- Home
- Products
- Services
- Resources
- About Us
- News
- Contact
The 2-in-1 ALK FFPE Slide IHC Reference Standard is a breakthrough tool designed to standardize anaplastic lymphoma kinase (ALK) detection in formalin-fixed paraffin-embedded (FFPE) tissues, a critical step in guiding targeted therapy decisions for non-small cell lung cancer (NSCLC) and inflammatory myofibroblastic tumors. This reference standard integrates two key components: FFPE-preserved human tissue matrices with naturally occurring ALK rearrangements and synthetic peptide-coated beads (8-µm diameter) covalently bound to ALK antigens. This dual design mimics real clinical specimens while providing consistent antigen expression levels, addressing the variability in staining intensity and interpretation that plagues conventional tissue controls.
Certified under ISO 13485 standards, the product ensures reliable performance across different immunohistochemistry (IHC) platforms. Its development aligns with guidelines from leading oncology organizations, which recommend ALK testing as a first-line diagnostic step for NSCLC patients. By bridging the gap between laboratory practice and clinical requirements, this reference standard enables laboratories to validate their ALK IHC workflows with confidence.
• Dual-Matrix Design: Combines native FFPE tissue and synthetic antigen beads to simulate both physiological antigen distribution and controlled staining intensity, ensuring ≥99.5% concordance with gold-standard FISH testing.
• Stability Optimization: Maintains antigen integrity for up to 36 months when stored at -20°C, with minimal degradation even after 50 freeze-thaw cycles. For short-term use, refrigeration at 4°C is recommended for up to 6 weeks post-opening .
• Sensitivity Verification: Detects subtle aberrations in antigen retrieval protocols, such as suboptimal temperatures or duration, which are common sources of false-negative results in clinical settings .
• Cross-Platform Compatibility: Validated for use with all major ALK IHC antibodies, including clone D5F3, ensuring consistent performance regardless of reagent brand.
Pre-Analytical Preparation:
• Allow slides to equilibrate to room temperature (22°C) for 30 minutes before use to prevent condensation artifacts.
• Deparaffinize using standard xylene or xylene-free alternatives, followed by ethanol rehydration as per laboratory protocols.
Immunostaining Integration:
• Include the reference standard in every IHC run as both positive and negative control (via non-ALK antigen beads).
• Follow manufacturer-recommended antigen retrieval conditions (typically 95°C in citrate buffer, pH 6.0, for 20 minutes).
Quality Control Checks:
• Evaluate staining intensity of ALK-positive beads using a semi-quantitative scale (0-3+). A score of ≥2+ confirms valid assay performance.
• Document results using the included digital scoring template to maintain audit trails for regulatory compliance.
How does this standard differ from traditional tissue controls?
Unlike variable human tissue controls, the synthetic bead component provides batch-to-batch consistency, reducing inter-laboratory variability by 40% compared to conventional methods .
Can it be used for antibody titration?
Yes. The gradient antigen density on beads allows optimization of primary antibody dilution, with optimal results typically observed between 1:50 and 1:200 for most clones.
What is the impact of fixative type on performance?
Only 10% neutral buffered formalin is recommended, as alternative fixatives may alter antigen conformation, leading to discordant results .
How should stained slides be stored post-assay?
Mount with glycerol-based medium and store at 4°C in the dark to preserve staining intensity for up to 6 months.
General information
Name | ALK Positive Negative 2 in 1 FFPE Microscope Slide Reference Standard |
Cat. No. | CBPN0021 |
Format | FFPE Microscope Slide |
Size | 5μm/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 | 5μm |
IHC staining results
Related Products List
Name | Catalog No. | Details |
ALK Positive Negative 2 in 1 FFPE Block Reference Standard | CBPN0022 |
The 2-in-1 ALK FFPE Slide IHC Reference Standard is a breakthrough tool designed to standardize anaplastic lymphoma kinase (ALK) detection in formalin-fixed paraffin-embedded (FFPE) tissues, a critical step in guiding targeted therapy decisions for non-small cell lung cancer (NSCLC) and inflammatory myofibroblastic tumors. This reference standard integrates two key components: FFPE-preserved human tissue matrices with naturally occurring ALK rearrangements and synthetic peptide-coated beads (8-µm diameter) covalently bound to ALK antigens. This dual design mimics real clinical specimens while providing consistent antigen expression levels, addressing the variability in staining intensity and interpretation that plagues conventional tissue controls.
Certified under ISO 13485 standards, the product ensures reliable performance across different immunohistochemistry (IHC) platforms. Its development aligns with guidelines from leading oncology organizations, which recommend ALK testing as a first-line diagnostic step for NSCLC patients. By bridging the gap between laboratory practice and clinical requirements, this reference standard enables laboratories to validate their ALK IHC workflows with confidence.
• Dual-Matrix Design: Combines native FFPE tissue and synthetic antigen beads to simulate both physiological antigen distribution and controlled staining intensity, ensuring ≥99.5% concordance with gold-standard FISH testing.
• Stability Optimization: Maintains antigen integrity for up to 36 months when stored at -20°C, with minimal degradation even after 50 freeze-thaw cycles. For short-term use, refrigeration at 4°C is recommended for up to 6 weeks post-opening .
• Sensitivity Verification: Detects subtle aberrations in antigen retrieval protocols, such as suboptimal temperatures or duration, which are common sources of false-negative results in clinical settings .
• Cross-Platform Compatibility: Validated for use with all major ALK IHC antibodies, including clone D5F3, ensuring consistent performance regardless of reagent brand.
Pre-Analytical Preparation:
• Allow slides to equilibrate to room temperature (22°C) for 30 minutes before use to prevent condensation artifacts.
• Deparaffinize using standard xylene or xylene-free alternatives, followed by ethanol rehydration as per laboratory protocols.
Immunostaining Integration:
• Include the reference standard in every IHC run as both positive and negative control (via non-ALK antigen beads).
• Follow manufacturer-recommended antigen retrieval conditions (typically 95°C in citrate buffer, pH 6.0, for 20 minutes).
Quality Control Checks:
• Evaluate staining intensity of ALK-positive beads using a semi-quantitative scale (0-3+). A score of ≥2+ confirms valid assay performance.
• Document results using the included digital scoring template to maintain audit trails for regulatory compliance.
How does this standard differ from traditional tissue controls?
Unlike variable human tissue controls, the synthetic bead component provides batch-to-batch consistency, reducing inter-laboratory variability by 40% compared to conventional methods .
Can it be used for antibody titration?
Yes. The gradient antigen density on beads allows optimization of primary antibody dilution, with optimal results typically observed between 1:50 and 1:200 for most clones.
What is the impact of fixative type on performance?
Only 10% neutral buffered formalin is recommended, as alternative fixatives may alter antigen conformation, leading to discordant results .
How should stained slides be stored post-assay?
Mount with glycerol-based medium and store at 4°C in the dark to preserve staining intensity for up to 6 months.
General information
Name | ALK Positive Negative 2 in 1 FFPE Microscope Slide Reference Standard |
Cat. No. | CBPN0021 |
Format | FFPE Microscope Slide |
Size | 5μm/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 | 5μm |
IHC staining results
Related Products List
Name | Catalog No. | Details |
ALK Positive Negative 2 in 1 FFPE Block Reference Standard | CBPN0022 |
