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Introduction
CLDN18.2 (Claudin 18.2) is a key member of the tight junction protein Claudin family, specifically expressed on the cell membrane surface. Under normal physiological conditions, CLDN18.2 expression is confined to differentiated gastric mucosal epithelial cells. However, in various malignant tumors such as gastric cancer, esophageal cancer, and pancreatic cancer, CLDN18.2 exhibits abnormal overexpression. This expression is not only present in primary tumor lesions but also significantly expressed in metastatic sites, making it a highly promising pan-tumor biomarker and a popular therapeutic target.
Immunohistochemistry (IHC) is the established method for detecting CLDN18.2 in research and clinical settings. However, the accuracy, reproducibility, and standardization of detection results directly impact the reliability of targeted drug development, patient selection, and efficacy evaluation. To meet this, we introduce our CLDN18.2 Mixed Positive FFPE Block Reference Standard, specifically designed for IHC experiments. Prepared under strict standardized protocols, this product integrates cells exhibiting varying expression levels. Serves as a stable, consistent positive control and quality assurance tool for laboratories, ensuring the authenticity and reliability of your CLDN18.2 detection data.
Product Features
Our product is meticulously designed and rigorously quality-controlled, featuring the following core characteristics:
1.Clear Expression Gradient: The product employs a unique cellular mixture formulation to mimic the heterogeneity found in real tissues. It contains cell populations exhibiting low (~ 20%), medium (~40%), and high (~40%). This gradient enables users to simultaneously evaluate a detection system's ability to recognize different expression levels on a single slide, optimize experimental conditions, and establish objective interpretation thresholds.
2.Standardized Preparation Process: Paraffin blocks are strictly controlled to a thickness of 4 mm, meeting standard sectioning requirements to ensure optimal morphological structure and antigen integrity. All preparation procedures are standardized to minimize batch-to-batch variability.
3.Rigorous Quality Control Process: Each batch of reference standards undergoes strict IHC staining detection to ensure the stability and specificity of CLDN18.2 antigen expression. We provide clear staining reference images as a benchmark for user experimental results.
4.Guaranteed Stability & Shelf Life: With a 36-month shelf life under recommended storage conditions (-25°C to -15°C). This ensures no performance degradation occurs within the validity period, facilitating long-term laboratory use and comparative analysis.
Product Advantages
Selecting our CLDN18.2 Mixed Positive FFPE Block Reference Standard will provide significant advantages for your R&D and QC work:
1.Enhance experimental reproducibility: By consistently using this reference standard in each batch of experiments, the stability of the staining process can be effectively monitored. Enables timely detection of deviations in reagents, equipment, or operational procedures, ensuring comparability of results both within a single laboratory and across different laboratories.
2.Simplified Workflow: Ready-to-use paraffin blocks as standard samples undergo dehydration, embedding, sectioning, and staining alongside test samples from the same batch. This streamlined process seamlessly integrates into existing IHC experimental procedures.
3.Assisting Result Interpretation and Standardization: Clear gradients of low, medium, and high expression, provide pathologists with an intuitive reference, facilitating the establishment and standardization of scoring criteria (e.g., H-Score, percentage of positive cells) and reducing subjective variation.
4.Accelerate R&D and Verification Processes: In antibody performance validation, laboratory-developed test (LDT) methodology development, and platform comparison studies, this product enables rapid assessment of a test system's sensitivity, specificity, and linear range, significantly enhancing R&D efficiency.
5.Ensuring Research Data Reliability: Providing high-quality quality control support for CLDN18.2-based targeted drug development, companion diagnostic development, and translational medical research to solidify the data foundation.
Primary Applications
This product is “Research Use Only” and is primarily intended for the following applications:
*Immunohistochemistry (IHC) Laboratory Internal QC: Serves as a positive control for daily, weekly, or per-batch experiments.
*CLDN18.2 Antibody Performance Validation and Comparison: Evaluate staining efficacy across different clonal numbers and antibody batches.
*Assay Development and Optimization: Assist in determining optimal primary antibody dilution, incubation time, antigen retrieval conditions, etc.
*Interlaboratory Comparison and Standardization: Serve as a common reference to harmonize testing standards across multicenter studies.
*Pathologist and Technician Training: Provide examples of typical expression profiles for interpretation training and assessment.
Why Choose Us
1.Expertise and Focus: We specialize in standardizing tumor biomarker detection, with deep insight into CLDN18.2's value in precision medicine and its testing key points.
2.Scientific Design: Our industry-innovative gradient-blended design concept better reflects the heterogeneity of real tumor microenvironments, providing multidimensional quality control information.
