| 注重IVD产品综合性能，提升国产体外诊断试剂的市场竞争力 |
| |
| 引用本文： | 郭健.注重IVD产品综合性能，提升国产体外诊断试剂的市场竞争力[J].中国医疗器械信息,2009,15(10):4-6. |
| |
| 作者姓名： | 郭健 |
| |
| 作者单位： | 卫生部北京医院,北京,100730 |
| |
| 摘 要： | IVD产品有具大的市场需求，随着质量管理不断深入，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。
|
| 关 键 词： | IVD产品 诊断试剂 性能参数 |
Improving the Quality and Competition of the Local Made IVD Reagent Products in Chinese Market |
| |
| Jian Guo.Improving the Quality and Competition of the Local Made IVD Reagent Products in Chinese Market[J].China Medical Devices Information,2009,15(10):4-6. |
| |
| Authors: | Jian Guo |
| |
| Institution: | Jian Guo (Beijing Hospital (Beijing 100730)) |
| |
| Abstract: | There is large market for IVD products in China. As the quality management are developed rapidly, the requirements on the measurement system are much more popular for clinical laboratories. The important characteristics of a measurement system are including precision, measurement or reportable range, limit of detection, calibration and traceability, reference interval, et al. The local manufactures should pay an attention to the characteristics of IVD products in order to improving the competition of the local products in the markets. |
| |
| Keywords: | IVD diagnostic reagents characteristics |
| 本文献已被 维普 万方数据 等数据库收录！ |
