| 泌乳素测定试剂盒行业标准的验证 |
| |
| 引用本文： | 于婷,黄杰,曲守方.泌乳素测定试剂盒行业标准的验证[J].中国药事,2017,31(5):495-500. |
| |
| 作者姓名： | 于婷 黄杰 曲守方 |
| |
| 作者单位： | 中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050 |
| |
| 摘 要： | 目的：对泌乳素测定试剂盒的行业标准进行验证。方法：选择化学发光法、电化学发光法、磁微粒酶联免疫法等10家泌乳素试剂盒，按照拟定的行业标准，对外观、空白限、线性、准确度、精密度、特异性和稳定性项目进行验证。结果：除个别试剂不满足准确度要求外，其余试剂均能满足拟定行业标准中的要求。结论：泌乳素测定试剂盒行业标准制定合理、可操作性强。
|
| 关 键 词： | 泌乳素 试剂盒 化学发光法 电化学发光法 磁微粒酶联免疫法 行业标准 验证 |
| 收稿时间： | 2016/10/23 0:00:00 |
Validation of Industry Standard for Prolactin Assay Kits |
| |
| Yu Ting,Huang Jie and Qu Shoufang.Validation of Industry Standard for Prolactin Assay Kits[J].Chinese Pharmaceutical Affairs,2017,31(5):495-500. |
| |
| Authors: | Yu Ting Huang Jie and Qu Shoufang |
| |
| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China |
| |
| Abstract: | Objective: To validate the industry standard for the prolactin assay kits. Methods: Based on different methods, such as chemiluminescent assay, electrochemiluminescent assay and magnetic particle enzyme linked immunosorbent assay ten prolactin assay kits were selected. The appearance, blank limit, linearity, accuracy, precision, specificity and stability were validated according to the proposed industry standard. Results: Except for few kits that couldn''t meet the accuracy requirement, others could meet all the requirements of the proposed industry standard. Conclusion: The industry standard for prolactin assay kit is reasonable and operable. |
| |
| Keywords: | prolactin kit chemiluminescent assay electrochemiluminescent assay magnetic particle enzyme linked immunosorbent assay industry standard validation |
|
| 点击此处可从《中国药事》浏览原始摘要信息 |
| 点击此处可从《中国药事》下载免费的PDF全文 |
|
