| 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,(5):495-500 |
| 泌乳素测定试剂盒行业标准的验证 |
| Validation of Industry Standard for Prolactin Assay Kits |
| 投稿时间：2016-10-23 |
| DOI：10.16153/j.1002-7777.2017.05.006 |
| 中文关键词: 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 |
| 英文关键词: prolactin kit chemiluminescent assay electrochemiluminescent assay magnetic particle enzyme linked immunosorbent assay industry standard validation |
| 基金项目: |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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