PML/RARA Quantitative [Single Form] Test: Booking, Price, and Results
About PML/RARA Quantitative [Single Form] Test
| Field | Value |
|---|---|
| Also Known As | PML-RARA RT-qPCR test, PML/RARA quantitative PCR test, PML-RARA fusion gene test, t(15;17) quantitative PCR test |
| Sample Type | Peripheral blood (EDTA tube) or bone marrow aspirate (sodium heparin tube) |
| Fasting Required | No |
| Report Time | 4 days |
| Recommended For | All genders and ages; primarily patients with suspected or confirmed acute promyelocytic leukaemia (APL) |
| Price | Starting at ₹5,400 |
What Is a PML/RARA Quantitative [Single Form] Test?
A PML-RARA RT-qPCR test is a special test that looks for and measures a specific genetic change related to a type of blood cancer known as acute promyelocytic leukaemia (APL). It uses a technique called real-time PCR (polymerase chain reaction) to identify and quantify the PML-RARA fusion gene in a blood or bone marrow sample. Doctors use this test to confirm an APL diagnosis, assess how well treatment is working, and watch for signs of the disease returning. It is also known as PML-RARA RT-qPCR or the PML-RARA fusion gene test.
What Does a PML/RARA Quantitative [Single Form] Test Measure?
This test looks for a specific genetic change in blood or bone marrow cells. The key components measured are listed below.
| Component | What It Means |
|---|---|
| PML-RARA fusion gene transcript | The test detects the abnormal RNA produced when two genes, PML and RARA, fuse together on chromosomes 15 and 17 |
| PML-RARA to ABL1 ratio | The result is expressed as a percentage ratio of the fusion gene to a stable reference gene (ABL1); higher values indicate more leukaemic cells |
| Isoform detected (L, V, or S) | Three breakpoint variants exist: long (BCR1), variant (BCR2), and short (BCR3); the specific form present is reported |
A result of "not detected" is considered normal. Any measurable ratio indicates the presence of the fusion gene.
Why Is a PML/RARA Quantitative [Single Form] Test Done?
Doctors prescribe the PML/RARA quantitative PCR test in several situations, from initial diagnosis to ongoing monitoring of APL.
Common Symptoms That May Require This Test
A doctor may recommend this test when a patient presents with any of the following symptoms.
- Unusual bruising or petechiae (tiny red or purple spots on the skin).
- Frequent nosebleeds or bleeding from the gums.
- Blood in the urine (haematuria) or very heavy menstrual bleeding.
- Pale skin and persistent fatigue or tiredness.
- Unexplained fever, night sweats, or significant weight loss.
- You may experience repeated infections or a general feeling of poor health.
Conditions This Test Can Help Detect
This test is used to identify or monitor specific blood-related conditions.
- Acute promyelocytic leukaemia (APL), a subtype of acute myeloid leukaemia that accounts for 5% to 10% of all AML cases.
- Minimal residual disease (MRD), meaning very tiny numbers of leukaemic cells that remain in the body after treatment.
- Disease relapse or recurrence in patients who were previously in remission.
PML/RARA Quantitative [Single Form] Test for Chronic Disease Monitoring
Once a patient with APL completes consolidation therapy, this test is used to track their response over time. Monitoring is typically carried out every three months for the first three years after treatment, as most relapses occur during this period. A result that changes from undetectable to detectable, confirmed in a repeat sample, is regarded as a sign of imminent disease relapse.
How to Prepare and What to Expect
No special preparation is needed for this test. The process is straightforward, though the sample handling requirements are strict.
Do You Need to Fast?
No fasting is required before the PML-RARA fusion gene test. You can eat and drink normally on the day of your sample collection.
Practical Tips Before Your Test
The following points will help ensure the sample is collected and processed correctly.
- Bring a detailed clinical history, including your symptoms, previous test results, and family history, as it is required for the test.
- If you are currently receiving treatment for APL (such as ATRA or arsenic trioxide) or have recently had chemotherapy, inform the laboratory staff before sample collection.
- If this test is being used to monitor you after treatment, your doctor should confirm the test results that were performed at the time of diagnosis to establish a baseline.
- Tell your doctor about all current medications before sample collection, as certain medications can affect the accuracy of test results.
- Stay hydrated, as it will make it easier to draw a blood sample.
Step-by-Step Procedure
Two sample types may be used for this test: peripheral blood or bone marrow. The procedure for each is described below.
Peripheral Blood Sample
- A phlebotomist cleans the skin with antiseptic liquid, normally on your inner arm, and draws 3 ml of blood from a vein using a needle.
- The blood is collected into a lavender-top EDTA tube, and the tube is gently inverted several times to mix the blood with the anticoagulant.
- The sample is labelled and stored at a low temperature (2 to 8 degrees Celsius) for transport to the laboratory.
