PML/RARA Qualitative [BCR 1 & 3] Test: Booking, Price, and Results
About PML/RARA Qualitative [BCR 1 & 3] Test
| Field | Value |
|---|---|
| Also Known As | PML-RARA qualitative PCR test, t(15; 17) qualitative test, promyelocytic leukaemia/retinoic acid receptor alpha test |
| Sample Type | Peripheral blood (EDTA tube) and bone marrow (sodium heparin tube) |
| Fasting Required | No fasting required |
| Report Time | 4 days |
| Recommended For | Male and female adults with suspected acute promyelocytic leukaemia (APL) |
| Price | Starting at ₹4,800 |
What Is a PML/RARA Qualitative [BCR 1 & 3] Test?
The PML/RARA Qualitative [BCR 1 & 3] test is a specialised molecular diagnostic test. It detects an abnormal gene fusion linked to a specific type of blood cancer called acute promyelocytic leukaemia (APL). It works by identifying whether the PML gene (on chromosome 15) has fused with the RARA gene (on chromosome 17), a change that acts as a biological trigger for APL. The test uses a method called real-time PCR (polymerase chain reaction), which analyses genetic material from a blood or bone marrow sample. It is also known as the PML-RARA qualitative PCR or t(15;17) qualitative test.
What Does a PML/RARA Qualitative [BCR 1 & 3] Test Measure?
This test detects and identifies three specific forms of the PML-RARA fusion gene, each arising from a slightly different chromosomal break point. It also checks an internal control gene to confirm that the sample quality is adequate for reliable results.
The following components are analysed:
| Component | What It Represents |
|---|---|
| PML-RARA BCR1 (long form) | Break point in intron 6 of the PML gene |
| PML-RARA BCR2 (variant form) | Break point in exon 6 of the PML gene |
| PML-RARA BCR3 (short form) | Break point in intron 3 of the PML gene |
| ABL1 gene (internal control) | Confirms that the RNA (genetic material) in the sample is intact and suitable for testing |
Why Is a PML-RARA Qualitative PCR Test Done?
Doctors order this test when a patient shows signs that may point towards acute promyelocytic leukaemia or when monitoring a patient already diagnosed with APL. The PML/RARA Qualitative [BCR 1 & 3] test procedure helps confirm a diagnosis, guide treatment decisions, and track how well treatment is working.
Common Symptoms That May Require This Test
A doctor may prescribe this test when a patient presents with symptoms that suggest a blood disorder. These include:
- Unusual or uncontrolled bleeding, such as bruising easily or prolonged bleeding from cuts.
- Excessive and unexplained fatigue.
- Frequent infections that do not resolve normally.
- Anaemia (low red blood cell levels), causing pallor and weakness.
- Low levels of blood cells overall (a condition called pancytopenia).
- Unexplained weight loss and reduced appetite.
- Pain in bones or joints.
Conditions This Test Can Help Detect
This test is primarily used to investigate or confirm the following conditions:
- Acute promyelocytic leukaemia (APL), a subtype of acute myeloid leukaemia (AML); the PML-RARA fusion is found in over 95% of APL cases.
- APL accounts for approximately 10 to 15% of all AML diagnoses.
- Risk of APL relapse in patients who have already completed treatment.
PML-RARA Qualitative PCR Test to Monitor Chronic Disease
The t(15; 17) qualitative test plays an important role in long-term disease management for patients diagnosed with APL. Real-time PCR is the only technique that identifies the specific PML break point type, which allows doctors to plan an appropriate monitoring strategy for minimal residual disease (MRD), meaning minute cancer that may remain after treatment. Identifying the transcript type at diagnosis also makes it possible to track any sign of relapse during and after treatment.
How to Prepare and What to Expect
No special preparation is needed for this test. The steps below describe what happens from the time you arrive for collection to the point your sample is sent to the laboratory.
Do You Need to Fast?
No. Fasting is not required before the PML/RARA qualitative [BCR 1 & 3] test. You may eat and drink as usual before your appointment.
Practical Tips Before Your Test
Being prepared helps ensure the sample is collected smoothly and produces accurate results. Keep the following points in mind:
- Bring a detailed clinical history, including your symptoms, previous test results, and any relevant medical records, as it is required for the test.
- Tell the healthcare professional about any medications you are currently taking, as certain medicines may affect the test results.
- Let the team know about any allergies or medical conditions before the sample is collected.
- If this test is being done to monitor your condition after treatment, it should also have been done at the time of diagnosis to serve as a baseline.
