IHC Marker - CK13 Test
About IHC Marker - CK13 Test
| Field | Value |
|---|---|
| Also Known As | Cytokeratin 13 IHC, Keratin 13 IHC, KRT13 Immunohistochemistry, CK-13 Marker |
| Sample Type | FFPE tissue block (formalin-fixed paraffin-embedded tissue) |
| Fasting Required | No, this is a tissue-based test and does not require fasting |
| Report Time | 3 days |
| Recommended For | Males and females; typically adults with suspected squamous cell or urothelial tumours |
| Price | Starting at ₹1,920 |
What Is an IHC Marker - CK13 Test?
The IHC Marker - CK13 test is a laboratory test that detects a protein called Cytokeratin 13 in tissue samples. It uses a technique called immunohistochemistry (IHC), where specific antibodies are applied to tissue to reveal whether and where this protein is present. Doctors order this test to help classify tumours and understand their behaviour. It is also known as Cytokeratin 13 IHC, Keratin 13 IHC, or KRT13 Immunohistochemistry.
What Does an IHC Marker - CK13 Test Measure?
This test detects the presence, location, and staining intensity of the CK13 protein within a tissue sample. The following points explain what is assessed during the test:
- CK13 protein expression: CK13 is a structural protein found in the upper layers of mucosal tissues, such as those lining the mouth, throat, food pipe, cervix, and bladder. Its presence or absence helps identify the tissue type and grade of a tumour.
- Staining pattern: The pathologist notes whether staining is strong and widespread (diffuse), moderate, weak, or absent. This pattern guides interpretation.
- Distribution within tissue: Whether the protein appears in expected cell layers or is lost helps identify normal tissue, pre-cancerous changes, or malignant transformation.
Note: IHC results are reported qualitatively as positive or negative, with semi-quantitative scoring of intensity. No numeric reference range applies.
Why Is an IHC Marker - CK13 Test Done?
This test is ordered when a doctor needs to characterise tissue from a biopsy or surgical specimen. Below are the common reasons it may be requested.
Common Symptoms That May Require This Test
The following symptoms may prompt a doctor to request tissue-based investigations including the CK13 IHC test:
- Unexplained white patches inside the mouth
- Difficulty swallowing food or liquids
- Persistent hoarseness or change in voice
- Blood in urine or frequent urination without infection
- Abnormal results on cervical screening
- A visible or palpable lump requiring further classification
Conditions This Test Can Help Detect
The CK13 test procedure assists in identifying or characterising the following conditions:
- Squamous cell carcinomas of the oral cavity, larynx, oesophagus, and cervix
- Urothelial neoplasms, including bladder tumours
- Laryngeal squamous cell carcinoma, where CK13 has shown 100% sensitivity in distinguishing malignant from benign lesions
- White sponge nevus, a hereditary condition linked to KRT13 gene mutations
- Oral epithelial dysplasia, which refers to pre-cancerous changes in the mouth lining
How to Prepare and What to Expect
Unlike blood or urine tests, the IHC Marker - CK13 test is performed on tissue that is already collected or will be collected through a biopsy. The steps below outline what to expect.
Do You Need to Fast?
No fasting is required for this test. It is a tissue-based examination and is unrelated to food or drink intake.
Practical Tips Before Your Test
The following tips will help ensure a smooth process:
- Bring a detailed clinical history, including your symptoms, previous test results, and relevant radiological reports, as this is required for the test.
- Carry the original histopathology report if a biopsy has already been performed.
- If you have a paraffin-embedded tissue block from a prior biopsy, this can be submitted directly for CK13 IHC testing without a new procedure.
- Ensure the treating doctor confirms that adequate tissue was collected during the biopsy for this analysis.
- Inform the pathology team of any prior treatments, such as radiation or chemotherapy, as these can affect tissue.
Step-by-Step Procedure
The following steps describe how the IHC Marker - CK13 test procedure is carried out in the laboratory.
