Quality control and out-of-control issues in HER2 gene fluorescence in situ hybridization detection
ZHANG Honglan
YANG Congying
ZHANG Chunfang
LIU Yi
DONG Yanbin
SONG Dong
Abstract：Objective: To explore the quality control and countermeasures for out-of-control issues in fluorescence in situ hybridization (FISH) detection of HER2 gene in breast cancer and gastric cancer, thereby improving the controllability, accuracy, and economy of FISH technology. Methods: Based on existing diagnostic consensus and guidelines for FISH detection of HER2 gene in breast and gastric cancers, this study analyzed the key points of quality control and specific operating methods at each step of FISH detection, proposed precautions for personnel configuration, operating environment, and reagent procurement, and detailed some out-of-control issues with corresponding countermeasures. Results: This laboratory systematically sorted out all aspects of HER2 gene FISH detection and formulated a detailed, standardized, and highly operational SOP, avoiding operational pitfalls. Conclusion: By developing a practical and executable quality control plan, the controllability and accuracy of HER2 gene FISH detection in breast and gastric cancers in our laboratory were improved, reducing inter-laboratory differences and experimental repetition rates, and providing more accurate basis for anti-HER2 targeted therapy in breast and gastric cancers.
Keywords：Fluorescence in situ hybridizationQuality managementQuality controlBreast cancerGastric cancerHER2 gene
Publication Date：2025-09-28
Online Publishing Date：2025-11-13(First online date of this platform, not the publication date of the document)
Pages：3( 1199-1201 )