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CBPN0017
CBPN0017
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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.
• 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 .
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.
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 .
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
Related Products List
Name | Catalog No. | Details |
NTRK Positive FFPE Block Reference Standard | CBPN0018 |
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.
• 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 .
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.
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 .
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
Related Products List
Name | Catalog No. | Details |
NTRK Positive FFPE Block Reference Standard | CBPN0018 |
Experimental Procedure
CB-Gene Bio chose NTRK as the research object and launched two standard products: FFPE Block and FFPE Microscope Slide.
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 |
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
IHC Staining Results
Related Products List
Name | Catalog No. | Details |
NTRK Positive FFPE Block Reference Standard | CBPN0018 |
Related Products List
Name | Catalog No. | Details |
NTRK Positive FFPE Block Reference Standard | CBPN0018 |