- Tissue collected during a biopsy or surgery is fixed in formalin and embedded in paraffin wax to create an FFPE block, which preserves the tissue for analysis.
- Thin sections of the tissue, typically 3 to 5 microns thick, are cut from the block and placed on glass slides.
- The paraffin wax is removed from the slides, and the tissue is rehydrated in preparation for staining.
- Antigen retrieval is performed using heat to expose the CK13 protein targets within the tissue cells.
- CK13-specific antibodies linked to a coloured dye are applied to the slides. These antibodies bind to the CK13 protein wherever it is present in the tissue.
- A qualified pathologist examines the stained slides under a microscope and assesses the pattern, intensity, and distribution of CK13 staining to produce the final report.
Factors That Can Affect Accuracy
The following factors may influence the quality or reliability of the test result:
- Inadequate formalin fixation time (24 to 48 hours is optimal)
- Tissue section thickness that is too thick or too thin
- Delayed or improper tissue processing after collection
- Antibody quality and specificity used in the laboratory
- Pathologist experience in interpreting IHC staining patterns
Understanding Your IHC Marker - CK13 Test Results
Results from the IHC Marker - CK13 test are interpreted by a trained pathologist alongside clinical, radiological, and other pathological findings. The table below outlines the general interpretation of staining patterns:
| Staining Result | Interpretation |
|---|---|
| Positive, strong and diffuse | Normal non-keratinising squamous epithelium; expected in healthy mucosal tissue |
| Positive, moderate or weak | May suggest partial differentiation or early dysplastic (pre-cancerous) change |
| Negative or reduced | Associated with malignant transformation; seen in high-grade squamous cell carcinomas and advanced bladder cancer |
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
The following general wellness tips are relevant to the mucosal tissues assessed by this test:
- Avoid tobacco use and limit alcohol consumption, as both are linked to mucosal cancers of the mouth, throat, and food pipe.
- Maintain good oral hygiene and attend regular dental check-ups to help identify unusual changes early.
- Report any persistent white patches, sores, or unusual growths in the mouth or throat to your doctor without delay.
Lupin Diagnostics IHC Marker - CK13 Test Price
The IHC Marker - CK13 test cost at Lupin Diagnostics starts at ₹1,920. This test requires a visit to a Lupin Diagnostics centre or the submission of an existing FFPE tissue block; home collection is not available for this test.
| 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
The following steps explain the IHC Marker - CK13 test online booking process 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 to submit your FFPE tissue block or biopsy sample.
- Receive your report via email or WhatsApp within the stipulated turnaround time.
Frequently Asked Questions
The IHC Marker - CK13 test helps doctors characterise tumour tissue, particularly in identifying the origin of a primary tumour in cases where cancer has spread. It is used to distinguish squamous cell and urothelial tumours from other cancer types and supports diagnosis when combined with clinical and imaging findings.
The test itself is performed entirely in the laboratory on tissue that has already been collected. If a new biopsy is needed to obtain the tissue sample, local anaesthesia is typically used during collection to minimise discomfort.
No. The CK13 IHC result is one part of a broader diagnostic picture. A pathologist interprets it alongside other markers, the histopathology report, clinical history, and imaging results. It is a supportive tool, not a standalone cancer test.
A negative or reduced CK13 result in certain tissues may point to malignant change or more aggressive disease. For example, loss of CK13 is associated with high-grade bladder cancer and high-grade cervical squamous cell carcinoma. Your doctor will explain what this finding means in your specific case.
Lupin Diagnostics delivers results for the IHC Marker - CK13 test within 3 days. Processing involves multiple laboratory steps, which is why it takes longer than a routine blood test.
White sponge nevus is a hereditary condition that causes white, spongy patches on the inner lining of the mouth. It is linked to mutations in the KRT13 gene, which provides the instructions for making the keratin 13 protein. At least five such mutations are known to disrupt the protein's normal structure, leading to the characteristic appearance of this condition.
IHC Marker - CK13 Test
