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PML RARA t(1517)(q22q12) Gene Rearrangement Qualitative PCR Test

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PML RARA t(1517)(q22q12) Gene Rearrangement Qualitative PCR Test

Short Name: PML-RARA PCR

Also known as: PML-RARA translocation test, t(15;17) PCR, PML/RARA fusion gene test

PML RARA t(1517)(q22q12) Gene Rearrangement Qualitative PCR Test test available at DNA Labs India for ₹7,500. Uses Real Time PCR on Whole Blood samples. Results in Samples are accepted on Monday, Wednesday, and Friday by 9 am. Reports are issued on the following Tuesday, Thursday, and Saturday respectively (approximately 24 hours after acceptance).. Free home collection in 300+ cities across India.

Qualitative PCR🏠 Home Collection

🩺 Medically Reviewed By

Overview

To detect the PML-RARA gene rearrangement in patients with suspected acute promyelocytic leukemia (APL), confirm the diagnosis, and guide treatment decisions with all-trans retinoic acid (ATRA)-based therapy.

Test Code
3558
Price
₹7,500
Sample Type
Whole Blood
Result Time
Samples are accepted on Monday, Wednesday, and Friday by 9 am. Reports are issued on the following Tuesday, Thursday, and Saturday respectively (approximately 24 hours after acceptance).
Fasting Required
No
Method
Real Time PCR
Step 1

Sample Collection

No fasting is required. A duly filled Genomics Clinical Information Requisition Form (Form 20) is mandatory. Inform your doctor about any current medications or recent blood transfusion.

Method: Venipuncture

Step 2

Laboratory Analysis

A blood sample will be collected from a vein in the arm using a sterile needle. The procedure takes only a few minutes.

Step 3

Report Delivery

You may immediately resume daily activities. Keep the pressure bandage on for a few minutes and avoid heavy lifting for an hour.

Timeline: Samples are accepted on Monday, Wednesday, and Friday by 9 am. Reports are issued on the following Tuesday, Thursday, and Saturday respectively (approximately 24 hours after acceptance).

Patient Instructions

1
Before the Test:No fasting is required. Complete the mandatory Genomics Clinical Information Requisition Form (Form 20) and follow any additional instructions provided by your physician.
2
During the Test:A blood sample is drawn from a vein in your arm. The procedure typically takes less than 5 minutes.
3
After the Test:You can go back to your routine immediately. Slight bruising at the puncture site may occur but usually resolves within a few days.

About This Test

Who Should Get This Test

To detect the PML-RARA gene rearrangement in patients with suspected acute promyelocytic leukemia (APL), confirm the diagnosis, and guide treatment decisions with all-trans retinoic acid (ATRA)-based therapy.

How to Prepare

  • Ensure the Genomics Clinical Information Requisition Form (Form 20) is completely filled and signed.
  • Collect blood in two lavender top (EDTA) tubes with a minimum volume of 3 mL each (total 5 mL preferred).
  • Label the tubes with patient identifiers and the date/time of collection.
  • Ship the sample refrigerated (2-8°C) using a cold pack. Do not freeze.
  • Transport the sample to the laboratory within 72 hours of collection.

Doctor's Notes

Reviewed by — MBBS, MD (Medical Genetics) · Reg. No. 8532

"Early detection of PML-RARA fusion via PCR is critical—APL is a medical emergency where timely ATRA therapy can change the course of the disease."

Last medically reviewed: September 7, 2026

Test Parameters & Specifications

Sample TypeWhole Blood
Sample Volume5 mL (3 mL min.)
Container2 Lavender Top (EDTA) tubes
Collection MethodVenipuncture

Sample Stability

Room temperature6 hours
Refrigerated (2-8°C)72 hours
Frozen (Freeze)Not suitable (Do not freeze)
Sample Rejection Criteria:
  • Clotted specimen
  • Hemolyzed specimen
  • Frozen specimen
  • Incorrect tube type
  • Improper labeling
  • Missing requisition form
  • Sample received after 72 hours

Understanding Your Results

This qualitative PCR test detects the presence or absence of the PML-RARA fusion gene associated with t(15;17)(q22;q12).
📊

Negative

No PML-RARA fusion detected. APL is less likely, though clinical correlation is needed.

📊

Positive

PML-RARA fusion is detected, supporting a diagnosis of APL. ATRA-based therapy is indicated.

⚠️ When to Consult a Doctor:

If you have symptoms suggestive of APL or if the test result is positive, seek urgent evaluation by an oncologist. Even a negative result does not rule out other blood conditions; follow your doctor's advice.

Limitations

  • Qualitative test does not quantify fusion transcript levels; for monitoring residual disease, quantitative PCR may be required.
  • Breakpoint variants outside the commonly tested regions may lead to false negative results.
  • This test does not detect other gene rearrangements associated with APL.
  • Results should be interpreted in conjunction with clinical findings and other laboratory tests.

Risks & Considerations

  • Minimal risk of slight bruising or bleeding at the puncture site
  • Rare risk of infection at the needle insertion site

Interfering Factors

  • Degraded RNA due to delayed sample processing
  • Sample collected in EDTA tube stored for more than 72 hours
  • Clotted or insufficient sample
  • Presence of PCR inhibitors

Compare With Similar Tests

TestPML RARA t(1517)(q22q12) Gene Rearrangement Qualitative PCR TestCytogenetic Analysis (Karyotyping)Fluorescence In Situ Hybridization (FISH)
ComparisonPML RARA t(1517)(q22q12) Gene Rearrangement Qualitative PCR Test

Frequently Asked Questions

What is the PML RARA t(15;17) qualitative PCR test?
It is a molecular diagnostic test that detects the PML-RARA fusion gene resulting from a translocation between chromosomes 15 and 17, commonly associated with acute promyelocytic leukemia (APL).
What is the cost of this test?
The cost is INR 7500 at DNA Labs India. Free home sample collection is included for online bookings.
Is fasting required before the test?
No, fasting is not required for this PCR test. However, you must submit a duly completed Genomics Clinical Information Requisition Form (Form 20).
What sample is needed?
A 5 mL (3 mL minimum) whole blood sample is required, collected in two lavender top (EDTA) tubes.
How should the sample be transported?
The sample should be shipped refrigerated. Do not freeze the sample.
What is the sample stability at different conditions?
The sample is stable for 6 hours at room temperature, 72 hours when refrigerated, and should not be frozen.
How long does it take to get the report?
Samples are accepted on Monday, Wednesday, and Friday by 9 am, and reports are issued on Tuesday, Thursday, and Saturday respectively.
What does a positive result indicate?
A positive result indicates the presence of the PML-RARA gene rearrangement, supporting a diagnosis of APL and the likely benefit of ATRA therapy.
What does a negative result mean?
A negative result means the PML-RARA rearrangement was not detected. It does not completely exclude APL, and clinical correlation is needed.
Why is this test important in APL?
Detection of the PML-RARA fusion is essential for a definitive diagnosis of APL and for making treatment decisions with all-trans retinoic acid, which dramatically improves survival.
Can this test be done at home?
Yes, DNA Labs India offers free home sample collection for online bookings in major cities across India.
Are there any risks associated with the test?
The risk is minimal, similar to a regular blood draw. Some mild bruising, bleeding, or, rarely, infection may occur at the puncture site.
Worried about the process? Our certified phlebotomists collect thousands of samples every month across India. The process takes under 5 minutes and is virtually painless. Questions? Message us on WhatsApp — we're here 7 days a week.

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