Objective:To develop genetic testing quality control material which has good biological compatibility that can simulate the real sample properties.Methods:Study of the quality control material. The quality control matertial was prepared by embedding the cells and DNA containing specific gene mutations in a biological matrix formed by cross-linking γ-polyglutamic acid and gelatin, followed by formalin fixation and paraffin embedding. Fourier infrared spectroscopy and scanning electron microscopy were used to analyze the morphology and structure of the quality control material. The repeatability and homogeneity were verified by detecting the DNA extraction amount and mutation frequency at different parts of the quality control material. The quality control material was stored at 25 ℃ for 16 weeks, and the stability was verified by detecting the DNA extraction amount, mutation frequency and DNA fragment distribution.Results:The results of Fourier infrared spectroscopy and scanning electron microscopy analysis indicated that the quality control material prepared in this study was formed by cross-linking and had a dense three-dimensional framework structure. The amount of DNA extraction and mutation frequency from different parts of the quality control material varied within a small range ( CV<10%). After storage at 25 ℃ for 16 weeks, the DNA extraction amount and mutation frequency of the quality control material varied within a small range ( CV<5%), and the distribution range of the DNA fragments did not show significant change compared to the day of preparation of the quality control material. Conclusion:This study successfully prepared a genetic testing quality control material based on cross-linked biological matrix, which exhibited good repeatability, homogeneity and stability.

Objective:To develop genetic testing quality control material which has good biological compatibility that can simulate the real sample properties.Methods:Study of the quality control material. The quality control matertial was prepared by embedding the cells and DNA containing specific gene mutations in a biological matrix formed by cross-linking γ-polyglutamic acid and gelatin, followed by formalin fixation and paraffin embedding. Fourier infrared spectroscopy and scanning electron microscopy were used to analyze the morphology and structure of the quality control material. The repeatability and homogeneity were verified by detecting the DNA extraction amount and mutation frequency at different parts of the quality control material. The quality control material was stored at 25 ℃ for 16 weeks, and the stability was verified by detecting the DNA extraction amount, mutation frequency and DNA fragment distribution.Results:The results of Fourier infrared spectroscopy and scanning electron microscopy analysis indicated that the quality control material prepared in this study was formed by cross-linking and had a dense three-dimensional framework structure. The amount of DNA extraction and mutation frequency from different parts of the quality control material varied within a small range ( CV<10%). After storage at 25 ℃ for 16 weeks, the DNA extraction amount and mutation frequency of the quality control material varied within a small range ( CV<5%), and the distribution range of the DNA fragments did not show significant change compared to the day of preparation of the quality control material. Conclusion:This study successfully prepared a genetic testing quality control material based on cross-linked biological matrix, which exhibited good repeatability, homogeneity and stability.