carry a valid doctor's prescription for the test
- Arrange for someone to accompany you if a bone marrow sample is being collected, as the procedure may require mild sedation
Step-by-Step Procedure
This test may require either a bone marrow sample or a peripheral blood sample, so the collection process differs by sample type. Your doctor will advise which is appropriate for you.
Bone Marrow Sample Collection:
- The procedure is performed in a hospital or clinical setting. The sample is usually taken from the hip or breastbone.
- The area is cleaned and a numbing medicine is injected into the skin and bone surface. A mild relaxant may also be given.
- A special needle is inserted into the bone, and a small amount of bone marrow fluid is drawn out using suction.
- The site is covered with a dressing, and you will be observed briefly before leaving.
- The sample is refrigerated and sent to the laboratory within 48 hours to preserve RNA quality.
Peripheral Blood Sample Collection:
- A trained phlebotomist cleans a vein in your arm and draws a small blood sample into an EDTA (lavender-top) tube.
- The sample is labelled, stored at refrigeration temperature (2 to 8 degrees Celsius), and dispatched to the laboratory promptly.
- Real Time PCR analysis is carried out in a specialised molecular laboratory to check for the fusion gene.
Factors That Can Affect Accuracy
The following factors may affect the reliability of your test result:
- Delay in sample processing beyond 48 hours, as RNA degrades quickly
- Incorrect storage temperature during transport
- Insufficient sample volume collected
- Poor RNA extraction quality in the laboratory
- Certain medications that may affect cell counts or gene expression
Understanding Your RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test Results
Results from this test are reported as either "Detected" or "Not Detected." A qualified hematologist or oncologist should always interpret these findings in the context of your full clinical picture.
| Result | Interpretation |
|---|---|
| Not Detected (Negative) | The t(8;21) translocation was not found. This does not completely rule out other types of leukemia or blood disorders. |
| Detected (Positive) | The RUNX1-RUNX1T1 fusion gene is present. In a patient with bone marrow pathology, this finding alone can confirm an AML diagnosis. |
A positive result with the t(8;21) translocation is generally associated with a more favourable prognosis compared to other AML subtypes. However, the presence of additional mutations, particularly KIT mutations, may affect outcomes.
Disclaimer: These ranges are general guidelines. Your doctor will interpret your results based on your age, health history, and other factors. Always consult a qualified healthcare professional for personalised medical advice.
Results During Special Conditions
Certain factors may influence how results are interpreted:
A high white blood cell count (above 20 × 10⁹/L) at diagnosis is generally considered an unfavourable prognostic sign in t(8;21) AML, even when the fusion gene is detected. KIT mutations, particularly the D816 mutation, are associated with a higher risk of relapse and reduced survival in adults with t(8;21) AML. Your doctor may recommend additional testing for these mutations.
Managing Your Health After Testing
This is a diagnostic test for a specific genetic abnormality; lifestyle changes cannot alter the result. The following general points may support your overall wellbeing during this period:
- Attend all follow-up appointments with your hematologist or oncologist as scheduled
- Maintain a balanced diet and adequate hydration to support general health during treatment
- Report any new or worsening symptoms to your doctor promptly
Lupin Diagnostics RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test Price
The AML1-ETO test cost at Lupin Diagnostics starts at ₹4,800. This test requires a bone marrow aspirate or peripheral blood sample collected by a healthcare professional and submitted for laboratory analysis.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 4800 |
| CHENNAI | 4800 |
| HYDERABAD | 4800 |
| KOLKATA | 4800 |
| NAVI MUMBAI | 4800 |
| PUNE | 4800 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps to book your AML1-ETO test online booking with Lupin Diagnostics:
- Select the test on the Lupin Diagnostics website
- Choose your city and preferred centre location
- Arrange for sample collection as advised by your treating doctor or healthcare facility
- Receive your report via email or WhatsApp within the stipulated turnaround time
Frequently Asked Questions
The RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative test is a molecular diagnostic test that checks for a specific genetic abnormality called the AML1-ETO fusion gene. This abnormality results from a swap of genetic material between chromosomes 8 and 21 and is associated with a particular subtype of acute myeloid leukemia. The test is performed using Real Time PCR on bone marrow or peripheral blood samples.
The AML1-ETO test procedure involves collecting either a bone marrow aspirate or a peripheral blood sample. Bone marrow collection is done in a clinical setting under local anesthesia, while a blood draw follows a standard venepuncture approach. The sample is then analysed in a specialised molecular laboratory using Real Time PCR to detect the presence or absence of the fusion gene.
No fasting is required before the RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative test. You can eat and drink as normal before your appointment. However, bring your clinical history and any previous medical records, as these are required for the test.
A positive or "Detected" result means the RUNX1-RUNX1T1 fusion gene is present in your cells. In a patient with bone marrow pathology, this finding can confirm a diagnosis of AML with the t(8;21) translocation. This subtype is generally associated with a better prognosis than many other AML types, though your oncologist will consider your full results before advising on next steps.
The qualitative test simply reports whether the fusion gene is present or absent. A quantitative test measures how much of the fusion transcript is present in the sample. Quantitative testing is typically used to monitor treatment response and track minimal residual disease over time, rather than for initial diagnosis.
The AML1-ETO test cost at Lupin Diagnostics starts at ₹4,800. Prices may vary depending on the city and centre. It is advisable to confirm the current price when booking. Results are typically available within 5 days.
Yes. The RUNX1-RUNX1T1 fusion transcript is a recognised marker for minimal residual disease monitoring in AML patients who have this translocation. Regular monitoring helps detect early signs of relapse. For ongoing post-treatment monitoring, a hematologist may recommend the quantitative version of this test rather than the qualitative one.
RUNX1-RUNX1T1 (AML1-ETO) t(8;21) Qualitative Test
