AML ETO t(8;21) Gene Rearrangement PCR Qualitative Test
Short Name: AML-ETO PCR
Also known as: AML1-ETO t(8;21) Gene Rearrangement Test, RUNX1-RUNX1T1 Fusion Gene PCR Test, Core Binding Factor AML Molecular Test, t(8;21) Translocation Qualitative PCR
AML ETO t(8;21) Gene Rearrangement PCR Qualitative Test test available at DNA Labs India for ₹6,000. Uses Real Time PCR (Polymerase Chain Reaction) on Whole blood or Bone marrow aspirate samples. Results in Reports are available within 48 hours from sample receipt. Samples collected on Monday (by 11 AM) will have reports by Wednesday. Samples collected on Thursday (by 11 AM) will have reports by Saturday.. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr SHAILAJA RAGHUNATH MURDESHWAR
Consultant Physician · Reg: 8052
Last reviewed: September 7, 2026
Overview
The primary purpose of this test is to detect the AML-ETO (RUNX1-RUNX1T1) fusion gene resulting from the t(8;21)(q22;q22) chromosomal translocation in patients with suspected or confirmed Acute Myeloid Leukemia. This molecular confirmation aids in sub-classifying AML, determining prognosis, guiding treatment decisions, and monitoring for minimal residual disease during and after therapy. The qualitative result indicates the presence or absence of the fusion transcript and is a critical component of the comprehensive diagnostic workup recommended by international haematology guidelines.
- Test Code
- 108
- ICD Code
- C92.0
- Price
- ₹6,000
- Sample Type
- Whole blood or Bone marrow aspirate
- Result Time
- Reports are available within 48 hours from sample receipt. Samples collected on Monday (by 11 AM) will have reports by Wednesday. Samples collected on Thursday (by 11 AM) will have reports by Saturday.
- Fasting Required
- No
- Method
- Real Time PCR (Polymerase Chain Reaction)
Sample Collection
No special preparation such as fasting is required. Patients should inform their physician about any recent blood transfusions, medications, or ongoing treatments. Maintain adequate hydration for easier venipuncture.
Method: Venipuncture (whole blood) or Bone marrow aspiration
Laboratory Analysis
A trained phlebotomist or haematologist will collect approximately 3 mL of whole blood via venipuncture into a Lavender Top (EDTA) tube. If bone marrow is required, the sample will be collected by a specialist via bone marrow aspiration, typically from the posterior iliac crest.
Report Delivery
Apply gentle pressure to the puncture site with sterile gauze for a few minutes to prevent bruising. There are no significant restrictions following blood collection. If a bone marrow aspirate was taken, follow the physician's post-procedure instructions regarding activity and wound care.
Timeline: Reports are available within 48 hours from sample receipt. Samples collected on Monday (by 11 AM) will have reports by Wednesday. Samples collected on Thursday (by 11 AM) will have reports by Saturday.
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of this test is to detect the AML-ETO (RUNX1-RUNX1T1) fusion gene resulting from the t(8;21)(q22;q22) chromosomal translocation in patients with suspected or confirmed Acute Myeloid Leukemia. This molecular confirmation aids in sub-classifying AML, determining prognosis, guiding treatment decisions, and monitoring for minimal residual disease during and after therapy. The qualitative result indicates the presence or absence of the fusion transcript and is a critical component of the comprehensive diagnostic workup recommended by international haematology guidelines.
How to Prepare
- Collect 3 mL (minimum 2 mL) of whole blood or bone marrow aspirate in a Lavender Top (EDTA) tube
- Label the specimen clearly with patient name, date of birth, and sample ID
- Ship the sample refrigerated (2–8°C) to the laboratory
- DO NOT FREEZE the sample at any point
- Ensure the sample reaches the laboratory within the specified stability window
- Sample collection is scheduled: Monday or Thursday by 11:00 AM
Doctor's Notes
Reviewed by Dr SHAILAJA RAGHUNATH MURDESHWAR — MBBS, MD (General Medicine) · Reg. No. 8052
"The AML-ETO t(8;21) translocation is one of the most common cytogenetic abnormalities in Acute Myeloid Leukemia, found in approximately 5–12% of AML cases. Detection of this rearrangement by qualitative PCR provides critical information for risk stratification. Patients harbouring t(8;21) are generally classified as having a favourable-risk AML according to ELN guidelines, which may influence decisions regarding consolidation chemotherapy and allogeneic stem cell transplantation. This test is recommended at diagnosis and during follow-up to assess molecular remission status."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Haemolysed, clotted, or insufficient sample volume
- Sample collected in an incorrect tube type (non-EDTA)
- Sample received frozen
- Sample exceeds the maximum stability duration
- Unlabelled or mislabelled specimens
- Leaked or damaged sample containers
Understanding Your Results
Detected
The presence of the AML-ETO (RUNX1-RUNX1T1) fusion transcript confirms the t(8;21)(q22;q22) chromosomal translocation. This finding is consistent with a diagnosis of AML with recurrent genetic abnormalities (AML with t(8;21) per WHO classification). Patients with this abnormality are generally classified in the favourable-risk group per ELN 2022 guidelines. Treatment decisions, including the potential avoidance of allogeneic stem cell transplantation in first complete remission, may be influenced by this result.
