体外诊断(IVD)产品有巨大的市场需求,随着质量管理的不断深入,临床实验室对检测系统的要求逐渐成熟,试剂产品的性能,如精密度、可报告范围/测量范围、检测极限参数、校准要求与溯源性、参考区间等直接反映了IVD产品的质量,国内IVD生产者应注重产品的综合性能,才能有效提升产品的市场竞争力。 In vitro diagnostic (IVD) products have huge market demand. With the continuous deepening of quality management, clinical laboratory testing system requirements gradually mature, reagent product performance, such as precision, reportable range / measurement range, detection limit parameters , Calibration requirements and traceability, reference interval directly reflects the quality of IVD products, domestic IVD producers should pay attention to the comprehensive performance of products in order to effectively enhance the market competitiveness of products.