t(9;11) (p21-22;q23) (MLL-AF9) PCR Qualitative Test
Short Name: MLL-AF9 PCR Qualitative
Also known as: MLL-AF9 Fusion Gene Test, t(9;11) Translocation Test, MLL-AF9 RT-PCR Test, MLL Gene Rearrangement Test, KMT2A-MLLT3 Fusion Test
t(9;11) (p21-22;q23) (MLL-AF9) PCR Qualitative Test test available at DNA Labs India for ₹5,000. Uses Real Time PCR (RT-PCR) on Whole blood or Bone marrow samples. Results in Sample collected Mon/Thu before 11 AM; Report available Wed/Sat. Free home collection in 300+ cities across India.
🩺 Medically Reviewed By
Dr SULOCHANA HEMCHANDRA HOLLA
Consultant Medical Geneticist · Reg: 8532
Last reviewed: September 7, 2026
Overview
The primary purpose of this test is to detect the MLL-AF9 fusion transcript in patients with suspected or confirmed acute leukemia. It supports accurate diagnosis, guides risk-adapted treatment decisions, and serves as a tool for monitoring minimal residual disease (MRD) during and after therapy. The presence of the t(9;11) translocation carries prognostic significance and may influence decisions regarding intensification of chemotherapy or consideration for hematopoietic stem cell transplantation.
- Test Code
- 1418
- CPT Code
- 81172
- ICD Code
- C92.0
- Price
- ₹5,000
- Sample Type
- Whole blood or Bone marrow
- Result Time
- Sample collected Mon/Thu before 11 AM; Report available Wed/Sat
- Fasting Required
- No
- Method
- Real Time PCR (RT-PCR)
Sample Collection
No fasting is required. Provide complete clinical history including current diagnosis, prior treatment history, and any previous molecular or cytogenetic reports. Inform the phlebotomist of any anticoagulant therapy.
Method: Venipuncture / Bone marrow aspiration
Laboratory Analysis
A peripheral venous blood sample (3 mL minimum) is collected in a Lavender Top (EDTA) tube. Alternatively, a bone marrow aspirate (2 mL minimum) in EDTA may be collected by the treating physician. Aseptic technique must be maintained.
Report Delivery
Label the sample clearly with patient details and date/time of collection. Ship the sample refrigerated (2–8°C). Do not freeze. Ensure the sample reaches the laboratory within 6 hours at room temperature or 72 hours if refrigerated.
Timeline: Sample collected Mon/Thu before 11 AM; Report available Wed/Sat
Patient Instructions
About This Test
Who Should Get This Test
The primary purpose of this test is to detect the MLL-AF9 fusion transcript in patients with suspected or confirmed acute leukemia. It supports accurate diagnosis, guides risk-adapted treatment decisions, and serves as a tool for monitoring minimal residual disease (MRD) during and after therapy. The presence of the t(9;11) translocation carries prognostic significance and may influence decisions regarding intensification of chemotherapy or consideration for hematopoietic stem cell transplantation.
How to Prepare
- Collect 3 mL (2 mL min.) whole blood or bone marrow in a Lavender Top (EDTA) tube
- Mix the sample gently by inverting 8–10 times immediately after collection
- Ship refrigerated (2–8°C). Do NOT freeze the sample
- Ensure clinical history is filled on the requisition form
- Deliver to laboratory within 6 hours (room temperature) or 72 hours (refrigerated)
Doctor's Notes
Reviewed by Dr SULOCHANA HEMCHANDRA HOLLA — MBBS, MD (Medical Genetics) · Reg. No. 8532
"The t(9;11)(p21.3;q23.3)/MLL-AF9 fusion is one of the most frequently observed MLL rearrangements in acute myeloid leukemia, particularly the monocytic subtypes (FAB M4/M5). Qualitative PCR detection is essential at diagnosis for risk stratification and during follow-up to monitor for minimal residual disease. Its presence often influences treatment decisions, including consideration for allogeneic stem cell transplantation in appropriate clinical settings."