3.Reliable Quality: From cell sources to finished products, we implement rigorous end-to-end quality control to ensure stable and reliable product performance.
4.Professional Service: We not only offer high-quality products but also provide professional technical consultation and application support.
5.Customer Trust: Our products are adopted by numerous renowned R&D institutions, pharmaceutical companies, and medical laboratories, establishing us as a trusted partner.
Q&A
Which cell line is used in this reference standard? Has the CLDN18.2 expression status been validated?
We employ cell lines that have been comprehensively authenticated and demonstrate stable CLDN18.2 expression profiles for the preparation process. Prior to pooling, all cells are subjected to multiple validations using authoritative IHC methods to guarantee the accuracy of their low, medium, and high expression levels, and verification data are provided for reference.
How should paraffin blocks be sectioned and used for the best results?
It is recommended to use standard methods for continuous sectioning, with a thickness of 3-5 μm being optimal. During each staining procedure, place sections of the standard material alongside sections of the test tissue on the same slide or within the same batch to ensure identical processing conditions. Any paraffin blocks that remain unused after opening should be resealed and promptly returned to the recommended storage temperature.
In addition to IHC, can this reference material be used for other detection platforms (such as immunofluorescence IF)?
This product has been predominantly optimized and validated for IHC experiments. Therefore, we predominantly recommend its utilization for IHC quality control. Nevertheless, in theory, it can also be tried on other antigen - antibody reaction - based platforms, such as IF, given that the experimental workflow includes the processing of paraffin - embedded samples (e.g., dewaxing, antigen retrieval). The user is required to verify its performance.
Can you provide custom services for specific expression ratios (e.g., 100% high expression)?
We acknowledge that cutting - edge research frequently necessitates customized tools. In addition to our standard multiplex blocks, we offer comprehensive custom services. Our professionals are capable of engineering paraffin blocks or tissue microarrays (TMAs) with precisely specified CLDN18.2 expression levels, including single - level controls, to fulfill your distinctive study design and validation requirements.
What precautions should be taken for product transportation and storage?
The product is shipped at low temperatures using insulated packaging. Upon receipt, inspect immediately and store in a freezer at -25°C to -15°C, avoiding repeated freeze-thaw cycles. Use within the expiration date to ensure optimal performance.
Introduction
CLDN18.2 (Claudin 18.2) is a key member of the tight junction protein Claudin family, specifically expressed on the cell membrane surface. Under normal physiological conditions, CLDN18.2 expression is confined to differentiated gastric mucosal epithelial cells. However, in various malignant tumors such as gastric cancer, esophageal cancer, and pancreatic cancer, CLDN18.2 exhibits abnormal overexpression. This expression is not only present in primary tumor lesions but also significantly expressed in metastatic sites, making it a highly promising pan-tumor biomarker and a popular therapeutic target.
Immunohistochemistry (IHC) is the established method for detecting CLDN18.2 in research and clinical settings. However, the accuracy, reproducibility, and standardization of detection results directly impact the reliability of targeted drug development, patient selection, and efficacy evaluation. To meet this, we introduce our CLDN18.2 Mixed Positive FFPE Block Reference Standard, specifically designed for IHC experiments. Prepared under strict standardized protocols, this product integrates cells exhibiting varying expression levels. Serves as a stable, consistent positive control and quality assurance tool for laboratories, ensuring the authenticity and reliability of your CLDN18.2 detection data.
Product Features
Our product is meticulously designed and rigorously quality-controlled, featuring the following core characteristics:
1.Clear Expression Gradient: The product employs a unique cellular mixture formulation to mimic the heterogeneity found in real tissues. It contains cell populations exhibiting low (~ 20%), medium (~40%), and high (~40%). This gradient enables users to simultaneously evaluate a detection system's ability to recognize different expression levels on a single slide, optimize experimental conditions, and establish objective interpretation thresholds.
2.Standardized Preparation Process: Paraffin blocks are strictly controlled to a thickness of 4 mm, meeting standard sectioning requirements to ensure optimal morphological structure and antigen integrity. All preparation procedures are standardized to minimize batch-to-batch variability.
3.Rigorous Quality Control Process: Each batch of reference standards undergoes strict IHC staining detection to ensure the stability and specificity of CLDN18.2 antigen expression. We provide clear staining reference images as a benchmark for user experimental results.
4.Guaranteed Stability & Shelf Life: With a 36-month shelf life under recommended storage conditions (-25°C to -15°C). This ensures no performance degradation occurs within the validity period, facilitating long-term laboratory use and comparative analysis.
