IHC Marker - ALK for Lung Tumour (D5F3) Test: Booking, Price, and Results
About IHC Marker - ALK for Lung Tumour (D5F3) Test
| Field | Value |
|---|---|
| Also Known As | ALK IHC, ALK-D5F3 IHC, VENTANA ALK (D5F3) CDx Assay, ALK Immunohistochemistry for Lung Tumour |
| Sample Type | Tumour tissue (formalin-fixed, paraffin-embedded FFPE block) |
| Fasting Required | No |
| Report Time | 3 days |
| Recommended For | Male and female adults with suspected or confirmed non-small cell lung cancer (NSCLC) |
| Price | Starting at ₹1,920 |
What is an IHC Marker - ALK for Lung Tumour (D5F3) Test?
The ALK D5F3 test is a specialised laboratory test that detects the ALK (Anaplastic Lymphoma Kinase) protein in lung tumour tissue. It is used to identify a specific gene change found in a small proportion of non-small cell lung cancer (NSCLC) cases. Also known as ALK IHC or the VENTANA ALK (D5F3) CDx Assay, this test is performed on a tissue sample — usually obtained through a biopsy — and helps doctors decide whether a patient may respond to targeted cancer treatments.
What Does an IHC Marker - ALK for Lung Tumour (D5F3) Test Measure?
This test uses immunohistochemistry (IHC), a method that applies special antibodies to a tissue sample to reveal specific proteins under a microscope. The table below describes what the test assesses.
| Component | What it tells us |
|---|---|
| ALK protein expression | Whether an abnormal ALK protein is present in tumour cells |
| Staining pattern (granular, cytoplasmic) | Helps the pathologist determine a positive or negative result |
| Binary scoring (positive or negative) | Guides decisions about targeted therapy eligibility |
The D5F3 test procedure uses antibodies that bind to ALK proteins in the tissue. A colour reaction makes the proteins visible under a microscope. A pathologist then reads the slide using a simple positive or negative classification.
Why is an IHC Marker - ALK for Lung Tumour (D5F3) Test Done?
This test is ordered when a doctor suspects or has confirmed NSCLC and wants to check whether the tumour carries an ALK gene change that may make it suitable for targeted therapy.
Common Symptoms That May Require This Test
The following symptoms may prompt a doctor to investigate for lung cancer and order this test:
- Persistent cough that does not go away
- Unexplained weight loss
- Shortness of breath
- Chest pain
- Coughing up blood (haemoptysis)
- Unusual fatigue
- Recurrent respiratory infections
Conditions This Test Can Help Detect
This test helps identify specific tumour characteristics that guide treatment choices:
- ALK-positive NSCLC, particularly adenocarcinoma of the lung
- ALK gene rearrangements, which are found in approximately 5% of NSCLC cases
- Inflammatory myofibroblastic tumour, where ALK protein overexpression may also be present
How to Prepare and What to Expect
No special preparation is required for the D5F3 test. However, understanding the process can help reduce any anxiety.
Do You Need to Fast?
No fasting is required before this test. The sample used is tumour tissue, not blood or urine, so diet before the test does not affect results.
Practical Tips Before Your Test
- Bring a detailed clinical history, including your symptoms, previous test results, and any imaging reports, as this is required for the test.
- Inform your doctor about all medications, supplements, and underlying health conditions before the biopsy procedure.
- Follow all pre-biopsy and post-biopsy care instructions given by your healthcare team.
- Ensure the tissue sample is preserved correctly; your doctor and the lab team will manage this.
Step-by-Step Procedure
- A tissue sample is obtained from the lung tumour, usually through a needle biopsy, bronchoscopy-guided biopsy, or surgical resection.
- The tissue is fixed in 10% neutral buffered formalin for a minimum of six hours and no more than 72 hours, then embedded in a paraffin block (FFPE block) for preservation.
- Thin slices of the tissue (4 to 5 microns thick) are cut and mounted onto glass slides.
