医疗机构实验室自制体外诊断试剂质量评价体系建立的探讨

目的：为医疗机构建立和运行与开展自制诊断试剂研究项目相适应的质量评价体系提供参考，为监管部门提供科学监管的方法工具，从而更好地提高患者生命和健康质量。方法：通过梳理新版《医疗器械监督管理条例》及体外诊断试剂产品监管的法规要求，结合自制诊断试剂的特点和应用现状，探讨自制诊断试剂质量评价体系的建立和运行及生产体系质量管理关键要点，分析存在的监管问题，并提出针对性建议。结果与结论：自制诊断试剂是典型的集设计开发、生产转化、临床应用于一体的体外诊断试剂产品。质量评价体系的建立和运行是自制诊断试剂产品质量稳定的有力保证，建立原材料质量评价标准，是研制单位和使用单位对自制诊断试剂实施质量监控和评价的有效手段。目前其监管存在法规要求不明确、临床应用风险高、临床性能验证难度大、质量评价体系不完善以及生产体系质量控制经验不足等问题。建议明确自制诊断试剂的界定；探索自制诊断试剂准入监管模式，开展质量评价标准化体系研究，促进临床转化；加强质量管理，提出明确的原材料质控要求和成品及留样质控要求。建立科学、 规范的自制诊断试剂质量评价体系是科学监管的需要，是激发产学研检用协同创新的有效探索，有助于促进医学检验的发展。

Discussion on the Establishment of Quality Evaluation System for Self-made in vitro Diagnostic Reagents in Laboratory of Medical Institutions

Objective: To provide guidance for medical institutions to establish and run a quality evaluation system that is compatible with the self-made diagnostic reagents research project, and provide scientific supervision methods and tools for the regulatory authorities so as to better improve the quality of life and health of patients. Methods: The key points for the establishment and operation of the quality evaluation system of selfmade diagnostic reagents were discussed, supervision problems were analyzed, and specific suggestions were proposed by sorting out the new version of the Regulations for the Supervision and Administration of Medical Devices and the regulatory requirements of in vitro diagnostic reagents products, combined with the characteristics and application status of self-made diagnostic reagents. Results and Conclusion: The self-made diagnostic reagent is a typical in vitro diagnostic reagent product that integrates design and development, production transformation, and clinical application. The establishment and operation of the quality evaluation system is a strong guarantee for the stable quality of self-made diagnostic reagents, and establishing quality evaluation criteria for raw materials is an eff ective means for R&D institutions as well as users to implement quality supervision and evaluation of self-made diagnostic reagents. At present, there are many problems as unclear regulatory requirements for supervision, high risks in clinical application, great difficulty in the verification of clinical performance, imperfect quality evaluation system, and poor experience in quality control of production system. It is suggested to clearly defi ne the self-made diagnostic reagent; explore the admittance supervision mode of selfmade diagnostic reagents, carry out the research of quality evaluation system, and promote clinical transformation; enhance quality management, and propose explicit quality control requirements of raw materials as well as that of fi nished products and retained samples. The establishment of a scientifi c and standardized quality evaluation system for self-made diagnostic reagents is necessary for scientifi c supervision and an eff ective exploration to stimulate collaborative innovation among industry, education, research, inspection, and application, and helps promote the development of medical testing.