Product Advantages
Selecting our CLDN18.2 Mixed Positive FFPE Block Reference Standard will provide significant advantages for your R&D and QC work:
1.Enhance experimental reproducibility: By consistently using this reference standard in each batch of experiments, the stability of the staining process can be effectively monitored. Enables timely detection of deviations in reagents, equipment, or operational procedures, ensuring comparability of results both within a single laboratory and across different laboratories.
2.Simplified Workflow: Ready-to-use paraffin blocks as standard samples undergo dehydration, embedding, sectioning, and staining alongside test samples from the same batch. This streamlined process seamlessly integrates into existing IHC experimental procedures.
3.Assisting Result Interpretation and Standardization: Clear gradients of low, medium, and high expression, provide pathologists with an intuitive reference, facilitating the establishment and standardization of scoring criteria (e.g., H-Score, percentage of positive cells) and reducing subjective variation.
4.Accelerate R&D and Verification Processes: In antibody performance validation, laboratory-developed test (LDT) methodology development, and platform comparison studies, this product enables rapid assessment of a test system's sensitivity, specificity, and linear range, significantly enhancing R&D efficiency.
5.Ensuring Research Data Reliability: Providing high-quality quality control support for CLDN18.2-based targeted drug development, companion diagnostic development, and translational medical research to solidify the data foundation.
Primary Applications
This product is “Research Use Only” and is primarily intended for the following applications:
*Immunohistochemistry (IHC) Laboratory Internal QC: Serves as a positive control for daily, weekly, or per-batch experiments.
*CLDN18.2 Antibody Performance Validation and Comparison: Evaluate staining efficacy across different clonal numbers and antibody batches.
*Assay Development and Optimization: Assist in determining optimal primary antibody dilution, incubation time, antigen retrieval conditions, etc.
*Interlaboratory Comparison and Standardization: Serve as a common reference to harmonize testing standards across multicenter studies.
*Pathologist and Technician Training: Provide examples of typical expression profiles for interpretation training and assessment.
Why Choose Us
1.Expertise and Focus: We specialize in standardizing tumor biomarker detection, with deep insight into CLDN18.2's value in precision medicine and its testing key points.
2.Scientific Design: Our industry-innovative gradient-blended design concept better reflects the heterogeneity of real tumor microenvironments, providing multidimensional quality control information.
3.Reliable Quality: From cell sources to finished products, we implement rigorous end-to-end quality control to ensure stable and reliable product performance.
4.Professional Service: We not only offer high-quality products but also provide professional technical consultation and application support.
5.Customer Trust: Our products are adopted by numerous renowned R&D institutions, pharmaceutical companies, and medical laboratories, establishing us as a trusted partner.
Q&A
Which cell line is used in this reference standard? Has the CLDN18.2 expression status been validated?
We employ cell lines that have been comprehensively authenticated and demonstrate stable CLDN18.2 expression profiles for the preparation process. Prior to pooling, all cells are subjected to multiple validations using authoritative IHC methods to guarantee the accuracy of their low, medium, and high expression levels, and verification data are provided for reference.
How should paraffin blocks be sectioned and used for the best results?
It is recommended to use standard methods for continuous sectioning, with a thickness of 3-5 μm being optimal. During each staining procedure, place sections of the standard material alongside sections of the test tissue on the same slide or within the same batch to ensure identical processing conditions. Any paraffin blocks that remain unused after opening should be resealed and promptly returned to the recommended storage temperature.
In addition to IHC, can this reference material be used for other detection platforms (such as immunofluorescence IF)?
This product has been predominantly optimized and validated for IHC experiments. Therefore, we predominantly recommend its utilization for IHC quality control. Nevertheless, in theory, it can also be tried on other antigen - antibody reaction - based platforms, such as IF, given that the experimental workflow includes the processing of paraffin - embedded samples (e.g., dewaxing, antigen retrieval). The user is required to verify its performance.
Can you provide custom services for specific expression ratios (e.g., 100% high expression)?
We acknowledge that cutting - edge research frequently necessitates customized tools. In addition to our standard multiplex blocks, we offer comprehensive custom services. Our professionals are capable of engineering paraffin blocks or tissue microarrays (TMAs) with precisely specified CLDN18.2 expression levels, including single - level controls, to fulfill your distinctive study design and validation requirements.
What precautions should be taken for product transportation and storage?
The product is shipped at low temperatures using insulated packaging. Upon receipt, inspect immediately and store in a freezer at -25°C to -15°C, avoiding repeated freeze-thaw cycles. Use within the expiration date to ensure optimal performance.