Step-by-Step Procedure
This test requires two types of samples: peripheral blood (from a vein) and bone marrow. Here is what to expect for each.
Peripheral blood collection:
- A vein in your arm will be cleaned with an antiseptic liquid by a healthcare professional, and a small blood sample will be put into a lavender-top EDTA tube.
- The site is covered with a small bandage. The process takes only a few minutes.
Bone marrow collection:
- Bone marrow is collected by a trained doctor using an aspiration procedure, most commonly from the hip bone, under local anaesthetic.
- The bone marrow sample is placed into a sodium heparin (green-top) tube.
- Both samples are refrigerated immediately after collection to preserve the integrity of the RNA (genetic material).
- Samples must reach the laboratory within 48 hours of collection. Delays beyond this window can cause RNA to break down, potentially affecting the reliability of results.
Factors That Can Affect Accuracy
- Quality of the RNA in the sample at the time of processing.
- Time between sample collection and laboratory receipt (samples older than 48 to 72 hours may produce unreliable results).
- Rare or unusual PML-RARA fusions that this assay may not detect.
- Certain medications may cause false results during the test.
- Very low levels of fusion transcripts that fall below the detection threshold of the test.
Understanding Your Test Results
Results for this test are reported as "Detected" or "Not Detected" for each transcript variant. A trained haematologist or oncologist will interpret your results alongside your clinical history, blood counts, and other findings.
| Parameter | Normal Result | What It Means |
|---|---|---|
| PML-RARA BCR1 | Not Detected | No long-form fusion transcript found |
| PML-RARA BCR2 | Not Detected | No variant-form fusion transcript found |
| PML-RARA BCR3 | Not Detected | No short-form fusion transcript found |
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.
A "Detected" result for any transcript suggests the presence of the PML-RARA gene fusion associated with APL. In a patient already receiving treatment, a detected result may indicate residual disease or a risk of relapse. A "Not Detected" result does not rule out other types of leukaemia, as this test is specific to the PML-RARA fusion only.
Results During Special Conditions
In the promyelocytic leukaemia/retinoic acid receptor alpha test, the PML-RARA mutation is not inherited. It occurs spontaneously during a person's lifetime and cannot be passed from parent to child. In patients with immune system disorders, results may need careful interpretation, as these conditions can affect the body's overall immune response and the context in which results are read.
Do lifestyle changes affect the results?
Because the PML-RARA fusion is an acquired genetic change rather than a lifestyle-related condition, there are no specific dietary or lifestyle measures that prevent it. However, the following general points are worth keeping in mind:
- Seek prompt medical attention if you notice symptoms such as unusual bleeding, persistent fatigue, or frequent infections.
- Early detection through timely testing significantly improves treatment outcomes for APL.
- Attend all follow-up appointments if you are already under treatment, as regular monitoring is key to managing this condition effectively.
Lupin Diagnostics PML/RARA Qualitative [BCR 1 & 3] Test Price
The PML/RARA Qualitative [BCR 1 & 3] test cost at Lupin Diagnostics starts at ₹4,800. This test requires a visit to a Lupin Diagnostics centre, as home collection is not available for this test.
| 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
- Select this test on the Lupin Diagnostics website.
- Choose your city and Lupin Diagnostics location according to your convenience.
- 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 detects the PML-RARA gene fusion, which is associated with acute promyelocytic leukaemia (APL). It is used to confirm a diagnosis, identify the specific transcript type, and monitor patients already receiving treatment for signs of residual disease or relapse.
Different break points on the PML gene produce three distinct fusion transcripts: BCR1, BCR2, and BCR3. Identifying which transcript type is present at diagnosis is important because it determines the correct monitoring strategy for the patient throughout and after treatment.
The PML/RARA Qualitative [BCR 1 & 3] test procedure requires both a peripheral blood sample and a bone marrow sample. Blood is drawn from a vein in the usual way, while bone marrow is collected by a doctor through an aspiration procedure.
No fasting is required. You can eat and drink as normal before your appointment. No other special preparation is needed apart from bringing your clinical history.
The report is typically delivered within 4 days. Processing time may vary slightly depending on sample quality and laboratory scheduling.
Not necessarily. A negative result means the PML-RARA fusion gene was not detected, but this test only identifies the specific genetic abnormality linked to APL. Other forms of leukaemia involve different genetic changes and require different diagnostic tests. Your doctor will advise on any further investigations needed.
No. The PML-RARA mutation is acquired spontaneously during a person's lifetime. It is not a hereditary condition and cannot be passed from parent to child.
PML/RARA Qualitative [BCR 1 & 3] Test: Booking, Price, and Results
