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NTRK Positive FFPE Microscope Slide Reference Standard

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Relying on its huge cell resource library, powerful and reliable cell expression screening technology, and stable FFPE cell wax block preparation process, CB-Gene Bio has completed several IHC quality control products that cover multiple targets such as CLDN18.2, EGFR, HER2, ALK, NTRK, and is constantly developing more cutting-edge biological targets.
 
  • CBPN0017

  • CBPN0017

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Product Overview


The NTRK Positive FFPE Microscope Slide Reference Standard is a specialized tool designed to standardize the detection of neurotrophic tyrosine receptor kinase (NTRK) gene fusions, pan-cancer biomarkers that predict response to TRK inhibitor therapy. This reference standard features FFPE-embedded human tumor tissue with confirmed NTRK1/2/3 rearrangements, preserved using 10% neutral buffered formalin to replicate real-world clinical specimens . Its design addresses the challenges of NTRK testing, including low fusion frequency (<1% in most solid tumors) and variability in IHC and FISH assay performance.


Certified to meet CLIA and CAP requirements, this reference standard supports laboratories in validating their NTRK detection workflows, ensuring accurate identification of patients eligible for TRK inhibitors. By providing a consistent positive control, it helps mitigate the risk of false negatives, which can deprive patients of life-extending targeted therapy.


Product Features


Multi-Fusion Coverage: Contains representative samples of NTRK1 (TPM3-NTRK1), NTRK2 (SS18-NTRK2), and NTRK3 (ETV6-NTRK3) fusions, covering 90% of clinically reported NTRK rearrangements.

Morphological Preservation: Maintains tissue architecture and cellular detail after prolonged storage, with intact nuclei and cytoplasm essential for accurate IHC interpretation.

Staining Consistency: Exhibits uniform immunoreactivity with anti-TRK antibodies (e.g., clone EPR17341), with ≥95% positive cells in the tumor area to ensure clear signal detection.

Long-Term Stability: Preserves antigenicity for up to 5 years when stored at -20°C, with stable performance even after 20 cycles of deparaffinization and rehydration .


Usage


Slide Preparation:

• Section slides at 4-5 µm thickness using a microtome, ensuring even sections without folding or tearing.

• Mount sections on poly-L-lysine-coated slides and air-dry overnight at room temperature; avoid oven drying to prevent antigen denaturation .

Assay Integration:

• Include the reference standard in every NTRK IHC or FISH run as a positive control.

• For IHC, use standard antigen retrieval protocols (e.g., Tris-EDTA buffer, pH 9.0, at 95°C for 20 minutes) followed by antibody incubation per manufacturer instructions.

Result Validation:

• Confirm strong cytoplasmic staining in tumor cells for IHC; for FISH, verify split signals in ≥15% of nuclei using a fluorescence microscope.

• Document results using digital imaging to maintain a visual record of assay performance over time.


FAQ


Is this standard suitable for both IHC and FISH validation?

Yes. The preserved tissue architecture supports both IHC (protein-level detection) and FISH (genetic-level confirmation) workflows.

How does it handle different fixative times?

It is validated for specimens fixed in 10% formalin for 6-48 hours, reflecting the range of fixation times encountered in clinical practice .

Can it be used to train new laboratory staff?

Absolutely. Its consistent staining pattern makes it ideal for training personnel in identifying NTRK-positive tumors and distinguishing true positives from background staining.

What is the recommended storage temperature for unused slides?

Store unopened slides at -20°C for maximum stability; once opened, keep at 4°C and use within 6 weeks .


NTRK Positive FFPE Microscope Slide Reference Standard

General information

Name

NTRK Positive FFPE Microscope Slide Standard

Cat. No.

CBPN0017

Format

FFPE Microscope Slide

Size

4μm/section

Intended Use

Research Use Only

Buffer

Tris-EDTA

Storage Conditions

-25~-15℃

Expiry

36 months from the date of manufacture


Technical Data

Slice thickness

4μm


IHC staining results

NTRK Positive FFPE Microscope Slide Standard CBPN0017

Related Products List

Name

Catalog No.

Details

NTRK Positive FFPE Block Reference Standard

CBPN0018

NTRK Positive FFPE Block Reference Standard



Experimental Procedure

CB-Gene Bio chose NTRK as the research object and launched two standard products: FFPE Block and FFPE Microscope Slide.



General Information

Name

NTRK Positive FFPE Microscope Slide Standard

Cat. No.

CBPN0017

Format

FFPE Microscope Slide

Size

4μm/section

Intended Use

Research Use Only

Buffer

Tris-EDTA

Storage Conditions

-25~-15℃

Expiry

36 months from the date of manufacture



IHC Staining Results


NTRK Positive FFPE Microscope Slide Standard CBPN0017


Related Products List

Name

Catalog No.

Details

NTRK Positive FFPE Block Reference Standard

CBPN0018

NTRK Positive FFPE Block Reference Standard


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