Action: Consult your haemato-oncologist for personalised treatment planning and risk assessment.
Not Detected
The AML-ETO fusion transcript was not detected in the analysed sample. This may indicate: (a) the patient's AML is driven by a different genetic abnormality, (b) the level of leukaemic cells is below the detection threshold of the assay, or (c) the sample quality was suboptimal. A negative result does not rule out AML.
Action: Discuss the complete diagnostic workup results with your physician. Additional molecular and cytogenetic testing may be recommended.
Consult a haemato-oncologist or haematologist if the test result is positive (Detected) to discuss prognosis, treatment planning, and the need for additional molecular testing or monitoring. If the test is negative but clinical suspicion for AML remains high, consult your physician regarding further investigations such as conventional cytogenetics, FISH, comprehensive molecular panels, or repeat testing.
Limitations
- ⚠This is a qualitative test; it detects the presence or absence of the fusion transcript but does not quantify the level of the gene rearrangement. For quantitative monitoring, a separate quantitative RT-PCR (qPCR) assay is recommended.
- ⚠A negative result does not exclude AML, as AML can be driven by numerous other genetic abnormalities.
- ⚠False negatives may occur if the fusion transcript level is below the analytical sensitivity threshold of the assay.
- ⚠This test specifically detects the t(8;21) rearrangement; other AML-associated translocations such as inv(16), t(15;17), or MLL rearrangements require separate testing.
- ⚠Results should always be interpreted in conjunction with clinical findings, morphological evaluation, immunophenotyping, and conventional cytogenetics.
Risks & Considerations
- ●Minor bruising or discomfort at the venipuncture site
- ●Slight risk of infection at the puncture site (extremely rare)
- ●If bone marrow aspirate is collected, risks include localised pain, bleeding, or infection at the aspiration site (uncommon when performed by an experienced specialist)
Interfering Factors
- ●Haemolysed or improperly stored blood/bone marrow specimens may affect RNA quality and test reliability
- ●Recent blood transfusions may dilute leukaemic cells and reduce sensitivity
- ●Samples stored beyond the recommended stability window may yield inaccurate results
- ●Excessive sample contamination during collection or transport
Compare With Similar Tests
| Test | AML ETO t(8;21) Gene Rearrangement PCR Qualitative Test | Conventional Cytogenetics (Karyotyping) | FISH for t(8;21) | Next Generation Sequencing (NGS) Panel |
|---|---|---|---|---|
| Comparison | AML ETO t(8;21) Gene Rearrangement PCR Qualitative Test | Karyotyping visualises chromosomal abnormalities including t(8;21) but requires dividing cells and has lower sensitivity (typically 5–10% detection threshold). PCR is faster and more sensitive for detecting the specific fusion transcript. | FISH (Fluorescence In Situ Hybridisation) can detect the translocation at the DNA level in interphase cells with moderate sensitivity. PCR detects the actual fusion transcript at the RNA level and offers higher analytical sensitivity for minimal residual disease monitoring. | Comprehensive NGS panels can detect t(8;21) along with numerous other mutations (e.g., KIT, FLT3, CEBPA). NGS provides broader genomic profiling but may have longer turnaround times and higher costs compared to targeted PCR. |
Frequently Asked Questions
What is the AML ETO t(8;21) Gene Rearrangement PCR Qualitative Test?
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What sample is required for this test?
How much does the AML ETO t(8;21) Gene Rearrangement PCR Qualitative Test cost?
Is fasting required before this test?
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What does a positive (Detected) result mean?
What does a negative (Not Detected) result mean?
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What is the difference between a qualitative and quantitative PCR test for AML-ETO?
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