- The slides are processed on an automated staining system. The tissue is treated with anti-ALK antibody (clone D5F3) for approximately 20 minutes, which binds to any ALK protein present.
- A qualified pathologist examines the stained slides under a microscope to assess ALK protein expression and records the result as either positive or negative.
- The FFPE block is stored and transported at ambient temperature (18 to 28°C), and the final report is typically ready within three days.
Factors That Can Affect Accuracy
- Quality and adequacy of the tissue sample collected
- Correct formalin fixation time (must be between 6 and 72 hours)
- Proper tissue processing and embedding in the lab
- Freshness of the cut slides, as the antigenicity of the tissue diminishes over time
- Experience and training of the pathologist interpreting the slides
Understanding Your IHC Marker - ALK for Lung Tumour (D5F3) Test Results
Results are reported as either positive or negative. Your oncologist and pathologist will review these results together with your overall clinical picture.
| Result | What it Means |
|---|---|
| Positive (ALK-positive) | Strong granular cytoplasmic staining is present in tumour cells; ALK gene rearrangement is likely |
| Negative (ALK-negative) | No strong granular cytoplasmic staining detected; ALK rearrangement is unlikely |
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.
How to Maintain Healthy Levels
While this test is diagnostic rather than a routine monitoring test, the following general steps support lung health and overall well-being:
- If you smoke, stopping is the single most important step for lung health.
- Attend all follow-up appointments with your oncologist as scheduled.
- Discuss the full range of treatment options and any available clinical trials with your doctor.
Lupin Diagnostics IHC Marker - ALK for Lung Tumour (D5F3) Test Price
The D5F3 test cost at Lupin Diagnostics starts at ₹1,920. This test requires a visit to a Lupin Diagnostics centre; home collection is not available, as it involves specialised tissue handling and laboratory processing.
| City | Approximate Price (₹) |
|---|---|
| BHOPAL | 1920 |
| CHENNAI | 1920 |
| HYDERABAD | 1920 |
| KOLKATA | 1920 |
| NAVI MUMBAI | 1920 |
| PUNE | 1920 |
Prices are indicative and may vary by location. Please confirm the current price at the time of booking.
How to Book
Follow these steps for D5F3 test online booking through Lupin Diagnostics:
- Select the test on the Lupin Diagnostics website.
- Choose your city and preferred centre location.
- Visit the centre at your scheduled time for sample collection or submission of your FFPE tissue block.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
The ALK D5F3 test is used to detect ALK gene rearrangements in lung tumour tissue. It helps oncologists determine whether a patient with NSCLC is likely to respond to ALK-targeted therapies. It is a key step in planning personalised cancer treatment.
The tissue sample is collected through a biopsy procedure. This may be a needle biopsy, a bronchoscopy-guided biopsy, or a sample taken during surgery. Your doctor will advise which method is most appropriate for your case.
The test itself is not painful, as it is performed entirely in the laboratory on a tissue sample. The biopsy procedure used to collect the tissue may cause some discomfort, but your medical team will take steps to keep you comfortable throughout.
Studies comparing the D5F3 antibody IHC test to fluorescence in situ hybridisation (FISH) show that the sensitivity and specificity of this test consistently exceed 90 percent. It is considered a reliable first-line method for detecting ALK rearrangements.
No. D5F3 test home collection is not available. This test requires a tissue sample from a tumour, specialised laboratory equipment, and expert pathologist interpretation. It cannot be performed at home and must be carried out at an accredited diagnostic centre.
A positive result indicates the presence of ALK protein overexpression in the tumour, suggesting an ALK gene rearrangement. Your oncologist will discuss what this means for your treatment plan. Patients with ALK-positive tumours may be eligible for specific targeted therapies.
Medical guidelines recommend ALK testing for all patients diagnosed with non-squamous non-small cell lung cancer (NSCLC) or NSCLC not otherwise specified. If you have been diagnosed with lung adenocarcinoma or a related lung tumour, speak to your doctor about whether this test is appropriate for you.
IHC Marker - ALK for Lung Tumour (D5F3) Test: Booking, Price, and Results