Last medically reviewed: September 7, 2026
Test Parameters & Specifications
Sample Stability
- Sample received frozen or thawed after freezing
- Sample collected in heparin (Green Top) tube
- Clotted or grossly hemolyzed sample
- Sample without proper labeling or clinical history
- Sample exceeding stability limits at the time of receipt
Understanding Your Results
Detected
The MLL-AF9 fusion transcript is present. This is consistent with the t(9;11)(p21.3;q23.3) chromosomal translocation and is commonly associated with acute myeloid leukemia (AML), particularly monocytic subtypes (M4/M5), and occasionally acute lymphoblastic leukemia (ALL). Clinical correlation and further workup are recommended.
Not Detected
The MLL-AF9 fusion transcript was not detected in the sample. This does not exclude the presence of leukemia or other MLL gene rearrangements with alternative fusion partners. If clinical suspicion remains, additional molecular and cytogenetic testing should be considered.
Consult your hematologist-oncologist if the test result is detected, if clinical symptoms of leukemia persist despite a negative result, or if you have previously been diagnosed with MLL-AF9-positive leukemia and are being monitored for relapse. Any new or worsening symptoms such as unexplained fatigue, recurrent infections, easy bruising, or unexplained weight loss warrant prompt medical evaluation.
Limitations
- ⚠This is a qualitative test and does not quantify the fusion transcript level
- ⚠A negative result does not exclude other MLL rearrangements or alternative fusion partners
- ⚠Sensitivity depends on sample quality and the proportion of leukemic cells present
- ⚠False negatives may occur if the breakpoint region falls outside the primer binding sites
- ⚠Results must always be interpreted in conjunction with morphology, immunophenotyping, and cytogenetics
Risks & Considerations
- ●Minor bruising or discomfort at the blood draw site
- ●Rare risk of infection at the puncture site
- ●Bone marrow aspiration (if applicable) may cause temporary soreness
Interfering Factors
- ●Heavily hemolyzed or clotted samples may yield inconclusive results
- ●Degraded RNA due to improper sample storage or delayed processing
- ●Sample collected in incorrect anticoagulant (e.g., heparin) may inhibit PCR
- ●Very low white cell count in peripheral blood may reduce sensitivity
Compare With Similar Tests
| Test | t(9;11) (p21-22;q23) (MLL-AF9) PCR Qualitative Test | Conventional Cytogenetics (Karyotyping) | Fluorescence In Situ Hybridization (FISH) | MLL-AF9 Quantitative PCR (RT-qPCR) |
|---|---|---|---|---|
| Comparison | t(9;11) (p21-22;q23) (MLL-AF9) PCR Qualitative Test | Karyotyping can detect the t(9;11) translocation at the chromosomal level but requires dividing cells and has lower sensitivity. PCR detects the fusion transcript at the molecular level with much higher sensitivity and faster turnaround. | FISH can detect MLL (11q23) rearrangements using specific probes and does not require dividing cells. However, it does not identify the specific fusion partner. PCR specifically confirms the MLL-AF9 fusion. | The qualitative test reports presence or absence of the fusion transcript, while the quantitative version measures transcript levels for precise MRD monitoring and treatment response assessment. |
Frequently Asked Questions
What is the t(9;11)(p21.3;q23.3) / MLL-AF9 fusion gene?
Which types of leukemia are associated with MLL-AF9?
What sample is required for this test?
Is fasting required before this test?
How long does it take to get the results?
What does a positive (Detected) result mean?
What does a negative (Not Detected) result mean?
Can this test be used to monitor for disease relapse?
What is the difference between qualitative and quantitative MLL-AF9 PCR?
Is home sample collection available for this test?
What is the cost of the t(9;11) MLL-AF9 PCR Qualitative Test?
Is this test covered under government health insurance schemes?
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