What are the applications and quality control strategies of CD117 antibody in immunohistochemical detection?

I. What are the biological characteristics and clinical significance of CD117?

CD117 is a type III tyrosine kinase receptor encoded by the c-kit proto-oncogene. As a transmembrane protein for stem cell factor, it widely participates in the regulation of cell proliferation and differentiation. In normal tissues, it is expressed in mast cells, melanocytes, and gastrointestinal interstitial cells of Cajal, showing a co-localization staining pattern on cell membranes and cytoplasm. Additionally, some epithelial cells (such as breast, renal tubules, and thyroid follicular cells) may show weak cytoplasmic positive reactions.

In pathological diagnosis, CD117 is a specific marker for gastrointestinal stromal tumors (GIST) and is also expressed in some testicular germ cell tumors. Its immunohistochemical detection results are of critical guidance value for tumor classification, treatment selection, and prognosis assessment.

II. What are the standardized requirements for CD117 immunohistochemical detection?

To ensure the accuracy and reproducibility of CD117 detection results, the following standardization principles should be followed:

- Reagent compliance: CD117 antibody reagents approved by the national drug regulatory authorities should be selected to ensure their analytical performance meets clinical testing requirements.

- Combined antibody application: It is recommended to use CD117 in combination with DOG1, CD34, and other antibodies to improve the specificity and sensitivity of GIST diagnosis.

• Standardized control settings: Positive and negative controls should be set for each detection to monitor the stability of the staining process and reagent effectiveness
• III. What is the value of liquid cell control materials in CD117 detection?

Liquid cell control materials are a new type of immunohistochemical quality control material preserved in cell suspension form, with intact subcellular structures that can simulate the expression patterns of target proteins in real tissues. In CD117 detection, these control materials can exhibit the following typical staining characteristics:

- Positive control: 40%-60% of cells show moderate to strong complete membrane staining

- Negative control: All cells show no specific staining

Compared with traditional tissue controls, liquid cell control materials have significant advantages:

- Standardization guarantee: Ensures comparability of inter-laboratory quality assessment results and promotes standardization between laboratories

- Operational convenience: Direct drop-to-use simplifies the process and improves detection efficiency

- Sample accessibility: Solves the difficulty of obtaining rare positive tissues

- Comprehensive quality control: Supports quality control for each slide to ensure result reliability

- Technical compatibility: Particularly suitable for digital pathology and AI analysis, ensuring color reproduction and structural integrity

IV. How to establish a comprehensive CD117 detection quality control system?

A comprehensive quality control system should include the following key components:

- Routine internal quality control: Use liquid cell control materials as essential components of daily detection, setting positive and negative controls to continuously monitor reagent potency and process stability.

- Participation in external quality assessment: Actively participate in proficiency testing organized by authoritative institutions to ensure the accuracy and consistency of detection results through inter-laboratory comparisons.

- Multi-marker validation: Establish a combined detection scheme of CD117, DOG1, and CD34 for GIST diagnosis to improve diagnostic accuracy through multi-parameter analysis.

- Standardized operating procedures: Develop detailed standards for sample processing, antibody incubation, and result interpretation to ensure process controllability and result reproducibility.

V. What are the development trends of CD117 detection quality control?

With the increasing demand for precision medicine, CD117 detection quality control is developing in the following directions:

- Innovation in control materials: New liquid cell control materials will gradually replace traditional tissue blocks, achieving more efficient standardized quality control.

- Integration with artificial intelligence: Digital pathology images based on standardized quality control will promote the development and application of AI-assisted diagnostic systems.

- Multi-omics integration: CD117 detection will combine with gene sequencing, proteomics, and other technologies to provide more comprehensive information for tumor precise typing.

- Systematization of quality control: Establish a full-process quality control system from sample collection to report issuance to ensure the clinical reliability of detection results.

By establishing a comprehensive quality control system and adopting advanced quality control methods, CD117 immunohistochemical detection will play a more important role in tumor diagnosis and treatment monitoring, providing more reliable decision-making basis for clinical practice.

VI. Which manufacturers provide CD117 antibodies?

Hangzhou Start Biotech Co., Ltd. independently developed the "S-RMab® CD117 Recombinant Rabbit Monoclonal Antibody" (product name: S-RMab® CD117 Recombinant Rabbit mAb (SDT-125-51), catalog number: S0B2084), which is a high-specificity, excellent sensitivity, and outstanding staining consistency antibody for stem cell factor receptor detection. This product was developed using the proprietary S-RMab® recombinant rabbit monoclonal antibody technology platform and has been strictly validated on various technical platforms such as immunohistochemistry (IHC). It has key application value in GIST diagnosis, mast cell disease identification, and stem cell function research.

Professional technical support: We provide detailed product technical materials, including complete IHC experimental procedures, optimized antigen retrieval solutions, and professional interpretation guidance, fully assisting customers in obtaining accurate and reliable results in soft tissue tumor and hematopathology diagnosis.

Hangzhou Start Biotech Co., Ltd. is always committed to providing high-quality, high-value biological reagents and solutions for global innovative pharmaceutical companies and research institutions. For more details about the "S-RMab® CD117 Recombinant Rabbit Monoclonal Antibody" (catalog number S0B2084) or to request sample testing, please feel free to contact us.

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