Bone Marrow Sample
- A specialist doctor performs a bone marrow aspiration, usually from the hip bone (iliac crest), under local anaesthesia.
- A small amount of bone marrow (3 ml) is drawn into a sodium heparin (green-top) tube.
- The sample is immediately refrigerated and dispatched to the laboratory; it must arrive within 48 hours to preserve RNA quality.
At the Laboratory
- Total RNA is extracted from the sample and converted into complementary DNA (cDNA).
- Real-time PCR is performed to detect and quantify the PML-RARA fusion gene relative to the ABL1 reference gene.
- An interpretive report is generated and delivered within 4 days.
Factors That Can Affect Accuracy
- Delayed sample delivery: RNA degrades quickly, so the sample must reach the lab within 48 hours.
- Use of incorrect collection tubes: containers other than EDTA (for blood) or sodium heparin (for bone marrow) may make the sample unacceptable.
- Severely haemolysed (broken-down red blood cells) or clotted samples.
- Active treatment with ATRA or arsenic trioxide, which alters transcript levels during monitoring.
- Testing in different laboratories over time; results are most reliable when each test is performed at the same laboratory using the same method.
Understanding Your PML/RARA Quantitative [Single Form] Test Results
Results from this test are reported as either "not detected" (negative) or as a numeric ratio of the PML-RARA fusion gene to the ABL1 reference gene. Always review your results with your haematologist or oncologist, who will interpret them in the context of your full clinical picture.
| Result | Typical Interpretation |
|---|---|
| Not detected (negative) | No PML-RARA fusion gene found; no evidence of APL or molecular remission achieved |
| Positive (ratio reported) | PML-RARA fusion gene is present, consistent with an APL diagnosis or residual/recurrent disease |
| Rising ratio over time | May indicate disease progression or impending relapse |
| Falling ratio over time | Suggests a positive response to treatment |
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 situations can affect how results are interpreted. This test detects only PML-RARA fusion transcripts. In the rare 2% of APL cases involving other RARA gene fusions, results may appear negative even when APL is present. Additionally, because the assay is semiquantitative, proper consultation with your doctor is mandatory.
How to maintain health after the test results?
This test measures a cancer-related genetic marker rather than a general health indicator. The following points are worth keeping in mind.
- The PML-RARA fusion is not an inherited mutation; it occurs spontaneously during a person's lifetime and cannot be prevented through lifestyle changes.
- Follow your haematologist's or oncologist's recommendations regarding treatment schedules and monitoring frequency.
- Attend all follow-up appointments; regular monitoring is the most reliable way to detect any changes early.
Lupin Diagnostics PML/RARA Quantitative [Single Form] Test Price
The t(15;17) quantitative PCR test is priced starting at ₹5,400 at Lupin Diagnostics. This test requires a visit to a Lupin Diagnostics centre because home collection is not available for this test due to the specialised sample handling requirements.
| City | Approximate Price ( ₹) |
|---|---|
| BHOPAL | 5400 |
| CHENNAI | 5400 |
| HYDERABAD | 5400 |
| KOLKATA | 5400 |
| NAVI MUMBAI | 5400 |
| PUNE | 5400 |
Disclaimer: Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
- Select the test on the Lupin Diagnostics website.
- Choose your preferred Lupin Diagnostics centre location.
- Visit the centre at your scheduled time for sample collection.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
This test is used to help diagnose acute promyelocytic leukaemia (APL), guide treatment decisions, assess how well treatment is working, and monitor for disease recurrence. It detects the PML-RARA fusion gene, which is present in approximately 98% of APL cases.
The test uses either a peripheral blood sample drawn from a vein in the arm or a bone marrow sample collected by a specialist through a bone marrow aspiration procedure. Your doctor will advise which sample type is most appropriate based on your clinical situation.
No, fasting is not required. You can eat and drink normally before the test. However, do inform the laboratory staff about any ongoing treatment or medications.
This test involves RNA analysis, and RNA degrades very quickly. Samples must reach the laboratory within 48 hours under strict refrigerated conditions. Bone marrow collection also requires a trained specialist in a medical facility, making home collection unsuitable.
During active treatment and after consolidation therapy, this test is typically repeated every three months for the first two to three years. Your haematologist will set a personalised monitoring schedule based on your risk profile and treatment response.
A positive result means the PML-RARA fusion gene has been detected. In a newly diagnosed patient, this confirms APL. In a patient who was previously in remission, a newly positive result may indicate the disease is returning, and your doctor will advise on the next steps.
This test detects the PML-RARA fusion gene, which accounts for approximately 98% of APL cases. In a small number of cases where APL is caused by a different RARA gene fusion, this test may not give a positive result. Your doctor will order additional tests if APL is still suspected despite a negative result.
PML/RARA Quantitative [Single Form] Test: Booking, Price, and Results
